Yu Yue, Chen Jiajing, Zhao Zhao, Qian Moting, Zhang Yufei, Ma Chunlai
Department of Pharmacy, Huashan Hospital, Fudan University, Shanghai, 200040, People's Republic of China.
J Inflamm Res. 2025 Aug 22;18:11539-11549. doi: 10.2147/JIR.S516825. eCollection 2025.
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.
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.
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.
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.
复发性心包炎（RP）是一种罕见的心脏疾病，其特征为反复发生炎症，其中白细胞介素-1（IL-1）是关键介质。尽管IL-1抑制剂的使用日益增加，但对利罗那肽治疗RP的全面评估非常有限，尤其是在中国，RP于2023年新被列为罕见病。本综述通过系统评估利罗那肽在RP管理中的疗效、安全性、成本效益、创新性、适用性和可及性，填补了当前的空白，为临床实践提供循证指导。
进行了一项系统的文献综述（PROSPERO注册号：CRD42024609978），检索了六个电子数据库（三个国际数据库，即PubMed、Ovid/Embase、Cochrane图书馆；三个中国平台，即知网、万方、维普），检索时间从各数据库建库至2024年9月30日。检索方案纳入了利罗那肽和RP的控制词汇（医学主题词）以及自由文本词。如果研究调查了利罗那肽治疗RP的情况，并符合所有预先定义的纳入/排除标准，则纳入研究。对检索到的文献进行全面分析，重点关注利罗那肽在RP管理中的疗效、安全性、成本效益、创新性、适用性和可及性。
确定了五项临床研究，但未找到药物经济学研究。所有患者治疗后心包炎疼痛降至0.4 - 0.6分，C反应蛋白水平降至0.22 mg/dL。达到治疗终点的中位时间约为5 - 7天，复发率显著降低，生活质量明显改善。该治疗显示出良好的长期耐受性。它满足了关键的临床需求，给药方便，具有有前景的创新性、适用性和可及性。虽然其经济可行性需要上市后分析，但该药物在未来临床应用中显示出相当大的潜力。
利罗那肽在治疗RP方面有效、耐受性好、具有创新性且适用，同时在提高其成本效益和可及性方面也显示出前景。需要进一步的比较研究和成本效益研究，以全面确定利罗那肽在RP治疗模式中的治疗作用。
