An observational study in Psoriatic Arthritis, sponsored by Pfizer. Completed at 41 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-14.
Sponsored by Pfizer · Observational
This is a Multinational Study of Tofacitinib in Patients Treated for Psoriatic Arthritis in order to evaluate the effectiveness of treatment with tofacitinib on disease activity, remission, and Quality of Life, in a real-world setting over a 12-month observation period
579 studies on the registry are indexed under Arthritis, Psoriatic; 132 are open to participants now.
This study's enrollment of 116 is below the median of 300 across 235 observational studies indexed under Arthritis, Psoriatic.
Browse Arthritis, Psoriatic studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
This study will enroll approximately 500 patients from rheumatologists and/or PsA specialist centers in 10 countries (Belgium, Czech Republic, Denmark, Finland, France, Israel, Netherlands, Spain, Sweden, and Switzerland) over an enrollment period of 12 months. The above list of countries are anticipated to participate in this study, however additional countries may be included at a later time. Each patient will have up to 12 months of follow-up for a total study duration of 24 months. Consecutive patients attending a routine clinical visit will be invited to participate if they meet the eligibility criteria for the study and are to start on treatment with tofacitinib for active PsA.
Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
Exclusion Criteria: Patients meeting any of the following criteria will not be included in the study:
Percentage of Participants Who Achieved Low Disease Activity (LDA) Based on Psoriatic Arthritis Disease Activity Score (PASDAS) at Month 6
PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global psoriatic arthritis assessment (PAA), physician global PAA, each scored on 100 mm visual analog scale (VAS), 0=no disease activity (DA), 100=maximum DA; tender joint count (TJC) (0-68); swollen joint count (SJC) (0-66); Leed's Enthesitis index (LEI) score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; physical component summary (PCS) of short form 36 (SF-36) score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and C-reactive protein (CRP) in milligram per liter (mg/L). PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease. LDA was defined as PASDAS score less than or equal to (\<=) 3.2.
Time frame: At Month 6
Percentage of Participants Who Achieved LDA Based on PASDAS at Months 3 and 12
PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease. LDA was defined as PASDAS score less than or equal to (\<=) 3.2.
Time frame: At Month 3 and Month 12
Percentage of Participants Who Achieved Minimum Disease Activity (MDA) at Months 3, 6 and 12
A participant was classified as MDA achieved if they met 5 of 7 criteria: (i) (TJC66) \<=1, (ii) (SJC68)\<=1, (iii) psoriasis area and severity index (PASI) score \<=1 (PASI=combined assessment of lesion severity and area affected into single score; range=0 \[no disease\] to 72 \[maximal disease\], higher scores=more disease. or body surface area (BSA) \<=3%,(iv) patient pain assessment (VAS, 0-100) \<=15; where 0='no pain' and 100='pain as severe as can be imagined', higher scores=more pain, (v) patient global assessment (VAS, 0-100) \<=20, where 0='lowest level of disease activity' and 100= 'highest level of disease activity, higher scores=more disease activity, (vi) health assessment questionnaire-disability index (HAQ- DI) \<=0.5; scale ranged=0-3, where 0='normal or no difficulty' and 3='inability to perform', higher scores=more difficulty, (vii) tender enthesial points \<=1 using Leed's index range=0=non tender to 6=more enthesitis burden, higher scores=more burden.
Time frame: At Month 3, Month 6 and Month 12
Percentage of Participants Who Achieved Remission Based on PASDAS at Months 3, 6 and 12
PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease. Remission was defined as PASDAS score less than or equal to (\<=) 1.9.
Time frame: At Month 3, Month 6 and Month 12
Percentage of Participants Who Achieved Remission Based on Disease Activity in Psoriatic Arthritis (DAPSA) Score at Months 3, 6 and 12
DAPSA was composite disease activity measure and was calculated as: SJC66 + TJC68 + patient global assessment VAS (0 to 10 cm VAS, 0= excellent and 10= poor, higher scores indicated more disease activity) + patient pain assessment (0 to 10 cm VAS, 0= no pain, 10= worst possible pain, higher scores indicated more pain) + CRP (mg/dL). DAPSA score ranged from 0 to 164, higher scores indicated more disease activity. Remission was defined as DAPSA score =\<4.0.
Time frame: At Month 3, Month 6 and Month 12
Change From Baseline in Psoriatic Arthritis Impact of Disease 12 Questions (PsAID12) Score at Months 3, 6 and 12
PsAID12: questionnaire used for evaluating how much PsA impacted quality of life (QoL) and comprised of following domains: Pain, Fatigue, Skin problems, Work and/or leisure activities, Function, Discomfort, Sleep disturbance, Coping, Anxiety, Embarrassment, Social life and Depression. Each one of domain was based on a 0-10 numerical rating scale (NRS) and with different weight. PsAID12= (PsAID12.Q1 \[pain\] NRS value\*3) +(PsAID12.Q2\[fatigue\] NRS value\*2) +(PsAID12.Q3 \[skin\] NRS value\*2) +(PsAID12.Q4\[Work and/or leisure activities\] NRS value\*2) +(PsAID12.Q5\[function\] NRS value\*2) +(PsAID12.Q6\[discomfort\]NRS value\*2) +(PsAID12.Q7\[sleep\] NRS value\*2) +(PsAID12.Q8 \[coping\]NRS value\*1) +(PsAID12.Q9\[anxiety\] NRS value\*1) +(PsAID12.Q10\[embarrassment\] NRS value\*1) +(PsAID12.Q11\[social life\] NRS value\*1) +(PsAID12.Q12\[depression\] NRS value\*1). Total is divided by 20 for final score. Range of final PsAID score is 0-10 (higher numbers indicate worse status).
Time frame: Baseline (measurement at enrollment), at Month 3, Month 6 and Month 12
Change From Baseline in Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC-EI) Score at Months 3, 6 and 12
The SPARCC-EI evaluated 16 enthesial sites: greater trochanter (Right/Left \[R/L\]), quadriceps tendon insertion into the patella (R/L), patellar ligament insertion into the patella and tibial tuberosity (R/L), achilles tendon insertion (R/L), plantar fascia insertion (R/L), medial epicondyles (R/L), lateral epicondyles (R/L) and supraspinatus insertion (R/L) for the presence or absence of tenderness. Tenderness at each site was quantified as: 0 = non-tender and 1 = tender. The maximum score of the SPARCC-EI was 16. SPARCC-EI score range: 0 (no enthesitis) to 16 (enthesitis is present at all assessed sites), higher scores indicated more presence of enthesitis.
Time frame: Baseline (measurement at enrollment), at Month 3, Month 6 and Month 12
Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12
BMI = Weight (kilograms \[kg\]) / Height (meter square \[m\]\^2). LDA was defined as PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease. In this outcome measure, participants with PASDAS scores are reported according to BMI categories of 18.5 - \<25 kg/m\^2, 25 - \<30 kg/m\^2, \>= 30 kg/m\^2 and missing.
Time frame: At Month 3, Month 6 and Month 12
Number of Participants Who Achieved LDA According to Treatment Line at Months 3, 6 and 12
Participants who achieved LDA according to treatment line were reported in this outcome measure. Treatment line included: tofacitinib monotherapy, combination therapy with MTX, and combination therapy with other csDMARDs. LDA was defined as PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease.
Time frame: At Month 3, Month 6 and Month 12
Number of Participants Who Achieved LDA According to Duration of Current Episode Symptoms of at Least 6 Weeks Prior to Enrollment at Months 3, 6 and 12
Duration of current episode of symptoms prior to enrollment were presented as: \< 6, \>=6 weeks. LDA was defined as PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease.
