Summary of disease-activity and quality-of-life clinical end points for patients treated with placebo vs rituximab 2×500 mg and 2×1000 mg (all plus a stable dose of methotrexate (MTX) 10−25 mg/week) at week 24 and week 48 (intention-to-treat population)
| Week 24 | Week 48 | ||||
|---|---|---|---|---|---|
| Clinical end point | Placebo + MTX (n=172) | Rituximab 2×500 mg + MTX (n=167) | Rituximab 2×1000 mg + MTX (n=170) | Rituximab 2×500 mg + MTX (n=167) | Rituximab 2×1000 mg + MTX (n=170) |
| Adjusted mean change in DAS28-ESR score from baseline† | −0.75 | −1.76*** | −1.69*** | −1.96 | −2.02 |
| EULAR response, n (%) | |||||
| Moderate | 50 (29.1) | 82 (49.1)*** | 87 (51.2)*** | 89 (53.3) | 81 (47.6) |
| Good | 8 (4.7) | 29 (17.4)*** | 20 (11.8)*** | 33 (19.8) | 35 (20.6) |
| DAS28-ESR end points, n (%)‡ | |||||
| LDA (DAS28-ESR ≤3.2) | 8 (4.7) | 29 (17.5)** | 21 (12.4)* | 33 (20.0) | 41 (24.3) |
| Clinical remission (DAS28-ESR <2.6) | 4 (2.3) | 16 (9.6)** | 16 (9.4)** | 15 (9.1) | 19 (11.2) |
| Clinically relevant HAQ-DI improvement, mean change from baseline ≥MCID of 0.22, n (%)§ | 82 (47.7) | 109 (66.1)** | 99 (58.2)** | 121 (73.3) | 117 (68.8) |
| FACIT-F change from baseline score¶ | |||||
| Adjusted mean | 2.12 | 5.51** | 6.53*** | NA | NA |
| SF-36 mean change from baseline†† | |||||
| SF-36 summary score mean adjusted | |||||
| Mental component | 1.66 | 3.31 | 4.58** | NA | NA |
| Physical component | 2.49 | 5.91*** | 5.70*** | NA | NA |
| Clinically relevant improvement in summary score (n (%)) | |||||
| Mental health (≥MCID of 6.33) | 35 (23.8) | 51 (33.6) | 54 (34.8)* | NA | NA |
| Physical health (≥MCID of 5.42) | 45 (30.6) | 70 (46.1)** | 75 (48.4)** | NA | NA |
Missing data were imputed using non-responder imputation for EULAR and ACR20/50/70 and LOCF for DAS28-ESR, LDA, clinical remission and quality-of-life end points.
↵* p<0.05;
↵** p<0.01;
↵*** p≤0.0001 vs placebo.
↵† Negative change represents an improvement. Patient numbers for this assessment: week 24 placebo (n=171), rituximab 2×500 mg (n=166), rituximab 2×1000 mg (n=168).
↵‡ Patient numbers for this assessment: week 24 rituximab 2×500 mg + MTX (n=166); week 48 rituximab 2×500 mg + MTX (n=165), rituximab 2×1000 mg + MTX (n=169).
↵§ Patient numbers for this assessment: weeks 24 and 48 rituximab 2×500 mg (n=165).
↵¶ Patient numbers for this assessment: week 24 placebo + MTX (n=170), rituximab 2×500 mg (n=165), rituximab 2×1000 mg (n=168).
↵†† Patient numbers for this assessment: week 24 placebo + MTX (n=147), rituximab 2×500 mg (n=152), rituximab 2×1000 mg (n=155).
ACR, American College of Rheumatology; DAS28, Disease Activity Score (28 joints); ESR, erythrocyte sedimentation rate; EULAR, European League Against Rheumatism; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; HAQ-DI, Health Assessment Questionnaire Disability Index; LDA, low disease activity; LOCF, last observation carried forward; MCID, minimum clinically important difference; NA, not available; SF-36, Medical Outcomes Study 36-item Short Form Health Survey.