Nintedanib for non-IPF progressive pulmonary fibrosis: 12-month outcome data from a real-world multicentre observational study

Lavanya Raman, Iain Stewart, Shaney L Barratt, Felix Chua, Nazia Chaudhuri, Anjali Crawshaw, Michael Gibbons, Charlotte Hogben, Rachel Hoyles, Vasilis Kouranos, Jennifer Martinovic, Sarah Mulholland, Katherine J Myall, Marium Naqvi, Elisabetta A Renzoni, Peter Saunders, Matthew Steward, Dharmic Suresh, Muhunthan Thillai, Athol U WellsAlex West, Jane A Mitchell, Peter M George

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Abstract

Background Nintedanib slows lung function decline for patients with non-idiopathic pulmonary fibrosis progressive pulmonary fibrosis (PPF) in clinical trials, but the real-world safety and efficacy are not known. Methods In this retrospective cohort study, standardised data were collected from patients in whom nintedanib was initiated for PPF between 2019 and 2020 through an early-access programme across eight centres in the United Kingdom. Rate of lung function change in the 12 months pre-and post-nintedanib initiation was the primary analysis. Symptoms, drug safety, tolerability and stratification by interstitial lung disease subtype and computed tomography pattern were secondary analyses. Results 126 patients were included; 67 (53%) females; mean±SD age 60±13 years. At initiation of nintedanib, mean forced vital capacity (FVC) was 1.87 L (58% predicted) and diffusing capacity of the lung for carbon monoxide (D LCO) was 32.7% predicted. 68% of patients were prescribed prednisolone (median dose 10 mg) and 69% were prescribed a steroid-sparing agent. In the 12 months after nintedanib initiation, lung function decline was significantly lower than in the preceding 12 months: FVC −88.8 mL versus −239.9 mL (p=0.004), and absolute decline in D LCO −2.1% versus −6.1% (p=0.004). Response to nintedanib was consistent in sensitivity and secondary analyses. 89 (71%) out of 126 patients reported side-effects, but 86 (80%) of the surviving 108 patients were still taking nintedanib at 12 months with patients reporting a reduced perception of symptom decline. There were no serious adverse events. Conclusion In PPF, the real-world efficacy of nintedanib replicated that of clinical trials, significantly attenuating lung function decline. Despite the severity of disease, nintedanib was safe and well tolerated in this real-world multicentre study.

Original languageEnglish
Article number00423-2022
JournalERJ Open Research
Volume9
Issue number2
Early online date3 Jan 2023
DOIs
Publication statusPublished online - 3 Jan 2023

Bibliographical note

Funding Information:
Conflict of interest: I. Stewart receives funding from the Rayne Foundation. F. Chua reports personal fees from Boehringer Ingelheim. N. Chaudhuri reports personal fees from Boehringer Ingelheim, Redex, Novartis, Liminal Biosciences, Vicor Pharma, Bridge Biotherapeutics and Roche. M. Gibbons reports personal fees for advisory boards and support for attending conferences from Boehringer Ingelheim. C. Hogben has received personal fees from Boehringer Ingelheim. V. Kouranos reports personal fees from Boehringer Ingelheim and Novartis. S. Mulholland reports personal fees from Boehringer Ingelheim. M. Naqvi reports honoraria from Boehringer Ingelheim, Astra Zeneca and Roche, and grant support paid to their institution from an NHSX digital award. E.A. Renzoni reports fees paid to their institution from Boehringer Ingelheim, Novartis and Roche, and research grants paid to their institution from Boehringer Ingelheim. M. Thillai reports personal fees from Boehringer Ingelheim, research grants paid to their institution from Boehringer Ingelheim and support for conference attendance from Boehringer Ingelheim. A.U. Wells is president elect of WASOG, and reports personal fees from Boehringer Ingelheim and Roche, and support for conference from Boehringer Ingelheim. P.M. George reports personal fees from Boehringer Ingelheim, Roche, Teva, Cipla and Brainomix, research grants paid to their institution from Boehringer Ingelheim, and support for conference attendance from Boehringer Ingelheim and Roche. No other authors report any conflicts of interest.

Publisher Copyright:
© The authors 2023.

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