Time frame: At Month 3, Month 6 and Month 12
Number of Participants Who Achieved LDA According to Erythrocyte Sedimentation Rate (ESR) Results at Months 3, 6 and 12
ESR result=abnormal if test result was above normal range. ESR normal range:0-50 years(male \<15 mm/h, female \<20 mm/h), 51-85 years(\<20 mm/h males and \<30 mm/h females),older than 85 years(\<30 mm/h males and \<42 mm/h females). Number of participants who achieved LDA according to ESR results(normal and abnormal) were reported. LDA=PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of following:participant global PAA,physician global PAA,each scored on 100 mm VAS,0=no DA, 100=maximum DA; TJC(0-68); SJC(0-66); LEI score=0-6;0=non tender,6=more enthesitis burden; tender dactylitis digit score=0-3,0=no tenderness,3=participant withdrew digit; PCS of SF-36 score=0-100; 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged=0(no disease)to 10(severe disease);higher scores=more severe disease.
Time frame: At Month 3, Month 6 and Month 12
Number of Participants Who Achieved LDA According to C-reactive Protein (CRP) Results at Months 3, 6 and 12
For CRP, result was considered abnormal if t the test result was above the normal range (0.3 to 10 mg/L). LDA was defined as PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease.
Time frame: At Month 3, Month 6 and Month 12
Number of Participants Who Achieved LDA According to Presence of Rheumatoid Nodules at Months 3, 6 and 12
Number of participants who achieved LDA according to presence (present/absent) of rheumatoid nodules is presented in this outcome measure. LDA was defined as PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease.
Time frame: At Month 3, Month 6 and Month 12
Number of Participants Who Achieved LDA According to Presence of Unequivocal Radiological Erosion at Months 3, 6 and 12
Unequivocal radiological erosion: 'present',if Sharp-Van der Heijde modified score (S-VH MS)for erosion \>0;'absent',if S-VH MS for erosion score=0. S-VH MS sum of erosion,JSN scores(range 0-528). Higher score=more severe disease. If a component score is missing, S-VH MS is missing. LDA=PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of following: participant global PAA,physician global PAA,each scored on 100 mm VAS,0=no DA,100=maximum DA; TJC(0-68); SJC(0-66); LEI score range=0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score range=0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score range=0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0(no disease)to 10(severe disease); higher scores=more severe disease.
Time frame: At Month 3, Month 6 and Month 12
Number of Participants Who Achieved LDA According to Presence of Unequivocal Bony Decalcification Localized to the Joints of the Hands and Wrists at Months 3, 6 and 12
Unequivocal Bony decalcification was reported as present or absent at enrollment. LDA was defined as PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease.
Time frame: At Month 3, Month 6 and Month 12
Number of Participants Who Achieved LDA According to Presence of Symmetric Arthritis at Months 3, 6 and 12
Arthritis at enrollment was identified when a participant reported swelling and/or tenderness/pain in any joint. Number of participants who achieved LDA according to presence (Yes/No) of symmetric arthritis was reported. LDA was defined as PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease.
Time frame: At Month 3, Month 6 and Month 12
Number of Participants Who Achieved LDA According to Arthritis of the Hand Joints at Months 3, 6 and 12
Hand joints included metacarpal phalangeal joints(MCP), finger proximal interphalangeal and finger distal interphalangeal joints. Number of participants who achieved LDA according to presence(Yes/No) of arthritis of any of hand joints was reported. LDA=PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of following: participant global PAA,physician global PAA, each scored on 100 mm VAS,0=no DA,100=maximum DA;TJC(0-68); SJC(0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease.
Time frame: At Month 3, Month 6 and Month 12
Number of Participants Who Achieved LDA According to Arthritis of Only 1 Medium-Large Joint at Months 3, 6 and 12
Medium joints=temporomandibular, sternoclavicular, acromioclavicular, finger proximal interphalangeal, finger distal interphalangeal and tarsus/midfoot(feet) joints. Large joints=glenohumeral, elbows, hips, knees and ankles joint. Number of participants who achieved LDA according to presence (Yes/No) of arthritis of only 1 medium-large joint was reported. LDA=PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA incorporated assessment of: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA;TJC(0-68);SJC(0-66); LEI score ranging from 0-6;0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3;0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100;0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS score (0-10) uses a weighted formula; higher scores=more severe disease.
Time frame: At Month 3, Month 6 and Month 12
Number of Participants Who Achieved LDA According to Arthritis of 2-10 Medium-Large Joints and/or 1-3 Small Joints at Months 3, 6 and 12
Medium joints=temporomandibular, sternoclavicular, acromioclavicular, finger proximal interphalangeal (IP), finger distal interphalangeal, tarsus/midfoot (feet). Large joints=glenohumeral, elbows, hips, knees, ankles. Small joints=MCP, proximal IP, second through fifth metatarsal phalangeal (MTP), thumb IP, wrists. Number of participants who achieved LDA according to presence (Yes/No) arthritis of 2-10 medium-large joints and/or 1-3 small joints was reported. LDA=PASDAS score =\<3.2. PASDAS is a composite PsA activity score including: participant /physician global (VAS 0-100; 0=no DA, 100=maximum DA), TJC (0-68), SJC (0-66), LEI (0-6; 0=non tender, 6=more enthesitis burden), tender dactylitis digit score (0-3; 0=no tenderness, 3=participant withdrew digit), SF-36 PCS (0-100; 0=severe physical health limitations, 100=excellent physical health),CRP in mg/L. PASDAS score (0-10) uses a weighted formula; higher scores=more severe disease.
Time frame: At Month 3, Month 6 and Month 12
Number of Participants Who Achieved LDA According to Arthritis of 4-10 Small Joints With or Without Involvement of Large Joints at Months 3, 6 and 12
Large joints=glenohumeral, elbows, hips, knees and ankles joint. Small joints=MCP, proximal IP, second through fifth MTP, thumb IP, wrists. Number of participants who achieved LDA according to presence (Yes/No) of arthritis of 4-10 small joints with or without involvement of large joints was reported. LDA=PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA incorporated assessment of: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA;TJC(0-68); SJC(0-66); LEI score range=0-6; 0=non tender, 6=more enthesitis burden; tender dactylitis digit score range=0-3; 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores=more severe disease.
Time frame: At Month 3, Month 6 and Month 12
Number of Participants Who Achieved LDA According to Arthritis of >10 Joints (With at Least One Small Joint) at Months 3, 6 and 12
Small joints=MCP, proximal IP, second through fifth MTP, thumb IP, wrists. Number of participants who achieved LDA according to presence (Yes/No) of arthritis of \>10 joints (with at least one small joint) was reported in this outcome measure. LDA=PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA incorporated assessment of: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC(0-68); SJC(0-66); LEI score ranging from 0-6; 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3; 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores=more severe disease.
Time frame: At Month 3, Month 6 and Month 12
Change From Baseline in Quality of Life (QoL) Based on Short Form 36 (SF-36) Score at Months 3, 6 and 12
The SF-36 is a participant administered scale assessing general quality of life. It consists of self-administered 36-item questionnaire that measured 8 health domains: physical function, role-physical, bodily pain, general health, vitality, social function, role-emotional, and mental health. These 8 domains are also summarized as physical and mental component scores. The score for each domain and component score is the mean of the individual question scores, which are scaled from 0 (minimum) to 100 (maximum), where high scores in each dimension and high overall scores indicate a better quality of life.
