ArticleAdvances in therapy2026
Safety and Tolerability of Nintedanib in Japanese Patients with Progressive Fibrosing Interstitial Lung Diseases: Final Results of 2-Year Post-Marketing Surveillance.
Article in Advances in therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04559581 (Post-marketing Surveillance of Ofev Capsules in Chronic Fibrosing Interstitial Lung Diseases With a Progressive Phenotype in Japan), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Post-marketing Surveillance of Ofev Capsules in Chronic Fibrosing Interstitial Lung Diseases With a Progressive Phenotype in Japan
Who cites it
1 citing paper in PubMed.
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionNintedanib, a tyrosine kinase inhibitor, is approved for treatment of progressive fibrosing interstitial lung disease (PF-ILD). Existing clinical safety data for nintedanib treatment of PF-ILD in Japanese patients is based on relatively few patients, therefore, further evaluation is needed. An interim report of the present surveillance has been previously published; here, we report data from the full surveillance.
methodsNon-interventional, prospective, 2-year post-marketing surveillance evaluated the safety of nintedanib in a real-world setting in Japan, in patients with PF-ILD other than idiopathic pulmonary fibrosis or systemic sclerosis-associated ILD between October 2, 2020, and January 22, 2025. Patients newly initiated on nintedanib, 150 mg bid or 100 mg bid, were included. The primary outcome was the incidence of adverse drug reactions (ADRs). Other safety outcomes included the incidence of adverse events (AEs) leading to treatment discontinuation, AEs leading to death, and serious adverse events (SAEs).
resultsADRs were reported in 246/408 (60.29%) patients; the most common were diarrhea (30.88%), nausea (8.82%), and hepatic function abnormal (8.33%). There were no noticeable differences in the incidence of ADRs between subgroups by clinical ILD diagnosis. AEs were the main reason for treatment discontinuation. AEs leading to treatment discontinuation were reported for 145 (35.54%) patients. The most common reason was diarrhea (6.86%). The adjusted annual rate of decline in forced vital capacity was - 93.2 mL/year [SE: 65.6, 95% confidence interval - 223.1 to 36.8 (n = 200)].
conclusionsThe safety profile of nintedanib in clinical practice is consistent with previous reports. No new safety concerns were observed. However, the effectiveness of nintedanib in this real-world setting was not sufficient to stop disease progression, and the treatment discontinuation rate due to AEs was high.
trial registrationNCT04559581.
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