在对利罗那肽产生临床反应后以及治疗中断复发前进行的纵向心脏磁共振成像：一项RHAPSODY亚组分析。
Longitudinal cardiac magnetic resonance imaging following clinical response to rilonacept and prior to recurrence upon treatment suspension: a RHAPSODY subgroup analysis.
作者信息
Cremer Paul C, Brucato Antonio, Insalaco Antonella, Lin David, Luis Sushil A, Kwon Deborah H, Jellis Christine L, Clair JoAnn, Curtis Allison, Wang Sheldon, Klein Allan L, Imazio Massimo, Paolini John F
机构信息
Department of Cardiovascular Imaging, Center for the Diagnosis and Treatment of Pericardial Diseases, Cleveland Clinic, Heart and Vascular Institute, Cleveland, OH, USA.
Department of Biomedical and Clinical Science, Fatebenefratelli Hospital, University of Milano, Milano, Italy.
出版信息
Eur Heart J Cardiovasc Imaging. 2024 Dec 31;26(1):72-79. doi: 10.1093/ehjci/jeae200.
AIMS
In the Phase 3 trial, RHAPSODY, rilonacept effectively resolved active pericarditis recurrences, and long-term treatment led to sustained pericarditis recurrence risk reduction. Prior analysis suggested association between higher late gadolinium enhancement (LGE) at baseline and more rapid recurrence upon rilonacept suspension after 12 weeks of treatment. This subgroup analysis assessed the utility of longitudinal serial cardiac magnetic resonance (CMR) imaging for tracking clinical improvement and predicting post-treatment cessation outcomes to help guide clinical decision-making.
METHODS AND RESULTS
At an 18-month decision milestone (18MDM) in the RHAPSODY long-term extension, investigators decided if patients would continue rilonacept, suspend rilonacept for off-treatment observation, or discontinue the study. Pericardial thickness, pericardial oedema (T2-short tau inversion recovery, T2-STIR), and LGE were determined at baseline and 18MDM by an imaging core lab blinded to clinical data, and pericarditis recurrence was investigator-assessed. CMR results in patients with data at both baseline and 18MDM (n = 13) showed that pericardial thickness, T2-STIR, and LGE were reduced during rilonacept treatment. Among patients with CMR data who suspended rilonacept at the 18MDM (n = 7), five (71%) had a pericarditis recurrence within 1-4 months of rilonacept suspension, despite all having had none/trace LGE (n = 7) and negative T2-STIR (n = 7) at the 18MDM and two having received prophylactic colchicine.
CONCLUSION
Continued clinical improvement during prolonged rilonacept treatment corresponded with improvement on CMR, including reduced pericardial thickness, resolution of pericardial oedema, and resolution of LGE. However, none/trace LGE at 18MDM while on treatment did not predict absence of pericarditis recurrence upon subsequent rilonacept suspension in this size-limited subgroup.
目的
在3期试验RHAPSODY中，rilonacept可有效解决活动性心包炎复发问题，长期治疗可降低心包炎复发风险。先前的分析表明，基线时较高的晚期钆增强（LGE）与治疗12周后停用rilonacept后更快复发之间存在关联。该亚组分析评估了纵向连续心脏磁共振（CMR）成像在跟踪临床改善情况和预测治疗后停药结果以帮助指导临床决策方面的效用。
方法与结果
在RHAPSODY长期扩展研究的18个月决策里程碑（18MDM）时，研究人员决定患者是继续使用rilonacept、停用rilonacept进行停药观察还是终止研究。由对临床数据不知情的成像核心实验室在基线和18MDM时测定心包厚度、心包水肿（T2加权短tau反转恢复序列，T2-STIR）和LGE，心包炎复发情况由研究人员评估。在基线和18MDM时均有数据的患者（n = 13）的CMR结果显示，在rilonacept治疗期间心包厚度、T2-STIR和LGE均降低。在18MDM时停用rilonacept的有CMR数据的患者（n = 7）中，5例（71%）在停用rilonacept后的1 - 4个月内出现心包炎复发，尽管所有患者在18MDM时LGE均为无/微量（n = 7）且T2-STIR为阴性（n = 7），还有2例接受了预防性秋水仙碱治疗。
结论
在rilonacept长期治疗期间持续的临床改善与CMR的改善相对应，包括心包厚度降低、心包水肿消退和LGE消退。然而，在该规模有限的亚组中，治疗期间18MDM时LGE为无/微量并不能预测随后停用rilonacept时心包炎不会复发。
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