Time frame: Baseline (measurement at enrollment), Month 3, Month 6 and Month 12
Change From Baseline in QoL Based on Health Assessment Questionnaire - Disability Index (HAQ-DI41) at Months 3, 6 and 12
The HAQ-DI41 assessed the degree of difficulty a participant had experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. For each question in the questionnaire, the level of difficulty was scored from 0 to 3 with 0 =no difficulty," 1 = "some difficulty," 2 = "much difficulty," and 3 = "unable to do". The disability index was computed by adding the scores for each of the components and dividing by the number of components with an available score. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities.
Time frame: Baseline (measurement at enrollment), Month 3, Month 6 and Month 12
Participants diagnosed with psoriatic arthritis (PsA) and treated with tofacitinib in routine clinical practice were included in this prospective study.
| Milestone | All Participants |
|---|---|
| Started | 116 |
| Safety (started tofacitinib irrespective of eligibility criteria) | 113 |
| Full analysis set | 109 |
| Completed | 59 |
| Not completed | 57 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Drug withdrawn | 44 |
| Withdrew: Other | 1 |
| Withdrew: Eligibility criteria not met | 4 |
| Withdrew: Did not receive treatment | 3 |
PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global psoriatic arthritis assessment (PAA), physician global PAA, each scored on 100 mm visual analog scale (VAS), 0=no disease activity (DA), 100=maximum DA; tender joint count (TJC) (0-68); swollen joint count (SJC) (0-66); Leed's Enthesitis index (LEI) score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; physical component summary (PCS) of short form 36 (SF-36) score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and C-reactive protein (CRP) in milligram per liter (mg/L). PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease. LDA was defined as PASDAS score less than or equal to (\<=) 3.2.
| Percentage of participants | All Participants |
|---|---|
| Overall | 43.1 (29.9 to 56.3) |
| Tofacitinib monotherapy | 46.9 (31.4 to 62.4) |
| Combined tofacitinib and methotrexate (MTX) therapy | 33.4 (9.4 to 57.5) |
| Combined tofacitinib and other conventional synthetic disease-modifying antirheumatic drug (csDMARD) | 4.0 (NA to NA) |
PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease. LDA was defined as PASDAS score less than or equal to (\<=) 3.2.
| Percentage of participants | All Participants |
|---|---|
| Overall-Month 3 | 23.5 (13.9 to 36.9) |
| Tofacitinib monotherapy-Month 3 | 21.1 (10.8 to 36.6) |
| Combined tofacitinib and MTX therapy-Month 3 | 33.3 (13.6 to 61.2) |
| Combined tofacitinib and other csDMARD-Month 3 | 0 (0.0 to 82.9) |
| Overall-Month 12 | 46.2 (28.7 to 64.5) |
| Tofacitinib monotherapy-Month 12 | 47.4 (27.3 to 68.3) |
| Combined tofacitinib and MTX therapy-Month 12 | 42.9 (15.8 to 75.0) |
A participant was classified as MDA achieved if they met 5 of 7 criteria: (i) (TJC66) \<=1, (ii) (SJC68)\<=1, (iii) psoriasis area and severity index (PASI) score \<=1 (PASI=combined assessment of lesion severity and area affected into single score; range=0 \[no disease\] to 72 \[maximal disease\], higher scores=more disease. or body surface area (BSA) \<=3%,(iv) patient pain assessment (VAS, 0-100) \<=15; where 0='no pain' and 100='pain as severe as can be imagined', higher scores=more pain, (v) patient global assessment (VAS, 0-100) \<=20, where 0='lowest level of disease activity' and 100= 'highest level of disease activity, higher scores=more disease activity, (vi) health assessment questionnaire-disability index (HAQ- DI) \<=0.5; scale ranged=0-3, where 0='normal or no difficulty' and 3='inability to perform', higher scores=more difficulty, (vii) tender enthesial points \<=1 using Leed's index range=0=non tender to 6=more enthesitis burden, higher scores=more burden.
| Percentage of participants | All Participants |
|---|---|
| Overall-Month 3 | 17.6 (11.0 to 26.8) |
| Tofacitinib monotherapy-Month 3 | 16.7 (9.4 to 27.6) |
| Combined tofacitinib and MTX therapy-Month 3 | 21.7 (9.2 to 42.3) |
| Combined tofacitinib and other csDMARD-Month 3 | 0 (0.0 to 71.1) |
| Overall-Month 6 | 42.3 (31.4 to 53.9) |
| Tofacitinib monotherapy-Month 6 | 42.0 (29.4 to 55.8) |
| Combined tofacitinib and MTX therapy-Month 6 | 45.0 (25.8 to 65.8) |
| Combined tofacitinib and other csDMARD-Month 6 | 0 (0.0 to 82.9) |
| Overall-Month 12 | 43.9 (31.8 to 56.7) |
| Tofacitinib monotherapy-Month 12 | 45.0 (30.7 to 60.2) |
| Combined tofacitinib and MTX therapy-Month 12 | 43.8 (23.1 to 66.8) |
| Combined tofacitinib and other csDMARD-Month 12 | 0 (0.0 to 82.9) |
PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease. Remission was defined as PASDAS score less than or equal to (\<=) 1.9.
| Percentage of participants | All Participants |
|---|---|
| Overall-Month 3 | 12.1 (6.0 to 22.4) |
| Tofacitinib monotherapy-Month 3 | 14.3 (6.8 to 27.0) |
| Combined tofacitinib and MTX therapy-Month 3 | 7.1 (0.0 to 33.5) |
| Combined tofacitinib and other csDMARD-Month 3 | 0 (0.0 to 62.0) |
| Overall-Month 6 | 15.7 (7.9 to 28.3) |
| Tofacitinib monotherapy-Month 6 | 20.0 (9.7 to 36.2) |
| Combined tofacitinib and MTX therapy-Month 6 | 6.7 (0.0 to 31.8) |
| Combined tofacitinib and other csDMARD-Month 6 | 0 (0.0 to 82.9) |
| Overall-Month 12 | 21.6 (11.1 to 37.4) |
| Tofacitinib monotherapy-Month 12 | 25.9 (12.9 to 44.9) |
| Combined tofacitinib and MTX therapy-Month 12 | 11.1 (0.0 to 45.7) |
| Combined tofacitinib and other csDMARD-Month 12 | 0 (0.0 to 82.9) |
DAPSA was composite disease activity measure and was calculated as: SJC66 + TJC68 + patient global assessment VAS (0 to 10 cm VAS, 0= excellent and 10= poor, higher scores indicated more disease activity) + patient pain assessment (0 to 10 cm VAS, 0= no pain, 10= worst possible pain, higher scores indicated more pain) + CRP (mg/dL). DAPSA score ranged from 0 to 164, higher scores indicated more disease activity. Remission was defined as DAPSA score =\<4.0.
