Joseph A Lasky1, Gerard J Criner2, Howard M Lazarus3, Veronika Kohlbrenner3, Shaun Bender3, Luca Richeldi4. 1. School of Medicine, Tulane University, New Orleans, LA, USA. jlasky@tulane.edu. 2. Department of Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA. 3. Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA. 4. Fondazione Policlinico A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.
Abstract
INTRODUCTION: The safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis (IPF) have been characterized using data from clinical trials. METHODS: We further characterized the safety and tolerability of nintedanib in patients with IPF in clinical practice using the global pharmacovigilance database. The database included spontaneously reported adverse events and data collected via solicited reporting in patients treated with nintedanib from 15 October 2014 to 15 October 2018. Adverse events were coded using the Medical Dictionary for Regulatory Activities. Cumulative exposure to nintedanib was estimated on the basis of sales data. RESULTS: Cumulative exposure to nintedanib was estimated as 60,107 patient-years. Diarrhea was the most frequent event (301.6 events per 1000 patient-years). Most (97.0%) diarrhea events were non-serious. The median (25th, 75th percentile) time to onset of the first diarrhea event was 60 (11, 182) days. Elevated liver enzyme or bilirubin levels were reported at a rate of 31.5 events per 1000 patient-years. Bleeding was reported at a rate of 36.8 events per 1000 patient-years; 81.0% of events were non-serious. Major cardiovascular adverse events were reported at a rate of 13.4 events per 1000 patient-years and myocardial infarction at a rate of 4.3 events per 1000 patient-years. Gastrointestinal perforation was reported at a rate of 1.0 event per 1000 patient-years. CONCLUSIONS: On the basis of pharmacovigilance data collected over 4 years, the safety profile of nintedanib in patients with IPF was consistent with that observed in clinical trials and described in the product label, with no new safety concerns observed.
INTRODUCTION: The safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis (IPF) have been characterized using data from clinical trials. METHODS: We further characterized the safety and tolerability of nintedanib in patients with IPF in clinical practice using the global pharmacovigilance database. The database included spontaneously reported adverse events and data collected via solicited reporting in patients treated with nintedanib from 15 October 2014 to 15 October 2018. Adverse events were coded using the Medical Dictionary for Regulatory Activities. Cumulative exposure to nintedanib was estimated on the basis of sales data. RESULTS: Cumulative exposure to nintedanib was estimated as 60,107 patient-years. Diarrhea was the most frequent event (301.6 events per 1000 patient-years). Most (97.0%) diarrhea events were non-serious. The median (25th, 75th percentile) time to onset of the first diarrhea event was 60 (11, 182) days. Elevated liver enzyme or bilirubin levels were reported at a rate of 31.5 events per 1000 patient-years. Bleeding was reported at a rate of 36.8 events per 1000 patient-years; 81.0% of events were non-serious. Major cardiovascular adverse events were reported at a rate of 13.4 events per 1000 patient-years and myocardial infarction at a rate of 4.3 events per 1000 patient-years. Gastrointestinal perforation was reported at a rate of 1.0 event per 1000 patient-years. CONCLUSIONS: On the basis of pharmacovigilance data collected over 4 years, the safety profile of nintedanib in patients with IPF was consistent with that observed in clinical trials and described in the product label, with no new safety concerns observed.
Authors: Vincent Cottin; Fernando J Martinez; R Gisli Jenkins; John A Belperio; Hideya Kitamura; Maria Molina-Molina; Inga Tschoepe; Carl Coeck; Dirk Lievens; Ulrich Costabel Journal: Respir Res Date: 2022-04-07
Authors: Katarzyna Górska; Marta Maskey-Warzęchowska; Małgorzata Barnaś; Adam Białas; Adam Barczyk; Hanna Jagielska-Len; Ewa Jassem; Aleksander Kania; Katarzyna Lewandowska; Sebastian Majewski; Magdalena M Martusewicz-Boros; Wojciech J Piotrowski; Alicja Siemińska; Krzysztof Sładek; Małgorzata Sobiecka; Marzena Trzaska-Sobczak; Witold Tomkowski; Beata Żołnowska; Rafał Krenke Journal: Ther Adv Chronic Dis Date: 2022-08-22 Impact factor: 4.970