An observational study in Rheumatoid Arthritis, sponsored by Pfizer. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-09.
Sponsored by Pfizer · Observational
To address the objectives, a retrospective cohort design will be employed to evaluate patient characteristics, treatment patterns, medication effectiveness, and health care cost and utilization in RA patients newly initiating tofacitinib in combination with oral methotrexate (MTX)
2,962 studies on the registry are indexed under Arthritis, Rheumatoid; 396 are open to participants now.
This study's enrollment of 479 is above the median of 176 across 854 observational studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.
Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
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Individuals who are privately insured and with Medicare Supplemental insurance
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Exclusion Criteria:
Compare treatment patterns including dosing, concomitant medication use, adherence, persistence, and switching among tofacitinb+MTX patients who withdraw MTX vs. persist with MTX or experience interrupted MTX
Number of Participants as Per Type of Insurance Plan
Number of participants covered by type of insurance is reported. There were two types of insurance: 1) a private insurance plan, that is, one purchased by the participants, commercially available; 2) employer-provided insurance plan, that is, the participant's employer provided the insurance.
Time frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Number of Participants in Each Geographic Region
Number of participants enrolled in the study per geographic region of the United States (northeast; north central; south; west; unknown) is reported.
Time frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Number of Participants With Biologic Disease Modifying Antirheumatic Drug (bDMARD) Use During Pre-Index Period
Number of Participants with use of at least one bDMARD during pre-index period is reported. The bDMARD could have been any tumor-necrosis factor-alpha inhibitors (TNFi), any non-TNFi, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, anakinra, abatacept, tocilizumab or rituximab.
Time frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Number of Participants With Biologic Disease Modifying Antirheumatic Drug (bDMARD) Use During Variable Length Pre-Index Period
Number of Participants with use of at least one bDMARD during variable length pre-index period is reported. The bDMARD could have been any TNFi, any non-TNFi, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, anakinra, abatacept, tocilizumab or rituximab. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant, could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.
Time frame: During variable length pre-index period (1 year before the index date up to 5.2 years)
Mean Number of Biologic Disease Modifying Antirheumatic Drug (bDMARD) Received During Pre-Index Period
Mean number of bDMARD received during pre-index period is reported. The bDMARD could have been any TNFi, any non-TNFi, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, anakinra, abatacept, tocilizumab or rituximab.
Time frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Mean Number of Biologic Disease Modifying Antirheumatic Drug (bDMARD) Received During Variable Length Pre-Index Period
Mean number of bDMARD received during variable length pre-index period is reported. The bDMARD could have been any TNFi, any non-TNFi, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, anakinra, abatacept, tocilizumab or rituximab. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.
Time frame: During variable length pre-index period (1 year before the index date up to 5.2 years)
Number of Participants With Non-biologic Disease Modifying Antirheumatic Drug (NB-DMARD) Use During Pre-Index Period
Number of Participants with NB-DMARD use during pre-index period is reported. The NB-DMARD could have been hydroxychloroquine, MTX oral, leflunomide, sulfasalazine, chloroquine, cyclosporine, thalidomide, azathioprine, cyclophosphamide, auranofin, aurothioglucose, gold sodium thiomalate, penicillamine, tacrolimus or minocycline.
Time frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Number of Participants With Non-Biologic Disease Modifying Antirheumatic Drug (NB-DMARD) Use During Variable Length Pre-Index Period
Number of Participants with NB-MARD use during variable length pre-index period is reported. The NB-DMARD could have been hydroxychloroquine, MTX oral, leflunomide, sulfasalazine, chloroquine, cyclosporine, thalidomide, azathioprine, cyclophosphamide, auranofin, aurothioglucose, gold sodium thiomalate, penicillamine, tacrolimus or minocycline. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.
Time frame: During variable length pre-index period (1 year before the index date up to 5.2 years)
Mean Number of Non-Biologic Disease Modifying Antirheumatic Drug (NB-DMARD) Received During Pre-Index Period
Mean number of NB-DMARD received during pre-index period is reported. The NB-DMARD could have been hydroxychloroquine, MTX oral, leflunomide, sulfasalazine, chloroquine, cyclosporine, thalidomide, azathioprine, cyclophosphamide, auranofin, aurothioglucose, gold sodium thiomalate, penicillamine, tacrolimus or minocycline.
Time frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Mean Number of Non-Biologic Disease Modifying Antirheumatic Drug (NB-DMARD) Received During Variable Length Pre-Index Period
Mean number of NB-DMARD received during variable length pre-index period is reported. The NB-DMARD could have been hydroxychloroquine, MTX oral, leflunomide, sulfasalazine, chloroquine, cyclosporine, thalidomide, azathioprine, cyclophosphamide, auranofin, aurothioglucose, gold sodium thiomalate, penicillamine, tacrolimus or minocycline. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.
Time frame: During variable length pre-index period (1 year before the index date up to 5.2 years)
Mean Quan-Charlson Comorbidity Score of Participants
The mean Quan-Charlson Comorbidity Score during the Pre-Index Period is reported. Quan-Charlson Comorbidity Score predicts the probability of death within one year in participants and was based on the presence of any diagnosis codes on medical claims at any time during the 12-month pre-index period, based on the International Classification of Diseases (ICD) diagnosis codes. Total score ranges from 0 to 9.0. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome could result in mortality or higher healthcare resource utilization.
Time frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Pre-Index Period
Top 25 comorbid conditions: 1) rheumatoid arthritis/related disease, 2)other aftercare, 3)other connective tissue disease, 4)other non-traumatic joint disorders, 5)medical examination/evaluation, 6) other suspected conditions(other miscellaneous conditions other than mental disorders/infectious disease), 7)immunizations/screening for infectious disease, 8)osteoarthritis, 9)essential hypertension, 10) residual codes: unclassified, 11)disorders of lipid metabolism, 12)back problems, 13)other upper respiratory infections, 14)other lower respiratory disease, 15)other nervous system disorders, 16)other skin disorders, 17)thyroid disorders, 18)other bone disease/musculoskeletal deformities, 19) malaise/fatigue, 20)esophageal disorders, 21)nutritional deficiencies, 22)other nutritional: endocrine, metabolic disorders, 23)diabetes mellitus without complication, 24)other/unspecified benign neoplasm, 25)genitourinary symptoms/ill-defined conditions. A participant could have had \>=1 comorbidity.
Time frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Post-Index Period
Top 25 comorbid conditions: 1) rheumatoid arthritis/related disease, 2)other aftercare, 3)other connective tissue disease, 4)other non-traumatic joint disorders, 5)medical examination/evaluation, 6) other suspected conditions(other miscellaneous conditions other than mental disorders/infectious disease), 7)immunizations/screening for infectious disease, 8)osteoarthritis, 9)essential hypertension, 10) residual codes: unclassified, 11)disorders of lipid metabolism, 12)back problems, 13)other upper respiratory infections, 14)other lower respiratory disease, 15)other nervous system disorders, 16)other skin disorders, 17)thyroid disorders, 18)other bone disease/musculoskeletal deformities, 19) malaise/fatigue, 20)esophageal disorders, 21)nutritional deficiencies, 22)other nutritional: endocrine, metabolic disorders, 23)diabetes mellitus without complication, 24)other/unspecified benign neoplasm, 25)Other upper respiratory disease. A participant could have had \>=1 comorbidity.
Time frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Mean Claims Based Index of RA Severity (CIRAS) Score During Pre-Index Period
The mean of the CIRAS score during pre-index period is reported. The CIRAS is based on claims at any time during the 12-month pre-index period, used to measure RA disease severity using 9 measures (age at index, gender, inflammatory marker test ordered, rehabilitation visit, rheumatoid factor test, Felty's syndrome, number of platelet counts ordered, number of chemistry panels ordered, rheumatologist visit). Value of all 9 measure was used to derive the overall CIRAS score which ranges from 0-7.9 with higher value indicating greater severity of RA.
Time frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Number of Participants With 25 Most Common Medications Use During Pre-Index Period
Number of participants with 25 most common medications use during the pre-index period are reported. The 25 most medications: 1) MTX sodium, 2) folic acid, 3) prednisone, 4) acetaminophen/hydrocodone bitartrate, 5) azithromycin, 6) adalimumab, 7) hydroxychloroquine sulfate, 8) etanercept, 9) levothyroxine sodium, 10) methylprednisolone, 11) omeprazole, 12) tramadol hydrochloride, 13) meloxicam, 14) amoxicillin, 15) albuterol sulfate, 16) gabapentin, 17) acetaminophen/oxycodone hydrochloride, 18) amoxicillin/clavulanate potassium, 19) cyclobenzaprine hydrochloride, 20) fluticasone propionate, 21) ciprofloxacin hydrochloride, 22) duloxetine hydrochloride, 23) atorvastatin calcium, 24) diclofenac sodium, 25) levofloxacin. A participant could have received \>=1 most common medication.