| Percentage of participants | All Participants |
|---|---|
| Overall-Month 3 | 11.3 (4.9 to 22.9) |
| Tofacitinib monotherapy-Month 3 | 11.6 (4.6 to 24.9) |
| Combined tofacitinib and MTX therapy-Month 3 | 11.1 (0.0 to 45.7) |
| Combined tofacitinib and other csDMARD-Month 3 | 0 (0.0 to 82.9) |
| Overall-Month 6 | 28.9 (17.6 to 43.5) |
| Tofacitinib monotherapy-Month 6 | 36.4 (22.1 to 53.4) |
| Combined tofacitinib and MTX therapy-Month 6 | 8.3 (0.0 to 37.5) |
| Overall-Month 12 | 38.7 (23.7 to 56.2) |
| Tofacitinib monotherapy-Month 12 | 47.6 (28.3 to 67.6) |
| Combined tofacitinib and MTX therapy-Month 12 | 20.0 (4.6 to 52.1) |
PsAID12: questionnaire used for evaluating how much PsA impacted quality of life (QoL) and comprised of following domains: Pain, Fatigue, Skin problems, Work and/or leisure activities, Function, Discomfort, Sleep disturbance, Coping, Anxiety, Embarrassment, Social life and Depression. Each one of domain was based on a 0-10 numerical rating scale (NRS) and with different weight. PsAID12= (PsAID12.Q1 \[pain\] NRS value\*3) +(PsAID12.Q2\[fatigue\] NRS value\*2) +(PsAID12.Q3 \[skin\] NRS value\*2) +(PsAID12.Q4\[Work and/or leisure activities\] NRS value\*2) +(PsAID12.Q5\[function\] NRS value\*2) +(PsAID12.Q6\[discomfort\]NRS value\*2) +(PsAID12.Q7\[sleep\] NRS value\*2) +(PsAID12.Q8 \[coping\]NRS value\*1) +(PsAID12.Q9\[anxiety\] NRS value\*1) +(PsAID12.Q10\[embarrassment\] NRS value\*1) +(PsAID12.Q11\[social life\] NRS value\*1) +(PsAID12.Q12\[depression\] NRS value\*1). Total is divided by 20 for final score. Range of final PsAID score is 0-10 (higher numbers indicate worse status).
| Units on a scale | All Participants |
|---|---|
| Overall-Month 3 | -1.3 (-1.69 to -0.84) |
| Tofacitinib monotherapy-Month 3 | -1.4 (-1.91 to -0.86) |
| Combined tofacitinib and MTX therapy-Month 3 | -1.0 (-1.84 to -0.15) |
| Combined tofacitinib and other csDMARD-Month 3 | NA (NA to NA) |
| Overall-Month 6 | -1.3 (-1.79 to -0.80) |
| Tofacitinib monotherapy-Month 6 | -1.5 (-2.06 to -0.87) |
| Combined tofacitinib and MTX therapy-Month 6 | -0.9 (-1.91 to 0.08) |
| Combined tofacitinib and other csDMARD-Month 6 | NA (NA to NA) |
| Overall-Month 12 | -1.1 (-1.61 to -0.56) |
| Tofacitinib monotherapy-Month 12 | -1.3 (-1.94 to -0.64) |
| Combined tofacitinib and MTX therapy-Month 12 | -0.7 (-1.69 to 0.25) |
| Combined tofacitinib and other csDMARD-Month 12 | NA (NA to NA) |
The SPARCC-EI evaluated 16 enthesial sites: greater trochanter (Right/Left \[R/L\]), quadriceps tendon insertion into the patella (R/L), patellar ligament insertion into the patella and tibial tuberosity (R/L), achilles tendon insertion (R/L), plantar fascia insertion (R/L), medial epicondyles (R/L), lateral epicondyles (R/L) and supraspinatus insertion (R/L) for the presence or absence of tenderness. Tenderness at each site was quantified as: 0 = non-tender and 1 = tender. The maximum score of the SPARCC-EI was 16. SPARCC-EI score range: 0 (no enthesitis) to 16 (enthesitis is present at all assessed sites), higher scores indicated more presence of enthesitis.
| Units on a scale | All Participants |
|---|---|
| Overall-Month 3 | 0.1 (-0.67 to 0.85) |
| Tofacitinib monotherapy-Month 3 | 0.1 (-0.80 to 0.95) |
| Combined tofacitinib and MTX therapy-Month 3 | 0.2 (-1.87 to 2.18) |
| Combined tofacitinib and other csDMARD-Month 3 | NA (NA to NA) |
| Overall-Month 6 | -0.8 (-1.47 to -0.21) |
| Tofacitinib monotherapy-Month 6 | -0.4 (-1.17 to 0.28) |
| Combined tofacitinib and MTX therapy-Month 6 | -1.8 (-3.20 to -0.39) |
| Overall-Month 12 | -0.3 (-0.95 to 0.44) |
| Tofacitinib monotherapy-Month 12 | 0.0 (-0.81 to 0.82) |
| Combined tofacitinib and MTX therapy-Month 12 | -0.9 (-2.42 to 0.71) |
BMI = Weight (kilograms \[kg\]) / Height (meter square \[m\]\^2). LDA was defined as PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease. In this outcome measure, participants with PASDAS scores are reported according to BMI categories of 18.5 - \<25 kg/m\^2, 25 - \<30 kg/m\^2, \>= 30 kg/m\^2 and missing.
| Participants | All Participants |
|---|---|
| Overall: 18.5 - <25 kg/m^2-Month 3 | 2 |
| Overall: 25 - <30 kg/m^2-Month 3 | 6 |
| Overall: >= 30 kg/m^2-Month 3 | 3 |
| Overall: Missing-Month 3 | 1 |
| Overall: 18.5 - <25 kg/m^2-Month 6 | 8 |
| Overall: 25 - <30 kg/m^2-Month 6 | 8 |
| Overall: >= 30 kg/m^2-Month 6 | 2 |
| Overall: Missing-Month 6 | 2 |
| Overall: 18.5 - <25 kg/m^2-Month 12 | 5 |
| Overall: 25 - <30 kg/m^2-Month 12 | 4 |
| Overall: >= 30 kg/m^2-Month 12 | 2 |
| Overall: Missing-Month 12 | 1 |
| Tofacitinib monotherapy: 18.5 - <25 kg/m^2-Month 3 | 1 |
| Tofacitinib monotherapy: 25 - <30 kg/m^2-Month 3 | 5 |
| Tofacitinib monotherapy: >= 30 kg/m^2-Month 3 | 1 |
| Tofacitinib monotherapy: Missing-Month 3 | 1 |
| Tofacitinib monotherapy: 18.5 - <25 kg/m^2-Month 6 | 4 |
| Tofacitinib monotherapy: 25 - <30 kg/m^2-Month 6 | 8 |
| Tofacitinib monotherapy: >= 30 kg/m^2-Month 6 | 1 |
| Tofacitinib monotherapy: Missing-Month 6 | 2 |
| Tofacitinib monotherapy: 18.5 - <25 kg/m^2-Month 12 | 3 |
| Tofacitinib monotherapy: 25 - <30 kg/m^2-Month 12 | 4 |
| Tofacitinib monotherapy: >= 30 kg/m^2-Month 12 | 1 |
| Tofacitinib monotherapy: Missing-Month 12 | 1 |
| Combined tofacitinib and MTX therapy: 18.5 - <25 kg/m^2-Month 3 | 1 |
| Combined tofacitinib and MTX therapy: 25 - <30 kg/m^2-Month 3 | 1 |
| Combined tofacitinib and MTX therapy: >= 30 kg/m^2-Month 3 | 2 |
| Combined tofacitinib and MTX therapy: Missing-Month 3 | 0 |
| Combined tofacitinib and MTX therapy: 18.5 - <25 kg/m^2-Month 6 | 4 |
| Combined tofacitinib and MTX therapy: 25 - <30 kg/m^2-Month 6 | 0 |
| Combined tofacitinib and MTX therapy: >= 30 kg/m^2-Month 6 | 1 |
| Combined tofacitinib and MTX therapy: Missing-Month 6 | 0 |
| Combined tofacitinib and MTX therapy: 18.5 - <25 kg/m^2-Month 12 | 2 |
| Combined tofacitinib and MTX therapy: >= 30 kg/m^2-Month 12 | 1 |
| Combined tofacitinib and other csDMARD: >= 30 kg/m^2-Month 3 | 0 |
Participants who achieved LDA according to treatment line were reported in this outcome measure. Treatment line included: tofacitinib monotherapy, combination therapy with MTX, and combination therapy with other csDMARDs. LDA was defined as PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease.
