The efficacy, safety, and cost-effectiveness of conventional synthetic disease-modifying anti-rheumatic drugs triple therapy in preventing relapse in rheumatoid arthritis patients: a randomized controlled trial (ESCoRT study)

Abstract BackgroundTumor necrosis factor inhibitors (TNFi) have been widely used in rheumatoid arthritis (RA) patients who failed to conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs). But how to prevent relapse after discontinuation of TNFi remains challengeable.MethodsRA patients who failed to csDMARDs received an induction therapy of MTX+TNFi for maximally 12 weeks. Those achieving LDA in 12 weeks were randomly assigned at a 1:1:1 ratio into three groups: (A) adding hydroxychloroquine and sulfasalazine for the first 12 weeks and then discontinuing TNFi for the following 48 weeks; (B) maintaining TNFi+MTX for 60 weeks; and (C) maintaining TNFi+MTX for the first 12 weeks and then discontinuing TNFi for the following 48 weeks. The primary outcome was relapse.Results117 patients were enrolled for induction therapy and 67 patients who achieved LDA within 12 weeks were randomized, with 24, 21 and 22 patients in each group. The relapse rates during 60 weeks were comparable between group A and B [10/22 (45.5%) vs 7/20 (35%), p=0.491], however, both significantly lower than that of group C [17/20 (85%), p=0.019, p=0.004, respectively]. Taken ¥100000 as the threshold of willingness to pay, compared to MTX monotherapy, both TNFi maintenance and triple csDMARDs therapies were cost-effective, but triple therapy was better.ConclusionFor RA patients achieving LDA with TNFi and MTX, csDMARDs triple therapy was a cost-effective option in favor of reducing relapse.Trial registrationRegistration number: NCT02320630.