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

Authors

Robin Deterding, Lisa R Young, Emily M DeBoer, David Warburton, Steven Cunningham, Nicolaus Schwerk, Kevin K Brown, Václav Koucký, Jason P Weinman, Jill Simmons, Mihaela Dumistracel, Frauke Jantzen, Martina Gahlemann, Matthias Griese, InPedILD‐ON trial investigators

Published in

Pediatric pulmonology. Volume 61. Issue 6. Pages e71707.

Abstract

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.
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.
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 SpO₂ (%) on room air at rest at Week 52 (n = 30) was 0.3 (0.8).
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.

PMID:
42324891
Bibliographic data and abstract were imported from PubMed on 22 Jun 2026.

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