| Participants | All Participants |
|---|---|
| Overall: Tofacitinib as monotherapy-Month 3 | 8 |
| Overall: Combination therapy with MTX-Month 3 | 4 |
| Overall: Combination with other csDMARD-Month 3 | 0 |
| Overall: Tofacitinib as monotherapy-Month 6 | 15 |
| Overall: Combination therapy with MTX-Month 6 | 5 |
| Overall: Tofacitinib as monotherapy-Month 12 | 9 |
| Overall: Combination therapy with MTX-Month 12 | 3 |
| Tofacitinib monotherapy: Tofacitinib as monotherapy-Month 3 | 8 |
| Tofacitinib monotherapy: Tofacitinib as monotherapy-Month 6 | 15 |
| Tofacitinib monotherapy: Tofacitinib as monotherapy-Month 12 | 9 |
| Combined tofacitinib and MTX therapy: Combination therapy with MTX-Month 3 | 4 |
| Combined tofacitinib and MTX therapy: Combination therapy with MTX-Month 6 | 5 |
| Combined tofacitinib and MTX therapy: Combination therapy with MTX-Month 12 | 3 |
| Combined tofacitinib and other csDMARD: Combination with other csDMARD-Month 3 | 0 |
Duration of current episode of symptoms prior to enrollment were presented as: \< 6, \>=6 weeks. LDA was defined as PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease.
| Participants | All Participants |
|---|---|
| Overall: < 6 weeks-Month 3 | 4 |
| Overall: >= 6 weeks-Month 3 | 6 |
| Overall: Missing-Month 3 | 2 |
| Overall: < 6 weeks-Month 6 | 11 |
| Overall: >= 6 weeks-Month 6 | 8 |
| Overall: Missing-Month 6 | 1 |
| Overall: < 6 weeks-Month 12 | 4 |
| Overall: >= 6 weeks-Month 12 | 8 |
| Tofacitinib monotherapy: < 6 weeks-Month 3 | 3 |
| Tofacitinib monotherapy: >= 6 weeks-Month 3 | 3 |
| Tofacitinib monotherapy: Missing-Month 3 | 2 |
| Tofacitinib monotherapy: < 6 weeks-Month 6 | 7 |
| Tofacitinib monotherapy: >= 6 weeks-Month 6 | 7 |
| Tofacitinib monotherapy: Missing-Month 6 | 1 |
| Tofacitinib monotherapy: < 6 weeks-Month 12 | 2 |
| Tofacitinib monotherapy: >= 6 weeks-Month 12 | 7 |
| Combined tofacitinib and MTX therapy: < 6 weeks-Month 3 | 1 |
| Combined tofacitinib and MTX therapy: >= 6 weeks-Month 3 | 3 |
| Combined tofacitinib and MTX therapy: < 6 weeks-Month 6 | 4 |
| Combined tofacitinib and MTX therapy: >= 6 weeks-Month 6 | 1 |
| Combined tofacitinib and MTX therapy: < 6 weeks-Month 12 | 2 |
| Combined tofacitinib and MTX therapy: >= 6 weeks-Month 12 | 1 |
| Combined tofacitinib and other csDMARD: >= 6 weeks-Month 3 | 0 |
ESR result=abnormal if test result was above normal range. ESR normal range:0-50 years(male \<15 mm/h, female \<20 mm/h), 51-85 years(\<20 mm/h males and \<30 mm/h females),older than 85 years(\<30 mm/h males and \<42 mm/h females). Number of participants who achieved LDA according to ESR results(normal and abnormal) were reported. LDA=PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of following:participant global PAA,physician global PAA,each scored on 100 mm VAS,0=no DA, 100=maximum DA; TJC(0-68); SJC(0-66); LEI score=0-6;0=non tender,6=more enthesitis burden; tender dactylitis digit score=0-3,0=no tenderness,3=participant withdrew digit; PCS of SF-36 score=0-100; 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged=0(no disease)to 10(severe disease);higher scores=more severe disease.
| Participants | All Participants |
|---|---|
| Overall: Abnormal-Month 3 | 2 |
| Overall: Normal-Month 3 | 8 |
| Overall: Missing-Month 3 | 2 |
| Overall: Abnormal-Month 6 | 4 |
| Overall: Normal-Month 6 | 10 |
| Overall: Missing-Month 6 | 6 |
| Overall: Abnormal-Month 12 | 3 |
| Overall: Normal-Month 12 | 7 |
| Overall: Missing-Month 12 | 2 |
| Tofacitinib monotherapy: Abnormal-Month 3 | 1 |
| Tofacitinib monotherapy: Normal-Month 3 | 6 |
| Tofacitinib monotherapy: Missing-Month 3 | 1 |
| Tofacitinib monotherapy: Abnormal-Month 6 | 2 |
| Tofacitinib monotherapy: Normal-Month 6 | 8 |
| Tofacitinib monotherapy: Missing-Month 6 | 5 |
| Tofacitinib monotherapy: Abnormal-Month 12 | 2 |
| Tofacitinib monotherapy: Normal-Month 12 | 5 |
| Tofacitinib monotherapy: Missing-Month 12 | 2 |
| Combined tofacitinib and MTX therapy: Abnormal-Month 3 | 1 |
| Combined tofacitinib and MTX therapy: Normal-Month 3 | 2 |
| Combined tofacitinib and MTX therapy: Missing-Month 3 | 1 |
| Combined tofacitinib and MTX therapy: Abnormal-Month 6 | 2 |
| Combined tofacitinib and MTX therapy: Normal-Month 6 | 2 |
| Combined tofacitinib and MTX therapy: Missing-Month 6 | 1 |
| Combined tofacitinib and MTX therapy: Abnormal-Month 12 | 1 |
| Combined tofacitinib and MTX therapy: Normal-Month 12 | 2 |
| Combined tofacitinib and MTX therapy: Missing-Month 12 | 0 |
| Combined tofacitinib and other csDMARD: Normal-Month 3 | 0 |
For CRP, result was considered abnormal if t the test result was above the normal range (0.3 to 10 mg/L). LDA was defined as PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease.
| Participants | All Participants |
|---|---|
| Overall: Abnormal-Month 3 | 7 |
| Overall: Normal-Month 3 | 5 |
| Overall: Abnormal-Month 6 | 8 |
| Overall: Normal-Month 6 | 12 |
| Overall: Abnormal-Month 12 | 4 |
| Overall: Normal-Month 12 | 8 |
| Tofacitinib monotherapy: Abnormal-Month 3 | 4 |
| Tofacitinib monotherapy: Normal-Month 3 | 4 |
| Tofacitinib monotherapy: Abnormal-Month 6 | 5 |
| Tofacitinib monotherapy: Normal-Month 6 | 10 |
| Tofacitinib monotherapy: Abnormal-Month 12 | 2 |
| Tofacitinib monotherapy: Normal-Month 12 | 7 |
| Combined tofacitinib and MTX therapy: Abnormal-Month 3 | 3 |
| Combined tofacitinib and MTX therapy: Normal-Month 3 | 1 |
| Combined tofacitinib and MTX therapy: Abnormal-Month 6 | 3 |
| Combined tofacitinib and MTX therapy: Normal-Month 6 | 2 |
| Combined tofacitinib and MTX therapy: Abnormal-Month 12 | 2 |
| Combined tofacitinib and MTX therapy: Normal-Month 12 | 1 |
| Combined tofacitinib and other csDMARD: Normal-Month 3 | 0 |
Number of participants who achieved LDA according to presence (present/absent) of rheumatoid nodules is presented in this outcome measure. LDA was defined as PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease.
