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

doi:10.3390/biomedicines10102362

NICEFIT-A Prospective, Non-Interventional, and Multicentric Study for the Management of Idiopathic Pulmonary Fibrosis with Antifibrotic Therapy in Taiwan

Biomedicines. 2022 Sep 22;10(10):2362. doi: 10.3390/biomedicines10102362.

Authors

Shih-Lung Cheng^{1

2}, Chau-Chyun Sheu³, Chih-Feng Chian⁴, Jeng-Yuan Hsu⁵, Kuo-Chin Kao⁶, Liang-Wen Hang⁷, Ching-Hsiung Lin^{8

9

10

11}, Wen-Feng Fang¹², Hao-Chien Wang¹³, Diahn-Warng Perng¹⁴

Affiliations

¹ Department of Chemical Engineering and Materials Science, Yuan Ze University, Taoyuan City 320, Taiwan.
² Department of Pulmonary, Far Eastern Memorial Hospital, New Taipei City 220, Taiwan.
³ Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung 807, Taiwan.
⁴ Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei 114, Taiwan.
⁵ Division of Clinical Research, Taichung Veterans General Hospital, Taichung 407, Taiwan.
⁶ Department of Thoracic Medicine, Linkou Chang Gung Memorial Hospital, Taoyuan 333, Taiwan.
⁷ Department of Pulmonary, China Medical University Hospital, Taichung 404, Taiwan.
⁸ Institute of Genomics and Bioinformatics, National Chung Hsing University, Taichung 402, Taiwan.
⁹ Ph.D. Program in Translational Medicine, National Chung Hsing University, Taichung 402, Taiwan.
¹⁰ Department of Recreation and Holistic Wellness, MingDao University, Changhua 403, Taiwan.
¹¹ Division of Chest Medicine, Department of Internal Medicine, Changhua Christian Hospital, Changhua 403, Taiwan.
¹² 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.
¹³ Department of Medicine, National Taiwan University Cancer Center, Taipei 100, Taiwan.
¹⁴ Department of Chest Medicine, School of Medicine, National Yang-Ming Chiao-Tung University, Taipei Veterans General Hospital, Taipei 112, Taiwan.

Abstract

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.

Keywords: Taiwan; idiopathic pulmonary fibrosis; lung function; nintedanib; pirfenidone; real-world registry.

Grants and funding

This study was supported and funded by Boehringer Ingelheim Taiwan Ltd. The authors did not receive payment related to the development of the manuscript and publication. Divyaanka Iyer, PhD, of MIMS provided writing, editorial support, and formatting assistance, which was contracted and funded by Boehringer Ingelheim (BI). BI was given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations.