Retrospective, multicentre (UK) analysis of bleeding risk from nintedanib with or without concomitant anticoagulation in fibrotic ILD patients

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Introduction: Nintedanib is associated with a theoretical increased bleeding risk. Its use is cautioned with concomitant anticoagulation (AC). Data on risk of major or minor bleeding events with AC in the real-world is limited. Aims: To determine the bleeding incidence and safety in ILD patients prescribed nintedanib with or without AC. Methods: Study on 12 ILD centres. All patients initiated on nintedanib from 01/08/22 to 31/07/23 were included. Details of concomitant AC and bleeding events up to 31/08/24 were ascertained. Bleeding was defined by type and severity using International Society on Thrombosis and Haemostasis criteria1. Chi-squared and logistic regression analysis were used. Results: Baseline demographics (n=996) included sex (male 64%), diagnosis (IPF 47%; PPF 53%), AC status (non-AC 88%; AC 12%) and nintedanib dose (150mg 56%). Mean nintedanib duration in months did not differ between groups (14.0 [SD 6.87] non-AC; 13.3 [SD 6.92] AC, p=0.356). AC is associated with bleeding occurrence (n=70, p=0.002). The odds ratio of bleeding is 2.33 (p<0.006) for AC, independent of baseline demographics. There is no association between AC and major bleed (n=9, p=0.315), however there is an association with minor bleed (n=60, p=0.009). Accounting for baseline demographics, AC is not individually associated with major bleeds. Conclusion: Concomitant AC with nintedanib is associated with increased risk of minor bleeding. Pharmacovigilance data since 2015 from UK2 reported fewer bleeding events than our cohort, highlighting the importance of adverse event reporting. References 1. Franco L, et al. JTH 2020;18(11):2852-60 2. MHRA. iDAP: Nintedanib (online) 2025

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