A Comprehensive Clinical Evaluation of Rilonacept in the Treatment of Recurrent Pericarditis: A Systematic Review.

Objective: Recurrent pericarditis (RP) is a rare cardiac condition characterized by recurrent inflammation, in which interleukin-1 (IL-1) is a key mediator. Despite increasing use of IL-1 inhibitors, comprehensive evaluations of rilonacept for RP are very limited, especially in China, where RP was newly listed as a rare disease in 2023. This review addresses the current gap by systematically assessing the efficacy, safety, cost-effectiveness, innovativeness, suitability, and accessibility of rilonacept in the management of RP, providing evidence-based guidance for clinical practice.

Methods: A systematic literature review (PROSPERO registration: CRD42024609978) was conducted across six electronic databases (three international databases, PubMed, Ovid/Embase, The Cochrane Library; three Chinese platforms, CNKI, Wanfang, VIP) from their inception to September 30, 2024. The search protocol incorporated both controlled vocabulary (MeSH terms) and free-text terms specific to rilonacept and RP. Studies were included if they investigated rilonacept for the treatment of RP, and fulfilled all predefined inclusion/exclusion criteria. The retrieved literature underwent comprehensive analysis focusing on efficacy, safety, cost-effectiveness, innovativeness, suitability, and accessibility of rilonacept in RP management.

Results: Five clinical studies were identified but no pharmacoeconomic studies were found. All patients experienced a decrease in pericarditis pain to 0.4-0.6 points and a decrease in C-reactive protein levels to 0.22 mg/dL after treatment. The median time to reach therapeutic endpoints was approximately 5-7 days, with significantly reduced recurrence rates and markedly improved quality of life. The treatment demonstrates excellent long-term tolerability. It addresses a critical clinical need, offers convenient administration, and exhibits promising innovation, appropriateness, and accessibility. While its economic feasibility requires post-marketing analysis, the drug shows considerable potential for future clinical application.

Conclusion: Rilonacept is effective, tolerable, innovative, and suitable in the treatment of RP, while also showing promise in improving its cost-effectiveness and accessibility. Further comparative and cost-effectiveness studies are needed to fully define the therapeutic role of rilonacept in the RP treatment paradigm.