학술논문
A Real-World Multicenter Retrospective Observational Study on Polish Experience with Nintedanib Therapy in Patients with Idiopathic Pulmonary Fibrosis: The PolExNIB Study
Document Type
Clinical report
Author
Majewski, Sebastian; Białas, Adam J.; Barczyk, Adam; Batura-Gabryel, Halina; Buchczyk, Małgorzata; Doboszyńska, Anna; Górska, Katarzyna; Grabowska-Skudlarz, Luiza; Jagielska-Len, Hanna; Jarzemska, Agnieszka; Jassem, Ewa; Jastrzębski, Dariusz; Kania, Aleksander; Koprowski, Marek; Krawczyk, Michał; Krenke, Rafał; Lewandowska, Katarzyna; Mackiewicz, Barbara; Martusewicz-Boros, Magdalena M.; Milanowski, Janusz; Noceń-Piskorowska, Małgorzata; Nowicka, Agata; Roszkowski-Śliż, Kazimierz; Siemińska, Alicja; Sładek, Krzysztof; Sobiecka, Małgorzata; Stachura, Tomasz; Tomczak, Małgorzata; Tomkowski, Witold; Trzaska-Sobczak, Marzena; Ziora, Dariusz; Żołnowska, Beata; Piotrowski, Wojciech J.
Source
Journal of Clinical Medicine. July 2023, Vol. 12 Issue 14
Subject
Language
English
ISSN
2077-0383
Abstract
Author(s): Sebastian Majewski (corresponding author) [1,*]; Adam J. Białas [1]; Adam Barczyk [2]; Halina Batura-Gabryel [3]; Małgorzata Buchczyk [4]; Anna Doboszyńska [5]; Katarzyna Górska [6]; Luiza Grabowska-Skudlarz [5]; Hanna Jagielska-Len [...]
Nintedanib is a disease-modifying agent licensed for the treatment of IPF. Data on Polish experience with nintedanib in IPF are lacking. The present study aimed to describe the safety and efficacy profiles of nintedanib in a large real-world cohort of Polish patients with IPF. This was a multicenter, retrospective, observational study of IPF patients treated with nintedanib between March 2018 and October 2021. Data collection included baseline clinical characteristics, results of pulmonary function tests (PFTs), and a six-minute walk test (6MWT). Longitudinal data on PFTs, 6MWT, adverse drug reactions (ADRs), and treatment persistence were also retrieved. A total of 501 patients (70% male) with a median age of 70.9 years (IQR 65–75.7) were included in this study. Patients were followed on treatment for a median of 15 months (7–25.5). The majority of patients (66.7%) were treated with the full recommended dose of nintedanib and 33.3% of patients were treated with a reduced dose of a drug. Intermittent dose reductions or drug interruptions were needed in 20% of patients. Over up to 3 years of follow-up, pulmonary function remained largely stable with the minority experiencing disease progression. The most frequent ADRs included diarrhea (45.3%), decreased appetite (29.9%), abdominal discomfort (29.5%), weight loss (32.1%), nausea (20.8%), fatigue (19.2%), increased liver aminotransferases (15.4%), and vomiting (8.2%). A total of 203 patients (40.5%) discontinued nintedanib treatment due to diverse reasons including ADRs (10.2%), death (11.6%), disease progression (4.6%), patient’s request (6.6%), and neoplastic disease (2.2%). This real-world study of a large cohort of Polish patients with IPF demonstrates that nintedanib therapy is safe, and is associated with acceptable tolerance and disease stabilization. These data support the findings of previously conducted clinical trials and observational studies on the safety and efficacy profiles of nintedanib in IPF.
Nintedanib is a disease-modifying agent licensed for the treatment of IPF. Data on Polish experience with nintedanib in IPF are lacking. The present study aimed to describe the safety and efficacy profiles of nintedanib in a large real-world cohort of Polish patients with IPF. This was a multicenter, retrospective, observational study of IPF patients treated with nintedanib between March 2018 and October 2021. Data collection included baseline clinical characteristics, results of pulmonary function tests (PFTs), and a six-minute walk test (6MWT). Longitudinal data on PFTs, 6MWT, adverse drug reactions (ADRs), and treatment persistence were also retrieved. A total of 501 patients (70% male) with a median age of 70.9 years (IQR 65–75.7) were included in this study. Patients were followed on treatment for a median of 15 months (7–25.5). The majority of patients (66.7%) were treated with the full recommended dose of nintedanib and 33.3% of patients were treated with a reduced dose of a drug. Intermittent dose reductions or drug interruptions were needed in 20% of patients. Over up to 3 years of follow-up, pulmonary function remained largely stable with the minority experiencing disease progression. The most frequent ADRs included diarrhea (45.3%), decreased appetite (29.9%), abdominal discomfort (29.5%), weight loss (32.1%), nausea (20.8%), fatigue (19.2%), increased liver aminotransferases (15.4%), and vomiting (8.2%). A total of 203 patients (40.5%) discontinued nintedanib treatment due to diverse reasons including ADRs (10.2%), death (11.6%), disease progression (4.6%), patient’s request (6.6%), and neoplastic disease (2.2%). This real-world study of a large cohort of Polish patients with IPF demonstrates that nintedanib therapy is safe, and is associated with acceptable tolerance and disease stabilization. These data support the findings of previously conducted clinical trials and observational studies on the safety and efficacy profiles of nintedanib in IPF.