Table 1

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

OutcomePlacebo+MTX (n=249)Rituximab 2×500 mg+MTX (n=249)Rituximab 2×1000 mg+MTX (n=250)
Disease activity
Major clinical response(%)2239**40**
Mean ACRn30.755.458.5
EULAR good response (%)2344**48**
DAS28 LDA (%)2545**48**
DAS28 remission (%)1334**32**
Physical function
HAQ-DI decrease ≥0.22 (%)778486*
  • * 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.