Time frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Number of Participants With 26 Most Common Medications Use During Post-Index Period
Number of participants with 26 most common medications use during the post-index period are reported. The 26 most common medications: 1) MTX sodium, 2) folic acid, 3) prednisone, 4) acetaminophen/hydrocodone bitartrate, 5) azithromycin, 6) adalimumab, 7) hydroxychloroquine sulfate, 8) etanercept, 9) levothyroxine sodium, 10) methylprednisolone, 11) omeprazole, 12) tramadol hydrochloride, 13) meloxicam, 14) amoxicillin, 15) albuterol sulfate, 16) gabapentin, 17) acetaminophen/oxycodone hydrochloride, 18) amoxicillin/clavulanate potassium, 19) cyclobenzaprine hydrochloride, 20) fluticasone propionate, 21) ciprofloxacin hydrochloride, 22) duloxetine hydrochloride, 23) diclofenac Sodium, 24) levofloxacin, 25) cephalexin, 26) ibuprofen. A participant could have received \>=1 most common medication.
Time frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Number of Participants Who Used Opioids During Pre-Index Period
Number of participants who used at least one opioid during pre-index period are reported.
Time frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Number of Participants Who Used Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) During Pre-Index Period
Number of participants who used at least one NSAID during pre-index period are reported.
Time frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Number of Participants Who Used Opioids During Post-Index Period
Number of participants who used at least one opioid during the post-index period are reported.
Time frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Number of Participants Who Used NSAIDs During Post-Index Period
Number of participants who used at least one NSAID during the post-index period are reported.
Time frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Mean Number of Pharmacy Claims for Opioids During Pre-Index Period
The mean number of pharmacy claims for opioids during the pre-index period are reported. A pharmacy claim is defined as a claim made by participants to their insurance provider in purchasing opioids from their pharmacy.
Time frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Mean Number of Pharmacy Claims for Non-Steroidal Anti Inflammatory Drugs (NSAIDs) During Pre-Index Period
The mean number of pharmacy claims for NSAIDs during the pre-index period are reported. A pharmacy claim is defined as a claim made by participants to their insurance provider in purchasing NSAIDs from their pharmacy.
Time frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Mean Number of Pharmacy Claims for Opioids During Post-Index Period
The mean number of pharmacy claims for opioids during the post-index period are reported. A pharmacy claim is defined as a claim made by participants to their insurance provider in purchasing opioids from their pharmacy.
Time frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Mean Number of Pharmacy Claims for Non-Steroidal Anti Inflammatory Drugs (NSAIDs) During Post-Index Period
The mean number of pharmacy claims for NSAIDs during the post-index period are reported. A pharmacy claim is defined as a claim made by participants to their insurance provider in purchasing NSAIDs from their pharmacy.
Time frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Mean Number of Days From The Index Date to The First Opioid Claim During Post Index Period
Mean number of days from the index date to the first opioid claim during post index period are reported.
Time frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Mean Number of Days From The Index Date to The First NSAIDs Claim During Post Index Period
Mean number of days from the index date to the first NSAIDs claim during post index period are reported.
Time frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Number of Participants Who Used Opioids During Tofacitinib Persistency and Post-Persistency
Number of participants who used opioids during tofacitinib persistency and post-persistency are reported. Persistence for participants is defined as the period of treatment with tofacitinib. Post persistence refers to switching to another medication from tofacitinib; or discontinuing tofacitinib either permanently or for a gap in time \>60 days before restarting.
Time frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Number of Participants Who Used NSAIDs During Tofacitinib Persistency and Post-Persistency
Number of participants who used NSAIDs during tofacitinib persistency and post-persistency are reported. Persistence for participants is defined as the period of treatment with tofacitinib. Post persistence refers to switching to another medication from tofacitinib; or discontinuing tofacitinib either permanently or for a gap in time \>60 days before restarting.
Time frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Number of Participants Who Used Oral Corticosteroids During Pre-Index Period
The number of participants who used at least one oral corticosteroid during the pre-index period is reported.
Time frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Number of Participants Who Used Oral Corticosteroids During Post-Index Period
The number of participants who used at least one oral corticosteroid during the post-index period is reported.
Time frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Mean Total Dose of Oral Corticosteroids During Pre-Index Period
Mean total dose of oral corticosteroids during pre-index period is reported. The total dose is expressed as a prednisone-equivalent dose of the oral corticosteroids used.
Time frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Mean Total Dose of Oral Corticosteroid During Post-Index Period
Mean total dose of oral corticosteroids during post-index period is reported. The total dose is expressed as a prednisone-equivalent dose of the oral corticosteroids used.
Time frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Mean Number of Visits to Rheumatologist During Pre-Index Period
Mean number of visits to a rheumatologist during pre-index period is reported. A visit is referring to out-patient visit specifically to a rheumatologist.
Time frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Mean Number of Visits to Rheumatologist During Variable-Length Pre-Index Period
Mean number of visits to rheumatologist during the variable-length pre-index period is reported. A visit is referring to out-patient visit specifically to a rheumatologist. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.
Time frame: During variable length pre-index period (1 year before the index date up to 5.2 years)
Mean Disease Duration
Mean Disease Duration of RA based upon the variable length pre-index period is reported. Disease duration (in days) defined as the number of days from the earliest claim with a diagnosis of RA in the variable length pre-index period until the index date. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.
Time frame: During variable length pre-index period (1 year before the index date up to 5.2 years)
Mean Out of Pocket Health Care Costs for Healthcare Services During Pre-Index Period
Mean out of pocket health care costs for healthcare services during pre-index period is reported. It is categorized as: All causes and RA related. All cause consisted of money spent by participants on all health care services (pharmacy, medical \[ambulatory, emergency department and inpatient admission\]). RA related signifies money spent by participants on health care services for RA.
Time frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Mean Out of Pocket Health Care Costs for Healthcare Services During Variable Length Pre-Index Period
Mean out of pocket health care costs for healthcare services during variable length pre-index period is reported. It is categorized as: All causes and RA related. All cause consisted of money spent by participants on all health care services (pharmacy, medical \[ambulatory, emergency department and inpatient admission\]). RA related signifies one spent by participants on health care services for RA. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.
Time frame: During variable length pre-index period (1 year before the index date up to 5.2 years)
Number of Participants With Comorbidities of Interest During Pre-Index Period
Number of participants with at least one of comorbidity of interest during pre-index period is reported. The comorbidities of interest included cardiovascular diseases, chronic obstructive pulmonary disorder (COPD), asthma, kidney disease, diabetes, depression, anxiety, liver disease, sleep disorders. A participant could have \>1 comorbidity of interest.
Time frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Number of Participants With Non-persistence to Index Medication (Tofacitinib)
Non-persistence was defined as the gap of at least 60 days in treatment with the index medication (tofacitinib) or switching to other biologic.
Time frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Number of Participants With Post-Persistence Treatment Patterns
Number of participants with post-persistence treatment patterns is reported. Post-persistence was categorized as: 1) switch immediately (if participants initiated a non-index biologic before a 60-day gap in treatment is observed for the index medication); 2) discontinue then restart (if there was a gap in the index therapy of at least 60 days and the first medication observed after the gap is the index medication); 3) discontinue then switch ( if there was a gap in the index therapy of at least 60 days and the first medication observed after the gap is a biologic \[including Tofacitinib\] different from index medication), 4) discontinue without switch or restart (if participant's had a gap in therapy of at least 60 days and there are no claims for either the index medication or a different biologic for the remaining observation period).
Time frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Number of Participants Who Switched From Index Medication (Tofacitinib) at Any Time During Post-Index Period
Number of participants who switched from index medication (tofacitinib) to a biologic at any time during post-index period is reported.
Time frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Number of Participants Who Re-started Index Medication (Tofacitinib) at Any Time During Post-Index Period
Number of participants who re-started tofacitinib (after considered as non-persistence with the tofacitinib) after discontinuation at any time during post-index period is reported.
Time frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Mean Medication Possession Ratio (MPR) for Methotrexate (MTX)
Mean MPR for Methotrexate is reported. MPR was calculated as the total days supply of MTX between the first and including the last prescription/administration divided by the time between the first through and including last biologic prescription/administration days supply.
