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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/18956

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
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
Issue Date: 2015
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
URI: http://hdl.handle.net/1942/18956
DOI: 10.1186/s13075-015-0611-8
ISI #: 000354066200001
ISSN: 1478-6354
Category: A1
Type: Journal Contribution
Validation: ecoom, 2016
Appears in Collections: Research publications

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