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Tumour-necrosis-factor (TNF) inhibitors, used to treat rheumatoid arthritis (RA), have non-specific (placebo effect) and specific effects. This meta-analysis appraises these effects within the first 3 months of treatment. Data were collected from ACR 20, 50 and 70 scores at week-24 from RA patients receiving TNF-blockers or a placebo after methotrexate (MTX) failure. Methods: A systematic literature review evaluated RCTs of TNFblockers vs. placebo given to patients after MTX failure (10 mg/ week during 6 months), published until October 2015. RA patients were naive to biotherapies. Results: Twenty-two RCTs (out of 1,388) were evaluated: six studied infliximab, five etanercept, four adalimumab, three certolizumab and four golimumab. Thirteen RCTs were available for the ACR 20 score at week-24. The overall placebo effect was 24.7% (CI95% [0.192;0.301] p = 0), the adalimumab one was 26.7% ((CI95% [0.161;0.373]) p = 0.001), certolizumab 16.4% ((CI95% [0.068;0.26]) p = 0), and infliximab 31.9% ((CI95% [0.154;0.485]) p = 0.001). Subgroup analyses showed the i.v. route generated a 31.90% placebo effect vs. 23.30% via the subcutaneous route (95%CI [0.154;0.485] p = 0.001). The placebo ACR-50 response was 10.90% ((CI95% [0.074;0.144]) p = 0) for 14 RCTs: only adalimumab was significant (15.40%, (CI95% [0.026;0.281]) p = 0). The ACR-70 placebo effect was 3.40% (95% (CI [0.019; 0.049]) p = 0) in 13 studies (NS). Conclusions: Even though TNF-blockers had greater efficacy, placebo effect should be considered. Indeed, it is estimated at ~20% even treatment failure. Adalimumab, certolizumab and infliximab had higher placebo effects, as did the i.v route. The greater the stringency of ACR criteria, the more the placebo effect was decreased.

journal of rheumatic diseases and treatment

Meta-Analysis of the Clinical Efficacy of the Placebo Effect from Tumour-Necrosis-Factor Inhibitors to Treat Rheumatoid Arthritis after Methotrexate Failure