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Efficacy of Pharmacological Treatment in Rheumatoid Arthritis

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Efficacy of Pharmacological Treatment in Rheumatoid Arthritis Ann Rheum Dis: first published as 10.1136/annrheumdis-2019-216656 on 7 February 2020. Downloaded from Rheumatoid arthritis CLINICAL SCIENCE Efficacy of pharmacological treatment in rheumatoid arthritis: a systematic literature research informing the 2019 update of the EULAR recommendations for management of rheumatoid arthritis Andreas Kerschbaumer ,1 Alexandre Sepriano ,2,3 Josef S Smolen,1 Désirée van der Heijde ,2 Maxime Dougados,4 Ronald van Vollenhoven,5 Iain B McInnes,6 Johannes W J Bijlsma,7 Gerd R Burmester,8 Maarten de Wit ,9 Louise Falzon,10 Robert Landewé5 Handling editor Dimitrios T ABStract Key messages Boumpas Objectives To inform the 2019 update of the European League against Rheumatism (EULAR) ► Additional material is What is already known about this subject? published online only. To view recommendations for the management of rheumatoid ► Since the 2016 update of the recommendations please visit the journal online arthritis (RA). for the management of rheumatoid arthritis (http:// dx. doi. org/ 10. 1136/ Methods A systematic literature research (SLR) annrheumdis- 2019- 216656). (RA), the body of evidence has grown vividly. to investigate the efficacy of any disease- modifying Therefore, this systematic literature research For numbered affiliations see antirheumatic drug (DMARD) (conventional synthetic (SLR) was performed to inform the 2019 end of article. (cs)DMARD, biological (b) and biosimilar DMARD, European League against Rheumatism (EULAR) targeted synthetic (ts)DMARD) or glucocorticoid (GC) task force with the summarised evidence Correspondence to therapy in patients with RA was done by searching on efficacy of conventional and targeted Dr Andreas Kerschbaumer, MEDLINE, Embase and the Cochrane Library for articles Division of Rheumatology, synthetic disease-modifying antirheumatic Department of Medicine 3, published between 2016 and 8 March 2019. drugs (DMARDs), biological DMARDs and Medical University of Vienna, Results 234 abstracts were selected for detailed glucocorticoids. Vienna, Austria; assessment, with 136 finally included. They comprised andreas. kerschbaumer@ the efficacy of bDMARDs versus placebo or other meduniwien. ac. at What does this study add? bDMARDs, efficacy of Janus kinase (JAK) inhibitors ► Trials comparing biological DMARDs have Received 17 November 2019 (JAKi) across different patient populations and shown similar efficacy, regardless of the Revised 7 January 2020 head- to- head of different bDMARDs versus JAKi or underlying mode of action. Accepted 8 January 2020 other bDMARDs. Switching of bDMARDs to other Published Online First ► Head- to- head trials between Janus kinase (JAK) http://ard.bmj.com/ 7 February 2020 bDMARDs or tsDMARDs, strategic trials and tapering inhibitors (JAKi) and tumour necrosis factor studies of bDMARDs, csDMARDs and JAKi were inhibitor inhibitors did not reveal clinically assessed. The drugs evaluated included abatacept, important differences in efficacy. adalimumab, ABT-122, baricitinib, certolizumab ► Drug tapering of DMARDs, including JAKi is pegol, SBI-087, CNTO6785, decernotinib, etanercept, possible, especially in patients achieving stable filgotinib, golimumab, GCs, GS-9876, guselkumab, remission. hydroxychloroquine, infliximab, leflunomide, ► Treating patients to target using MRI- defined on September 26, 2021 by guest. Protected copyright. mavrilimumab, methotrexate, olokizumab, otilimab, remission does not lead to better outcomes peficitinib, rituximab, sarilumab, salazopyrine, when compared with a conventional clinical ► http:// dx. doi. org/ 10.1136/ secukinumab, sirukumab, tacrolimus, tocilizumab, treat- to- target strategy. annrheumdis- 2019- 216653 tofacitinib, tregalizumab, upadacitinib, ustekinumab ► http:// dx. doi. org/ 10.1136/ and vobarilizumab. The efficacy of many bDMARDs How might this impact on clinical practice or annrheumdis- 2019- 216655 and tsDMARDs was shown. Switching to another future developments? http:// dx. doi. org/ 10.1136/ ► annrheumdis- 2019- 216821 tumour necrosis factor inhibitor (TNFi) or non-T NFi ► This SLR, alongside with the safety SLR, bDMARDs after TNFi treatment failure is efficacious. provided the 2019 EULAR RA management Tapering of DMARDs is possible in patients achieving recommendations task force with the emerged long-standing stringent clinical remission; in patients evidence since 2016. © Author(s) (or their with residual disease activity (including patients employer(s)) 2020. Re- use permitted under CC BY-­NC. No in LDA) the risk of flares is increased during the commercial re- use. See rights tapering. Biosimilars are non-inferior to their reference INTRODUCTION and permissions. Published products. To