SAT0130 Defining the Optimal Biological Monotherapy in Rheumatoid Arthritis (RA): Network Meta-Analysis of Randomized Trials

Background Methotrexate (MTX) is considered the anchor drug in RA, both as monotherapy, as well as for its ability to increase the efficacy of biologic agents when used in combination [1]. Some RA patients have to discontinue DMARD therapy. Thus, it is important to define the optimal biological monotherapy in RA patients. Objectives To review the evidence for short-term efficacy and safety of biologic monotherapy in RA. The aim was to define the optimal biological monotherapy in RA patients without concomitant use of any DMARD therapy. Methods Systematic review and Network Meta-Analysis of RCTs with DMARD inadequate responders (IR) and DMARD naïve RA patients, comparing biologic agents in monotherapy with either placebo (no DMARD) or DMARD, were considered eligible for inclusion. The co-primary outcomes were the number of patients achieving an ACR50 response, and the number discontinuing therapy due to adverse events (AE) [2] preferably after 6 months (3-12 months), respectively. The network meta-analysis was based on mixed-effects logistic regression (GLMM modelled in SAS) [2]; combining statistical inference from both direct and indirect comparisons of the treatment effects between biologics. All dosages applied for all of the nine biologics. Results are reported as odds ratios (OR [95%CI]). For sensitivity, in terms of the included patients, we compared DMARD IR responder trials with DMARD Naïve trials. Results From the literature search 27 individual studies (7,938 patients) were included: abatacept [Aba:1], adalimumab [Ada:5], anakinra [Ana:2], certolizumab [Cer:2], etanercept [Eta:6], golimumab [Gol:3], infliximab [Inf:1], rituximab [Rit:1] and tocilizumab [Toc:6]. The network only included one ‘closed loop’ with biologics head-to-head: ADACTA (Toc vs. Ada) [3]. Benefit (ACR50): Ana was statistically less likely than Ada, Eta, Gol, and Toc, respectively, to have a clinical response (p