接种 COVID-19 和 SARS-CoV-2 疫苗的利隆那塞治疗患者心包炎未复发：RHAPSODY长期推广研究的结果

IF 2.5 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS CJC Open Pub Date : 2024-06-01 DOI:10.1016/j.cjco.2024.02.002

Antonio Brucato MD , Lucia Trotta MD , Michael Arad MD , Paul C. Cremer MD , Antonella Insalaco MD , Marc Klutstein MD , Martin LeWinter MD , David Lin MD , Sushil A. Luis MBBS, PhD , Yishay Wasserstrum MD , JoAnn Clair PhD, MBA , Sheldon Wang PhD , Allan L. Klein MD , Massimo Imazio MD , John F. Paolini MD, PhD

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引用次数: 0

摘要

背景利龙赛普能抑制白细胞介素-1通路，在RHAPSODY长期延长（LTE）3期试验中，对复发性心包炎（RP）患者延长治疗可使复发风险降低98%。严重急性呼吸系统综合征（SARS）-CoV-2 疫苗接种和/或感染可能会诱发心包炎复发，在临床实践中，是否在 SARS-CoV-2 感染期间继续使用利洛那普尚属未知。这项 RHAPSODY LTE 的事后分析旨在为接种 SARS-CoV-2 疫苗或感染 COVID-19 的 RP 患者的利隆那普管理提供参考。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洛那赛普治疗。评估了利洛那西普预防心包炎复发的疗效数据，并评估了同时接种SARS-CoV-2疫苗和COVID-19不良事件的数据。报告了 16 例 COVID-19 病例；30 例未接种疫苗或部分接种疫苗的患者中有 10 例（33%），而 44 例完全接种疫苗的患者中有 6 例（14%；P = 0.04）。16名患者中有12名（75%）在感染时正在接受利洛那普治疗，没有人出现心包炎复发。4名患者中有1名患者在COVID-19期间复发了心包炎，他们在4.5个月前停止了利龙赛普治疗。13例患者的COVID-19严重程度为轻度，2例为中度，1例为重度。在利龙赛普治疗期间接种疫苗或COVID-19不会增加心包炎的复发。感染 COVID-19 的患者继续接受利隆塞普治疗不会加重疾病的严重程度，而利隆塞普治疗中断则会增加心包炎的复发，因此建议在接种疫苗或 COVID-19 期间继续接受利隆塞普治疗。

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Absence of Pericarditis Recurrence in Rilonacept-Treated Patients With COVID-19 and SARS-CoV-2 Vaccination: Results From the RHAPSODY Long-term Extension

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%; P = 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.