A Phase 3 interventional study of Tocilizumab in Rheumatoid Arthritis, sponsored by Hoffmann-La Roche. Completed at 69 sites in 17 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-11-28.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
This open-label, international multi-center extension study WA18695 was designed to assess the long term safety of tocilizumab in patients who had moderate to severe active rheumatoid arthritis (RA). Patients enrolled in the WA18695 study had previously received treatment in the 24-week, placebo-controlled, Phase III Study WA17822. Eligible patients were assigned to treatment with 8 mg/kg tocilizumab every 4 weeks for a maximum of 5 years.
The primary objective of this extension study was to assess the long-term safety of 8 mg/kg tocilizumab with regard to adverse events (AEs) and laboratory result abnormalities.
The secondary objectives were as follows:
No viable biomarkers for TCZ treatment effects were identified from the controlled studies. There were, therefore, no biomarkers that warranted further investigation in long-term studies, so no biomarker data are reported.
The extension study WA18695 was an open-label, international multi-center study in patients with moderate to severe active rheumatoid arthritis (RA) who had completed treatment in the 24 weeks placebo-controlled Phase III study WA17822. Patients entering WA17822 had an inadequate response to methotrexate (MTX), and, during WA17822, patients had received treatment with intravenous infusions of tocilizumab 4 mg/kg, 8 mg/kg, or placebo every 4 weeks with background MTX therapy.
All patients who completed the planned course of treatment or escape therapy in the WA17822 study were eligible to enter the WA18695 long-term extension study, where they were assigned to treatment with 8 mg/kg RoActemra/Actemra plus MTX. The dose of RA medications such as MTX and nonsteroidal anti-inflammatory drugs (NSAIDs), but excluding corticosteroids, was to be kept stable for the first 48 weeks of the WA18695 study. During this time dose reductions in these treatments were only allowed as clinically required for safety reasons. After week 48, the administration of disease-modifying antirheumatic drugs (DMARDs) and NSAIDs could be changed, according to the investigator's practice and as tolerated by the patient.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 538 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All participants received tocilizumab 8 mg/kg to a maximum of 800 mg, administered by intravenous (IV) infusion over one hour, every 4 weeks. Concomitant therapies were limited to dosage and administration constraints detailed in the protocol.
Drug: Tocilizumab
Tocilizumab (myeloma receptor antibody \[MRA\]) was supplied in sterile solution of 20 mg TCZ/mL for aseptic preparation of infusion bags for IV administration.
Also known as: RoActemra, Actemra, Tocilizumab (MRA), TCZ
Adverse Event (AE) Summary Over Time
The number of participants experiencing at least one adverse event (AE) is recorded for each 12-month time period, with multiple occurrences in a single individual counted. Because months were calculated as 28 days, the periods actually equate to 48 weeks.
Time frame: through 264 Weeks
Summary Adverse Event Rates Over Time
Patient year (PY) refers to duration in study, calculated from first active drug intake to last safety assessment available + 1. Patient year rates with confidence interval were calculated for adverse events of interest in evaluating the long-term safety of the product being studied. Abbreviations include the following: adverse event (AE), adverse event of special interest (AESI), gastrointestinal (GI), serious adverse event (SAE), and investigational product (IP). Hypersensitivity events were defined as AEs that occurred during or within 24 hours of IP infusion and were not deemed "unrelated" to trial treatment by the investigator. This definition includes all types of AEs, regardless of whether or not they were consistent with hypersensitivity. Medical confirmation of the AESI "GI perforation" was based on medical adjudication of events captured by the GI Perforation Standardised MedDRA Queries (SMQs).
Time frame: through 264 Weeks
Overall Death Rate Over Time
Patient year (PY) refers to duration in study, calculated from first active drug intake to last safety assessment available + 1. To calculate the death rate, the total cumulative number of years that all participants were exposed to the drug, from first active drug intake to last safety assessment available + 1, was calculated as 2461.94. Since 10 participants died during that time, the death rate per year was not informative (0.00). Therefore, the overall death rate was calculated with the confidence interval based on events per 100 patient years exposure.
