Table 2

Summary of efficacy outcomes

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 2455.677.40.01173.30.045
 Week 5260.377.40.04266.70.455
Patients with no progression of erosions, %‡
 Week 2433.350.00.05551.70.039
 Week 5227.048.40.01155.0<0.001
Mean change from baseline in Genant-modified Sharp radiographic erosion score
 Week 240.620.210.0490.140.097
 Week 520.990.340.0270.140.003
Mean change from baseline in Genant-modified Sharp radiographic JSN score
 Week 520.380.060.0030.150.102
Mean change from baseline in total Genant-modified Sharp radiographic score
 Week 240.760.310.0340.300.310
 Week 521.370.400.0100.290.002
Mean change from baseline in DAS28-ESR
 Week 24−0.85−1.690.007−1.640.277
 Week 52−0.81−2.08<0.001−1.900.075
Patients with good EULAR response, %
 Week 2419.029.00.01735.0<0.001
 Week 527.933.9<0.00137.3<0.001
Patients with moderate EULAR response, %
 Week 2422.237.10.017¶42.4<0.001¶
 Week 5231.745.2<0.001¶49.2<0.001¶
Change from baseline in HAQ-DI score
 Week 24−0.19−0.4250.026−0.440.778
 Week 52−0.18−0.5200.001−0.420.165
Patients achieving ACR20, %
 Week 2428.651.60.00351.70.006
 Week 5228.667.7<0.00168.3<0.001
Patients achieving ACR50, %
 Week 2411.124.20.05026.70.013
 Week 5214.337.10.00335.00.005
Patients achieving ACR70, %
 Week 241.611.30.0368.30.085
 Week 526.317.70.05616.70.049
  • *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.