COBRA-Slim bio-induction: no benefit compared with the standard regimen

The CareRA2020 study did not find a significant difference in the long-term effectiveness of COBRA-Slim bio-induction (addition of etanercept) compared with the standard COBRA-Slim regimen (addition of leflunomide) in initial insufficient responders in participants with early rheumatoid arthritis (RA). However, the bio-induction group showed a higher rate of participants on methotrexate monotherapy and a lower requirement for biological or targeted disease-modifying antirheumatic drugs (DMARDs).

The management of early RA is crucial to prevent long-term joint damage and to improve patient outcomes. The EULAR recommends a combination of methotrexate and short-term glucocorticoids as the first-line treatment for early RA. However, there is ongoing research to explore alternative approaches that offer a better balance between efficacy, safety, and cost-effectiveness.

The Care in Early RA 2020 (CareRA2020) trial was conducted to determine the long-term effectiveness of 2 treatment strategies in participants who had an insufficient response to the initial COBRA-Slim induction therapy, which consisted of methotrexate and step-down prednisone [1]. The trial compared the outcomes of adding a second conventional DMARD, leflunomide, with the outcomes of using a temporary course of etanercept, a biological DMARD.

Participants were classified as insufficient responders if they did not achieve the target 28-joint Disease Activity Score using C-reactive protein (DAS28-CRP) with the induction regimen. Insufficient responders were randomised into 2 groups: 1 group received the standard COBRA-Slim treatment with the addition of leflunomide 10 mg/day, while the other group received COBRA-Slim bio-induction with the addition of etanercept 50 mg/week for 24 weeks. The primary outcome was the difference in DAS28-CRP over time.

Both treatment groups had comparable DAS28-CRP scores over 104 weeks, indicating no superiority of COBRA-Slim bio-induction therapy compared with the standard COBRA-Slim regimen (ß 0.061; 95% CI -0.172 to 0.294; P=0.609). However, at the end of the trial, a higher proportion of participants in the bio-induction group were treated with methotrexate monotherapy, while fewer required biological or targeted synthetic DMARDs.

According to the authors, further investigation is needed to assess the potential advantages of incorporating temporary biological DMARDs earlier in the treat-to-target approach.

1. Bertrand D, et al. Effectiveness of COBRA-Slim with or without early access to a temporary 6-month course of etanercept in early RA: Primary outcome of the 2-year, pragmatic, randomized CareRA2020 trial. OP0129, EULAR 2023, 31 May–3 June, Milan, Italy.

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Posted on 31 July, 20231 February, 2024