Time frame: through 264 Weeks
Participants Showing Improvement in Rheumatoid Arthritis Symptoms Over Time, Through 264 Weeks
The American College of Rheumatology (ACR) established certain criteria to measure improvement in rheumatoid arthritis symptoms that include tender or swollen joint counts and five other criteria, including acute phase reactant, patient assessment, physician assessment, pain scale, and disability/functional questionnaire. Clinical trials use the ACR Score, based on those criteria, as a standard for reporting different degrees of improvement in rheumatoid arthritis symptoms. Scores on the ACR scale may be up to ACR100 because the number after "ACR" is the percent of improvement in tender or swollen joint counts as well as in three of the other five criteria. Clinical trials determine the percentage of participants who achieve that score - that percentage of improvement.
Time frame: through 264 Weeks
Percentage of Participants Classified as Responders by Disease Activity Scores Over Time, Through 264 Weeks
The disease activity score 28 (DAS28) is a combined index for measuring disease activity in rheumatic arthritis (RA) that includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The DAS28 scale ranges from 0 to 10, where lower scores represent less disease activity. Participants with DAS28 scores less than 2.6 were categorized as responders with remission and those with DAS 28 scores of 3.2 or less were categorized as responders with low disease activity (LDA). The percentage of participants classified as responders in each category was recorded over time.
Time frame: through 264 Weeks
Percentage of Participants Classified as Responders by EULAR Response Over Time, Through 264 Weeks
Participants were classified as responders based on a European League Against Rheumatism (EULAR) response of Good or Moderate. Comparing the DAS28 from one patient on two different time points, it is possible to define improvement or response. The EULAR response criteria take into consideration both the first score and the change in score in order to classify them as good response, moderate response or no response. The percentage of participants who were classified as responders was recorded, as posted below.
Time frame: through 264 Weeks
Change From Baseline in Scores for Swollen and Tender Joint Counts Over Time, Through 264 Weeks
Swollen joint count (SJC) includes an assessment of 66 joints, and tender joint count (TJC) include an assessment of 68 joints. Joint prosthesis, arthrodesis or fused joints were not considered. Joints were assessed and classified as swollen/not swollen, and tender/not tender, by pressure and joint manipulation on physical examination. Change from Baseline in the SJC and TJC were calculated at given time points, and a negative change indicates improvement. A small proportion of participants in the all-exposure population reduced or stopped their oral corticosteroid use due to sustained efficacy (defined as at least a 50% improvement in both swollen joint count (SJC) and tender joint count (TJC).
Time frame: through 264 Weeks
Change From Baseline in Scores for Health Assessment Questionnaire - Disability Index Over Time, Through 264 Weeks
The Stanford Health Assessment Questionnaire - Disability Index (HAQ-DI) is a questionnaire specific for rheumatoid arthritis with 8 component sets (domains): dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each domain has 2-3 questions (for a total of 20) that participants answer with categorical answers enumerated as a scale of 0-3, where 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. To calculate the HAQ-DI the patient must have a domain score for at least 6 of the eight domains. The HAQ-DI is the sum of the domain scores, divided by the number of domains that have a score (in range 6-8). The resulting HAQ-DI scores are on a scale that ranges from 0 to 3, where 0=lowest level of difficulty and 3=highest level of difficulty. A negative change from baseline indicates improvement.
Time frame: through 264 Weeks
Change From Baseline in Scores for Patient's Global Assessment of Disease Activity Over Time, Through 264 Weeks
Patient's global assessment of disease activity is the patient's overall assessment of their disease activity during specified time periods on a 100 mm horizontal visual analogue scale (VAS). The left-hand extreme of the line was described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme as "maximum disease activity" (maximum arthritis disease activity). Change from baseline was calculated for given periods, and a negative change indicates improvement.
Time frame: through 264 Weeks
Change From Baseline in Scores for Physician's Global Assessment of Disease Activity Over Time, Through 264 Weeks
Physician's global assessment of disease activity is the treating physician's assessment of the patient's current disease activity on a 100 mm horizontal visual analogue scale (VAS). The extreme left end of the line was described as "no disease activity" (symptom-free and no arthritis symptoms) and the extreme right end as "maximum disease activity". Change from baseline was calculated for given periods, and a negative change indicates improvement.
Time frame: through 264 Weeks
Change From Baseline in Scores for Patient's Level of Pain Over Time, Through 264 Weeks
The patient's assessment of the patient's current level of pain on a 100 mm horizontal VAS was recorded. The extreme left end of the line was described as "no pain" and the extreme right end as "unbearable pain". Change from baseline was calculated for given periods, and a negative change indicates improvement.
