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THU0214 LONG-TERM EFFECTIVENESS OF METHOTREXATE WITH STEP DOWN GLUCOCORTICOID BRIDGING (COBRA SLIM) VERSUS OTHER CONVENTIONAL DMARD REGIMENS AS INITIAL RA THERAPY: 5-YEAR OUTCOMES OF THE CARERA TRIAL.

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Background: The treat-to-target Care in Early Rheumatoid Arthritis (CareRA) trial demonstrated that remission induction with csDMARD combinations and step-down glucocorticoids (GCs) was not superior over methotrexate (MTX) monotherapy with step-down… Click to show full abstract

Background: The treat-to-target Care in Early Rheumatoid Arthritis (CareRA) trial demonstrated that remission induction with csDMARD combinations and step-down glucocorticoids (GCs) was not superior over methotrexate (MTX) monotherapy with step-down GCs (Cobra Slim) in RA patients with a high-risk profile (1). Moreover, Cobra Slim showed benefit over a tight step-up with MTX in monotherapy (TSU) in RA patients with a low-risk profile. Objectives: To compare the long term outcomes up to 5 years of different initial intensive treatment strategies in participants of the CareRA-plus study. Methods: In the CareRA trial, patients with DMARD naive early RA were stratified in a high- or low-risk group based upon the presence of serummarkers, disease activity and erosive status. High-risk patients were randomised to Cobra Classic (MTX+sulphasalazine with highly dosed GC remission induction scheme), Cobra Avant-Garde (MTX+leflunomide with moderately dosed GC scheme) or Cobra Slim. Low-risk patients were randomised to Cobra Slim or TSU. Patients completing this trial were eligible for the CareRA-plus observational study. Here, patients were evaluated 6-monthly over 3 years. Therapy adaptation was left to the treating physician. Efficacy was assessed by DAS28-CRP and HAQ and compared between the originally allocated treatment arms. The 5-year evolution from CareRA baseline of DAS28-CRP and HAQ was assessed via linear mixed models. All adverse events (AEs), considered to be clinically relevant by investigators, and DMARD/GCs therapy were registered. Results: Of 322 eligible patients, 252 (78%) were included in CareRA-plus, of which 203 (81%) completed the study. Characteristics and outcomes at the CareRA closing visit (year 2) did not differ between patients entering CareRA-plus or not. DAS28-CRP 3 months). Conclusion: All intensive treatment strategies resulted in excellent long-term clinical outcomes. Initial Cobra Slim therapy showed comparable 5-year effectiveness as Cobra Classic and Avant-Garde in high-risk early RA patients and better efficacy and safety than conservative step up treatment in low-risk patients. References: [1]Stouten, V. et al. Effectiveness of different combinations of DMARDs and glucocorticoid bridging in early rheumatoid arthritis: two-year results of CareRA. Rheumatology (Oxford). (2019) doi:10.1093/rheumatology/kez213. Disclosure of Interests: : Veerle Stouten: None declared, Rene Westhovens Grant/research support from: Celltrion Inc, Galapagos, Gilead, Consultant of: Celltrion Inc, Galapagos, Gilead, Speakers bureau: Celltrion Inc, Galapagos, Gilead, Diederik De Cock: None declared, Sofia Pazmino: None declared, Johan Joly: None declared, Delphine Bertrand: None declared, Kristien Van der Elst: None declared, Patrick Verschueren Grant/research support from: Pfizer unrestricted chair of early RA research, Speakers bureau: various companies

Keywords: none declared; cobra; risk; year; cobra slim; trial

Journal Title: Annals of the Rheumatic Diseases
Year Published: 2020

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