provide the task force on the 2019 update by BMJ. Conclusion This SLR informed the task force of the European League against Rheumatism To cite: Kerschbaumer A, regarding the evidence base of various therapeutic (EULAR) recommendations for the pharmacolog- Sepriano A, Smolen JS, regimen for the development of the update of EULAR’s ical management of rheumatoid arthritis (RA) with et al. Ann Rheum Dis RA management recommendation. all available evidence that had emerged since the 2020;79:744–759. last update, systematic literature researches (SLRs) 744 Kerschbaumer A, et al. Ann Rheum Dis 2020;79:744–759. doi:10.1136/annrheumdis-2019-216656 Ann Rheum Dis: first published as 10.1136/annrheumdis-2019-216656 on 7 February 2020. Downloaded from Rheumatoid arthritis were performed. In 2016, three SLRs were conducted assessing variables, physical function, patient- reported outcomes and efficacy of biological disease- modifying antirheumatic drugs measures of structural damage. (bDMARDs),1 efficacy of glucocorticoids (GCs), conventional Sixteen research questions were defined according to the synthetic (cs) and targeted synthetic (ts) DMARDs,2 and safety of Patient population, Intervention, Control, Outcome (PICO) pharmacological treatments in RA.3 The 2019 update was based principle with the help of the steering committee. All typical RA on two SLRs, one on safety and the present one on efficacy of study populations were included, methotrexate (MTX)- naïve pharmacological interventions in RA. or generally DMARD- naïve patients, csDMARD insufficient The body of evidence has grown vividly in the last 3 years, responders (IR), bDMARD-IR or tsDMARD-IR . Adequately especially regarding tsDMARDs inhibiting Janus Kinase inhib- defined control groups receiving either placebo or active treat- itor (JAKi), novel bDMARDs targeting new as well as established ment were mandatory for inclusion in this analysis. These pathways and trials comparing bDMARDs to other bDMARDs involved the efficacy of bDMARDs with or without csDMARD or tsDMARDs, providing important information on the compar- combination, head- to- head comparisons of bDMARDs and ative efficacy of these compounds.4 Further, studies on tapering switching between different bDMARDs, tapering and stopping and stopping treatment broaden the information base for rheu- bDMARDs, as well as the efficacy of tsDMARDs and the respec- matologists and patients on the question of possible disease tive head- to- head comparison to bDMARDs. Other research flares after tapering or cessation of drugs, once patients have questions involved biosimilars, switching between bsDMARDs reached the clinical target. Strategic studies on how to optimally and respective boDMARD, the efficacy of csDMARDs and the treat patients to target,5 using clinical and imaging targets have efficacy of GC (in combination with csDMARDs). All interven- also answered important research questions.6 Finally, a large tions of interest are shown in online supplementary table S1.7. number of trials compared the efficacy and safety of biosimilars A detailed description of the PICOs is shown in online supple- (bs) DMARDs with those of their bio-originators (bo), including mentary table S1.8. switching between boDMARD and respective bsDMARDs. Risk of bias (RoB) in individual studies was assessed at study This SLR was conducted to update the evidence on efficacy of level using the Cochrane Collaborations Risk of Bias tool for pharmacological interventions in RA. This involves the evidence randomised controlled trials (RCTs). The assessment was done accrued since the last update of the treatment recommendations independently by two investigators (AK and AS). Differing for RA, published by EULAR in 2016.7 Another SLR focusing assessments were discussed until consensus was reached. on safety of pharmacological treatments in RA is published Due to the heterogeneity of the available studies, no meta- separately.8 analysis was performed, and results will be reported narra- tively. Descriptive forest plots were created using RevMan V.5.3 (Copenhagen: The Nordic Cochrane Centre, The Cochrane METHODS Collaboration, 2014). The EULAR updated standard operating procedures were followed,9 and an SLR protocol was developed and approved by the steering committee. RESULTS Studies eligible for inclusion in this SLR were randomised, The study selection process involved 15 037 references. After controlled, double-blind trials investigating csDMARDs, deduplication, 7876 remained for title and abstract screening, of bDMARDs (bo and bsDMARDs), tsDMARDs or GCs in adult which 234 were selected for full article review and 136 articles patients with RA classified according to the 2010 American finally included. A detailed flow chart is depicted in figure 1. http://ard.bmj.com/ College of Rheumatology (ACR)/EULAR or the ACR 1987 Details
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