Time frame: through 264 Weeks
Percentage of Participants With at Least a 5-point Improvement From Baseline in Quality of Life Measure for Fatigue Over Time, Through 264 Weeks
Quality of life is measured using the sub-scale for Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F). The assessment was originally developed for chronic illnesses and is now widely used for patients with rheumatoid arthritis. FACIT-F is a 13-item questionnaire. Participants score each item on a 5-point scale: 0 (Not at all) to 4 (Very much), for a highest possible score of 52. The responses are transformed into a FACIT-F score, where a higher score reflects an improvement. The percentage of participants with at least a 5-point improvement from baseline in the Facit-F score is shown at categorical time points.
Time frame: through 264 Weeks
Percentage of Participants With at Least a 5-point Improvement From Baseline in Quality of Life Using the 36-Item Short-Form Health Survey (SF-36) Over Time, Through 264 Weeks
The SF-36 Health Survey is a standardized questionnaire consisting of 36 questions that measures patient-reported symptoms on 8 dimensions; it is used to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100. A positive change score indicates better HRQoL. The percentage of participants with at least a 5-point improvement from baseline is presented for each subscale.
Time frame: through 264 Weeks
| Milestone | Tocilizumab 8 mg/kg |
|---|---|
| Started | 538 |
| Completed | 355 |
| Not completed | 183 |
| Withdrew: Adverse event | 96 |
| Withdrew: Death | 10 |
| Withdrew: Insufficient therapeutic response | 21 |
| Withdrew: Protocol violation | 1 |
| Withdrew: Refused treatment | 41 |
| Withdrew: Failure to return | 9 |
| Withdrew: Withdrawal by subject | 5 |
The number of participants experiencing at least one adverse event (AE) is recorded for each 12-month time period, with multiple occurrences in a single individual counted. Because months were calculated as 28 days, the periods actually equate to 48 weeks.
| Participants | Months 0 - 12 | Months 13 - 24 | Months 25 - 36 | Months 37 - 48 | Months Greater Than 48 |
|---|---|---|---|---|---|
| Experienced an adverse event | 433 | 390 | 333 | 294 | 329 |
| Experienced a serious adverse event | 55 | 55 | 55 | 35 | 74 |
| Experienced AE leading to withdrawal | 24 | 17 | 22 | 8 | 32 |
The American College of Rheumatology (ACR) established certain criteria to measure improvement in rheumatoid arthritis symptoms that include tender or swollen joint counts and five other criteria, including acute phase reactant, patient assessment, physician assessment, pain scale, and disability/functional questionnaire. Clinical trials use the ACR Score, based on those criteria, as a standard for reporting different degrees of improvement in rheumatoid arthritis symptoms. Scores on the ACR scale may be up to ACR100 because the number after "ACR" is the percent of improvement in tender or swollen joint counts as well as in three of the other five criteria. Clinical trials determine the percentage of participants who achieve that score - that percentage of improvement.
| Percentage of Participants | Week 24 | Week 48 | Week 108 | Week 156 | Week 204 | Week 264 |
|---|---|---|---|---|---|---|
| ACR20 | 63.2 | 76.0 | 81.2 | 83.3 | 82.2 | 83.9 |
| ACR50 | 41.2 | 50.6 | 58.1 | 59.6 | 62.5 | 67.8 |
| ACR70 | 17.4 | 27.1 | 38.2 | 41.9 | 42.1 | 45.8 |
| ACR90 | 4.8 | 5.2 | 11.3 | 15.3 | 16.8 | 19.3 |
The disease activity score 28 (DAS28) is a combined index for measuring disease activity in rheumatic arthritis (RA) that includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The DAS28 scale ranges from 0 to 10, where lower scores represent less disease activity. Participants with DAS28 scores less than 2.6 were categorized as responders with remission and those with DAS 28 scores of 3.2 or less were categorized as responders with low disease activity (LDA). The percentage of participants classified as responders in each category was recorded over time.
| Percentage of Participants | Week 24 | Week 48 | Week 108 | Week 156 | Week 204 | Week 264 |
|---|---|---|---|---|---|---|
| Responders with Remission (DAS<2.6) | 24.6 | 43.0 | 53.7 | 54.9 | 57.2 | 60.6 |
| Responders with Low Disease Activity (DAS</= 3.2) | 41.7 | 57.7 | 67.0 | 71.2 | 70.6 | 72.2 |
Participants were classified as responders based on a European League Against Rheumatism (EULAR) response of Good or Moderate. Comparing the DAS28 from one patient on two different time points, it is possible to define improvement or response. The EULAR response criteria take into consideration both the first score and the change in score in order to classify them as good response, moderate response or no response. The percentage of participants who were classified as responders was recorded, as posted below.