| Participants | All Participants |
|---|---|
| Overall: Absent-Month 3 | 12 |
| Overall: Missing-Month 3 | 0 |
| Overall: Absent-Month 6 | 20 |
| Overall: Missing-Month 6 | 0 |
| Overall: Absent-Month 12 | 12 |
| Overall: Missing-Month 12 | 0 |
| Tofacitinib monotherapy: Absent-Month 3 | 8 |
| Tofacitinib monotherapy: Missing-Month 3 | 0 |
| Tofacitinib monotherapy: Absent-Month 6 | 15 |
| Tofacitinib monotherapy: Missing-Month 6 | 0 |
| Tofacitinib monotherapy: Absent-Month 12 | 9 |
| Tofacitinib monotherapy: Missing-Month 12 | 0 |
| Combined tofacitinib and MTX therapy: Absent-Month 3 | 4 |
| Combined tofacitinib and MTX therapy: Absent-Month 6 | 5 |
| Combined tofacitinib and MTX therapy: Absent-Month 12 | 3 |
| Combined tofacitinib and other csDMARD: Absent-Month 3 | 0 |
Unequivocal radiological erosion: 'present',if Sharp-Van der Heijde modified score (S-VH MS)for erosion \>0;'absent',if S-VH MS for erosion score=0. S-VH MS sum of erosion,JSN scores(range 0-528). Higher score=more severe disease. If a component score is missing, S-VH MS is missing. LDA=PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of following: participant global PAA,physician global PAA,each scored on 100 mm VAS,0=no DA,100=maximum DA; TJC(0-68); SJC(0-66); LEI score range=0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score range=0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score range=0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0(no disease)to 10(severe disease); higher scores=more severe disease.
| Participants | All Participants |
|---|---|
| Overall: Present-Month 3 | 1 |
| Overall: Absent-Month 3 | 1 |
| Overall: Missing-Month 3 | 10 |
| Overall: Present-Month 6 | 1 |
| Overall: Absent-Month 6 | 2 |
| Overall: Missing-Month 6 | 17 |
| Overall: Present-Month 12 | 0 |
| Overall: Absent-Month 12 | 1 |
| Overall: Missing-Month 12 | 11 |
| Tofacitinib monotherapy: Present-Month 3 | 1 |
| Tofacitinib monotherapy: Absent-Month 3 | 0 |
| Tofacitinib monotherapy: Missing-Month 3 | 7 |
| Tofacitinib monotherapy: Present-Month 6 | 1 |
| Tofacitinib monotherapy: Absent-Month 6 | 2 |
| Tofacitinib monotherapy: Missing-Month 6 | 12 |
| Tofacitinib monotherapy: Present-Month 12 | 0 |
| Tofacitinib monotherapy: Absent-Month 12 | 1 |
| Tofacitinib monotherapy: Missing-Month 12 | 8 |
| Combined tofacitinib and MTX therapy: Absent-Month 3 | 1 |
| Combined tofacitinib and MTX therapy: Missing-Month 3 | 3 |
| Combined tofacitinib and MTX therapy: Absent-Month 6 | 0 |
| Combined tofacitinib and MTX therapy: Missing-Month 6 | 5 |
| Combined tofacitinib and MTX therapy: Missing-Month 12 | 3 |
| Combined tofacitinib and other csDMARD: Missing-Month 3 | 0 |
Unequivocal Bony decalcification was reported as present or absent at enrollment. LDA was defined as PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease.
| Participants | All Participants |
|---|---|
| Overall: Present-Month 3 | 1 |
| Overall: Absent-Month 3 | 7 |
| Overall: Missing-Month 3 | 4 |
| Overall: Present-Month 6 | 3 |
| Overall: Absent-Month 6 | 12 |
| Overall: Missing-Month 6 | 5 |
| Overall: Present-Month 12 | 2 |
| Overall: Absent-Month 12 | 7 |
| Overall: Missing-Month 12 | 3 |
| Tofacitinib monotherapy: Present-Month 3 | 1 |
| Tofacitinib monotherapy: Absent-Month 3 | 6 |
| Tofacitinib monotherapy: Missing-Month 3 | 1 |
| Tofacitinib monotherapy: Present-Month 6 | 2 |
| Tofacitinib monotherapy: Absent-Month 6 | 11 |
| Tofacitinib monotherapy: Missing-Month 6 | 2 |
| Tofacitinib monotherapy: Present-Month 12 | 1 |
| Tofacitinib monotherapy: Absent-Month 12 | 6 |
| Tofacitinib monotherapy: Missing-Month 12 | 2 |
| Combined tofacitinib and MTX therapy: Present-Month 3 | 0 |
| Combined tofacitinib and MTX therapy: Absent-Month 3 | 1 |
| Combined tofacitinib and MTX therapy: Missing-Month 3 | 3 |
| Combined tofacitinib and MTX therapy: Present-Month 6 | 1 |
| Combined tofacitinib and MTX therapy: Absent-Month 6 | 1 |
| Combined tofacitinib and MTX therapy: Missing-Month 6 | 3 |
| Combined tofacitinib and MTX therapy: Present-Month 12 | 1 |
| Combined tofacitinib and MTX therapy: Absent-Month 12 | 1 |
| Combined tofacitinib and MTX therapy: Missing-Month 12 | 1 |
| Combined tofacitinib and other csDMARD: Absent-Month 3 | 0 |
Arthritis at enrollment was identified when a participant reported swelling and/or tenderness/pain in any joint. Number of participants who achieved LDA according to presence (Yes/No) of symmetric arthritis was reported. LDA was defined as PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease.
| Participants | All Participants |
|---|---|
| Overall: No-Month 3 | 12 |
| Overall: Yes-Month 3 | 0 |
| Overall: No-Month 6 | 20 |
| Overall: Yes-Month 6 | 0 |
| Overall: No-Month 12 | 12 |
| Tofacitinib monotherapy: No-Month 3 | 8 |
| Tofacitinib monotherapy: Yes-Month 3 | 0 |
| Tofacitinib monotherapy: No-Month 6 | 15 |
| Tofacitinib monotherapy: Yes-Month 6 | 0 |
| Tofacitinib monotherapy: No-Month 12 | 9 |
| Combined tofacitinib and MTX therapy: No-Month 3 | 4 |
| Combined tofacitinib and MTX therapy: Yes-Month 3 | 0 |
| Combined tofacitinib and MTX therapy: No-Month 6 | 5 |
| Combined tofacitinib and MTX therapy: No-Month 12 | 3 |
| Combined tofacitinib and other csDMARD: No-Month 3 | 0 |
Hand joints included metacarpal phalangeal joints(MCP), finger proximal interphalangeal and finger distal interphalangeal joints. Number of participants who achieved LDA according to presence(Yes/No) of arthritis of any of hand joints was reported. LDA=PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of following: participant global PAA,physician global PAA, each scored on 100 mm VAS,0=no DA,100=maximum DA;TJC(0-68); SJC(0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease.
