Real world efficacy and safety of nintedanib in idiopathic pulmonary fibrosis: A single center, observational study from India

Abstract

Background: Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis (IPF) has been established by multiple clinical trials. This study aims to assess the efficacy and safety of nintedanib in real-world IPF patients in India. Methods: Clinical records of IPF patients (prescribed with nintedanib) visiting tertiary pulmonary care center, between June 2016 and December 2019, were analyzed retrospectively. Data were analyzed for forced vital capacity (FVC), Diffusing capacity of lung for carbon monoxide(DLCO), 6-min walk distance (6-MWD). Acute exacerbations and adverse events were also analyzed. Results: A total of 76 IPF patients were prescribed with nintedanib. Drug was prescribed at 100 and 150 mg BD dose to 37 and 39 patients. Ten patients (13.1%), of which eight were over the age of 60 years, died during the study period. Only 42 patients visited for follow-up. Mean baseline FVC was 1.67 L and mean annualized absolute change in FVC and FVC % predicted was −0.07 L and −1.80%, respectively. Mean baseline DLCO was 37.21% and mean annualized absolute change in DLCO % predicted was-2.20%. At follow-up, 1 (2.38%), 17 (40.47%), and 24 (57.14%) patients were at Deparatment of Internal Medicine stage I, II, and III, respectively. Acute exacerbations and adverse events were reported by 48 and 6 patients, respectively. Conclusion: Our results support the findings from previous studies, that nintedanib leads to annual decline in parameters such as FVC and DLCO and increased 6-MWD. It was found to be well tolerated in the Indian patients with IPF.

A Real-World Multicenter Retrospective Observational Study on Polish Experience with Nintedanib Therapy in Patients with Idiopathic Pulmonary Fibrosis: The PolExNIB Study

“…It is of note that in INPULSIS-1 diarrhea was a reason for premature discontinuation in 4.5% of patients and in INPULSIS-2 in 4.3% of patients [6]. Other gastrointestinal ADRs noted in our study included decreased appetite, weight loss, abdominal discomfort, nausea, and hepatic enzyme elevations which is in line with the findings on the safety profile of nintedanib reported previously [6,[11][12][13][14][18][19][20][21][22][23][24][25]35].…”

“…A similar frequency of diarrhea was noted in two other RWD studies, one from Greece (45%) and one from the UK (49.7%) [12,21]. However, the frequency of diarrhea in other real-world clinical setting studies on nintedanib in IPF varies considerably between 32% and 78.9% [11][12][13][14][15][18][19][20][21][22][23][24][25], and is invariably related to differences in the methodologies for collecting data in retrospective studies. Diarrhea was also a main reason for permanent treatment discontinuations due to ADRs in our study (n = 16, 3.2%) which is in complete agreement with the known tolerance profile of nintedanib [6,14,22,35].…”

“…PolExNIB is the first retrospective and observational study evaluating the long-term safety and efficacy of nintedanib in Polish patients with IPF and is one of the largest multicenter real-world setting studies reporting nationwide experiences of nintedanib in IPF published to date [11][12][13][14][15][16][17][18][19][20][21][22][23][24][25]. The main findings of the present study confirm the long-term acceptable safety and tolerability profiles of nintedanib and suggest that nintedanib therapy is associated with disease stabilization and a low discontinuation rate over up to 3 years of follow-up.…”

“…To date, several RWD studies on the safety and efficacy of nintedanib in heterogeneous IPF populations have been published; nevertheless, the scientific soundness of many of them suffers from the small number of patients included and/or short follow-up periods [11][12][13][14][15][16][17][18][19][20][21][22][23][24][25]. Moreover, data describing the clinical safety and efficacy of long-term nintedanib therapy in Polish patients with IPF are lacking.…”