A Real-World Multicenter Retrospective Observational Study on Polish Experience with Nintedanib Therapy in Patients with Idiopathic Pulmonary Fibrosis: The PolExNIB Study-Reference-Cited by-同舟云学术

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

Published:2023-07-12 Issue:14 Volume:12 Page:4635
ISSN:2077-0383
Container-title:Journal of Clinical Medicine
language:en
Short-container-title:JCM

Author:

Majewski Sebastian¹^ORCID,Białas Adam J.¹^ORCID,Barczyk Adam²^ORCID,Batura-Gabryel Halina³,Buchczyk Małgorzata⁴,Doboszyńska Anna⁵,Górska Katarzyna⁶^ORCID,Grabowska-Skudlarz Luiza⁵,Jagielska-Len Hanna⁷,Jarzemska Agnieszka⁸,Jassem Ewa⁹,Jastrzębski Dariusz⁴^ORCID,Kania Aleksander¹⁰^ORCID,Koprowski Marek¹¹,Krawczyk Michał¹²,Krenke Rafał⁶^ORCID,Lewandowska Katarzyna¹³^ORCID,Mackiewicz Barbara¹⁴,Martusewicz-Boros Magdalena M.¹⁵^ORCID,Milanowski Janusz¹⁴,Noceń-Piskorowska Małgorzata¹⁶,Nowicka Agata³,Roszkowski-Śliż Kazimierz¹⁵,Siemińska Alicja¹⁷^ORCID,Sładek Krzysztof¹⁰^ORCID,Sobiecka Małgorzata¹³,Stachura Tomasz¹⁰,Tomczak Małgorzata¹⁸,Tomkowski Witold¹³,Trzaska-Sobczak Marzena²,Ziora Dariusz⁴,Żołnowska Beata¹³,Piotrowski Wojciech J.¹^ORCID

Affiliation:

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.

Funder

Department of Pneumology of the Medical University of Lodz

Publisher

MDPI AG

Subject

General Medicine

Link

https://www.mdpi.com/2077-0383/12/14/4635/pdf

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