任天堂
医学
中止
不利影响
内科学
安慰剂
耐受性
特发性肺纤维化
胃肠病学
病理
肺
替代医学
作者
Wim Wuyts,Francesco Bonella,Nazia Chaudhuri,Francesco Varone,Danielle Antin‐Ozerkis,Heiko Mueller,Carl Coeck,Klaus Röhr,Vincent Cottin
标识
DOI:10.1183/13993003.congress-2021.pa2538
摘要
Background: In the INBUILD trial in patients with progressive fibrosing ILDs other than IPF, nintedanib reduced the rate of FVC decline with a safety profile characterised mainly by gastrointestinal events. Patients on treatment at the end of INBUILD could enter the open-label extension trial, INBUILD-ON. Aim: To assess the longer-term safety of nintedanib in patients with fibrosing ILDs. Methods: Patients who received nintedanib in INBUILD continued nintedanib in INBUILD-ON. Patients who received placebo in INBUILD initiated nintedanib in INBUILD-ON. A data snapshot was taken on 15 October 2020. Results: 434 patients were treated in INBUILD-ON. Median exposure to nintedanib in INBUILD-ON was 15.4 months. Diarrhoea was the most frequent adverse event (Table). Adverse events led to discontinuation of nintedanib in 9.0% and 19.8% of patients who continued nintedanib (n=212) and initiated nintedanib (n=222) in INBUILD-ON, respectively. The rate of decline in FVC in patients receiving nintedanib was similar during INBUILD and INBUILD-ON. Conclusions: The adverse event profile of nintedanib in INBUILD-ON was consistent with that reported in INBUILD, supporting its manageable safety profile over continued use in patients with fibrosing ILDs.
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