Table 2.
Hierarchical order of primary and secondary end points at week 24
| Adalimumab 40 mg q2w (n=185) |
Sarilumab 200 mg q2w (n=184) |
p Value | |
|---|---|---|---|
| Primary end point | |||
| DAS28-ESR | |||
| Mean (SD) | 4.5 (1.4) | 3.5 (1.4) | |
| LS mean change from baseline (SE) | −2.20 (0.106) | −3.28 (0.105) | <0.0001 |
| Secondary endpoints | |||
| DAS28-ESR <2.6 (remission), n (%) | 13 (7.0) | 49 (26.6) | <0.0001 |
| ACR50 response, n (%) | 55 (29.7) | 84 (45.7) | 0.0017 |
| ACR70 response, n (%) | 22 (11.9) | 43 (23.4) | 0.0036 |
| ACR20 response, n (%) | 108 (58.4) | 132 (71.7) | 0.0074 |
| HAQ-DI | |||
| Mean (SD) | 1.2 (0.7) | 1.0 (0.7) | |
| LS mean change from baseline (SE) | −0.43 (0.05) | −0.61 (0.05) | 0.0037 |
| SF-36 (physical component score) | |||
| LS mean change from baseline (SE) | 6.1 (0.6) | 8.7 (0.6) | 0.0006 |
| FACIT-Fatigue | |||
| LS mean change from baseline (SE) | 8.4 (0.7) | 10.2 (0.7) | 0.0689 |
| SF-36 (mental component score) | |||
| LS mean change from baseline (SE) | 6.8 (0.8) | 7.9 (0.8) | 0.3319 |
ACR, American College of Rheumatology; DAS28-ESR, 28-joint disease activity score using erythrocyte sedimentation rate; FACIT, Functional Assessment of Chronic Illness Therapy; HAQ-DI, Health Assessment Questionnaire-Disability Index; LS, least squares; q2w, every 2 weeks; SF-36, Medical Outcomes Short Form 36 Health Survey.