| Percentage of Participants | Week 24 | Week 48 | Week 108 | Week 156 | Week 204 | Week 264 |
|---|---|---|---|---|---|---|
| EULAR Good Response | 41.2 | 56.6 | 65.5 | 70.9 | 69.5 | 71.0 |
| EULAR Moderate Response | 48.1 | 39.1 | 29.8 | 25.9 | 26.8 | 25.1 |
Swollen joint count (SJC) includes an assessment of 66 joints, and tender joint count (TJC) include an assessment of 68 joints. Joint prosthesis, arthrodesis or fused joints were not considered. Joints were assessed and classified as swollen/not swollen, and tender/not tender, by pressure and joint manipulation on physical examination. Change from Baseline in the SJC and TJC were calculated at given time points, and a negative change indicates improvement. A small proportion of participants in the all-exposure population reduced or stopped their oral corticosteroid use due to sustained efficacy (defined as at least a 50% improvement in both swollen joint count (SJC) and tender joint count (TJC).
| Joints | Week 24 | Week 48 | Week 108 | Week 156 | Week 204 | Week 264 |
|---|---|---|---|---|---|---|
| Swollen Joint Count (SJC) | -11.7 ± 11.50 | -13.6 ± 11.04 | -15.6 ± 11.51 | -16.2 ± 11.46 | -16.2 ± 11.48 | -16.5 ± 11.26 |
| Tender Joint Count (TJC) | -17.4 ± 14.82 | -20.3 ± 15.12 | -23.1 ± 15.82 | -23.8 ± 16.14 | -23.8 ± 15.89 | -24.8 ± 16.37 |
The Stanford Health Assessment Questionnaire - Disability Index (HAQ-DI) is a questionnaire specific for rheumatoid arthritis with 8 component sets (domains): dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each domain has 2-3 questions (for a total of 20) that participants answer with categorical answers enumerated as a scale of 0-3, where 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. To calculate the HAQ-DI the patient must have a domain score for at least 6 of the eight domains. The HAQ-DI is the sum of the domain scores, divided by the number of domains that have a score (in range 6-8). The resulting HAQ-DI scores are on a scale that ranges from 0 to 3, where 0=lowest level of difficulty and 3=highest level of difficulty. A negative change from baseline indicates improvement.
| Units on a Scale | Week 24 | Week 48 | Week 108 | Week 156 | Week 204 | Week 264 |
|---|---|---|---|---|---|---|
| Change From Baseline in Scores for Health Assessment Questionnaire - Disability Index Over Time, Through 264 Weeks | -0.49 ± 0.582 | -0.53 ± 0.614 | -0.59 ± 0.636 | -0.61 ± 0.655 | -0.65 ± 0.661 | -0.62 ± 0.693 |
Patient's global assessment of disease activity is the patient's overall assessment of their disease activity during specified time periods on a 100 mm horizontal visual analogue scale (VAS). The left-hand extreme of the line was described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme as "maximum disease activity" (maximum arthritis disease activity). Change from baseline was calculated for given periods, and a negative change indicates improvement.
| Units on a Scale | Week 24 | Week 48 | Week 108 | Week 156 | Week 204 | Week 264 |
|---|---|---|---|---|---|---|
| Change From Baseline in Scores for Patient's Global Assessment of Disease Activity Over Time, Through 264 Weeks | -26.6 ± 26.87 | -30.3 ± 27.71 | -31.1 ± 27.65 | -31.6 ± 26.74 | -33.0 ± 26.83 | -32.9 ± 27.58 |
Physician's global assessment of disease activity is the treating physician's assessment of the patient's current disease activity on a 100 mm horizontal visual analogue scale (VAS). The extreme left end of the line was described as "no disease activity" (symptom-free and no arthritis symptoms) and the extreme right end as "maximum disease activity". Change from baseline was calculated for given periods, and a negative change indicates improvement.
| Units on a Scale | Week 24 | Week 48 | Week 108 | Week 156 | Week 204 | Week 264 |
|---|---|---|---|---|---|---|
| Change From Baseline in Scores for Physician's Global Assessment of Disease Activity Over Time, Through 264 Weeks | -33.8 ± 23.33 | -38.1 ± 23.77 | -41.1 ± 23.79 | -43.2 ± 23.26 | -44.8 ± 22.66 | -44.4 ± 23.64 |
The patient's assessment of the patient's current level of pain on a 100 mm horizontal VAS was recorded. The extreme left end of the line was described as "no pain" and the extreme right end as "unbearable pain". Change from baseline was calculated for given periods, and a negative change indicates improvement.
