Nintedanib in children and adolescents with fibrosing ILDs: interim analysis of InPedILD-ON

<bold>Introduction:</bold> In the InPedILD trial, nintedanib had an acceptable safety profile vs placebo in children and adolescents (aged 6 to 17 years) with fibrosing ILDs. <bold>Aim:</bold> Assess the safety and tolerability of nintedanib in children and adolescents with fibrosing ILDs in the open-label extension of the InPedILD trial, InPedILD-ON. <bold>Methods:</bold> Patients who completed the InPedILD trial on treatment (nintedanib or placebo) with a transition period ≤12 weeks entered InPedILD-ON as “rollover patients”. Patients from InPedILD who had a longer transition time, and new patients aged 6 to 17 years with fibrosing ILDs, entered InPedILD-ON as “new patients”. All received open-label nintedanib. A data snapshot was taken on 25 August 2023. <bold>Results:</bold> 48 patients were treated in InPedILD-ON (30 rollover, 18 new). At baseline, mean (SD) age was 13.7 (3.2) years and FVC % predicted was 59.4 (21.6). Median exposure to nintedanib in InPedILD-ON was 61.5 weeks. The most frequent adverse event was diarrhoea (Table). One patient discontinued nintedanib due to weight decrease. Six patients discontinued for reasons other than adverse events. Mean (SE) change in FVC % predicted from baseline to week 52 of InPedILD-ON (n=26) was −1.0 (1.4). <bold>Conclusion:</bold> The adverse event profile of nintedanib in InPedILD-ON was generally consistent with that seen in InPedILD, supporting the tolerability of nintedanib in children and adolescents with fibrosing ILDs. <fig><object-id>erj;64/suppl_68/OA1067/F1</object-id><object-id>F1</object-id><object-id>F1</object-id><graphic></graphic></fig>