Time frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Mean Adherence To Methotrexate (MTX)
Mean adherence for methotrexate is reported. Adherence was calculated as the total number of days supplied for MTX during the post-index period divided by the number of days from the first claim during the post-index period to the end of the post-index period
Time frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Number of Participants Who Used Additional NB-DMARD During Post Index Period
Number of participants who used additional NB-DMARD during post index period is reported. Additional NB-DMARD use could have been leflunomide, sulfasalazine and hydroxychloroquine.
Time frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Number of Participants Who Met Medication Effectiveness Criteria: Adherence to Index Medication (Tofacitinib)
Medication effectiveness criteria categorized as: 1) adherence to index medication, 2) no dose escalation for index medication, 3) no switch from index medication, 4) no addition of NB-DMARD, 5) criteria for oral glucocorticoids, 6) use of Injectable glucocorticoids. Adherence to index medication was defined as at least 30 days continuous supply of tofacitinib during post-index period.
Time frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Number of Participants Who Met Medication Effectiveness Criteria: No Dose Escalation for Index Medication (Tofacitinib)
Medication effectiveness criteria categorized as: 1) adherence to index medication, 2) no dose escalation for index medication, 3) no switch from index medication, 4) no addition of NB-DMARD, 5) criteria for oral glucocorticoids, 6) use of Injectable glucocorticoids. No dose escalation for index medication was defined as no increase in dose for index medication compared to the starting dose during post-index period.
Time frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Number of Participants Who Met Medication Effectiveness Criteria: No Switch From Index Medication (Tofacitinib)
Medication effectiveness criteria categorized as: 1) adherence to index medication, 2) no dose escalation for index medication, 3) no switch from index medication, 4) no addition of NB-DMARD, 5) criteria for oral glucocorticoids, 6) use of Injectable glucocorticoids. No switch from index medication was defined as no switching from the index medication to a (different) biologic agent during post-index period.
Time frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Number of Participants Who Met Medication Effectiveness Criteria: No Addition of NB-DMARD
Medication effectiveness criteria categorized as: 1) adherence to index medication, 2) no dose escalation for index medication, 3) no switch from index medication, 4) no addition of NB-DMARD, 5) criteria for oral glucocorticoids, 6) use of Injectable glucocorticoids. No addition of NB-DMARD was defined as no addition of new NB-DMARD to index therapy during post-index period.
Time frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Number of Participants Who Met Medication Effectiveness Criteria: Criteria for Oral Glucocorticoids
Medication effectiveness criteria categorized as: 1) adherence to index medication, 2) no dose escalation for index medication, 3) no switch from index medication, 4) no addition of NB-DMARD, 5) criteria for oral glucocorticoids, 6) use of Injectable glucocorticoids. Medication effectiveness criteria for oral glucocorticoids was defined as either of the following: 1) Participants cannot receive oral glucocorticoids for \> 30 days between (index date +91 days) to (index date + 359 days); 2) No increase in oral glucocorticoid dose during months 6-12 after index date.
Time frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Number of Participants Who Met Medication Effectiveness Criteria: Use of Injectable Glucocorticoids
Medication effectiveness criteria categorized as: 1) adherence to index medication, 2) no dose escalation for index medication, 3) no switch from index medication, 4) no addition of NB-DMARD, 5) criteria for oral glucocorticoids, 6) use of Injectable glucocorticoids. Use of Injectable glucocorticoids was defined as maximum one parenteral or intra-articular glucocorticoid joint injection use after the participant had been on biologic treatment for \>3 months post index date (\[index date +91 days\] to \[index date +359 days\]).
Time frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Number of Participants With All Cause Ambulatory Visits During Pre-Index Period
Number of participants with at least one ambulatory visit that was due to all cause during the pre-index period is reported. All cause refers to ambulatory visits due to all comorbidities, including RA.
Time frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Number of Participants With All Cause Emergency Department Visits During Pre-Index Period
Number of participants with at least one emergency department visits that was due to all cause during the pre-index period is reported. All cause refers to emergency visits due to all comorbidities, including RA.
Time frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Number of Participants With All Cause Inpatient Admissions During Pre-Index Period
Number of participants with at least one inpatient admissions that was due to all cause during the pre-index period is reported. All cause refers to inpatient admission due to all comorbidities, including RA.
Time frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Number of Participants With RA Related Ambulatory Visits During Pre-Index Period
Number of participants with at least one ambulatory visit that was due to RA during the pre-index period is reported. RA related refers to ambulatory visits due to RA.
Time frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Number of Participants With RA Related Emergency Department Visits During Pre-Index Period
Number of participants with at least one emergency department visits that was due to RA during the pre-index period is reported. RA related refers to emergency department visits due to RA.
Time frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Number of Participants With RA Related Inpatient Admissions During Pre-Index Period
Number of participants with at least one inpatient admissions that was due to RA during the pre-index period is reported. RA related refers to inpatient admission due to RA.
Time frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Number of Participants With All Cause Ambulatory Visits During Post-Index Period
Number of participants with at least one ambulatory visit that was due to all cause during the post-index period is reported. All cause refers to ambulatory visits due to all comorbidities, including RA.
Time frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Number of Participants With All Cause Emergency Department Visits During Post-Index Period
Number of participants with at least one emergency department visits that was due to all cause during the post-index period is reported. All cause refers to emergency department visits due to all comorbidities, including RA.
Time frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Number of Participants With All Cause Inpatient Admissions During Post-Index Period
Number of participants with at least one inpatient admissions that was due to all cause during the post-index period is reported. All cause refers to inpatient admissions due to all comorbidities, including RA.
Time frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Number of Participants With RA Related Ambulatory Visits During Post Index Period
Number of participants with at least one of the RA-related ambulatory visits during the post-index period is reported. RA related refers to ambulatory visits due to RA.
Time frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Number of Participants With RA Related Emergency Department Visits During Post Index Period
Number of participants with at least one of the RA-related emergency department visit during the post-index period is reported. RA related refers to emergency department visits due to RA.
Time frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Number of Participants With RA Related Inpatient Admissions During Post Index Period
Number of participants with at least one of an RA-related inpatient admission during the post-index period is reported. RA related refers to inpatient admissions due to RA.
Time frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Mean Total Health Care Cost All Cause During Pre-Index Period
Mean total health care cost all cause during pre-index period is reported. All cause refers to cost spent due to all comorbidities including RA and calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs).
Time frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Mean Total Health Care Cost RA Related During Pre-Index Period
RA related healthcare cost refers to cost spent due to RA alone and was calculated as the total of treatment cost (cost of tofacitinib, biologic DMARDs, NB-DMARDs and administration of intravenous (IV) biologics) and medical cost (cost of ambulatory cost, emergency department visits cost, inpatient admission cost, home health care cost, urgent care cost and other medical services cost).
Time frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Mean Total Health Care Cost Due to All Cause During Post-Index Period
Mean total health care cost due to all cause during post-index period is reported. All cause refers to cost spent due to all comorbidities, including RA and calculated as the total of pharmacy cost (cost of home healthcare cost, urgent care cost and other medical services costs) and medical cost (cost of ambulatory cost, emergency department visits cost, inpatient admission cost and other costs).
Time frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Mean Total Health Care Cost RA Related During Post-Index Period
RA related healthcare cost refers to cost spent due to RA alone and was calculated as the total of treatment cost (cost of tofacitinib, biologic DMARDs, NB-DMARDs and administration of IV biologics) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost, home health care cost, urgent care cost and other medical services cost).
Time frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Mean Treatment Persistence Duration Measured for Index Medication (Tofacitinib)
Treatment persistence with tofacitinib was defined as not having a gap in therapy of at least 60 days between prescription re-fills of tofacitinib.
Time frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Mean Total All Cause Monthly Health Care Cost
Mean total monthly health care cost due to all cause is reported. All cause refers to cost spent due to all comorbidities, including RA and calculated as the total of pharmacy cost (cost of home healthcare cost, urgent care cost and other medical services costs) and medical cost (cost of ambulatory cost, emergency department visits cost, inpatient admission cost and other costs). Total all cause monthly health care cost is reported for every month from 12 months duration before index date (pre-index period) to 12 months duration post index date (post index period). Index date is defined as the date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.
Time frame: During pre-index period (at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 months before index date) and post index period (at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 month post index date)
Mean Total RA Related Monthly Health Care Cost
Mean total monthly health care cost due to RA is reported. RA related refers to cost spent by participants due to RA on health care services. This is calculated as the total of treatment cost (cost of tofacitinib, biologic DMARDs, NB-DMARDs and administration of IV biologics) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost, home health care cost, urgent care cost and other medical services cost). RA related monthly health care cost is reported for every month from 12 months duration before index date (pre-index period) to 12 months duration post index date (post index period). Index date is defined as the date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.
