NICEFIT—A Prospective, Non-Interventional, and Multicentric Study for the Management of Idiopathic Pulmonary Fibrosis with Antifibrotic Therapy in Taiwan
Shih-Lung Cheng,
Chau-Chyun Sheu,
Chih-Feng Chian,
Jeng-Yuan Hsu,
Kuo-Chin Kao,
Liang-Wen Hang,
Ching-Hsiung Lin,
Wen-Feng Fang,
Hao-Chien Wang,
Diahn-Warng Perng
Affiliations
Shih-Lung Cheng
Department of Chemical Engineering and Materials Science, Yuan Ze University, Taoyuan City 320, Taiwan
Chau-Chyun Sheu
Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung 807, Taiwan
Chih-Feng Chian
Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei 114, Taiwan
Jeng-Yuan Hsu
Division of Clinical Research, Taichung Veterans General Hospital, Taichung 407, Taiwan
Kuo-Chin Kao
Department of Thoracic Medicine, Linkou Chang Gung Memorial Hospital, Taoyuan 333, Taiwan
Liang-Wen Hang
Department of Pulmonary, China Medical University Hospital, Taichung 404, Taiwan
Ching-Hsiung Lin
Institute of Genomics and Bioinformatics, National Chung Hsing University, Taichung 402, Taiwan
Wen-Feng Fang
Department of Internal Medicine, Division of Pulmonary and Critical Care Medicine, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung 833, Taiwan
Hao-Chien Wang
Department of Medicine, National Taiwan University Cancer Center, Taipei 100, Taiwan
Diahn-Warng Perng
Department of Chest Medicine, School of Medicine, National Yang-Ming Chiao-Tung University, Taipei Veterans General Hospital, Taipei 112, Taiwan
Idiopathic pulmonary fibrosis (IPF) causes progressive lung fibrosis with subsequent fatality and has limited treatment options. NICEFIT is the first Taiwan-based prospective, observational, and non-interventional registry for IPF progression under routine clinical practice in Taiwan. Data on 101 patients (aged 74.6 ± 9.1 years and 83.2% men) with IPF were collected over 2 years (2018−2020) from medical centers in Taiwan at baseline, 1 month, and subsequent 3-month intervals. Treated patients (n = 88) received the antifibrotics nintedanib or pirfenidone, compared with the untreated group (n = 13). The 2-year assessment revealed overall preserved lung functionality in the treated patients, with insignificant changes from baseline for percent predicted forced vital capacity or FVC (±1.7%). The presence of respiratory comorbidities significantly increased the risk of both AE and death (with or without AE) over the full study duration. Furthermore, the decline of predicted FVC significantly increased with the risk of acute exacerbations (AE) in the second year. Overall, antifibrotic medication was beneficial in stalling IPF progression, reducing AEs, and delaying mortality in the treated cohort, despite their lower baseline lung functions. Further, no new safety concerns over antifibrotic treatments were observed for the Taiwanese population.
