Pamrevlumab for Idiopathic Pulmonary Fibrosis

作者：Ganesh Raghu, Luca Richeldi, Evans R. Fernández Pérez, María Cristina De Salvo, Rafael S. Silva, Jin Woo Song, Takashi Ogura, Zuo Jun Xu, Elizabeth A. Belloli, Xueping Zhang, Lorilyn L. Seid, Lona Poole, ZEPHYRUS-1 Study Investigators, Simon Bowler, Tamera J. Corte, Mark Holmes, Francis Thien, John Wheatley, Choi Sun-Mi, Man-Pyo Chung, Sung-Hwan Jeong, Yonghyun Kim, Eunjoo Lee, Hyun-Kyung Lee, Choon‐Sik Park, Jong Sun Park, Joo Hun Park, David Lam, Ming-Cheng Chan, Kang‐Yun Lee, Jie Cao, Juan Chen, Rongchang Chen, Huaping Dai, Xiuhua Fu, Zongan Liang, Qun Luo, Guochao Shi, Zhaohui Tong, Limin Wang, Shuanying Yang, Hongtao Yu, Huilan Zhang, Jianchu Zhang, Hui Zhao, Wei Wang, Ying Meng, Hong Peng, Murali Ramaswamy, Mark Hamblin, John Fitzgerald, Nishant Gupta, Jane E. Dematte, Srihari Veeraraghavan, Thomas O’Brien, Tracy Luckhardt, Lisa Lancaster, M. Kokoszynska, Neil Ettinger, Thomas D. Kaelin, Ather Siddiqi, Bridget F. Collins, Mary Beth Scholand, Danielle Antin‐Ozerkis, Kim Hyun, Christopher Harden, Frank Averill, Jorge M. Mallea, Rebecca Bascom, Vandana Seeram, Amy Hajari Case, E. James Britt, Barry S. Shea, Gerard J. Criner, Mark H. Gotfried, Yolanda Mageto, Sherif El Bayadi, Cristina Reichner, Joshua J. Mooney, David Hotchkin, Rodeo Abrencillo, R. Boente, Joyce Lee, Alan Betensley, Niranjan Jeganathan, Rajat Walia, Timothy Albertson, Iván O. Rosas, Dileep Puppala, Ladly Abraham, Richard I. Enelow, Nitin Bhatt, Debabratra Bandyopadhyay, Pedro Carlos Elias, Miguel Bergna, Gabriel Ricardo Garcia, Gaston De Stefano, Luis Arturo Wehbe, Alejandro Chirino, Ramón Luévanos Rojas, María Otaola, G. Miranda, Matías Florenzano, Rafael Silva Orellana, Valeska Glasinovich, Olga Shangina, A.M. Nikishenkov, Н. А. Кузубова · 发表于：JAMA · 年份：2024 · DOI：10.1001/jama.2024.8693 · 被引用次数：72 · 研究领域：Interstitial Lung Diseases and Idiopathic Pulmonary Fibrosis、Connective Tissue Growth Factor Research、Systemic Sclerosis and Related Diseases

Importance: Current treatments for idiopathic pulmonary fibrosis slow the rate of lung function decline, but may be associated with adverse events that affect medication adherence. In phase 2 trials, pamrevlumab (a fully human monoclonal antibody that binds to and inhibits connective tissue growth factor activity) attenuated the progression of idiopathic pulmonary fibrosis without substantial adverse events. Objective: To assess the efficacy and safety of pamrevlumab for patients with idiopathic pulmonary fibrosis. Design, Setting, and Participants: Phase 3 randomized clinical trial including 356 patients aged 40 to 85 years with idiopathic pulmonary fibrosis who were not receiving antifibrotic treatment with nintedanib or pirfenidone at enrollment. Patients were recruited from 117 sites in 9 countries between July 18, 2019, and July 29, 2022; the last follow-up encounter occurred on August 28, 2023. Interventions: Pamrevlumab (30 mg/kg administered intravenously every 3 weeks; n = 181) or placebo (n = 175) for 48 weeks. Main Outcomes and Measures: The primary outcome was absolute change in forced vital capacity (FVC) from baseline to week 48. There were 5 secondary outcomes (including time to disease progression, which was defined as a decline of ≥10% in predicted FVC or death). The exploratory outcomes included patient-reported symptoms. Adverse events were reported. Results: Among 356 patients (mean age, 70.5 years; 258 [72.5%] were men; 221 [62.1%] were White), 277 (77.8%...