Placebo+MTX (n=63) | Rituximab 500 mg+MTX (n=62) | p Value* | Rituximab 1000 mg+MTX (n=60) | p Value† | |
---|---|---|---|---|---|
Patients with no newly eroded joints, % | |||||
Week 24 | 55.6 | 77.4 | 0.011 | 73.3 | 0.045 |
Week 52 | 60.3 | 77.4 | 0.042 | 66.7 | 0.455 |
Patients with no progression of erosions, %‡ | |||||
Week 24 | 33.3 | 50.0 | 0.055 | 51.7 | 0.039 |
Week 52 | 27.0 | 48.4 | 0.011 | 55.0 | <0.001 |
Mean change from baseline in Genant-modified Sharp radiographic erosion score | |||||
Week 24 | 0.62 | 0.21 | 0.049 | 0.14 | 0.097 |
Week 52 | 0.99 | 0.34 | 0.027 | 0.14 | 0.003 |
Mean change from baseline in Genant-modified Sharp radiographic JSN score | |||||
Week 24 | 0.14 | 0.09 | 0.286 | 0.16 | 0.796 |
Week 52 | 0.38 | 0.06 | 0.003 | 0.15 | 0.102 |
Mean change from baseline in total Genant-modified Sharp radiographic score | |||||
Week 24 | 0.76 | 0.31 | 0.034 | 0.30 | 0.310 |
Week 52 | 1.37 | 0.40 | 0.010 | 0.29 | 0.002 |
Mean change from baseline in DAS28-ESR | |||||
Week 24 | −0.85 | −1.69 | 0.007 | −1.64 | 0.277 |
Week 52 | −0.81 | −2.08 | <0.001 | −1.90 | 0.075 |
Patients with good EULAR response, % | |||||
Week 24 | 19.0 | 29.0 | 0.017 | 35.0 | <0.001 |
Week 52 | 7.9 | 33.9 | <0.001 | 37.3 | <0.001 |
Patients with moderate EULAR response, % | |||||
Week 24 | 22.2 | 37.1 | 0.017¶ | 42.4 | <0.001¶ |
Week 52 | 31.7 | 45.2 | <0.001¶ | 49.2 | <0.001¶ |
Change from baseline in HAQ-DI score | |||||
Week 24 | −0.19 | −0.425 | 0.026 | −0.44 | 0.778 |
Week 52 | −0.18 | −0.520 | 0.001 | −0.42 | 0.165 |
Patients achieving ACR20, % | |||||
Week 24 | 28.6 | 51.6 | 0.003 | 51.7 | 0.006 |
Week 52 | 28.6 | 67.7 | <0.001 | 68.3 | <0.001 |
Patients achieving ACR50, % | |||||
Week 24 | 11.1 | 24.2 | 0.050 | 26.7 | 0.013 |
Week 52 | 14.3 | 37.1 | 0.003 | 35.0 | 0.005 |
Patients achieving ACR70, % | |||||
Week 24 | 1.6 | 11.3 | 0.036 | 8.3 | 0.085 |
Week 52 | 6.3 | 17.7 | 0.056 | 16.7 | 0.049 |
*p Value for comparison of rituximab 500 mg versus placebo.
†p Value for comparison of rituximab 1000 mg versus placebo.
‡No progression defined as a change from baseline in the RAMRIS erosion score of ≤0.
¶ p Values consider the three response levels: good, moderate and no response.
ACR 20/50/70, 20%, 50% and 70% improvements in response per the American College of Rheumatology; DAS28, Disease Activity Score in 28 joints; ESR, erythrocyte sedimentation rate; EULAR, European League Against Rheumatism; HAQ-DI, Health Assessment Questionnaire Disability Index; JSN, joint-space narrowing; MTX, methotrexate; RAMRIS, RA MRI Scoring.