Comparative Long-term Effects of Nintedanib and Pirfenidone in Idiopathic Pulmonary Fibrosis: A Real-life Study with Five-year Follow-up.

Abstract

Objective: This study aimed to compare the clinical, radiological, and functional outcomes of idiopathic pulmonary fibrosis (IPF) patients treated with nintedanib or pirfenidone, focusing on long-term efficacy, safety, and survival.

Material and methods: A retrospective cross-sectional real-life study was conducted at a tertiary healthcare center between 2016 and 2021, including 93 IPF patients treated with either nintedanib (n = 41) or pirfenidone (n = 52). Data on demographics, pulmonary function tests [forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and diffusing capacity for carbon monoxide], radiological assessments, exacerbations, mortality, and side effects were analyzed using appropriate statistical methods.

Results: Both groups were comparable in age (nintedanib: 68.6 years; pirfenidone: 71.3 years) and gender distribution. Patients on pirfenidone had a higher body mass index (27.7 vs. 26.0 kg/m², P = 0.049) and more radiological involvement (P = 0.034). Baseline: Gender, Age, Physiology scores were lower in the nintedanib group (3.39 vs. 4.21, P = 0.007). Lung function (FVC, FEV1) was significantly better in the nintedanib group at two years; though differences were not sustained over five years. Side effects were more frequent with nintedanib (73.2% vs. 46.2%, P = 0.009), particularly affecting the gastrointestinal system. At five years after follow-up, mortality was higher in the pirfenidone group (53.4% vs. 17.5%, P = 0.02), although time from diagnosis to death was longer (33.8 vs. 19.0 months, P = 0.020).

Conclusion: Pirfenidone may prolong survival in patients with severe disease and greater radiological involvement, while nintedanib showed lower mortality in milder disease. Treatment outcomes appear influenced by baseline characteristics, highlighting the need for individualized therapeutic strategies. Comprehensive studies involving more homogeneous patient groups are needed to clarify the comparative efficacy of these treatments.