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Title: | Patients lacking classical poor prognostic markers might also benefit from a step-down glucocorticoid bridging scheme in early rheumatoid arthritis: week 16 results from the randomized multicenter CareRA trial | Authors: | Verschueren, Patrick De Cock, Diederik Corluy, Luk Joos, Rik Langenaken, Christine Taelman, Veerle Raeman, Frank Ravelingien, Isabelle Vandevyvere, Klaas Lenaerts, Jan Geens, Elke GEUSENS, Piet VANHOOF, Johan Durnez, Anne Remans, Jan Cruyssen, Bert Vander Van Essche, Els Sileghem, An De Brabanter, Griet Joly, Johan Van der Elst, Kristien Meyfroidt, Sabrina Westhovens, Rene |
Corporate Authors: | CareRA study group | Issue Date: | 2015 | Publisher: | BIOMED CENTRAL LTD | Source: | ARTHRITIS RESEARCH & THERAPY, 17 | Abstract: | Introduction: Considering a lack of efficacy data in patients with early rheumatoid arthritis (eRA) presenting without classical markers of poor prognosis, we compared methotrexate (MTX) with or without step-down glucocorticoids in the CareRA trial. Methods: Disease-modifying antirheumatic drug-naive patients with eRA were stratified into a low-risk group based on prognostic markers that included non-erosiveness, anti-citrullinated protein antibodies and rheumatoid factor negativity and low disease activity (Disease Activity Score in 28 joints based on C-reactive protein (DAS28(CRP)) <= 3.2). Patients were randomized to 15 mg of MTX weekly (MTX with tight step-up (MTX-TSU)) or 15 mg of MTX weekly with prednisone bridging, starting at 30 mg and tapered to 5 mg daily from week 6 (COmbinatie therapie bij Reumatoide Artritis (COBRA Slim)). A TSU approach was applied. Outcomes assessed were DAS28(CRP)-determined remission, cumulative disease activity, Health Assessment Questionnaire (HAQ) scores and adverse events (AEs) after 16 treatment weeks. Results: We analyzed 43 COBRA Slim and 47 MTX-TSU patients and found that 65.1% in the COBRA Slim group and 46.8% in the MTX-TSU group reached remission (P = 0.081). Mean +/- standard deviation area under the curve values of DAS28(CRP) were 13.84 +/- 4.58 and 11.18 +/- 4.25 for the MTX-TSU and COBRA Slim patients, respectively (P = 0.006). More COBRA Slim patients had an HAQ score of 0 (51.2% versus 23.4%, P = 0.006) at week 16. Therapy-related AEs between groups did not differ. Conclusion: In patients with low-risk eRA, MTX with step-down glucocorticoid bridging seems more efficacious than MTX step-up monotherapy, with a comparable number of AEs observed over the first 16 treatment weeks. | Notes: | [Verschueren, Patrick; De Cock, Diederik; Meyfroidt, Sabrina; Westhovens, Rene] Katholieke Univ Leuven, Dept Dev & Regenerat, Skeletal Biol & Engn Res Ctr, B-3000 Louvain, Belgium. [Verschueren, Patrick; Joly, Johan; Westhovens, Rene] Univ Hosp Leuven, Dept Rheumatol, B-3000 Louvain, Belgium. [Corluy, Luk; Langenaken, Christine; Lenaerts, Jan] Reuma Inst Hasselt, B-3500 Hasselt, Belgium. [Corluy, Luk; Langenaken, Christine; Lenaerts, Jan] Jessa Ziekenhuis Hasselt, B-3500 Hasselt, Belgium. [Joos, Rik; Raeman, Frank; Geens, Elke] ZNA Jan Palfijn Antwerpen, B-2170 Merksem, Belgium. [Taelman, Veerle] Heilig Hart Ziekenhuis Leuven, B-3000 Louvain, Belgium. [Ravelingien, Isabelle; Cruyssen, Bert Vander] Onze Lieve Vrouw Ziekenhuis Aalst, Dept Rheumatol, B-1730 Asse Aalst, Belgium. [Vandevyvere, Klaas; Durnez, Anne] AZ Groeninge Hosp Kortrijk, B-8500 Kortrijk, Belgium. [Geusens, Piet; Vanhoof, Johan] ReumaClin Genk & UHasselt, B-3600 Genk, Belgium. [Geusens, Piet] Maastricht UMC, NL-6229 HX Maastricht, Netherlands. [Remans, Jan] Reuma Inst Genk, B-3600 Genk, Belgium. [Van Essche, Els] Imeldaziekenhuis Bonheiden, B-2820 Bonheiden, Belgium. [Sileghem, An] ReumaClin Hasselt, B-3600 Genk, Belgium. [De Brabanter, Griet] AZ Sint Lucas Brugge, B-8310 Brugge, Belgium. [Van der Elst, Kristien] Katholieke Univ Leuven, Dept Publ Hlth & Primary Care, Skeletal Biol & Engn Res Ctr, B-3000 Louvain, Belgium. Correspondence: patrick.verschueren@uzleuven.be; diederik.decock@med.kuleuven.be Skeletal Biology and Engineering Research Center, KU Leuven Department of Development and Regeneration, Herestraat 49, 3000 Leuven, Belgium | Document URI: | http://hdl.handle.net/1942/18956 | ISSN: | 1478-6354 | e-ISSN: | 1478-6362 | DOI: | 10.1186/s13075-015-0611-8 | ISI #: | 000354066200001 | Rights: | © 2015 Verschueren et al.; licensee BioMed Central. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. | Category: | A1 | Type: | Journal Contribution | Validations: | ecoom 2016 |
Appears in Collections: | Research publications |
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