Placebo Works Best in Combination Save

Analysis of two large clinical trial datasets shows that placebo response rates in randomised controlled trials (RCTs) of patients with rheumatoid arthritis are better when the patient continued background methotrexate (MTX). 

RA patients with an insufficient MTX can either continue or stop MTX (continued background therapy) as they start a new agent. This post hoc analysis of placebo-treated patients included in two RCTs that had allowed inclusion of patients with and without ongoing MTX: the GO-AFTER and the SIRROUND-T trials.

They compared clinical outcomes in those receiving placebo on top of continued MTX and those receiving placebo without any background disease modifying antirheumatic drugs (DMARDs).

From a total of 398 who received placebo, 285 continued MTX and 113 had no background DMARDs. Baseline characteristics were similar.

The week 16 outcomes clearly favored PBO patients who continued MTX (vs PBO alone) with regard to ACR20 (25% vs. 12%; p=0.005); ACR50 (8.4% vs 0.9%; p=0.003); ACR70 (2.8% vs. 0%; p=0.112); and CDAI-LDA (8.8% vs.1.8%; p=0.013).

Clinical responses to placebo are higher in patients who continue an insufficient MTX background therapy. This data has clinical utility for those needing a change in DMARD therapy - it's best to continue the MTX!