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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/24151

Title: Effectiveness of methotrexate with step-down glucocorticoid remission induction ( COBRA Slim) versus other intensive treatment strategies for early rheumatoid arthritis in a treat-to-target approach: 1-year results of CareRA, a randomised pragmatic open-label superiority 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
Vander Cruyssen, Bert
Van Essche, Els
Sileghem, An
De Brabanter, Griet
Joly, Johan
Meyfroidt, Sabrina
Van der Elst, Kristien
Westhovens, Rene
Issue Date: 2017
Citation: ANNALS OF THE RHEUMATIC DISEASES, 76(3), p. 511-520
Abstract: Objectives Combining disease-modifying antirheumatic drugs (DMARDs) with glucocorticoids (GCs) is an effective treatment strategy for early rheumatoid arthritis (ERA), yet the ideal schedule and feasibility in daily practice are debated. We evaluated different DMARD combinations and GC remission induction schemes in poor prognosis patients; and methotrexate (MTX) with or without GC remission induction in good prognosis patients, during the first treatment year. Methods The Care in ERA (CareRA) trial is a 2-year investigator-initiated randomised pragmatic open-label superiority trial comparing remission induction regimens in a treat-to-target approach. DMARD-inexperienced patients with ERA were stratified into a high-risk or low-risk group based upon presence of erosions, disease activity, rheumatoid factor and anticitrullinated protein antibodies. High-risk patients were randomised to a COBRA Classic (MTX + sulfasalazine + prednisone step-down from 60 mg), COBRA Slim (MTX + prednisone step-down from 30 mg) or COBRA Avant Garde (MTX + leflunomide + prednisone step-down from 30 mg) scheme. Low-risk patients were randomised to MTX tight step-up (MTX-TSU) or COBRA Slim. Primary outcome was the proportion of patients in 28 joint disease activity score calculated with C-reactive protein remission at week 52 in an intention-to-treat analysis. Secondary outcomes were safety and effectiveness (ClinicalTrial.gov identifier NCT01172639). Results 98 COBRA Classic, 98 COBRA Slim (high risk), 93 COBRA Avant Garde, 47 MTX-TSU and 43 COBRA Slim (low risk) patients were evaluated. Remission was achieved in 64.3% (63/98) COBRA Classic, 60.2% (59/98) COBRA Slim (high risk) and 62.4% (58/93) COBRA Avant Garde patients at W52 (p=0.840); and in 57.4% (27/47) MTX-TSU and 67.4% (29/43) COBRA Slim (low risk) patients (p=0.329). Less adverse events occurred per patient with COBRA Slim (high risk) compared with COBRA Classic or COBRA Avant Garde (p=0.038). Adverse events were similar in MTX-TSU and COBRA Slim (low risk) patients (p=0.871). At W52, 76.0% patients were on DMARD monotherapy, 5.2% used GCs and 7.5% biologicals. Conclusions MTX with a moderate-dose GC remission induction scheme (COBRA Slim) seems an effective, safe, low-cost and feasible initial treatment strategy for patients with ERA regardless of their prognostic profile, provided a treat-to-target approach is followed.
Notes: [Verschueren, Patrick; De Cock, Diederik; Meyfroidt, Sabrina; Westhovens, Rene] Katholieke Univ Leuven, Skeletal Biol & Engn Res Ctr, Dept Dev & Regenerat, Leuven, Belgium. [Verschueren, Patrick; Joly, Johan; Van der Elst, Kristien; Westhovens, Rene] Univ Hosp Leuven, Dept Rheumatol, Leuven, Belgium. [Corluy, Luk; Langenaken, Christine; Lenaerts, Jan] Reuma Inst Hasselt, Hasselt, Belgium. [Corluy, Luk; Langenaken, Christine; Lenaerts, Jan] Jessa Ziekenhuis Hasselt, Hasselt, Belgium. [Joos, Rik; Raeman, Frank; Geens, Elke] ZNA Jan Palfijn Antwerpen, Antwerp, Belgium. [Taelman, Veerle] Heilig Hart Ziekenhuis Leuven, Leuven, Belgium. [Ravelingien, Isabelle; Vander Cruyssen, Bert] Onze Lieve Vrouw Ziekenhuis Aalst, Dept Rheumatol, Aalst, Belgium. [Vandevyvere, Klaas; Durnez, Anne] AZ Groeninge Hosp Kortrijk, Kortrijk, Belgium. [Geusens, Piet; Vanhoof, Johan] ReumaClin Genk & UHasselt, Genk, Belgium. [Geusens, Piet] Maastricht UMC, Maastricht, Netherlands. [Remans, Jan] Reuma Inst Genk, Genk, Belgium. [Van Essche, Els] Imeldaziekenhuis Bonheiden, Bonheiden, Belgium. [Sileghem, An] ReumaClin Hasselt, Hasselt, Belgium. [De Brabanter, Griet] AZ Sint Lucas Brugge, Brugge, Belgium. [Van der Elst, Kristien] Katholieke Univ Leuven, Skeletal Biol & Engn Res Ctr, Dept Publ Hlth & Primary Care, Leuven, Belgium.
URI: http://hdl.handle.net/1942/24151
DOI: 10.1136/annrheumdis-2016-209212
ISI #: 000394513300009
ISSN: 0003-4967
Category: A1
Type: Journal Contribution
Appears in Collections: Research publications

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