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

• Published in: Arthritis research & therapy Vol. 17; no. 1; p. 97
• Main 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, Van der Elst, Kristien, Meyfroidt, Sabrina, Westhovens, Rene
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 09.04.2015; BioMed Central
• Subjects: Adult; Aged; Analysis; Antirheumatic Agents - therapeutic use; Area Under Curve; Arthritis; Arthritis, Rheumatoid - blood; Arthritis, Rheumatoid - diagnosis; Arthritis, Rheumatoid - drug therapy; Biomarkers - blood; C-reactive protein; C-Reactive Protein - analysis; Care and treatment; Clinical trials; Comparative analysis; Corticosteroids; Dose-Response Relationship, Drug; Drug Administration Schedule; Evaluation; Female; Glucocorticoids - therapeutic use; Health aspects; Humans; Male; Methotrexate; Methotrexate - therapeutic use; Middle Aged; Prednisone; Prognosis; Prospective Studies; Rheumatoid factor; Severity of Illness Index; Steroids; Time Factors; Treatment Outcome; Belgium
• ISSN: 1478-6354; 1478-6362; 1478-6354
• DOI: 10.1186/s13075-015-0611-8

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. Disease-modifying antirheumatic drug-naïve 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 Reumatoïde 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. 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. 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. EU Clinical Trials Register Identifier: EudraCT number 2008-007225-39 . Registered 5 November 2008.