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Randomized Controlled Trial Multicenter Study
Gradual tapering TNF inhibitors versus conventional synthetic DMARDs after achieving controlled disease in patients with rheumatoid arthritis: first-year results of the randomised controlled TARA study.
- Elise van Mulligen, Pascal Hendrik Pieter de Jong, Tjallingius Martijn Kuijper, Myrthe van der Ven, Cathelijne Appels, Casper Bijkerk, Joop B Harbers, Yael de Man, T H Esmeralda Molenaar, Ilja Tchetverikov, Yvonne P M Goekoop-Ruiterman, Jende van Zeben, Hazes Johanna M W JMW Rheumatology, Erasmus Medical Centre, Rotterdam, The Netherlands., Weel Angelique E A M AEAM Rheumatology, Maasstad Ziekenhuis, Rotterdam, The Netherlands., and Jolanda J Luime.
- Rheumatology, Erasmus Medical Centre, Rotterdam, The Netherlands elise.vanmulligen@erasmusmc.nl.
- Ann. Rheum. Dis. 2019 Jun 1; 78 (6): 746-753.
ObjectivesThe aim of this study is to evaluate the effectiveness of two tapering strategies after achieving controlled disease in patients with rheumatoid arthritis (RA), during 1 year of follow-up.MethodsIn this multicentre single-blinded (research nurses) randomised controlled trial, patients with RA were included who achieved controlled disease, defined as a Disease Activity Score (DAS) ≤ 2.4 and a Swollen Joint Count (SJC) ≤ 1, treated with both a conventional synthetic disease-modifying antirheumatic drugs (csDMARD) and a TNF inhibitor. Eligible patients were randomised into gradual tapering csDMARDs or TNF inhibitors. Medication was tapered if the RA was still under control, by cutting the dosage into half, a quarter and thereafter it was stopped. Primary outcome was proportion of patients with a disease flare, defined as DAS > 2.4 and/or SJC > 1. Secondary outcomes were DAS, European Quality of Life-5 Dimensions (EQ5D) and functional ability (Health Assessment Questionnaire Disability Index [HAQ-DI]) after 1 year and over time.ResultsA total of 189 patients were randomly assigned to tapering csDMARDs (n = 94) or tapering anti-TNF (n = 95). The cumulative flare rates in the csDMARD and anti-TNF tapering group were, respectively, 33 % (95% CI,24% to 43 %) and 43 % (95% CI, 33% to 53 % (p = 0.17). Mean DAS, HAQ-DI and EQ-5D did not differ between tapering groups after 1 year and over time.ConclusionUp to 9 months, flare rates of tapering csDMARDs or TNF inhibitors were similar. After 1 year, a non-significant difference was found of 10 % favouring csDMARD tapering. Tapering TNF inhibitors was, therefore, not superior to tapering csDMARDs. From a societal perspective, it would be sensible to taper the TNF inhibitor first, because of possible cost reductions and less long-term side effects.Trial Registration NumberNTR2754.© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.
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