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

Sebastian Majewski; Adam J Białas; Adam Barczyk; Halina Batura-Gabryel; Małgorzata Buchczyk; Anna Doboszyńska; Katarzyna Górska; Luiza Grabowska-Skudlarz; Hanna Jagielska-Len; Agnieszka Jarzemska; Ewa Jassem; Dariusz Jastrzębski; Aleksander Kania; Marek Koprowski; Michał Krawczyk; Rafał Krenke; Katarzyna Lewandowska; Barbara Mackiewicz; Magdalena M Martusewicz-Boros; Janusz Milanowski; Małgorzata Noceń-Piskorowska; Agata Nowicka; Kazimierz Roszkowski-Śliż; Alicja Siemińska; Krzysztof Sładek; Małgorzata Sobiecka; Tomasz Stachura; Małgorzata Tomczak; Witold Tomkowski; Marzena Trzaska-Sobczak; Dariusz Ziora; Beata Żołnowska; Wojciech J Piotrowski

doi:10.3390/jcm12144635

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

J Clin Med. 2023 Jul 12;12(14):4635. doi: 10.3390/jcm12144635.

Authors

Sebastian Majewski¹, Adam J Białas¹, Adam Barczyk², Halina Batura-Gabryel³, Małgorzata Buchczyk⁴, Anna Doboszyńska⁵, Katarzyna Górska⁶, Luiza Grabowska-Skudlarz⁵, Hanna Jagielska-Len⁷, Agnieszka Jarzemska⁸, Ewa Jassem⁹, Dariusz Jastrzębski⁴, Aleksander Kania¹⁰, Marek Koprowski¹¹, Michał Krawczyk¹², Rafał Krenke⁶, Katarzyna Lewandowska¹³, Barbara Mackiewicz¹⁴, Magdalena M Martusewicz-Boros¹⁵, Janusz Milanowski¹⁴, Małgorzata Noceń-Piskorowska¹⁶, Agata Nowicka³, Kazimierz Roszkowski-Śliż¹⁵, Alicja Siemińska¹⁷, Krzysztof Sładek¹⁰, Małgorzata Sobiecka¹³, Tomasz Stachura¹⁰, Małgorzata Tomczak¹⁸, Witold Tomkowski¹³, Marzena Trzaska-Sobczak², Dariusz Ziora⁴, Beata Żołnowska¹³, Wojciech J Piotrowski¹

Affiliations

¹ Department of Pneumology, Medical University of Lodz, 90-153 Lodz, Poland.
² Department of Pneumonology, School of Medicine in Katowice, Medical University of Silesia, 40-752 Katowice, Poland.
³ Department of Pulmonology, Allergology and Pulmonary Oncology, Poznan University of Medical Sciences, 60-569 Poznan, Poland.
⁴ Department of Lung Diseases and Tuberculosis, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia, 40-032 Katowice, Poland.
⁵ Department of Pulmonology, University of Warmia and Mazury in Olsztyn, Pulmonology Hospital, 10-357 Olsztyn, Poland.
⁶ Department of Internal Medicine, Pulmonary Diseases and Allergy, Medical University of Warsaw, 02-091 Warsaw, Poland.
⁷ Clinical Department of Lung Diseases, K. Marcinkowski University Hospital, 65-046 Zielona Gora, Poland.
⁸ Department of Rapid Pulmonary Diagnostics, Kuyavian and Pomeranian Pulmonology Center, 85-326 Bydgoszcz, Poland.
⁹ Department of Pneumonology, Medical University of Gdansk, 80-211 Gdansk, Poland.
¹⁰ Department of Pulmonology, Jagiellonian University Medical College, 30-688 Cracow, Poland.
¹¹ Department of Civilization Diseases and Lung Diseases, John Paul II Specialist Hospital, 31-202 Cracow, Poland.
¹² 1st Department of Lung Diseases and Respiratory Allergy, Voivodeship Center for Lung Disease Treatment and Rehabilitation, 91-520 Lodz, Poland.
¹³ 1st Department of Lung Diseases, National Tuberculosis and Lung Diseases Research Institute, 01-138 Warsaw, Poland.
¹⁴ Department of Pneumonology, Oncology and Allergology, Medical University of Lublin, 20-090 Lublin, Poland.
¹⁵ 3rd Lung Diseases and Oncology Department, National Tuberculosis and Lung Diseases Research Institute, 01-138 Warsaw, Poland.
¹⁶ Department of Tuberculosis and Pulmonology, West Pomeranian Voivodeship Hospital, 70-204 Szczecin, Poland.
¹⁷ Department of Allergology, Medical University of Gdansk, 80-211 Gdansk, Poland.
¹⁸ Department of Pulmonology, E.J. Zeyland Wielkopolska Center of Pulmonology and Thoracic Surgery, 60-569 Poznan, Poland.

Abstract

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.

Keywords: Poland; efficacy; idiopathic pulmonary fibrosis (IPF); nintedanib; real-world data; safety.

Grants and funding

This research was not supported by any dedicated funding. The article processing charge (APC) was defrayed from the finances of the Department of Pneumology of the Medical University of Lodz (503/1–151-03/503–11–001-19-00).