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Purpose <p>In the INBUILD trial in patients with progressive pulmonary fibrosis (PPF), nintedanib slowed the decline in forced vital capacity (FVC) versus placebo, with a safety profile characterised mainly by gastrointestinal events. INBUILD-ON, the open-label extension of INBUILD, assessed the safety of nintedanib during longer-term treatment. Data on FVC were collected.</p> Study Design and Methods <p>Adverse events and changes in FVC in INBUILD-ON were assessed descriptively in all patients and in two subgroups: patients who received nintedanib in INBUILD and continued nintedanib in INBUILD-ON (“continued nintedanib” group) (<i>n</i> = 212) and patients who received placebo in INBUILD and initiated nintedanib in INBUILD-ON (“initiated nintedanib” group) (<i>n</i> = 222). Changes in FVC were based on observed values.</p> Results <p>Median exposure to nintedanib in INBUILD-ON was 22.0&#xa0;months. Diarrhoea was the most frequent adverse event. Amongst patients who had diarrhoea, 90.0% experienced only events of mild or moderate severity. Adverse events led to discontinuation of nintedanib at a rate of 16.7 per 100 patient-years. Serious and fatal adverse events were reported at rates of 37.2 and 9.5 per 100 patient-years. Mean (SE) changes in FVC from baseline to week 48 were − 71.6 (16.1) mL [− 128.5 (25.5) mL in continued nintedanib group (<i>n</i> = 106), − 14.8 (18.2) mL in initiated nintedanib group (<i>n</i> = 106)].</p> Conclusion <p>The safety profile of nintedanib in INBUILD-ON was consistent with that in INBUILD. Change in FVC in INBUILD-ON was consistent with decline in FVC in the nintedanib group of INBUILD. These results support the use of nintedanib in the long-term treatment of PPF.</p> <p><b>Clinical Trial Registration:</b> ClinicalTrials.gov; NCT03820726; registered January 29, 2019.</p>

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Continued Treatment with Nintedanib in Patients with Progressive Pulmonary Fibrosis: Data from INBUILD-ON

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年1月9日

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  • Wim A. Wuyts,
  • Francesco Bonella,
  • Nazia Chaudhuri,
  • Francesco Varone,
  • Danielle Antin-Ozerkis,
  • Jin Woo Song,
  • Corinna Miede,
  • Mihaela Dumistracel,
  • Carl Coeck,
  • Vincent Cottin

摘要

Purpose

In the INBUILD trial in patients with progressive pulmonary fibrosis (PPF), nintedanib slowed the decline in forced vital capacity (FVC) versus placebo, with a safety profile characterised mainly by gastrointestinal events. INBUILD-ON, the open-label extension of INBUILD, assessed the safety of nintedanib during longer-term treatment. Data on FVC were collected.

Study Design and Methods

Adverse events and changes in FVC in INBUILD-ON were assessed descriptively in all patients and in two subgroups: patients who received nintedanib in INBUILD and continued nintedanib in INBUILD-ON (“continued nintedanib” group) (n = 212) and patients who received placebo in INBUILD and initiated nintedanib in INBUILD-ON (“initiated nintedanib” group) (n = 222). Changes in FVC were based on observed values.

Results

Median exposure to nintedanib in INBUILD-ON was 22.0 months. Diarrhoea was the most frequent adverse event. Amongst patients who had diarrhoea, 90.0% experienced only events of mild or moderate severity. Adverse events led to discontinuation of nintedanib at a rate of 16.7 per 100 patient-years. Serious and fatal adverse events were reported at rates of 37.2 and 9.5 per 100 patient-years. Mean (SE) changes in FVC from baseline to week 48 were − 71.6 (16.1) mL [− 128.5 (25.5) mL in continued nintedanib group (n = 106), − 14.8 (18.2) mL in initiated nintedanib group (n = 106)].

Conclusion

The safety profile of nintedanib in INBUILD-ON was consistent with that in INBUILD. Change in FVC in INBUILD-ON was consistent with decline in FVC in the nintedanib group of INBUILD. These results support the use of nintedanib in the long-term treatment of PPF.

Clinical Trial Registration: ClinicalTrials.gov; NCT03820726; registered January 29, 2019.