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.