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Title: Methotrexate in combination with other DMARDs is not superior to methotrexate alone for remission induction with moderate-to-high-dose glucocorticoid bridging in early rheumatoid arthritis after 16 weeks of treatment: the CareRA trial
Authors: Verschueren, P.
De Cock, D.
Corluy, L.
Joos, R.
Langenaken, C.
Taelman, V.
Raeman, F.
Ravelingien, I.
Vandevyvere, K.
Lenaerts, J.
Geens, E.
Geusens, P.
Vanhoof, J.
Durnez, A.
Remans, J.
Vander Cruyssen, B.
Van Essche, E.
Sileghem, A.
De Brabanter, G.
Joly, J.
Meyfroidt, Sabrina
Van der Elst, K.
Westhovens, R.
Issue Date: 2015
Citation: ANNALS OF THE RHEUMATIC DISEASES, 74 (1), p. 27-34
Abstract: Objectives To compare the efficacy and safety of intensive combination strategies with glucocorticoids (GCs) in the first 16 weeks (W) of early rheumatoid arthritis (eRA) treatment, focusing on high-risk patients, in the Care in early RA trial. Methods 400 disease-modifying antirheumatic drugs (DMARD)-naive patients with eRA were recruited and stratified into high risk or low risk according to classical prognostic markers. High-risk patients (n=290) were randomised to 1/3 treatment strategies: combination therapy for early rheumatoid arthritis (COBRA) Classic (methotrexate (MTX)+ sulfasalazine+60 mg prednisone tapered to 7.5 mg daily from W7), COBRA Slim (MTX + 30 mg prednisone tapered to 5 mg from W6) and COBRA Avant-Garde (MTX+leflunomide+30 mg prednisone tapered to 5 mg from W6). Treatment modifications to target low-disease activity were mandatory from W8, if desirable and feasible according to the rheumatologist. The primary outcome was remission (28 joint disease activity score calculated with C-reactive protein <2.6) at W16 (intention-to-treat analysis). Secondary endpoints were good European League Against Rheumatism response, clinically meaningful health assessment questionnaire (HAQ) response and HAQ equal to zero. Adverse events (AEs) were registered. Results Data from 98 Classic, 98 Slim and 94 Avant-Garde patients were analysed. At W16, remission was reached in 70.4% Classic, 73.6% Slim and 68.1% Avant-Garde patients (p=0.713). Likewise, no significant differences were shown in other secondary endpoints. However, therapy-related AEs were reported in 61.2% of Classic, in 46.9% of Slim and in 69.1% of Avant-Garde patients (p=0.006). Conclusions For high-risk eRA, MTX associated with a moderate step-down dose of GCs was as effective in inducing remission at W16 as DMARD combination therapies with moderate or high step-down GC doses and it showed a more favourable short-term safety profile.
Notes: [Verschueren, P.; De Cock, D.; Meyfroidt, S.; Westhovens, R.] Katholieke Univ Leuven, Dept Dev & Regenerat, Skeletal Biol & Engn Res Ctr, B-3000 Leuven, Belgium. [Verschueren, P.; Joly, J.; Van der Elst, K.; Westhovens, R.] Univ Hosp Leuven, Dept Rheumatol, Leuven, Belgium. [Corluy, L.; Langenaken, C.; Lenaerts, J.] Reuma Inst Hasselt, Hasselt, Belgium. [Corluy, L.; Langenaken, C.; Lenaerts, J.] Jessa Ziekenhuis Hasselt, Hasselt, Belgium. [Joos, R.; Raeman, F.; Geens, E.] ZNA Jan Palfijn Antwerpen, Antwerp, Belgium. [Taelman, V.] Heilig Hart Ziekenhuis Leuven, Leuven, Belgium. [Ravelingien, I.; Vander Cruyssen, B.] Onze Lieve Vrouw Ziekenhuis Aalst, Dept Rheumatol, Aalst, Belgium. [Vandevyvere, K.; Durnez, A.] AZ Groeninge Hosp Kortrijk, Kortrijk, Belgium. [Geusens, P.; Vanhoof, J.] ReumaClin Genk, Hasselt, Belgium. [Geusens, P.; Vanhoof, J.] Univ Hasselt, Hasselt, Belgium. [Geusens, P.] Maastricht UMC, Maastricht, Netherlands. [Remans, J.] Reuma Inst Genk, Genk, Belgium. [Van Essche, E.] Imeldaziekenhuis Bonheiden, Bonheiden, Belgium. [Sileghem, A.] ReumaClin Hasselt, Hasselt, Belgium. [De Brabanter, G.] AZ St Lucas Brugge, Brugge, Belgium. [Van der Elst, K.] Katholieke Univ Leuven, Dept Publ Hlth & Primary Care, Skeletal Biol & Engn Res Ctr, B-3000 Leuven, Belgium.
URI: http://hdl.handle.net/1942/21834
DOI: 10.1136/annrheumdis-2014-205489
ISI #: 000345945700016
ISSN: 0003-4967
Category: A1
Type: Journal Contribution
Validation: ecoom, 2016
Appears in Collections: Research publications

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