Nintedanib for non-IPF progressive pulmonary fibrosis: 12-month outcome data from a real-world multicentre observational study. Issue 2 (20th March 2023)

• Record Type: Journal Article
• Authors: Raman, Lavanya; Stewart, Iain; Barratt, Shaney L.; Chua, Felix; Chaudhuri, Nazia; Crawshaw, Anjali; Gibbons, Michael; Hogben, Charlotte; Hoyles, Rachel; Kouranos, Vasilis; Martinovic, Jennifer; Mulholland, Sarah; Myall, Katherine J.; Naqvi, Marium; Renzoni, Elisabetta A.; Saunders, Peter; Steward, Matthew; Suresh, Dharmic; Thillai, Muhunthan; Wells, Athol U.; West, Alex; Mitchell, Jane A.; George, Peter M.
• Is Part Of: ERJ open research. Volume 9:Issue 2(2023)
• Publication Date: 2023-03-20
• Subjects: Respiratory organs -- Diseases -- Periodicals; Respiration -- Periodicals; Respiration; Respiratory organs -- Diseases; Respiratory organs -- Diseases -- Treatment; Respiratory Tract Diseases; Electronic journals; Fulltext; Internet Resources; Periodicals; Periodical; 616.2005
• DOI: 10.1183/23120541.00423-2022
• Languages: English
• ISSNs: 2312-0541

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. In a real-world multicentre observational study of patients with non-IPF progressive pulmonary fibrosis, nintedanib was safe, efficacious and well tolerated, reducing annual lung function decline with a similar magnitude of effect as in clinical trials https://bit.ly/3ElA10n