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
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Published in |
Arthritis Research & Therapy, April 2015
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DOI | 10.1186/s13075-015-0611-8 |
Pubmed ID | |
Authors |
Patrick Verschueren, Diederik De Cock, Luk Corluy, Rik Joos, Christine Langenaken, Veerle Taelman, Frank Raeman, Isabelle Ravelingien, Klaas Vandevyvere, Jan Lenaerts, Elke Geens, Piet Geusens, Johan Vanhoof, Anne Durnez, Jan Remans, Bert Vander Cruyssen, Els Van Essche, An Sileghem, Griet De Brabanter, Johan Joly, Kristien Van der Elst, Sabrina Meyfroidt, Rene Westhovens, on behalf of the CareRA study group |
Abstract |
Considering a lack of efficacy data in patients with early Rheumatoid Arthritis (eRA) presenting without classical poor prognosis markers, we compared methotrexate (MTX) with or without step-down glucocorticoids in the Care for early RA (CareRA) trial. Disease Modifying Anti-Rheumatic Drugs (DMARDs) naïve eRA patients were stratified into a low-risk group based on prognostic markers including non-erosiveness, Anti-Citrullinated-Protein Antibodies (ACPA) and Rheumatoid Factor (RF) negativity and low disease activity (DAS28(CRP) ≤ 3.2). Patients were randomized to 15 mg MTX weekly (MTX-TSU) or 15 mg MTX weekly with prednisone bridging, starting at 30 mg and tapered to 5 mg daily from week 6 (Cobra Slim). A tight step-up (TSU) approach was applied. Outcomes were DAS28(CRP) remission, cumulative disease activity, Health Assessment Questionnaire (HAQ) and adverse events (AEs) after 16 treatment weeks. 43 Cobra Slim and 47 MTX-TSU patients were analyzed: 65.1% in the Cobra Slim group and 46.8% in the MTX-TSU group reached remission (p = 0.081). Mean ± SD AUC-DAS28(CRP) was 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 a HAQ = 0 (51.2% vs 23.4%, p = 0.006) at week 16. Therapy related AEs did not differ. 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 over the first 16 treatment weeks. Eudract.ema.europa.eu; EudraCT number 2008-007225-39 ; registered 5 November 2008]. |
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