1. 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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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., van der Elst, K., Meyfroidt, S., Westhovens, R., CareRA study group, the, RS: CAPHRI School for Public Health and Primary Care, RS: CAPHRI - R3 - Functioning, Participating and Rehabilitation, Interne Geneeskunde, Public Health Sciences, and Cell Biology and Histology
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Glucocorticoids/therapeutic use ,Male ,Time Factors ,Arthritis ,Antirheumatic Agents/therapeutic use ,Cobra ,Severity of Illness Index ,THERAPY ,law.invention ,Arthritis, Rheumatoid ,Randomized controlled trial ,Prednisone ,law ,Immunology and Allergy ,Prospective Studies ,skin and connective tissue diseases ,Prospective cohort study ,computer.programming_language ,biology ,Middle Aged ,Prognosis ,EULAR RECOMMENDATIONS ,C-Reactive Protein ,Treatment Outcome ,Antirheumatic Agents ,Area Under Curve ,Female ,Research Article ,medicine.drug ,Adult ,musculoskeletal diseases ,medicine.medical_specialty ,Methotrexate/therapeutic use ,Arthritis, Rheumatoid/blood ,Immunology ,AMERICAN-COLLEGE ,Drug Administration Schedule ,CLASSIFICATION ,C-Reactive Protein/analysis ,Rheumatology ,Internal medicine ,MANAGEMENT ,medicine ,Humans ,Rheumatoid factor ,Glucocorticoids ,Aged ,COMBINATION-TREATMENT STRATEGIES ,Dose-Response Relationship, Drug ,business.industry ,TIGHT CONTROL ,C-reactive protein ,REMISSION ,medicine.disease ,Methotrexate ,MODIFYING ANTIRHEUMATIC DRUGS ,biology.protein ,Physical therapy ,FOLLOW-UP ,business ,computer ,Biomarkers/blood ,Biomarkers - 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–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. 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. Trial registration EU Clinical Trials Register Identifier: EudraCT number 2008-007225-39. Registered 5 November 2008. Electronic supplementary material The online version of this article (doi:10.1186/s13075-015-0611-8) contains supplementary material, which is available to authorized users.
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- 2015
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