Work

Continued Nintedanib Treatment in Children and Adolescents With Fibrosing ILDs: Data From InPedILD‐ON

Year: 2026

Type: article

Abstract: ABSTRACT Background In the InPedILD trial, nintedanib had an acceptable safety profile in children and adolescents (aged 6−17 years) with fibrosing ILDs. The open‐label extension of the InPedILD trial, InPedILD‐ON, is assessing the longer‐term safety of nintedanib in these patients. Methods Patients who completed the InPedILD trial on treatment and had a transition period of ≤12 weeks entered InPedILD‐ON as “rollover patients.” Patients who completed the InPedILD trial and had a transition period of > 12 weeks, and new patients aged 6−17 years with fibrosing ILDs, entered InPedILD‐ON as “new patients.” All patients received open‐label nintedanib in InPedILD‐ON. Results Forty‐eight patients received nintedanib in InPedILD‐ON. At baseline, mean (SD) age was 13.7 (3.2) years, and FVC was 59.4 (21.6) % predicted. At this data snapshot, median exposure to nintedanib in InPedILD‐ON was 61.5 weeks. Diarrhea was the most frequent adverse event, reported at a rate of 50.4 per 100 patient–years. Seven patients discontinued nintedanib, one for each of the following reasons: adverse event (weight decrease), change of residence, burden of study procedures, pregnancy planning, clinical deterioration, other treatment option available, no reason given. Mean (SE) change in FVC % predicted at Week 52 ( n = 26) was −1.0 (1.4). Mean (SE) change in SpO 2 (%) on room air at rest at Week 52 ( n = 30) was 0.3 (0.8). Conclusion The adverse event profile of nintedanib in InPedILD‐ON was generally consistent with that reported in the InPedILD trial, supporting the tolerability of nintedanib in children and adolescents with fibrosing ILDs.

Source: Pediatric Pulmonology

DOI: 10.1002/ppul.71707