Edwards et al., 2004 | 161 | MTX (n = 40) or RTX (n = 40) or RTX + MTX (n = 40), or RTX + CYC (n = 41) | Anti-TNFα naive | ACR50 response/24 weeks | ACR50: 13 vs. 33 vs. 43 vs. 41 | Only RF patients were included. MTX arm used very low doses (10 mg/week) |
Cohen et al., 2006REFLEX trial | 520 | MTX + PBO (n = 209) vs. RTX + MTX (n = 308) | Anti-TNFα failure | ACR20 response/24 weeks and post-treatment 2 years | At week 24: ACR20: 18 vs. 51 ACR50: 5 vs. 27 ACR70: 1 vs. 12 EULAR moderate or good: 22 vs. 65 | Most patients positive for RF (79%); nonsignificant differences at 6 months in radiographic progression. Significant reduction at 1 yeara |
Emery et al., 2006 DANCER trial | 465 | PBO + MTX (n = 149) or RTX 2× 500 mg + MTX (n = 124) or RTX 2× 1000 mg + MTX (n = 192) | DMARD or anti-TNFα failure | Proportion of RF-positive patients who met the ACR 20%/24 weeks | ACR20: 28, 55 and 55, respectively. ACR70: 5,13, 20b EULAR good response: 4, 14, 28b | No radiological outcomes measured. Better responses in patients not previously exposed to anti-TNFα |
Finckh et al., 2007 | 116 | RTX (n = 50) vs. alternative anti-TNFα (n = 66) | Anti-TNFα failure | Change from baseline of DAS-28 score/at least 6 months | Mean decrease in DAS-28: −1.61 in RTX vs. −0.98 in anti-TNFα | Treatment with RTX was more effective than a 2nd or 3rd anti-TNFα |
Tak et al., 2009 IMAGE study | 715 | PBO + MTX (n = 232), RTX + MTX (2× 500 mg) (n = 239) or RTX + MTX (2× 1000 mg) (n = 244) | Early RA MTX naive | Change from screening in the mTSSb at week 52/52 weeks | Mean change in mTSS at 52 weeks 1.08 vs. 0.65 vs. 0.36a ACR50: 41 vs. 59 vs. 64 | RTX (2× 1000 mg) + MTX significantly improved clinical outcomes and inhibited joint damage compared with MTX alone. Published only in abstract form |
Mease et al., 2010 SUNRISE trial | 475 | One open-label course of RTX. From week 24 RTX (retreatment group) vs. PBO | Anti-TNFα failure | ACR20 response at 48 weeks/48 weeks | ACR20: RTX vs. PBO 54 vs. 45%, mean change in DAS 28: −1.9 vs. −1.5 | Patients with very high disease activity at baseline (mean DAS-28, 6.7). No differences in ACR50, ACR70, and EULAR responses in both groups |