A Cochrane review [Abstract] 1 included 8 studies with a total of 2 720 subjects with rheumatoid arthritis (RA). Participants in the majority of the included studies had moderate to severe RA of at least nine years duration and few major co-morbidities. More people with rituximab (two 1000 mg doses) in combination with methotrexate (MTX) compared with MTX alone achieved clinical improvement and clinical remission (table T1). Rituximab + MTX compared with MTX alone also improved functional status and prevented radiographic progression (table T2). More patients achieved a clinically meaningful improvement on the physical and mental components of the quality of life, measured by the Short Form (SF)-36, in the rituximab in combination with MTX group compared with MTX alone at 24 to 52 weeks (RR 2.0, 95% CI 1.1 to 3.4; NNT 4, 95% CI 3 to 8 and RR 1.4, 95% CI 1.1 to 1.9; NNT 8, 95% CI 5 to 19, respectively).
| Outcome | Follow-up (weeks) | Relative effect(95% CI) | NNTB (95% CI) | Assumed risk - Methotrexate monotherapy | Corresponding risk - Rituximab (2 x 1000 mg) plus methotrexate (95% CI) | Participants(studies) |
|---|---|---|---|---|---|---|
| *Disease Activity Score (DAS) 28 joints< 2.6 (scale from 2 to 10) | ||||||
| Clinical improvement (ACR 50% improvement criteria) | 24 | RR 3.3 (2.3 to 4.6) | 6 (95% CI 9 to 4) | 88 per 1000 | 286 per 1000(203 to 402) | 1 165(4 studies) |
| 48 to 56 | RR 2.2 (1.3 to 4.0) | 4 (95% CI 6 to 3) | 331 per 1000 | 742 per 1000(418 to 1000) | 852(4 studies) | |
| 104 | RR 1.5 (1.3 to 1.8) | 6 (95% CI 11 to 4) | 377 per 1000 | 562 per 1000(471 to 668) | 579(2 studies) | |
| Clinical remission (DAS28)* | 24 | RR 9.1 (0.76 to 108.2) | N/A | 11 per 1000 | 99 per 1000(8 to 1000) | 834(2 studies) |
| 48 to 52 | RR 2.4 (1.7 to 3.5) | 7 (95% 13 CI to 4) | 112 per 1000 | 221 per 1000(190 to 387) | 772(3 studies) | |
| 104 | RR 2.5 (1.7 to 3.6) | 6 (95% 11 CI to 3) | 129 per 1000 | 320 per 1000(221 to 464) | 499(1 study) | |
| Outcome | Follow-up (weeks) | Relative effect(95% CI) | NNTB (95% CI) | Assumed risk - Methotrexate monotherapy | Corresponding risk - Rituximab (2 x 1000 mg) plus methotrexate (95% CI) | Participants(studies) |
|---|---|---|---|---|---|---|
| *HAQ-DI: Health Assessment Questionnaire - Disability Index; minimal clinically important difference in HAQ-DI reflecting a meaningful improvement in physical function is a decrease of HASH(0x2f82cc8) 0.22 | ||||||
| Physical function(HAQ-DI)* | 24 | RR 1.6 (1.2 to 2.1) | 5 (95% CI 13 to 3) | 387 per 1000 | 623 per 1000(472 to 821) | 1 161(4 studies) |
| 48 to 56 | RR 1.6 (0.71 to 3.4) | N/A | 726 per 1000 | 1000 per 1000(516 to 1000) | 562(2 studies) | |
| 104 | RR 1.4 (1.3 to 1.6) | 5 (95% CI 7 to 3) | 608 per 1000 | 845 per 1000(760 to 942) | 523(2 studies) | |
| No radiographic progression | 24 | RR 1.2 (1.0 to 1.4) | 10 (95% CI 57 to 5) | 591 per 1000 | 697 per 1000(608 to 797) | 476(1 study) |
| 56 | RR 1.3 (1.11 to 1.4) | 8 (95% CI 19 to 5) | 500 per 1000 | 625 per 1000(555 to 700) | 940(2 studies) | |
| 104 | RR 1.5 (1.3 to 1.7) | 6 (95% CI 9 to 4) | 379 per 1000 | 568 per 1000(492 to 655) | 945(2 studies) | |
There was no evidence of a statistically significant difference in the rates of withdrawals because of adverse events or for other reasons. However, statistically significantly more people receiving the control drug withdrew from the study compared to those receiving rituximab in combination with MTX at all times. At 104 weeks, 37% withdrew from the control group and 20% withdrew from the rituximab in combination with MTX group. A greater proportion of patients receiving rituximab in combination with MTX developed adverse events after their first infusion (26%) compared to those receiving MTX monotherapy and placebo infusions (16%) (RR 1.6, 95% CI 1.3 to 1.9). No statistically significant differences were noted in the rates of serious adverse events.
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