Studies «Nam JL, Ramiro S, Gaujoux-Viala C ym. Efficacy of ...»1 evaluating nine bDMARDs: infliximab (IFX), etanercept (ETN), adalimumab (ADA), certolizumab-pegol (CZP), golimumab (GLM), anakinra (ANA), abatacept (ABT), rituximab (RTX) and tocilizumab (TCZ) were included. Information on bsDMARDs in phase 3 development and tsDMARDs in the context of bDMARD therapy was also sought. The previous SLR included studies to 2009. This updated literature search was therefore performed for the period between January 2009 and February 2013 using Medline, Embase and Cochrane databases. Abstracts were also obtained from the 2011–2012 American College of Rheumatology (ACR) and 2011–2013 EULAR conferences. Where full papers of these abstracts were published online until mid-2013, the latter were obtained and used for data extraction. Relevant articles published after this time-point were also included.
The criteria for study selection were (1) randomised controlled trials (RCT) (double-blind stipulated for RCTs evaluating bDMARDs or bsDMARDs vs a csDMARD; for strategy-type trials and head-to-head studies open-label studies were also included as in the previous SLR); (2) patients with RA (1987 ACR7 or 2010 ACR/EULAR RA classification criteria) or UA at risk of developing RA; (3) studies evaluating one of the nine bDMARDs mentioned above or bsDMARDs in phase 3 or tsDMARDs in comparison with a bDMARD; (4) trials of ≥ 6 months’ duration; (5) studies with ≥ 50 patients; (6) publications in English. Published meta-analyses and SLRs were also reviewed and included where relevant.
Quality of published studies was assessed using the Cochrane risk of bias assessment tool for RevMan 5.1. Efficacy outcomes included those relating to signs and symptoms (ACR and EULAR responses), radiographic outcomes, physical function (Health Assessment Questionnaire Disability Index (HAQ)), quality-of-life measures (using the Physical Component Score and Mental Component Score of the Short Form-36) and fatigue (measured by the FACIT score and fatigue visual analogue scale (FAS)).
51 full papers and 57 abstracts met the inclusion criteria. Overall risk of bias for the majority of studies evaluated was low. The studies confirm enhanced efficacy of a bDMARD+MTX versus placebo+MTX in MTX-naive RA (RR (95% CI) 1.68 (1.54 to 1.84) for ACR 70 responses) , bDMARD+MTX versus placebo+MTX in MTX-IR (inadequate response to MTX )(RR (95% CI) 4.07 (3.21 to 5.17)).