Time frame: During pre-index period (at1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 months before index date) and post index period (at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 month after index date)
| Milestone | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Started | 337 | 94 | 48 |
| Completed | 337 | 94 | 48 |
| Not completed | 0 | 0 | 0 |
Number of participants covered by type of insurance is reported. There were two types of insurance: 1) a private insurance plan, that is, one purchased by the participants, commercially available; 2) employer-provided insurance plan, that is, the participant's employer provided the insurance.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Private insurance plan | 36 | 13 | 9 |
| Insurance plan from employer | 301 | 81 | 39 |
Number of participants enrolled in the study per geographic region of the United States (northeast; north central; south; west; unknown) is reported.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Northeast Region | 81 | 25 | 10 |
| North Central Region | 76 | 17 | 14 |
| South Region | 150 | 47 | 21 |
| West Region | 29 | 5 | 3 |
| Unknown Region | 1 | 0 | 0 |
Number of Participants with use of at least one bDMARD during pre-index period is reported. The bDMARD could have been any tumor-necrosis factor-alpha inhibitors (TNFi), any non-TNFi, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, anakinra, abatacept, tocilizumab or rituximab.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Number of Participants With Biologic Disease Modifying Antirheumatic Drug (bDMARD) Use During Pre-Index Period | 225 | 59 | 31 |
Number of Participants with use of at least one bDMARD during variable length pre-index period is reported. The bDMARD could have been any TNFi, any non-TNFi, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, anakinra, abatacept, tocilizumab or rituximab. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant, could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Number of Participants With Biologic Disease Modifying Antirheumatic Drug (bDMARD) Use During Variable Length Pre-Index Period | 247 | 69 | 36 |
Mean number of bDMARD received during pre-index period is reported. The bDMARD could have been any TNFi, any non-TNFi, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, anakinra, abatacept, tocilizumab or rituximab.
| bDMARD | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Mean Number of Biologic Disease Modifying Antirheumatic Drug (bDMARD) Received During Pre-Index Period | 1.38 ± 0.59 | 1.31 ± 0.46 | 1.23 ± 0.50 |
Mean number of bDMARD received during variable length pre-index period is reported. The bDMARD could have been any TNFi, any non-TNFi, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, anakinra, abatacept, tocilizumab or rituximab. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.
| bDMARD | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Mean Number of Biologic Disease Modifying Antirheumatic Drug (bDMARD) Received During Variable Length Pre-Index Period | 1.81 ± 0.87 | 1.55 ± 0.76 | 1.50 ± 0.61 |
Number of Participants with NB-DMARD use during pre-index period is reported. The NB-DMARD could have been hydroxychloroquine, MTX oral, leflunomide, sulfasalazine, chloroquine, cyclosporine, thalidomide, azathioprine, cyclophosphamide, auranofin, aurothioglucose, gold sodium thiomalate, penicillamine, tacrolimus or minocycline.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Number of Participants With Non-biologic Disease Modifying Antirheumatic Drug (NB-DMARD) Use During Pre-Index Period | 333 | 93 | 47 |
Number of Participants with NB-MARD use during variable length pre-index period is reported. The NB-DMARD could have been hydroxychloroquine, MTX oral, leflunomide, sulfasalazine, chloroquine, cyclosporine, thalidomide, azathioprine, cyclophosphamide, auranofin, aurothioglucose, gold sodium thiomalate, penicillamine, tacrolimus or minocycline. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Number of Participants With Non-Biologic Disease Modifying Antirheumatic Drug (NB-DMARD) Use During Variable Length Pre-Index Period | 334 | 94 | 48 |
Mean number of NB-DMARD received during pre-index period is reported. The NB-DMARD could have been hydroxychloroquine, MTX oral, leflunomide, sulfasalazine, chloroquine, cyclosporine, thalidomide, azathioprine, cyclophosphamide, auranofin, aurothioglucose, gold sodium thiomalate, penicillamine, tacrolimus or minocycline.
| NB-DMARD | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Mean Number of Non-Biologic Disease Modifying Antirheumatic Drug (NB-DMARD) Received During Pre-Index Period | 1.46 ± 0.67 | 1.41 ± 0.63 | 1.40 ± 0.65 |
Mean number of NB-DMARD received during variable length pre-index period is reported. The NB-DMARD could have been hydroxychloroquine, MTX oral, leflunomide, sulfasalazine, chloroquine, cyclosporine, thalidomide, azathioprine, cyclophosphamide, auranofin, aurothioglucose, gold sodium thiomalate, penicillamine, tacrolimus or minocycline. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.
| NB-DMARD | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Mean Number of Non-Biologic Disease Modifying Antirheumatic Drug (NB-DMARD) Received During Variable Length Pre-Index Period | 1.62 ± 0.77 | 1.52 ± 0.70 | 1.63 ± 0.82 |
The mean Quan-Charlson Comorbidity Score during the Pre-Index Period is reported. Quan-Charlson Comorbidity Score predicts the probability of death within one year in participants and was based on the presence of any diagnosis codes on medical claims at any time during the 12-month pre-index period, based on the International Classification of Diseases (ICD) diagnosis codes. Total score ranges from 0 to 9.0. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome could result in mortality or higher healthcare resource utilization.
| score on a scale | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Mean Quan-Charlson Comorbidity Score of Participants | 1.69 ± 1.08 | 1.76 ± 1.18 | 1.90 ± 1.46 |
Top 25 comorbid conditions: 1) rheumatoid arthritis/related disease, 2)other aftercare, 3)other connective tissue disease, 4)other non-traumatic joint disorders, 5)medical examination/evaluation, 6) other suspected conditions(other miscellaneous conditions other than mental disorders/infectious disease), 7)immunizations/screening for infectious disease, 8)osteoarthritis, 9)essential hypertension, 10) residual codes: unclassified, 11)disorders of lipid metabolism, 12)back problems, 13)other upper respiratory infections, 14)other lower respiratory disease, 15)other nervous system disorders, 16)other skin disorders, 17)thyroid disorders, 18)other bone disease/musculoskeletal deformities, 19) malaise/fatigue, 20)esophageal disorders, 21)nutritional deficiencies, 22)other nutritional: endocrine, metabolic disorders, 23)diabetes mellitus without complication, 24)other/unspecified benign neoplasm, 25)genitourinary symptoms/ill-defined conditions. A participant could have had \>=1 comorbidity.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Rheumatoid arthritis/related disease | 337 | 94 | 48 |
| Other aftercare | 277 | 68 | 36 |
| Other connective tissue disease | 203 | 66 | 26 |
| Other non-traumatic joint disorders | 200 | 56 | 29 |
| Medical examination/evaluation | 195 | 56 | 24 |
| Other suspected conditions | 179 | 49 | 21 |
| Immunizations/screening for infectious disease | 176 | 44 | 19 |
| Osteoarthritis | 154 | 37 | 28 |
| Essential hypertension | 144 | 44 | 27 |
| Residual codes; unclassified | 144 | 42 | 23 |
| Disorders of lipid metabolism | 147 | 36 | 22 |
| Back problems | 128 | 48 | 21 |
| Other upper respiratory infections | 114 | 31 | 13 |
| Other lower respiratory disease | 101 | 30 | 18 |
| Other nervous system disorders | 98 | 33 | 14 |
| Other skin disorders | 97 | 16 | 16 |
| Thyroid disorders | 95 | 24 | 9 |
| Other bone disease/musculoskeletal deformities | 88 | 26 | 12 |
| Malaise/fatigue | 81 | 21 | 9 |
| Esophageal disorders | 74 | 23 | 12 |
| Nutritional deficiencies | 75 | 22 | 12 |
| Other nutritional: endocrine, metabolic disorders | 74 | 17 | 12 |
| Diabetes mellitus without complication | 72 | 18 | 11 |
| Other/unspecified benign neoplasm | 65 | 18 | 5 |
| Genitourinary symptoms/ill-defined conditions | 59 | 12 | 9 |
Top 25 comorbid conditions: 1) rheumatoid arthritis/related disease, 2)other aftercare, 3)other connective tissue disease, 4)other non-traumatic joint disorders, 5)medical examination/evaluation, 6) other suspected conditions(other miscellaneous conditions other than mental disorders/infectious disease), 7)immunizations/screening for infectious disease, 8)osteoarthritis, 9)essential hypertension, 10) residual codes: unclassified, 11)disorders of lipid metabolism, 12)back problems, 13)other upper respiratory infections, 14)other lower respiratory disease, 15)other nervous system disorders, 16)other skin disorders, 17)thyroid disorders, 18)other bone disease/musculoskeletal deformities, 19) malaise/fatigue, 20)esophageal disorders, 21)nutritional deficiencies, 22)other nutritional: endocrine, metabolic disorders, 23)diabetes mellitus without complication, 24)other/unspecified benign neoplasm, 25)Other upper respiratory disease. A participant could have had \>=1 comorbidity.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Rheumatoid arthritis/related disease | 336 | 92 | 48 |
| Other aftercare | 290 | 69 | 39 |
| Other connective tissue disease | 187 | 54 | 32 |
| Other suspected conditions | 186 | 57 | 29 |
| Medical examination/evaluation | 186 | 51 | 22 |
| Other non-traumatic joint disorders | 169 | 53 | 29 |
| Essential hypertension | 156 | 51 | 26 |
| Residual codes; unclassified | 165 | 42 | 23 |
| Disorders of lipid metabolism | 155 | 42 | 20 |
| Osteoarthritis | 141 | 41 | 21 |
| Immunizations/screening for infectious disease | 142 | 44 | 15 |
| Back problems | 138 | 38 | 25 |
| Other upper respiratory infections | 123 | 29 | 21 |
| Other nervous system disorders | 100 | 37 | 20 |
| Other lower respiratory disease | 106 | 28 | 20 |
| Other skin disorders | 100 | 30 | 17 |
| Other nutritional, endocrine, metabolic disorders | 104 | 25 | 14 |
| Thyroid disorders | 90 | 23 | 11 |
| Other bone disease/musculoskeletal deformities | 90 | 20 | 13 |
| Nutritional deficiencies | 74 | 25 | 16 |
| Diabetes mellitus without complication | 71 | 24 | 11 |
| Esophageal disorders | 71 | 19 | 11 |
| Malaise/fatigue | 69 | 17 | 7 |
| Other/unspecified benign neoplasm | 60 | 19 | 11 |
| Other upper respiratory disease | 67 | 18 | 7 |
The mean of the CIRAS score during pre-index period is reported. The CIRAS is based on claims at any time during the 12-month pre-index period, used to measure RA disease severity using 9 measures (age at index, gender, inflammatory marker test ordered, rehabilitation visit, rheumatoid factor test, Felty's syndrome, number of platelet counts ordered, number of chemistry panels ordered, rheumatologist visit). Value of all 9 measure was used to derive the overall CIRAS score which ranges from 0-7.9 with higher value indicating greater severity of RA.
