Table 1.

Summary of clinical and physical function efficacy outcomes over 104 weeks (intention-to-treat population)

Outcome	Placebo+MTX (n=249)	Rituximab 2×500 mg+MTX (n=249)	Rituximab 2×1000 mg+MTX (n=250)
Disease activity
Major clinical response†(%)	22	39**	40**
Mean ACRn‡	30.7	55.4	58.5
EULAR good response (%)	23	44**	48**
DAS28 LDA (%)	25	45**	48**
DAS28 remission (%)	13	34**	32**
Physical function
HAQ-DI decrease ≥0.22 (%)	77	84	86*

^*p<0.05,

^**p<0.0001 versus placebo+MTX. All p-values are exploratory/descriptive.

^†Major clinical response=ACR70 ≥6 months.

^‡Number of patients with non-missing ACRn assessments for all groups was 248.

Analysis-of-variance model adjusted for stratification factors (RF status, region) (adjusted mean changes shown in the table); Cochran–Mantel–Haenszel test was used for categorical variables, non-responder imputation was used for ACR major clinical response and EULAR response variables and last observation carried forward was used for DAS28 LDA, DAS28 remission and HAQ-DI.

ACRn, American College of Rheumatology index of improvement in RA; DAS28, Disease Activity Score in 28 joints; EULAR, European League Against Rheumatism; HAQ-DI, Health Assessment Questionnaire-Disability Index; LDA, low disease activity; MTX, methotrexate; RF, rheumatoid factor.