接受利罗那肽治疗的 COVID-19 患者和接种 SARS-CoV-2 疫苗后心包炎未复发：RHAPSODY 长期扩展研究结果
Absence of Pericarditis Recurrence in Rilonacept-Treated Patients With COVID-19 and SARS-CoV-2 Vaccination: Results From the RHAPSODY Long-term Extension.
作者信息
Brucato Antonio, Trotta Lucia, Arad Michael, Cremer Paul C, Insalaco Antonella, Klutstein Marc, LeWinter Martin, Lin David, Luis Sushil A, Wasserstrum Yishay, Clair JoAnn, Wang Sheldon, Klein Allan L, Imazio Massimo, Paolini John F
机构信息
Department of Biomedical and Clinical Science, University of Milan, Fatebenefratelli Hospital, Milan, Italy.
Internal Medicine, Fatebenefratelli Hospital, Milan, Italy.
出版信息
CJC Open. 2024 Mar 4;6(6):805-810. doi: 10.1016/j.cjco.2024.02.002. eCollection 2024 Jun.
BACKGROUND
Rilonacept inhibits the interleukin-1 pathway, and extended treatment in patients with recurrent pericarditis (RP) reduced recurrence risk by 98% in the phase 3 trial, RHAPSODY long-term extension (LTE). Severe acute respiratory syndrome (SARS)-CoV-2 vaccination and/or infection may trigger pericarditis recurrence, and in clinical practice, it is unknown whether to continue rilonacept during SARS-CoV-2 infection. This post-hoc analysis of the RHAPSODY LTE aimed to inform rilonacept management in RP patients vaccinated against SARS-CoV-2 or who contract COVID-19.
METHODS
Analysis was conducted from May 2020 to June 2022. The LTE portion of RHAPSODY LTE enabled up to 24 months of additional open-label rilonacept treatment beyond the pivotal study. Rilonacept efficacy data in preventing pericarditis recurrence were assessed, and concomitant SARS-CoV-2 vaccination and COVID-19 adverse event data were evaluated.
RESULTS
No pericarditis recurrences were temporally associated with vaccination. Sixteen COVID-19 cases were reported; 10 in 30 unvaccinated or partially vaccinated patients (33%) vs 6 of 44 fully vaccinated patients (14%; = 0.04). Twelve of 16 patients (75%) were receiving rilonacept at the time of infection, and none experienced pericarditis recurrence. One pericarditis recurrence occurred in the peri-COVID-19 period in 1 of 4 patients who had stopped rilonacept treatment > 4.5 months prior. COVID-19 severity was mild in 13 patients, moderate in 2, and severe in 1.
CONCLUSIONS
Full vaccination effectively reduced COVID-19 events in patients treated with rilonacept. Vaccination or COVID-19 during rilonacept treatment did not increase pericarditis recurrence. Continued rilonacept treatment in patients contracting COVID-19 did not worsen disease severity, whereas rilonacept interruption increased pericarditis recurrence, supporting a recommendation for continued rilonacept treatment for RP during vaccination or COVID-19.
CLINICALTRIALSGOV IDENTIFIER
NCT03737110.
背景
利罗那肽可抑制白细胞介素-1通路，在3期试验“RHAPSODY长期扩展（LTE）”中，复发性心包炎（RP）患者接受延长治疗后，复发风险降低了98%。严重急性呼吸综合征（SARS）-CoV-2疫苗接种和/或感染可能会引发心包炎复发，在临床实践中，SARS-CoV-2感染期间是否继续使用利罗那肽尚不清楚。这项对RHAPSODY LTE的事后分析旨在为接种SARS-CoV-2疫苗或感染2019冠状病毒病（COVID-19）的RP患者的利罗那肽管理提供依据。
方法
分析于2020年5月至2022年6月进行。RHAPSODY LTE的LTE部分允许在关键研究之外进行长达24个月的额外开放标签利罗那肽治疗。评估了利罗那肽预防心包炎复发的疗效数据，并评估了同时发生的SARS-CoV-2疫苗接种和COVID-19不良事件数据。
结果
心包炎复发与疫苗接种在时间上无关联。报告了16例COVID-19病例；30例未接种或部分接种疫苗的患者中有10例（33%），44例完全接种疫苗的患者中有6例（14%；P = 0.04）。16例患者中有12例（75%）在感染时正在接受利罗那肽治疗，且均未出现心包炎复发。在4例在>4.5个月前停止利罗那肽治疗的患者中，有1例在COVID-19期间出现了1次心包炎复发。13例患者的COVID-19病情为轻度，2例为中度，1例为重度。
结论
全程接种疫苗有效减少了接受利罗那肽治疗患者的COVID-19事件。利罗那肽治疗期间接种疫苗或感染COVID-19并未增加心包炎复发率。感染COVID-19的患者继续使用利罗那肽治疗并未使疾病严重程度恶化，而中断利罗那肽治疗则增加了心包炎复发率，这支持了在接种疫苗或感染COVID-19期间对RP患者继续使用利罗那肽治疗的建议。
临床试验注册号
NCT03737110。
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