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 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.