Table 2

Summary of efficacy outcomes

Total populationSeropositive (RF +ve and/or ACPA +ve) subgroupSeronegative (RF -ve and ACPA -ve) subgroup
Placebo + MTXRituximab (2×500 mg) + MTXRituximab (2×1000 mg) + MTXPlacebo + MTXRituximab (2×1000 mg) + MTXPlacebo + MTXRituximab (2×1000 mg) + MTX
Joint damage outcomes (mITT population)n=232n=239n=244n=211n=218n=21n=24
Week 52
 Change in mTSS (mean)1.0790.6460.359**1.1480.354**0.3870.352
 Change in erosion score (mean)0.7380.4530.233**ncncncnc
 % patients with no progression535864*54625279
  OR (unadjusted)1.1901.5171.4383.455
  95% CI0.827 to 1.7121.051 to 2.1890.979 to 2.1140.936 to 12.743
Week 24
 Change in mTSS (mean)0.7010.5800.328*ncncncnc
 % patients with no progression596370*ncncncnc
Disease activity outcomes (ITT population) week 52
  OR (unadjusted)2.0432.5672.9150.985
  95% CI1.430 to 2.9191.788 to 3.6851.986 to 4.2780.308 to 3.146
 Major clinical response8%18%*21%***ncncncnc
 Mean ACRn19.542.9***46.0***29.858.433.640.8
 EULAR good response18%39%***42%***18%43%18%33%
 DAS28-ESR LDA20%40%***43%***20%44%23%33%
 DAS28-ESR remission13%25%**31%***12%31%18%25%
 Change in DAS28-ESR (mean)−2.06−3.05***−3.21***−2.60§−3.64§−2.95§−3.08
Physical function outcomes week 52
 Change in HAQ-DI (mean)−0.628−0.905***−0.916***ncncncnc
 % With HAQ-DI decrease ≥0.227787*88*ncncncnc
  • * p<0.05,

  • ** p<0.001,

  • *** p<0.0001 for differences vs placebo+MTX.

  • Total number of patients included in rituximab 2×1000 mg autoantibody subgroups differed by two versus total number of patients included in rituximab 2×1000 mg group throughout because two patients could not be classified (RF-negative but no ACPA data, so unable to be assigned to either group).

  • Adjusted mean presented for total population; standard mean presented for subgroups (where available). Analyses included baseline scores as additional covariates.

  • § No statistical analysis was performed on the subgroup data.

  • Van Elteren test for difference in distribution of changes in radiographic variables; ANOVA model adjusted for stratification factors (RF, region) (adjusted mean changes shown in table) for all other continuous variables; Cochran–Mantel–Haenszel test for categorical variables; non-responder imputation used for ACR major clinical response and EULAR response variables, last observation carried forward.

  • ACPA, anti citrullinated peptide antibodies; ACR, American College of Rheumatology; ACRn, American College of Rheumatology Index of Improvement in Rheumatoid Arthritis; ANOVA, analysis of variance; DAS28, Disease Activity Score in 28 joints; ESR, erythrocyte sedimentation rate; EULAR, European League Against Rheumatism; HAQ-DI, Health Assessment Questionnaire-Disability Index; ITT, intent-to-treat; LDA, low disease activity; mITT, modified intent-to-treat; mTSS, Genant-modified total Sharp score; MTX, methotrexate; nc, not calculated; RF, rheumatoid factor.