Nintedanib can be used safely and effectively for idiopathic pulmonary fibrosis with predicted forced vital capacity ≤ 50%: A multi-center retrospective analysis

Abstract

Background Nintedanib is a multi-kinase inhibitor approved for idiopathic pulmonary fibrosis (IPF); however, its efficacy and safety for patients with IPF and restricted pulmonary function remain unclear. Therefore, the objective of this study was to determine the efficacy and safety of nintedanib for patients with IPF and forced vital capacity (FVC) � 50%. Methods This was a multi-center retrospective study performed by the Okayama Respiratory Disease Study Group. Patients were allocated into FVC � 50% and FVC > 50% groups based on their predicted FVC. The primary endpoints were FVC changes from baseline after 6 and 12 months. Results 45 patients were eligible for the study. 18 patients had FVC � 50%, and 27 patients had FVC > 50%. Overall, 31 and 19 patients underwent pulmonary function tests at 6 and 12 months after initiating nintedanib, respectively. FVC changes from baseline at 6 and 12

A Narrative Review of Real-World Data on the Safety of Nintedanib in Patients with Idiopathic Pulmonary Fibrosis

“…In the INPULSIS trials, nausea was reported in 25% of patients in the nintedanib group and 7% of patients in the placebo group, while vomiting was reported in 12% of patients in the nintedanib group and 3% of patients who received placebo [ 8 ]. In real-world studies, nausea or vomiting adverse events have been reported in 2–53% of patients treated with nintedanib [ 17 , 19 – 23 , 26 – 28 , 30 , 31 , 33 – 37 , 43 – 46 ]. In a single-centre study in which five of 124 patients experienced nausea, the average time from starting nintedanib to the onset of nausea was 2.5 months [ 29 ].…”

“…Based on the annual rate of decline in weight, the mean weight loss over 52 weeks was 3.3 kg in the nintedanib group and 1.5 kg in the placebo group; 37.8% and 20.1% of patients in the nintedanib and placebo groups, respectively, had a weight loss greater than 5% [ 47 ]. In real-world studies, 5–32% of patients treated with nintedanib have been reported to experience weight loss [ 19 – 22 , 25 , 27 – 30 , 33 , 34 , 36 , 37 ]. In three studies that reported data on discontinuations due to weight loss, this occurred in about 5% of 49, 57 and 94 patients treated with nintedanib [ 22 , 27 , 44 ].…”

“…Real-world studies suggest that the adverse event profile of nintedanib is generally consistent between patients with advanced lung function impairment (i.e., FVC < 50% predicted or DLco < 30% predicted) and those with more highly preserved lung function [ 23 , 30 , 43 , 45 , 55 , 70 ]. Some studies have reported no difference in the rate of nintedanib discontinuation across these groups [ 30 , 43 , 45 ], while in others, treatment interruptions and permanent discontinuations were more frequent in patients with advanced disease [ 21 , 23 ] (Fig. 3 ).…”

Drugs that act on the respiratory tract

“…Nintedanib and pirfenidone are oral anti-fibrotic drugs used to slow the progression of idiopathic pulmonary fibrosis (IPF). A number of recent “real-world”, observational, and retrospective studies ( Antoniou et al, 2020 [C]; Cameli et al, 2020 [C]; Chung et al, 2020 [C]; Corral et al, 2020 [C]; Dhooria et al, 2020 [C]; Eaden et al, 2020 [C]; Harari et al, 2020 [c]; Justet et al, 2021 [c]; Lasky et al, 2020 [C]; Majewski et al, 2020 [C]; Senoo et al, 2020 [c]; Takeda et al, 2020 [c]; Uchida et al, 2021 [c]; Vianello et al, 2020 [c]), an open-label extension study ( Song et al, 2020 [C]), a small, prospective, patient-satisfaction study ( Moor et al, 2020 [c], and a post-hoc analysis ( Richeldi et al, 2020 [C]) further describe the safety profile of these drugs among patients with IPF from different nations, with more advanced disease, with advanced age, or who have been switched from nintedanib to pirfenidone. In these studies, the type, frequency, and severity of adverse drug events were similar to previously published clinical trial results and showed no new signals of adverse drug events with either nintedanib or pirfenidone.…”

Bleomycin-induced Pneumonitis in a Child Treated With Nintedanib: Report of the First Case in a Childhood

“…Oral nintedanib (BIBF 1120) is a tyrosine kinase inhibitor marketed for the treatment of idiopathic pulmonary fibrosis (IPF) in 2014, and there is an increasing number of publications on its successful use in IPF. [11][12][13] The mechanism of action of nintedanib in IPF is thought to be induced by the inhibition of profibrotic mediators including platelet-derived growth factor, fibroblast growth factor and transforming growth factor-β as well as vascular endothelial growth factor, reducing fibroblast activity. 14,15 In this article, we wanted to present a 13-year-old boy with Hodgkin lymphoma treated with bleomycin containing regimen and developed BIP during the treatment and was successfully treated with nintedanib.…”