Efficacy results at weeks 24 and 52
| Week 24 | Week 52 | |||||
|---|---|---|---|---|---|---|
| Variable | Add-on (N=277) | Switch (N=276) | Between group p value | Add-on (N=277) | Switch (N=276) | Between group p value |
| DAS28 remission rate, % | 40.4 | 34.8 | 0.21 | 45.5 | 36.6 | 0.03 |
| Change in DAS28, mean (SD) | −3.43 (1.326) | −3.21 (1.305) | 0.05 | −3.74 (1.406) | −3.67 (1.291) | 0.39 |
| LDAS, % | 61.7 | 51.4 | 0.03 | 62.5 | 57.2 | 0.12 |
| EULAR good/moderate responders, % | 89.5 | 86.2 | 0.03 | 84.5 | 78.2 | 0.12 |
| ACR-EULAR Boolean remission rate, % | 6.9 | 5.4 | 0.53 | 17.7 | 12.3 | 0.09 |
| SDAI remission rate (≤3.3), % | 11.9 | 9.8 | 0.56 | 24.2 | 18.1 | 0.10 |
| CDAI remission rate (≤2.8), % | 11.9 | 7.6 | 0.12 | 22.7 | 15.9 | 0.06 |
| Change in patient's global assessment of disease activity, mean (SD) | −34.3 (25.68) | −32.4 (24.34) | 0.31 | −38.9 (25.59) | −40.9 (26.21) | 0.29 |
| Change in physician's global assessment of disease activity, mean (SD) | −40.7 (19.50) | −38.5 (21.65) | 0.25 | −44.2 (21.10) | −44.7 (21.40) | 0.88 |
| Change in patient's global assessment of pain, mean (SD) | −29.3 (26.64) | −29.8 (24.92) | 0.97 | −33.1 (26.93) | −38.4 (25.54) | 0.03 |
| Change in RAQoL, mean (SD) | −6.07 (8.01) | −5.19 (7.06) | 0.27 | −7.28 (8.14) | −6.33 (7.69) | 0.20 |
| Fatigue,* % | 51.3 | 50.0 | 0.68 | 39.7 | 32.7 | - |
| Change in HAQ-DI, mean (SD) | −0.56 (0.666) | −0.55 (0.531) | 0.93 | −0.59 (0.713) | −0.67 (0.630) | 0.14 |
| Change in ESR, mean (SD) | −30.60 (24.187) | −29.10 (24.518) | 0.52 | −31.81 (23.025) | −31.18 (24.527) | 0.77 |
| Change in CRP, mean (SD) | −1.37 (2.043) | −1.39 (2.206) | 0.61 | −1.39 (1.943) | −1.40 (2.216) | 0.68 |
| Change in total GSS, adjusted mean (SEM) | 0.18 (0.161) | 0.35 (0.152) | 0.20 | 0.35 (0.370) | 0.63 (0.350) | 0.36 |
| Change in JSN score, adjusted mean (SEM) | 0.16 (0.121) | 0.19 (0.115) | 0.71 | 0.45 (0.314) | 0.39 (0.297) | 0.81 |
| Change in erosion score, adjusted mean (SEM) | 0.03 (0.077) | 0.15 (0.072) | 0.044 | −0.09 (0.125) | 0.25 (0.118) | 0.001 |
| Patients with no progression in GSS (≤1.5), % | 91.3 | 88 | 0.22 | 92.8 | 86.1 | 0.016 |
*Assessed by the proportion of patients answering ‘yes’ to question 21 of the Rheumatoid Arthritis Quality of Life questionnaire (‘I feel tired whatever I do’).
ACR, American College of Rheumatology; CDAI, Clinical Disease Activity Index; CRP, C reactive protein; DAS28, Disease Activity Score based on 28 joints; DMARD, disease-modifying antirheumatic drug; ESR; erythrocyte sedimentation rate; EULAR, European League Against Rheumatism; GSS, Genant-modified Sharp score; HAQ-DI; Health Assessment Questionnaire-disability index; JSN, joint space narrowing; LDAS, low-disease activity score; PBO, placebo; RA, rheumatoid arthritis; RAQoL, Rheumatoid Arthritis Quality of Life questionnaire; SDAI, Simplified Disease Activity Index; SDC, smallest detectable change; SJC, swollen joint count; TCZ, tocilizumab; TJC, tender joint count.