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Title: | Effectiveness of methotrexate and bridging glucocorticoids with or without early introduction of a 6-month course of etanercept in early RA: results of the 2-year, pragmatic, randomised CareRA2020 trial | Authors: | Bertrand, Delphine Joly, Johan Neerinckx, Barbara Durez, Patrick Lenaerts , Jan Joos, Rik THEVISSEN, Kristof Zwaenepoel, Tom VANHOOF, Johan Di Romana, Silvana Taelman, Veerle Van Essche, Els Corluy, Luk Ribbens, Clio Vanden Berghe, Marc Devinck, Mieke Ajeganova, Sofia Durnez, Anne Boutsen, Yves Margaux, Joelle Peene, Isabelle Van Offel, Jan Doumen, Michael Pazmino, Sofia De Meyst, Elias Kulyk, Myroslava Creten, Nelly Westhovens, Rene Verschueren, Patrick |
Issue Date: | 2024 | Publisher: | BMJ PUBLISHING GROUP | Source: | RMD open, 10 (3) (Art N° e004535) | Abstract: | Objectives To investigate if patients with early rheumatoid arthritis responding insufficiently to initial methotrexate (MTX) and bridging glucocorticoids (GCs) could benefit from early but temporary etanercept introduction as a second remission-induction attempt. Methods CareRA2020 (NCT03649061) was a 2-year, open-label, multicentre, pragmatic randomised controlled trial. Treatment-na & iuml;ve patients started MTX and GC bridging (COBRA-Slim: CS). Within a time window from week (W) 8 until W32, early insufficient responders (28-joint Disease Activity Score - C-reactive Protein (DAS28-CRP) >3.2 between W8 and W32 or >= 2.6 at W32) were randomised to a Standard-CS strategy (adding leflunomide first) or Bio-induction-CS strategy (adding etanercept for 24 weeks). Additional treatment adaptations followed the treat-to-target principle. Longitudinal disease activity (DAS28-CRP) over 104 weeks (primary outcome), achievement of DAS28-CRP <2.6 28 weeks after randomisation, and biologic or targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD) use at W104 were compared between randomisation groups. Results Following CS treatment, 142 patients were early responders; 55 early insufficient responders received Standard-CS and 55 Bio-induction-CS. Superiority of Bio-induction-CS over Standard-CS could not be demonstrated (beta =-0.204, (95% CI -0.486 to 0.078), p=0.157) for the primary outcome. More patients on Bio-induction-CS achieved DAS28-CRP <2.6 at 28 weeks after randomisation (59% (95% CI 44% to 72%) vs 44% (95% CI 31% to 59%) in Standard-CS) and they were treated less frequently with b/tsDMARDs at W104 (19/55, 35%) compared with Standard-CS (29/55, 53%). Conclusion Half of the patients responded well to initial COBRA-Slim induction therapy. In early insufficient responders, adding etanercept for 6 months did not improve disease control over 104 weeks versus adding leflunomide first. However, temporary introduction of etanercept resulted in improved disease control early after randomisation and less patients on b/tsDMARDs at W104. | Notes: | Bertrand, D (corresponding author), Katholieke Univ Leuven, Skeletal Biol & Engn Res Ctr, Dept Dev & Regenerat, Leuven, Flanders, Belgium. delphine.bertrand@kuleuven.be; johan.joly@uzleuven.be; barbara.neerinckx@uzleuven.be; patrick.durez@saintluc.uclouvain.be; jan.lenaerts@skynet.be; rik.joos@zna.be; Kristof.Thevissen@zol.be; tom.zwaenepoel@gmail.com; johan@vanhoofjohan.be; silvana.diromana@stpierre-bru.be; veerle.taelman1@gmail.com; Els.Van.Essche@imelda.be; luk.corluy@azherentals.be; Clio.Ribbens@chuliege.be; Marc.VANDENBERGHE@ghdc.be; Mieke.Devinck@stlucas.be; sofia.ajeganova@ki.se; annedurnez@hotmail.com; yves.boutsen@uclouvain.be; joelle.margaux@hubruxelles.be; Isabelle.Peene@azsintjan.be; jan.vanoffel@uantwerpen.be; michael.doumen@kuleuven.be; sofia.pazmino@kuleuven.be; elias.demeyst@kuleuven.be; myroslavakulyk@gmail.com; necre@skynet.be; rene.westhovens@uzleuven.be; patrick.verschueren@uzleuven.be |
Keywords: | early rheumatoid arthritis;glucocorticoids;biological therapy;methotrexate | Document URI: | http://hdl.handle.net/1942/43661 | ISSN: | 2056-5933 | e-ISSN: | 2056-5933 | DOI: | 10.1136/rmdopen-2024-004535 | ISI #: | 001294087600001 | Rights: | Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. | Category: | A1 | Type: | Journal Contribution |
Appears in Collections: | Research publications |
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