| Participants | All Participants |
|---|---|
| Overall: No-Month 3 | 4 |
| Overall: Yes-Month 3 | 8 |
| Overall: No-Month 6 | 6 |
| Overall: Yes-Month 6 | 14 |
| Overall: No-Month 12 | 1 |
| Overall: Yes-Month 12 | 11 |
| Tofacitinib monotherapy: No-Month 3 | 2 |
| Tofacitinib monotherapy: Yes-Month 3 | 6 |
| Tofacitinib monotherapy: No-Month 6 | 4 |
| Tofacitinib monotherapy: Yes-Month 6 | 11 |
| Tofacitinib monotherapy: No-Month 12 | 1 |
| Tofacitinib monotherapy: Yes-Month 12 | 8 |
| Combined tofacitinib and MTX therapy: No-Month 3 | 2 |
| Combined tofacitinib and MTX therapy: Yes-Month 3 | 2 |
| Combined tofacitinib and MTX therapy: No-Month 6 | 2 |
| Combined tofacitinib and MTX therapy: Yes-Month 6 | 3 |
| Combined tofacitinib and MTX therapy: No-Month 12 | 0 |
| Combined tofacitinib and MTX therapy: Yes-Month 12 | 3 |
| Combined tofacitinib and other csDMARD: Yes-Month 3 | 0 |
Medium joints=temporomandibular, sternoclavicular, acromioclavicular, finger proximal interphalangeal, finger distal interphalangeal and tarsus/midfoot(feet) joints. Large joints=glenohumeral, elbows, hips, knees and ankles joint. Number of participants who achieved LDA according to presence (Yes/No) of arthritis of only 1 medium-large joint was reported. LDA=PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA incorporated assessment of: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA;TJC(0-68);SJC(0-66); LEI score ranging from 0-6;0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3;0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100;0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS score (0-10) uses a weighted formula; higher scores=more severe disease.
| Participants | All Participants |
|---|---|
| Overall: No-Month 3 | 10 |
| Overall: Yes-Month 3 | 2 |
| Overall: No-Month 6 | 17 |
| Overall: Yes-Month 6 | 3 |
| Overall: No-Month 12 | 11 |
| Overall: Yes-Month 12 | 1 |
| Tofacitinib monotherapy: No-Month 3 | 7 |
| Tofacitinib monotherapy: Yes-Month 3 | 1 |
| Tofacitinib monotherapy: No-Month 6 | 14 |
| Tofacitinib monotherapy: Yes-Month 6 | 1 |
| Tofacitinib monotherapy: No-Month 12 | 9 |
| Combined tofacitinib and MTX therapy: No-Month 3 | 3 |
| Combined tofacitinib and MTX therapy: Yes-Month 3 | 1 |
| Combined tofacitinib and MTX therapy: No-Month 6 | 3 |
| Combined tofacitinib and MTX therapy: Yes-Month 6 | 2 |
| Combined tofacitinib and MTX therapy: No-Month 12 | 2 |
| Combined tofacitinib and MTX therapy: Yes-Month 12 | 1 |
| Combined tofacitinib and other csDMARD: No-Month 3 | 0 |
Medium joints=temporomandibular, sternoclavicular, acromioclavicular, finger proximal interphalangeal (IP), finger distal interphalangeal, tarsus/midfoot (feet). Large joints=glenohumeral, elbows, hips, knees, ankles. Small joints=MCP, proximal IP, second through fifth metatarsal phalangeal (MTP), thumb IP, wrists. Number of participants who achieved LDA according to presence (Yes/No) arthritis of 2-10 medium-large joints and/or 1-3 small joints was reported. LDA=PASDAS score =\<3.2. PASDAS is a composite PsA activity score including: participant /physician global (VAS 0-100; 0=no DA, 100=maximum DA), TJC (0-68), SJC (0-66), LEI (0-6; 0=non tender, 6=more enthesitis burden), tender dactylitis digit score (0-3; 0=no tenderness, 3=participant withdrew digit), SF-36 PCS (0-100; 0=severe physical health limitations, 100=excellent physical health),CRP in mg/L. PASDAS score (0-10) uses a weighted formula; higher scores=more severe disease.
| Participants | All Participants |
|---|---|
| Overall: No-Month 3 | 0 |
| Overall: Yes-Month 3 | 12 |
| Overall: No-Month 6 | 1 |
| Overall: Yes-Month 6 | 19 |
| Overall: No-Month 12 | 1 |
| Overall: Yes-Month 12 | 11 |
| Tofacitinib monotherapy: No-Month 3 | 0 |
| Tofacitinib monotherapy: Yes-Month 3 | 8 |
| Tofacitinib monotherapy: No-Month 6 | 1 |
| Tofacitinib monotherapy: Yes-Month 6 | 14 |
| Tofacitinib monotherapy: No-Month 12 | 1 |
| Tofacitinib monotherapy: Yes-Month 12 | 8 |
| Combined tofacitinib and MTX therapy: Yes-Month 3 | 4 |
| Combined tofacitinib and MTX therapy: Yes-Month 6 | 5 |
| Combined tofacitinib and MTX therapy: Yes-Month 12 | 3 |
| Combined tofacitinib and other csDMARD: Yes-Month 3 | 0 |
Large joints=glenohumeral, elbows, hips, knees and ankles joint. Small joints=MCP, proximal IP, second through fifth MTP, thumb IP, wrists. Number of participants who achieved LDA according to presence (Yes/No) of arthritis of 4-10 small joints with or without involvement of large joints was reported. LDA=PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA incorporated assessment of: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA;TJC(0-68); SJC(0-66); LEI score range=0-6; 0=non tender, 6=more enthesitis burden; tender dactylitis digit score range=0-3; 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores=more severe disease.
| Participants | All Participants |
|---|---|
| Overall: No-Month 3 | 8 |
| Overall: Yes-Month 3 | 4 |
| Overall: No-Month 6 | 12 |
| Overall: Yes-Month 6 | 8 |
| Overall: No-Month 12 | 6 |
| Overall: Yes-Month 12 | 6 |
| Tofacitinib monotherapy: No-Month 3 | 4 |
| Tofacitinib monotherapy: Yes-Month 3 | 4 |
| Tofacitinib monotherapy: No-Month 6 | 8 |
| Tofacitinib monotherapy: Yes-Month 6 | 7 |
| Tofacitinib monotherapy: No-Month 12 | 4 |
| Tofacitinib monotherapy: Yes-Month 12 | 5 |
| Combined tofacitinib and MTX therapy: No-Month 3 | 4 |
| Combined tofacitinib and MTX therapy: Yes-Month 3 | 0 |
| Combined tofacitinib and MTX therapy: No-Month 6 | 4 |
| Combined tofacitinib and MTX therapy: Yes-Month 6 | 1 |
| Combined tofacitinib and MTX therapy: No-Month 12 | 2 |
| Combined tofacitinib and MTX therapy: Yes-Month 12 | 1 |
| Combined tofacitinib and other csDMARD: No-Month 3 | 0 |
Small joints=MCP, proximal IP, second through fifth MTP, thumb IP, wrists. Number of participants who achieved LDA according to presence (Yes/No) of arthritis of \>10 joints (with at least one small joint) was reported in this outcome measure. LDA=PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA incorporated assessment of: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC(0-68); SJC(0-66); LEI score ranging from 0-6; 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3; 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores=more severe disease.