| score on a scale | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Mean Claims Based Index of RA Severity (CIRAS) Score During Pre-Index Period | 4.57 ± 1.37 | 4.76 ± 1.50 | 4.31 ± 1.20 |
Number of participants with 25 most common medications use during the pre-index period are reported. The 25 most medications: 1) MTX sodium, 2) folic acid, 3) prednisone, 4) acetaminophen/hydrocodone bitartrate, 5) azithromycin, 6) adalimumab, 7) hydroxychloroquine sulfate, 8) etanercept, 9) levothyroxine sodium, 10) methylprednisolone, 11) omeprazole, 12) tramadol hydrochloride, 13) meloxicam, 14) amoxicillin, 15) albuterol sulfate, 16) gabapentin, 17) acetaminophen/oxycodone hydrochloride, 18) amoxicillin/clavulanate potassium, 19) cyclobenzaprine hydrochloride, 20) fluticasone propionate, 21) ciprofloxacin hydrochloride, 22) duloxetine hydrochloride, 23) atorvastatin calcium, 24) diclofenac sodium, 25) levofloxacin. A participant could have received \>=1 most common medication.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| MTX Sodium | 330 | 92 | 47 |
| Folic Acid | 243 | 65 | 34 |
| Prednisone | 214 | 70 | 38 |
| Acetaminophen/Hydrocodone Bitartrate | 111 | 33 | 14 |
| Azithromycin | 80 | 28 | 15 |
| Adalimumab | 84 | 26 | 6 |
| Hydroxychloroquine Sulfate | 83 | 21 | 10 |
| Etanercept | 76 | 21 | 16 |
| Levothyroxine Sodium | 80 | 16 | 10 |
| Methylprednisolone | 66 | 22 | 15 |
| Omeprazole | 69 | 16 | 10 |
| Tramadol Hydrochloride | 59 | 22 | 11 |
| Meloxicam | 58 | 20 | 8 |
| Amoxicillin | 54 | 17 | 9 |
| Albuterol Sulfate | 58 | 17 | 4 |
| Gabapentin | 52 | 15 | 7 |
| Acetaminophen/Oxycodone Hydrochloride | 46 | 20 | 7 |
| Amoxicillin/Clavulanate Potassium | 53 | 11 | 6 |
| Cyclobenzaprine Hydrochloride | 45 | 16 | 7 |
| Fluticasone Propionate | 47 | 13 | 5 |
| Ciprofloxacin Hydrochloride | 46 | 10 | 8 |
| Duloxetine Hydrochloride | 42 | 17 | 4 |
| Atorvastatin Calcium | 44 | 11 | 7 |
| Diclofenac Sodium | 39 | 16 | 4 |
| Levofloxacin | 40 | 13 | 4 |
Number of participants with 26 most common medications use during the post-index period are reported. The 26 most common medications: 1) MTX sodium, 2) folic acid, 3) prednisone, 4) acetaminophen/hydrocodone bitartrate, 5) azithromycin, 6) adalimumab, 7) hydroxychloroquine sulfate, 8) etanercept, 9) levothyroxine sodium, 10) methylprednisolone, 11) omeprazole, 12) tramadol hydrochloride, 13) meloxicam, 14) amoxicillin, 15) albuterol sulfate, 16) gabapentin, 17) acetaminophen/oxycodone hydrochloride, 18) amoxicillin/clavulanate potassium, 19) cyclobenzaprine hydrochloride, 20) fluticasone propionate, 21) ciprofloxacin hydrochloride, 22) duloxetine hydrochloride, 23) diclofenac Sodium, 24) levofloxacin, 25) cephalexin, 26) ibuprofen. A participant could have received \>=1 most common medication.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| MTX Sodium | 332 | 94 | 48 |
| Folic Acid | 254 | 68 | 35 |
| Prednisone | 260 | 81 | 43 |
| Acetaminophen/Hydrocodone Bitartrate | 184 | 58 | 23 |
| Azithromycin | 153 | 47 | 25 |
| Adalimumab | 126 | 37 | 11 |
| Hydroxychloroquine Sulfate | 108 | 25 | 13 |
| Etanercept | 112 | 27 | 17 |
| Levothyroxine Sodium | 82 | 16 | 10 |
| Methylprednisolone | 123 | 43 | 22 |
| Omeprazole | 89 | 20 | 13 |
| Tramadol Hydrochloride | 96 | 39 | 17 |
| Meloxicam | 96 | 25 | 10 |
| Amoxicillin | 105 | 28 | 15 |
| Albuterol Sulfate | 91 | 25 | 8 |
| Gabapentin | 78 | 21 | 11 |
| Acetaminophen/Oxycodone Hydrochloride | 80 | 30 | 15 |
| Amoxicillin/Clavulanate Potassium | 94 | 20 | 14 |
| Cyclobenzaprine Hydrochloride | 83 | 31 | 11 |
| Fluticasone Propionate | 83 | 24 | 13 |
| Ciprofloxacin Hydrochloride | 88 | 26 | 11 |
| Duloxetine Hydrochloride | 52 | 23 | 8 |
| Diclofenac Sodium | 71 | 27 | 10 |
| Levofloxacin | 79 | 24 | 12 |
| Cephalexin | 76 | 15 | 11 |
| Ibuprofen | 50 | 22 | 11 |
Number of participants who used at least one opioid during pre-index period are reported.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Number of Participants Who Used Opioids During Pre-Index Period | 173 | 55 | 27 |
Number of participants who used at least one NSAID during pre-index period are reported.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Number of Participants Who Used Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) During Pre-Index Period | 160 | 44 | 21 |
Number of participants who used at least one opioid during the post-index period are reported.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Number of Participants Who Used Opioids During Post-Index Period | 170 | 47 | 28 |
Number of participants who used at least one NSAID during the post-index period are reported.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Number of Participants Who Used NSAIDs During Post-Index Period | 152 | 41 | 24 |
The mean number of pharmacy claims for opioids during the pre-index period are reported. A pharmacy claim is defined as a claim made by participants to their insurance provider in purchasing opioids from their pharmacy.
| pharmacy claims | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Mean Number of Pharmacy Claims for Opioids During Pre-Index Period | 5.21 ± 5.48 | 6.83 ± 7.33 | 9.00 ± 12.29 |
The mean number of pharmacy claims for NSAIDs during the pre-index period are reported. A pharmacy claim is defined as a claim made by participants to their insurance provider in purchasing NSAIDs from their pharmacy.
