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Background: Anakinra is an interleukin-1 receptor antagonist (IL-1Ra) that blocks the biological activity of IL-1, including inflammation. Ana kinra in combination with methotrexate (MTX) is indicated for reduction in signs and symptoms in active rheumatoid arthritis, in adults who have failed one or more disease-modifying antirheumatic drugs (DMARDs). Material and methods: According to the rules of evidence-based medicine popularized by The Cochrane Collaboration, a systematic review of medical literature has been performed in order to assess clinical efficacy and safety of the therapy. The review yielded three randomized clinical studies which compared the administration of anakinra in combination with MTX (or other DMARDs) to placebo with MTX. Results: Moderate clinical efficacy defined as ACR20, ACR50 and ACR70 response and safety profile of anakinra in combination with MTX or other DMARDs was proven in most studies mentioned and confirmed by the results of the meta-analysis performed. Conclusions: Injection site reactions were the most common adverse events frequently leading to withdrawal. S t r e s z c z e n i e

Anakinra in the treatment of rheumatoid arthritis in adult patients with an inadequate response to methotrexate. Systematic review and meta-analysis