| Units on a Scale | Week 24 | Week 48 | Week 108 | Week 156 | Week 204 | Week 264 |
|---|---|---|---|---|---|---|
| Change From Baseline in Scores for Patient's Level of Pain Over Time, Through 264 Weeks | -23.7 ± 26.38 | -26.7 ± 27.27 | -28.0 ± 26.33 | -28.1 ± 25.99 | -29.5 ± 26.98 | -29.2 ± 26.84 |
Patient year (PY) refers to duration in study, calculated from first active drug intake to last safety assessment available + 1. Patient year rates with confidence interval were calculated for adverse events of interest in evaluating the long-term safety of the product being studied. Abbreviations include the following: adverse event (AE), adverse event of special interest (AESI), gastrointestinal (GI), serious adverse event (SAE), and investigational product (IP). Hypersensitivity events were defined as AEs that occurred during or within 24 hours of IP infusion and were not deemed "unrelated" to trial treatment by the investigator. This definition includes all types of AEs, regardless of whether or not they were consistent with hypersensitivity. Medical confirmation of the AESI "GI perforation" was based on medical adjudication of events captured by the GI Perforation Standardised MedDRA Queries (SMQs).
| Adverse Events per 100 Patient Years | Months 0 - 12 | Months 13 - 24 | Months 25 - 36 | Months 37 - 48 | Months Greater Than 48 |
|---|---|---|---|---|---|
| Total AE rate | 393.76 (376.32 to 411.80) | 286.17 (270.66 to 302.34) | 260.14 (244.78 to 276.22) | 249.84 (234.36 to 266.07) | 212.04 (201.62 to 222.86) |
| Total SAE rate | 12.54 (9.59 to 16.11) | 13.05 (9.91 to 16.87) | 18.74 (14.79 to 23.42) | 12.62 (9.34 to 16.69) | 13.12 (10.62 to 16.02) |
| Rate for AEs leading to withdrawal | 5.14 (3.33 to 7.59) | 3.82 (2.23 to 6.12) | 5.35 (3.36 to 8.11) | 2.06 (0.89 to 4.06) | 4.37 (2.99 to 6.17) |
| AESI All Infections | 92.94 (84.57 to 101.92) | 87.52 (79.03 to 96.66) | 87.36 (78.56 to 96.88) | 87.32 (78.27 to 97.12) | 72.82 (66.77 to 79.27) |
| AESI Serious Infections | 3.29 (1.88 to 5.34) | 2.47 (1.24 to 4.43) | 5.60 (3.55 to 8.40) | 3.35 (1.78 to 5.73) | 3.55 (2.32 to 5.20) |
| AESI Opportunistic infections | 0 (NA to NA) | 0.22 (0.01 to 1.25) | 0 (NA to NA) | 0.52 (0.06 to 1.86) | 0.27 (0.03 to 0.99) |
| AESI Hypersensitivity events | 27.35 (22.90 to 32.41) | 9.90 (7.19 to 13.29) | 5.35 (3.36 to 8.11) | 3.86 (2.16 to 6.37) | 4.10 (2.77 to 5.85) |
| AESI Hepatic events | 0.41 (0.05 to 1.49) | 0.90 (0.25 to 2.30) | 0.49 (0.06 to 1.76) | 1.03 (0.28 to 2.64) | 0.68 (0.22 to 1.59) |
| AESI Myocardial infarction | 0.62 (0.13 to 1.80) | 0 (NA to NA) | 0.24 (0.01 to 1.36) | 0.77 (0.16 to 2.26) | 0.27 (0.03 to 0.99) |
| AESI Stroke, ischemic or hemorrhagic | 0.21 (0.01 to 1.15) | 0.22 (0.01 to 1.25) | 0.73 (0.15 to 2.13) | 0.26 (0.01 to 1.44) | 0.41 (0.08 to 1.20) |
| AESI GI perforation | 0 (NA to NA) | 0 (NA to NA) | 0.49 (0.06 to 1.76) | 0.26 (0.01 to 1.44) | 0 (NA to NA) |
| AESI Malignancy | 1.23 (0.45 to 2.69) | 1.80 (0.78 to 3.55) | 0.97 (0.27 to 2.49) | 0.77 (0.16 to 2.26) | 1.50 (0.75 to 2.69) |
| AESI Demyelinating disorders | 0.21 (0.01 to 1.15) | 0 (NA to NA) | 0 (NA to NA) | 0 (NA to NA) | 0 (NA to NA) |
| AESI Serious bleeding disorders | 0.62 (0.13 to 1.80) | 0.45 (0.05 to 1.63) | 0.49 (0.06 to 1.76) | 0.26 (0.01 to 1.44) | 0.68 (0.22 to 1.59) |
Patient year (PY) refers to duration in study, calculated from first active drug intake to last safety assessment available + 1. To calculate the death rate, the total cumulative number of years that all participants were exposed to the drug, from first active drug intake to last safety assessment available + 1, was calculated as 2461.94. Since 10 participants died during that time, the death rate per year was not informative (0.00). Therefore, the overall death rate was calculated with the confidence interval based on events per 100 patient years exposure.