| pharmacy claims | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Mean Number of Pharmacy Claims for Non-Steroidal Anti Inflammatory Drugs (NSAIDs) During Pre-Index Period | 3.81 ± 3.05 | 4.29 ± 3.68 | 3.48 ± 2.91 |
The mean number of pharmacy claims for opioids during the post-index period are reported. A pharmacy claim is defined as a claim made by participants to their insurance provider in purchasing opioids from their pharmacy.
| pharmacy claims | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Mean Number of Pharmacy Claims for Opioids During Post-Index Period | 5.35 ± 5.28 | 6.51 ± 7.57 | 7.29 ± 9.37 |
The mean number of pharmacy claims for NSAIDs during the post-index period are reported. A pharmacy claim is defined as a claim made by participants to their insurance provider in purchasing NSAIDs from their pharmacy.
| pharmacy claims | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Mean Number of Pharmacy Claims for Non-Steroidal Anti Inflammatory Drugs (NSAIDs) During Post-Index Period | 4.40 ± 3.83 | 4.57 ± 3.77 | 3.00 ± 1.80 |
Mean number of days from the index date to the first opioid claim during post index period are reported.
| days | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Mean Number of Days From The Index Date to The First Opioid Claim During Post Index Period | 106.71 ± 96.40 | 109.93 ± 108.35 | 92.85 ± 81.74 |
Mean number of days from the index date to the first NSAIDs claim during post index period are reported.
| days | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Mean Number of Days From The Index Date to The First NSAIDs Claim During Post Index Period | 100.25 ± 91.68 | 117.00 ± 93.12 | 124.08 ± 108.34 |
Number of participants who used opioids during tofacitinib persistency and post-persistency are reported. Persistence for participants is defined as the period of treatment with tofacitinib. Post persistence refers to switching to another medication from tofacitinib; or discontinuing tofacitinib either permanently or for a gap in time \>60 days before restarting.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| During Persistency | 159 | 40 | 25 |
| Post Persistency | 49 | 20 | 11 |
Number of participants who used NSAIDs during tofacitinib persistency and post-persistency are reported. Persistence for participants is defined as the period of treatment with tofacitinib. Post persistence refers to switching to another medication from tofacitinib; or discontinuing tofacitinib either permanently or for a gap in time \>60 days before restarting.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| During Persistency | 138 | 37 | 21 |
| Post Persistency | 51 | 17 | 8 |
The number of participants who used at least one oral corticosteroid during the pre-index period is reported.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Number of Participants Who Used Oral Corticosteroids During Pre-Index Period | 243 | 75 | 43 |
The number of participants who used at least one oral corticosteroid during the post-index period is reported.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Number of Participants Who Used Oral Corticosteroids During Post-Index Period | 213 | 59 | 34 |
Mean total dose of oral corticosteroids during pre-index period is reported. The total dose is expressed as a prednisone-equivalent dose of the oral corticosteroids used.
| milligram(mg) | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Mean Total Dose of Oral Corticosteroids During Pre-Index Period | 1617.82 ± 2148.87 | 1572.15 ± 1266.59 | 1209.77 ± 978.90 |
Mean total dose of oral corticosteroids during post-index period is reported. The total dose is expressed as a prednisone-equivalent dose of the oral corticosteroids used.
| mg | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Mean Total Dose of Oral Corticosteroid During Post-Index Period | 1792.20 ± 3855.57 | 1871.85 ± 4092.22 | 1593.97 ± 1724.89 |
Mean number of visits to a rheumatologist during pre-index period is reported. A visit is referring to out-patient visit specifically to a rheumatologist.
| visits | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Mean Number of Visits to Rheumatologist During Pre-Index Period | 5.43 ± 3.27 | 5.14 ± 3.50 | 4.74 ± 2.74 |
Mean number of visits to rheumatologist during the variable-length pre-index period is reported. A visit is referring to out-patient visit specifically to a rheumatologist. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.
| visits | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Mean Number of Visits to Rheumatologist During Variable-Length Pre-Index Period | 12.20 ± 9.28 | 11.72 ± 8.68 | 10.16 ± 6.22 |
Mean Disease Duration of RA based upon the variable length pre-index period is reported. Disease duration (in days) defined as the number of days from the earliest claim with a diagnosis of RA in the variable length pre-index period until the index date. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.
| days | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Mean Disease Duration | 852.13 ± 431.04 | 786.30 ± 428.83 | 862.75 ± 462.33 |
Mean out of pocket health care costs for healthcare services during pre-index period is reported. It is categorized as: All causes and RA related. All cause consisted of money spent by participants on all health care services (pharmacy, medical \[ambulatory, emergency department and inpatient admission\]). RA related signifies money spent by participants on health care services for RA.
| dollars | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| All cause | 2471.36 ± 1952.53 | 3296.62 ± 2643.12 | 2233.31 ± 1674.19 |
| RA related | 1261.49 ± 1578.25 | 1484.58 ± 1600.74 | 1002.81 ± 1364.90 |
Mean out of pocket health care costs for healthcare services during variable length pre-index period is reported. It is categorized as: All causes and RA related. All cause consisted of money spent by participants on all health care services (pharmacy, medical \[ambulatory, emergency department and inpatient admission\]). RA related signifies one spent by participants on health care services for RA. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.
| dollars | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| All cause | 7031.96 ± 6241.15 | 7779.41 ± 5492.89 | 6451.08 ± 4604.24 |
| RA related | 3023.26 ± 4459.08 | 3049.87 ± 2804.35 | 2684.47 ± 2577.28 |
Number of participants with at least one of comorbidity of interest during pre-index period is reported. The comorbidities of interest included cardiovascular diseases, chronic obstructive pulmonary disorder (COPD), asthma, kidney disease, diabetes, depression, anxiety, liver disease, sleep disorders. A participant could have \>1 comorbidity of interest.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Cardiovascular Disease | 90 | 25 | 12 |
| COPD | 20 | 7 | 4 |
| Asthma | 33 | 8 | 4 |
| Kidney disease | 17 | 5 | 3 |
| Diabetes | 58 | 16 | 8 |
| Depression | 44 | 12 | 6 |
| Anxiety | 36 | 14 | 8 |
| Liver disease | 13 | 2 | 3 |
| Sleep disorders | 43 | 13 | 10 |
Non-persistence was defined as the gap of at least 60 days in treatment with the index medication (tofacitinib) or switching to other biologic.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Number of Participants With Non-persistence to Index Medication (Tofacitinib) | 110 | 37 | 27 |
Number of participants with post-persistence treatment patterns is reported. Post-persistence was categorized as: 1) switch immediately (if participants initiated a non-index biologic before a 60-day gap in treatment is observed for the index medication); 2) discontinue then restart (if there was a gap in the index therapy of at least 60 days and the first medication observed after the gap is the index medication); 3) discontinue then switch ( if there was a gap in the index therapy of at least 60 days and the first medication observed after the gap is a biologic \[including Tofacitinib\] different from index medication), 4) discontinue without switch or restart (if participant's had a gap in therapy of at least 60 days and there are no claims for either the index medication or a different biologic for the remaining observation period).
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Switch immediately | 58 | 14 | 8 |
| Discontinue then switch | 6 | 3 | 3 |
| Discontinue then restart | 17 | 8 | 5 |
| Discontinue without switch or restart | 29 | 12 | 11 |
Number of participants who switched from index medication (tofacitinib) to a biologic at any time during post-index period is reported.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Number of Participants Who Switched From Index Medication (Tofacitinib) at Any Time During Post-Index Period | 64 | 17 | 12 |
Number of participants who re-started tofacitinib (after considered as non-persistence with the tofacitinib) after discontinuation at any time during post-index period is reported.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Number of Participants Who Re-started Index Medication (Tofacitinib) at Any Time During Post-Index Period | 17 | 8 | 5 |
Mean MPR for Methotrexate is reported. MPR was calculated as the total days supply of MTX between the first and including the last prescription/administration divided by the time between the first through and including last biologic prescription/administration days supply.
