Efficacy and safety of anti-ınterleukin-1 treatment in familial Mediterranean fever patients: a systematic review and meta-analysis.

Familial Mediterranean fever (FMF) is the most common hereditary monogenic fever syndrome marked by recurrent attacks of fever and polyserositis. Colchicine is the current recommended first-line treatment for FMF. However, a small portion of FMF patients are unresponsive or intolerant to colchicine. Anti-interleukin-1 (anti-IL-1) agents are alternative treatment options for colchicine-resistant or -intolerant FMF patients. This systematic review and meta-analysis aimed to provide qualitative and quantitative evidence for the efficacy and safety of anti-IL-1 agents in adult and pediatric FMF patients. MEDLINE, EMBASE, CENTRAL, and Web of Science were screened from inception to May 2023. We included adult and pediatric FMF patients, who received continuous treatment with at least one of the anti-IL-1 drugs: anakinra, canakinumab, and rilonacept. The primary efficacy outcome was the proportion of patients who achieved complete remission of attacks and the primary safety outcome was the proportion of patients who experienced at least one adverse event during treatment. A random-effects meta-analysis was performed for the quantitative synthesis. Fourty-four reports consisting of 1399 FMF patients were included. Sixty percent (95% CI: 49%, 72%) of the adult patients and 81% (95% CI: 72%, 89%) of the pediatric patients achieved complete remission. Anti-IL-1 agents significantly decreased levels of inflammatory markers. At least one adverse event was observed in 25% (95% CI: 13%, 37%) of the adult patients and 12% (95% CI: 3%, 21%) of the pediatric patients. Anti-IL-1 agents were effective and demonstrated a low adverse event profile in pediatric and adult FMF patients.

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