| Deaths per 100 PY | Tocilizumab 8 mg/kg |
|---|---|
| Overall Death Rate Over Time | 0.41 (0.19 to 0.75) |
Quality of life is measured using the sub-scale for Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F). The assessment was originally developed for chronic illnesses and is now widely used for patients with rheumatoid arthritis. FACIT-F is a 13-item questionnaire. Participants score each item on a 5-point scale: 0 (Not at all) to 4 (Very much), for a highest possible score of 52. The responses are transformed into a FACIT-F score, where a higher score reflects an improvement. The percentage of participants with at least a 5-point improvement from baseline in the Facit-F score is shown at categorical time points.
| Percentage of Participants | Week 24 | Week 48 | Week 108 | Week 156 | Week 204 | Week 264 |
|---|---|---|---|---|---|---|
| Percentage of Participants With at Least a 5-point Improvement From Baseline in Quality of Life Measure for Fatigue Over Time, Through 264 Weeks | 66.0 | 58.7 | 61.5 | 62.3 | 60.0 | 62.2 |
The SF-36 Health Survey is a standardized questionnaire consisting of 36 questions that measures patient-reported symptoms on 8 dimensions; it is used to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100. A positive change score indicates better HRQoL. The percentage of participants with at least a 5-point improvement from baseline is presented for each subscale.
| Percentage of Participants | Week 24 | Week 48 | Week 108 | Week 156 | Week 204 | Week 264 |
|---|---|---|---|---|---|---|
| SF-36 MCS | 48.2 | 46.2 | 48.6 | 49.9 | 49.7 | 49.1 |
| SF-36 PCS | 63.8 | 69.1 | 71.1 | 71.3 | 73.3 | 71.3 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tocilizumab 8 mg/kg | — | 199/538 (37%) | 475/538 (88.3%) |
| Event | Tocilizumab 8 mg/kg |
|---|---|
| PneumoniaInfections and infestations | 12/538 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 6/538 |
| DiverticulitisInfections and infestations | 5/538 |
| CellulitisInfections and infestations | 4/538 |
| ErysipelasInfections and infestations | 4/538 |
| GastroenteritisInfections and infestations | 4/538 |
| Inguinal herniaGastrointestinal disorders | 4/538 |
| CholecystitisHepatobiliary disorders | 4/538 |
| CholelithiasisHepatobiliary disorders | 4/538 |
| Abscess limbInfections and infestations | 3/538 |
| Event | Tocilizumab 8 mg/kg |
|---|---|
| Upper respiratory tract infectionInfections and infestations | 136/538 |
| NasopharyngitisInfections and infestations | 133/538 |
| HypertensionVascular disorders | 107/538 |
| Urinary tract infectionInfections and infestations | 93/538 |
| HeadacheNervous system disorders | 89/538 |
| DiarrhoeaGastrointestinal disorders | 85/538 |
| DyspepsiaGastrointestinal disorders | 85/538 |
| BronchitisInfections and infestations | 83/538 |
| GastroenteritisInfections and infestations | 69/538 |
| Back painMusculoskeletal and connective tissue disorders | 64/538 |
All-exposure population: All patients who entered the study and received at least one dose of tocilizumab at any time. Baseline was defined as the first dose of study drug, whether that occurred in the WA17822 study or the WA18695 study.
| Age Continuous(years) | Tocilizumab 8 mg/kg |
|---|---|
| Mean | 50.8 ± 12.03 |
| Sex: Female, Male(Participants) | Tocilizumab 8 mg/kg |
|---|---|
| Female | 443 |
| Male | 95 |
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