| ratio | Methotrexate (MTX) + Tofacitinib: MTX Persistent |
|---|---|
| Mean Medication Possession Ratio (MPR) for Methotrexate (MTX) | 0.93 ± 0.11 |
Mean adherence for methotrexate is reported. Adherence was calculated as the total number of days supplied for MTX during the post-index period divided by the number of days from the first claim during the post-index period to the end of the post-index period
| ratio | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Mean Adherence To Methotrexate (MTX) | 0.89 ± 0.11 | 0.43 ± 0.19 | 0.58 ± 0.15 |
Number of participants who used additional NB-DMARD during post index period is reported. Additional NB-DMARD use could have been leflunomide, sulfasalazine and hydroxychloroquine.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Leflunomide | 7 | 6 | 1 |
| Sulfasalazine | 3 | 4 | 1 |
| Hydroxychloroquine | 10 | 2 | 1 |
Medication effectiveness criteria categorized as: 1) adherence to index medication, 2) no dose escalation for index medication, 3) no switch from index medication, 4) no addition of NB-DMARD, 5) criteria for oral glucocorticoids, 6) use of Injectable glucocorticoids. Adherence to index medication was defined as at least 30 days continuous supply of tofacitinib during post-index period.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Number of Participants Who Met Medication Effectiveness Criteria: Adherence to Index Medication (Tofacitinib) | 212 | 50 | 14 |
Medication effectiveness criteria categorized as: 1) adherence to index medication, 2) no dose escalation for index medication, 3) no switch from index medication, 4) no addition of NB-DMARD, 5) criteria for oral glucocorticoids, 6) use of Injectable glucocorticoids. No dose escalation for index medication was defined as no increase in dose for index medication compared to the starting dose during post-index period.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Number of Participants Who Met Medication Effectiveness Criteria: No Dose Escalation for Index Medication (Tofacitinib) | 321 | 91 | 48 |
Medication effectiveness criteria categorized as: 1) adherence to index medication, 2) no dose escalation for index medication, 3) no switch from index medication, 4) no addition of NB-DMARD, 5) criteria for oral glucocorticoids, 6) use of Injectable glucocorticoids. No switch from index medication was defined as no switching from the index medication to a (different) biologic agent during post-index period.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Number of Participants Who Met Medication Effectiveness Criteria: No Switch From Index Medication (Tofacitinib) | 273 | 77 | 36 |
Medication effectiveness criteria categorized as: 1) adherence to index medication, 2) no dose escalation for index medication, 3) no switch from index medication, 4) no addition of NB-DMARD, 5) criteria for oral glucocorticoids, 6) use of Injectable glucocorticoids. No addition of NB-DMARD was defined as no addition of new NB-DMARD to index therapy during post-index period.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Number of Participants Who Met Medication Effectiveness Criteria: No Addition of NB-DMARD | 319 | 84 | 46 |
Medication effectiveness criteria categorized as: 1) adherence to index medication, 2) no dose escalation for index medication, 3) no switch from index medication, 4) no addition of NB-DMARD, 5) criteria for oral glucocorticoids, 6) use of Injectable glucocorticoids. Medication effectiveness criteria for oral glucocorticoids was defined as either of the following: 1) Participants cannot receive oral glucocorticoids for \> 30 days between (index date +91 days) to (index date + 359 days); 2) No increase in oral glucocorticoid dose during months 6-12 after index date.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Number of Participants Who Met Medication Effectiveness Criteria: Criteria for Oral Glucocorticoids | 281 | 81 | 39 |
Medication effectiveness criteria categorized as: 1) adherence to index medication, 2) no dose escalation for index medication, 3) no switch from index medication, 4) no addition of NB-DMARD, 5) criteria for oral glucocorticoids, 6) use of Injectable glucocorticoids. Use of Injectable glucocorticoids was defined as maximum one parenteral or intra-articular glucocorticoid joint injection use after the participant had been on biologic treatment for \>3 months post index date (\[index date +91 days\] to \[index date +359 days\]).
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Number of Participants Who Met Medication Effectiveness Criteria: Use of Injectable Glucocorticoids | 278 | 77 | 36 |
Number of participants with at least one ambulatory visit that was due to all cause during the pre-index period is reported. All cause refers to ambulatory visits due to all comorbidities, including RA.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Number of Participants With All Cause Ambulatory Visits During Pre-Index Period | 337 | 94 | 48 |
Number of participants with at least one emergency department visits that was due to all cause during the pre-index period is reported. All cause refers to emergency visits due to all comorbidities, including RA.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Number of Participants With All Cause Emergency Department Visits During Pre-Index Period | 88 | 29 | 15 |
Number of participants with at least one inpatient admissions that was due to all cause during the pre-index period is reported. All cause refers to inpatient admission due to all comorbidities, including RA.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Number of Participants With All Cause Inpatient Admissions During Pre-Index Period | 40 | 12 | 7 |
Number of participants with at least one ambulatory visit that was due to RA during the pre-index period is reported. RA related refers to ambulatory visits due to RA.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Number of Participants With RA Related Ambulatory Visits During Pre-Index Period | 336 | 94 | 48 |
Number of participants with at least one emergency department visits that was due to RA during the pre-index period is reported. RA related refers to emergency department visits due to RA.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Number of Participants With RA Related Emergency Department Visits During Pre-Index Period | 29 | 10 | 5 |
Number of participants with at least one inpatient admissions that was due to RA during the pre-index period is reported. RA related refers to inpatient admission due to RA.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Number of Participants With RA Related Inpatient Admissions During Pre-Index Period | 24 | 6 | 5 |
Number of participants with at least one ambulatory visit that was due to all cause during the post-index period is reported. All cause refers to ambulatory visits due to all comorbidities, including RA.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Number of Participants With All Cause Ambulatory Visits During Post-Index Period | 337 | 94 | 48 |
Number of participants with at least one emergency department visits that was due to all cause during the post-index period is reported. All cause refers to emergency department visits due to all comorbidities, including RA.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Number of Participants With All Cause Emergency Department Visits During Post-Index Period | 85 | 25 | 18 |
Number of participants with at least one inpatient admissions that was due to all cause during the post-index period is reported. All cause refers to inpatient admissions due to all comorbidities, including RA.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Number of Participants With All Cause Inpatient Admissions During Post-Index Period | 41 | 7 | 9 |
Number of participants with at least one of the RA-related ambulatory visits during the post-index period is reported. RA related refers to ambulatory visits due to RA.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Number of Participants With RA Related Ambulatory Visits During Post Index Period | 335 | 92 | 48 |
Number of participants with at least one of the RA-related emergency department visit during the post-index period is reported. RA related refers to emergency department visits due to RA.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Number of Participants With RA Related Emergency Department Visits During Post Index Period | 24 | 7 | 4 |
Number of participants with at least one of an RA-related inpatient admission during the post-index period is reported. RA related refers to inpatient admissions due to RA.
| Participants | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Number of Participants With RA Related Inpatient Admissions During Post Index Period | 31 | 4 | 9 |
Mean total health care cost all cause during pre-index period is reported. All cause refers to cost spent due to all comorbidities including RA and calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs).
| dollars | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Mean Total Health Care Cost All Cause During Pre-Index Period | 38294.06 ± 29855.01 | 37703.67 ± 34291.57 | 40845.52 ± 51582.10 |
RA related healthcare cost refers to cost spent due to RA alone and was calculated as the total of treatment cost (cost of tofacitinib, biologic DMARDs, NB-DMARDs and administration of intravenous (IV) biologics) and medical cost (cost of ambulatory cost, emergency department visits cost, inpatient admission cost, home health care cost, urgent care cost and other medical services cost).
| dollars | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Mean Total Health Care Cost RA Related During Pre-Index Period | 26310.56 ± 23044.42 | 21927.28 ± 18179.77 | 25941.25 ± 28226.04 |
Mean total health care cost due to all cause during post-index period is reported. All cause refers to cost spent due to all comorbidities, including RA and calculated as the total of pharmacy cost (cost of home healthcare cost, urgent care cost and other medical services costs) and medical cost (cost of ambulatory cost, emergency department visits cost, inpatient admission cost and other costs).
| dollars | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Mean Total Health Care Cost Due to All Cause During Post-Index Period | 54792.79 ± 29936.57 | 52877.64 ± 44741.22 | 54617.88 ± 51150.03 |
RA related healthcare cost refers to cost spent due to RA alone and was calculated as the total of treatment cost (cost of tofacitinib, biologic DMARDs, NB-DMARDs and administration of IV biologics) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost, home health care cost, urgent care cost and other medical services cost).
| dollars | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Mean Total Health Care Cost RA Related During Post-Index Period | 42402.93 ± 20786.01 | 35768.64 ± 13706.47 | 41984.33 ± 39638.80 |
Treatment persistence with tofacitinib was defined as not having a gap in therapy of at least 60 days between prescription re-fills of tofacitinib.
