Biologics for People with Rheumatoid Arthritis Naive to Methotrexate

Summary

A Cochrane review [Abstract] 1 included 19 studies with a total of 6 485 adult subjects with rheumatoid arthritis and naive to methotrexate (MTX). Half of the studies contained participants with early rheumatoid arthritis (RA; less than two years' duration) and the other half included participants with established RA (2 to 10 years). Study duration ranged from 6 to 24 months. Data were available for 4 TNF biologics (adalimumab, 6 studies, n=1851; etanercept, 3 studies, n=678; golimumab, 1 study, n=637; and infliximab, 7 studies, n=1363) and 2 non-TNF biologics (abatacept, 1 study, n=509; and rituximab, 1 study, n=748). Three studies used biologic monotherapy without methotrexate (MTX). There were no studies with placebo-only comparators and no studies of tofacitinib.

Biologic + MTX versus active comparator: The comparator was MTX in 17 studies (n=6 344) and MTX + methylprednisolone in 2 studies (n=141).In traditional meta-analyses, biologics with MTX were associated with statistically significant and clinically meaningful benefit versus comparator as demonstrated by ACR50 (American College of Rheumatology scale; RR 1.40, 95% CI 1.30 to 1.49; NNTB 7, 95% CI 6 to 8; 14 studies, n=5 720) and RA remission rates (RR 1.62, 95% CI 1.33 to 1.98; NNTB 5, 95% CI 6 to 7; 15 studies, n=5 128). Biologics with MTX were also associated with a statistically significant, but not clinically meaningful, benefit in physical function measured by improvement of a 0 to 3 scale HAQ scores (MD -0.10, 95% CI -0.16 to -0.04; NNTB 4, 95% CI 2 to 15; 13 studies, n=3 872). No differences between biologics with MTX compared to MTX for radiographic progression or serious adverse events were observed. Results were inconclusive for withdrawals due to adverse events (RR 1.32, 95% CI 0.89 to 1.97; 14 studies, n=5 800), and for cancer (Peto OR 0.71, 95% CI 0.38 to 1.33; 11 studies, n=4 611).

Biologic without MTX versus active comparator: The active comparator was MTX (3 studies, n=866).There was no statistically significant or clinically important differences for ACR50, HAQ, remission, withdrawals due to adverse events, and serious adverse events. All studies were for TNF biologic monotherapy and none for non-TNF biologic monotherapy. Radiographic progression was not measured.