| Participants | All Participants |
|---|---|
| Overall: No-Month 3 | 10 |
| Overall: Yes-Month 3 | 2 |
| Overall: No-Month 6 | 16 |
| Overall: Yes-Month 6 | 4 |
| Overall: No-Month 12 | 10 |
| Overall: Yes-Month 12 | 2 |
| Tofacitinib monotherapy: No-Month 3 | 6 |
| Tofacitinib monotherapy: Yes-Month 3 | 2 |
| Tofacitinib monotherapy: No-Month 6 | 11 |
| Tofacitinib monotherapy: Yes-Month 6 | 4 |
| Tofacitinib monotherapy: No-Month 12 | 7 |
| Tofacitinib monotherapy: Yes-Month 12 | 2 |
| Combined tofacitinib and MTX therapy: No-Month 3 | 4 |
| Combined tofacitinib and MTX therapy: Yes-Month 3 | 0 |
| Combined tofacitinib and MTX therapy: No-Month 6 | 5 |
| Combined tofacitinib and MTX therapy: Yes-Month 6 | 0 |
| Combined tofacitinib and MTX therapy: No-Month 12 | 3 |
| Combined tofacitinib and MTX therapy: Yes-Month 12 | 0 |
| Combined tofacitinib and other csDMARD: No-Month 3 | 0 |
The SF-36 is a participant administered scale assessing general quality of life. It consists of self-administered 36-item questionnaire that measured 8 health domains: physical function, role-physical, bodily pain, general health, vitality, social function, role-emotional, and mental health. These 8 domains are also summarized as physical and mental component scores. The score for each domain and component score is the mean of the individual question scores, which are scaled from 0 (minimum) to 100 (maximum), where high scores in each dimension and high overall scores indicate a better quality of life.
| Units on a scale | All Participants |
|---|---|
| Overall: Physical health component summary score-Month 3 | 4.8 (3.00 to 6.56) |
| Overall: Mental health component summary score-Month 3 | 2.4 (0.31 to 4.52) |
| Tofacitinib monotherapy: Physical health component summary score-Month 3 | 5.0 (2.78 to 7.20) |
| Tofacitinib monotherapy: Mental health component summary score-Month 3 | 2.5 (-0.23 to 5.26) |
| Combined tofacitinib and MTX therapy: Physical health component summary score-Month 3 | 3.6 (0.67 to 6.44) |
| Combined tofacitinib and MTX therapy: Mental health component summary score-Month 3 | 1.5 (-1.44 to 4.51) |
| Combined tofacitinib and other csDMARD: Physical health component summary score-Month 3 | NA (NA to NA) |
| Combined tofacitinib and other csDMARD: Mental health component summary score-Month 3 | NA (NA to NA) |
| Overall: Physical health component summary score-Month 6 | 5.5 (3.53 to 7.40) |
| Overall: Mental health component summary score-Month 6 | 2.6 (0.05 to 5.20) |
| Tofacitinib monotherapy: Physical health component summary score-Month 6 | 6.2 (3.94 to 8.51) |
| Tofacitinib monotherapy: Mental health component summary score-Month 6 | 2.9 (-0.41 to 6.20) |
| Combined tofacitinib and MTX therapy: Physical health component summary score-Month 6 | 3.2 (-0.48 to 6.92) |
| Combined tofacitinib and MTX therapy: Mental health component summary score-Month 6 | 0.9 (-3.22 to 5.01) |
| Combined tofacitinib and other csDMARD: Physical health component summary score-Month 6 | NA (NA to NA) |
| Combined tofacitinib and other csDMARD: Mental health component summary score-Month 6 | NA (NA to NA) |
| Overall: Physical health component summary score-Month 12 | 5.5 (3.33 to 7.69) |
| Overall: Mental health component summary score-Month 12 | 3.0 (0.11 to 5.83) |
| Tofacitinib monotherapy: Physical health component summary score-Month 12 | 6.8 (4.06 to 9.45) |
| Tofacitinib monotherapy: Mental health component summary score-Month 12 | 4.5 (1.04 to 8.03) |
| Combined tofacitinib and MTX therapy: Physical health component summary score-Month 12 | 3.8 (0.60 to 6.97) |
| Combined tofacitinib and MTX therapy: Mental health component summary score-Month 12 | -1.8 (-6.33 to 2.74) |
| Combined tofacitinib and other csDMARD: Physical health component summary score-Month 12 | NA (NA to NA) |
| Combined tofacitinib and other csDMARD: Mental health component summary score-Month 12 | NA (NA to NA) |
The HAQ-DI41 assessed the degree of difficulty a participant had experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. For each question in the questionnaire, the level of difficulty was scored from 0 to 3 with 0 =no difficulty," 1 = "some difficulty," 2 = "much difficulty," and 3 = "unable to do". The disability index was computed by adding the scores for each of the components and dividing by the number of components with an available score. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities.
| Units on a scale | All Participants |
|---|---|
| Overall-Month 3 | -0.1 (-0.21 to -0.01) |
| Tofacitinib monotherapy-Month 3 | -0.1 (-0.24 to 0.00) |
| Combined tofacitinib and MTX therapy-Month 3 | -0.0 (-0.23 to 0.14) |
| Combined tofacitinib and other csDMARD-Month 3 | NA (NA to NA) |
| Overall-Month 6 | -0.1 (-0.23 to 0.00) |
| Tofacitinib monotherapy-Month 6 | -0.1 (-0.29 to 0.01) |
| Combined tofacitinib and MTX therapy-Month 6 | 0.0 (-0.20 to 0.20) |
| Combined tofacitinib and other csDMARD-Month 6 | NA (NA to NA) |
| Overall-Month 12 | -0.2 (-0.32 to -0.02) |
| Tofacitinib monotherapy-Month 12 | -0.2 (-0.39 to -0.00) |
| Combined tofacitinib and MTX therapy-Month 12 | -0.2 (-0.39 to 0.07) |
| Combined tofacitinib and other csDMARD-Month 12 | NA (NA to NA) |
Collected over From Baseline (enrollment) until Month 12. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Participants | 0/113 (0%) | 7/113 (6.2%) | 50/113 (44.2%) |
| Event | All Participants |
|---|---|
| PyelonephritisInfections and infestations | 1/113 |
| Subcutaneous abscessInfections and infestations | 1/113 |
| MeningiomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/113 |
| Plasma cell leukaemiaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/113 |
| Acute myocardial infarctionCardiac disorders | 1/113 |
| Intestinal obstructionGastrointestinal disorders | 1/113 |
| Back painMusculoskeletal and connective tissue disorders | 1/113 |
| Deep vein thrombosisVascular disorders | 1/113 |
| Event | All Participants |
|---|---|
| Drug ineffectiveGeneral disorders | 21/113 |
| COVID-19Infections and infestations | 10/113 |
| HeadacheNervous system disorders | 8/113 |
| NauseaGastrointestinal disorders | 5/113 |
| Abdominal painGastrointestinal disorders | 4/113 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 4/113 |
| PsoriasisSkin and subcutaneous tissue disorders | 4/113 |
| InfluenzaInfections and infestations | 3/113 |
| NasopharyngitisInfections and infestations | 3/113 |
| Urinary tract infectionInfections and infestations | 3/113 |
Safety analysis set (SAS) included all participants who received at least one dose (including partial dose) of study medication independently of inclusion/exclusion criteria.
| Age, Continuous(Years) | All Participants |
|---|---|
| Mean | 49.8 ± 10.47 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 63 |
| Male | 50 |
| Race and Ethnicity Not Collected(Participants) | All Participants |
|---|
Documents are hosted by the registry — open the source record to download them.
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.
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