| days | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| Mean Treatment Persistence Duration Measured for Index Medication (Tofacitinib) | 297.61 ± 99.42 | 284.48 ± 102.42 | 246.94 ± 120.12 |
Mean total monthly health care cost due to all cause is reported. All cause refers to cost spent due to all comorbidities, including RA and calculated as the total of pharmacy cost (cost of home healthcare cost, urgent care cost and other medical services costs) and medical cost (cost of ambulatory cost, emergency department visits cost, inpatient admission cost and other costs). Total all cause monthly health care cost is reported for every month from 12 months duration before index date (pre-index period) to 12 months duration post index date (post index period). Index date is defined as the date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.
| dollars | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| 1 month before index date | 1982.85 ± 3160.93 | 1298.00 ± 1660.83 | 1590.23 ± 2342.22 |
| 2 months before index date | 2961.52 ± 6134.21 | 2859.41 ± 4782.43 | 2007.33 ± 2279.76 |
| 3 months before index date | 2920.21 ± 3787.33 | 3160.66 ± 5286.29 | 2283.86 ± 2405.21 |
| 4 months before index date | 3218.67 ± 4385.35 | 3481.17 ± 4512.71 | 3255.21 ± 3927.64 |
| 5 months before index date | 3085.10 ± 4078.22 | 2821.69 ± 3482.77 | 4322.60 ± 12892.15 |
| 6 months before index date | 3708.45 ± 6412.35 | 3469.21 ± 7966.20 | 6210.48 ± 15934.47 |
| 7 months before index date | 3004.67 ± 3751.57 | 5219.03 ± 20901.31 | 3332.57 ± 4279.40 |
| 8 months before index date | 3650.97 ± 7165.39 | 3407.89 ± 6513.74 | 4578.01 ± 16218.40 |
| 9 months before index date | 3902.43 ± 7411.23 | 2798.05 ± 3916.34 | 4698.18 ± 13942.52 |
| 10 months before index date | 3128.19 ± 4655.37 | 3074.57 ± 5981.65 | 2850.71 ± 3512.63 |
| 11 months before index date | 3226.98 ± 6905.09 | 2765.39 ± 3795.95 | 2268.61 ± 2941.55 |
| 12 months before index date | 3504.01 ± 7280.54 | 3348.60 ± 7074.21 | 3447.74 ± 7167.30 |
| 1 month after index date | 6493.14 ± 5621.42 | 6219.90 ± 4771.10 | 5613.83 ± 2685.11 |
| 2 months after index date | 3401.05 ± 3629.35 | 3335.68 ± 2638.48 | 3534.10 ± 3435.08 |
| 3 months after index date | 5192.25 ± 12424.70 | 4274.36 ± 3929.19 | 7069.72 ± 23449.05 |
| 4 months after index date | 5542.45 ± 12928.65 | 3884.67 ± 2886.54 | 3936.05 ± 5042.01 |
| 5 months after index date | 3502.04 ± 5264.36 | 3164.43 ± 3257.78 | 3558.20 ± 4942.20 |
| 6 months after index date | 4367.35 ± 5250.44 | 3430.03 ± 4363.37 | 4062.60 ± 4741.14 |
| 7 months after index date | 4335.90 ± 5099.96 | 4876.01 ± 5517.19 | 6839.45 ± 24302.54 |
| 8 months after index date | 3998.48 ± 5427.41 | 3232.79 ± 3365.36 | 3870.33 ± 5967.14 |
| 9 months after index date | 4562.22 ± 7188.96 | 4250.44 ± 5153.79 | 3033.80 ± 4573.15 |
| 10 months after index date | 4680.99 ± 6427.93 | 4507.04 ± 4474.32 | 4208.68 ± 6898.73 |
| 11 months after index date | 4297.17 ± 5507.21 | 3527.33 ± 5467.69 | 3958.85 ± 6181.37 |
| 12 months after index date | 4419.74 ± 6361.66 | 8174.95 ± 40068.17 | 4932.28 ± 13927.49 |
Mean total monthly health care cost due to RA is reported. RA related refers to cost spent by participants due to RA on health care services. This is calculated as the total of treatment cost (cost of tofacitinib, biologic DMARDs, NB-DMARDs and administration of IV biologics) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost, home health care cost, urgent care cost and other medical services cost). RA related monthly health care cost is reported for every month from 12 months duration before index date (pre-index period) to 12 months duration post index date (post index period). Index date is defined as the date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.
| dollars | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted |
|---|---|---|---|
| 1 month before index date | 1195.04 ± 2637.68 | 671.18 ± 1213.40 | 636.05 ± 1238.09 |
| 2 months before index date | 1903.16 ± 3155.45 | 1577.52 ± 2390.24 | 1141.74 ± 1700.28 |
| 3 months before index date | 2152.29 ± 3413.71 | 2361.03 ± 4927.73 | 1581.22 ± 2378.86 |
| 4 months before index date | 2168.50 ± 3489.71 | 2614.99 ± 4041.35 | 2285.37 ± 3322.71 |
| 5 months before index date | 2254.93 ± 3480.55 | 1917.28 ± 2766.38 | 3312.04 ± 12509.62 |
| 6 months before index date | 2422.23 ± 4000.01 | 1931.47 ± 3046.55 | 4535.86 ± 13927.05 |
| 7 months before index date | 2183.57 ± 3240.88 | 2403.88 ± 3808.44 | 1776.81 ± 2692.28 |
| 8 months before index date | 2697.28 ± 6295.30 | 1756.79 ± 2719.69 | 3511.39 ± 15412.06 |
| 9 months before index date | 2516.49 ± 4380.11 | 1700.46 ± 2463.15 | 1755.33 ± 2741.92 |
| 10 months before index date | 2420.82 ± 4487.55 | 1640.42 ± 2578.03 | 2197.70 ± 3256.25 |
| 11 months before index date | 1932.94 ± 3480.59 | 1664.42 ± 3182.62 | 1534.64 ± 2442.49 |
| 12 months before index date | 2463.30 ± 6488.79 | 1687.84 ± 2743.46 | 1673.11 ± 2538.14 |
| 1 month after index date | 5520.12 ± 3236.09 | 4864.96 ± 2427.19 | 5078.09 ± 2374.78 |
| 2 months after index date | 2475.97 ± 2565.47 | 2562.85 ± 1762.39 | 2467.49 ± 1841.74 |
| 3 months after index date | 4264.21 ± 11021.43 | 3525.69 ± 3579.91 | 5901.33 ± 22733.73 |
| 4 months after index date | 4513.18 ± 11997.33 | 3312.81 ± 2744.19 | 2193.74 ± 1997.44 |
| 5 months after index date | 2525.72 ± 3219.78 | 2171.23 ± 2225.60 | 2550.85 ± 4254.36 |
| 6 months after index date | 3448.44 ± 4479.50 | 2290.80 ± 2770.10 | 2715.92 ± 2695.20 |
| 7 months after index date | 3214.12 ± 3146.04 | 3172.63 ± 3093.67 | 6205.73 ± 23782.75 |
| 8 months after index date | 2792.29 ± 3675.52 | 2441.75 ± 2695.77 | 2888.44 ± 5532.83 |
| 9 months after index date | 3596.05 ± 6104.08 | 2667.32 ± 3922.25 | 2532.87 ± 4559.72 |
| 10 months after index date | 3536.10 ± 4403.21 | 3295.99 ± 3718.43 | 2521.96 ± 3201.05 |
| 11 months after index date | 3292.62 ± 4725.06 | 2574.32 ± 4803.21 | 2966.58 ± 5539.05 |
| 12 months after index date | 3224.11 ± 5151.51 | 2888.29 ± 4727.03 | 3961.34 ± 13543.17 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Methotrexate (MTX) + Tofacitinib: MTX Persistent | — | — | — |
| Methotrexate (MTX) + Tofacitinib: MTX Discontinued | — | — | — |
| Methotrexate (MTX) + Tofacitinib: MTX Interrupted | — | — | — |
Analysis was performed on all participants included in the study.
| Age, Continuous(years) | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted | Total |
|---|---|---|---|---|
| Mean | 56.10 ± 10.37 | 55.02 ± 9.81 | 58.08 ± 9.43 | 56.09 ± 10.18 |
| Sex: Female, Male(Participants) | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted | Total |
|---|---|---|---|---|
| Female | 269 | 82 | 35 | 386 |
| Male | 68 | 12 | 13 | 93 |
| Race and Ethnicity Not Collected(Participants) | Methotrexate (MTX) + Tofacitinib: MTX Persistent | Methotrexate (MTX) + Tofacitinib: MTX Discontinued | Methotrexate (MTX) + Tofacitinib: MTX Interrupted | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
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Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Ran from May 2018 to primary completion in Oct 2018, 4 months.
Results were first posted in Oct 2019, 1 year after primary completion.
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