Five-year treat-to-target outcomes after methotrexate induction therapy with or without other csDMARDs and temporary glucocorticoids for rheumatoid arthritis in the CareRA trial. Issue 8 (2nd April 2021)

• Record Type: Journal Article
• Authors: Stouten, Veerle; Westhovens, René; Pazmino, Sofia; De Cock, Diederik; Van der Elst, Kristien; Joly, Johan; Bertrand, Delphine; Verschueren, Patrick
• Is Part Of: Annals of the rheumatic diseases. Volume 80:Issue 8(2021)
• Page Start: 965
• Page End: 973
• Publication Date: 2021-04-02
• Subjects: glucocorticoids -- arthritis -- rheumatoid -- biological therapy -- methotrexate -- outcome assessment -- health care; Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2020-219825
• Languages: English
• ISSNs: 0003-4967

Abstract

Abstract : Objectives: To compare outcomes of different treatment schedules from the care in early rheumatoid arthritis (CareRA) trial over 5 years. Methods: Patients with RA completing the 2-year CareRA randomised controlled trial were eligible for the 3-year observational CareRA-plus study. 5-year outcomes after randomisation to initial methotrexate (MTX) monotherapy with glucocorticoid bridging (COBRA-Slim) were compared with MTX step-up without glucocorticoids or conventional synthetic disease-modifying antirheumatic drug (DMARD) combinations with glucocorticoid bridging, per prognostic patient group. Disease activity (Disease Activity Score based on 28 joints calculated with C reactive protein (DAS28-CRP)) and functionality (Health Assessment Questionnaire (HAQ)) were compared between treatment arms using longitudinal models; safety and drug use were detailed. Results: Of 322 eligible patients, 252 (78%) entered CareRA-plus, of which 203 (81%) completed the study. Treatments for high-risk patients resulted in comparable DAS28-CRP (p=0.539) and HAQ scores over 5 years (p=0.374). Low-risk patients starting COBRA-Slim had lower DAS28-CRP (p<0.001) and HAQ scores (p=0.041) than those starting only on MTX. At study completion, 114/203 (56%) patients never had their original DMARD therapy intensified, with comparable rates between all treatments. Safety was comparable between treatments in high-risk patients. In low-risk patients, there were 18 adverse events in 10 COBRA-Slim and 36 in 17 patients treated with initial MTX monotherapy (p=0.048). Over 5 years, 22% of patients initiated biologics, 25% took glucocorticoids for >3 months and 17% for >6 months outside the bridging period. Conclusions: All intensive treatments with glucocorticoids bridging demonstrated excellent 5 year outcomes. Initiating COBRA-Slim was comparably effective as more complex treatments for high-risk patients with early RA and more effective than initial MTX monotherapy for low-risk patients with limited need for biologics and chronic glucocorticoid use.