Effects of nintedanib on disease progression and safety in Japanese patients with progressive fibrosing interstitial lung diseases: Further subset analysis from the whole INBUILD trial

Abstract

Background: A previous subgroup analysis of data from the INBUILD trial showed that nintedanib reduced the annual rate of decline in forced vital capacity (FVC) in Japanese patients with progressive fibrosing interstitial lung diseases (PF-ILDs). The safety profile of nintedanib over 52 weeks in Japanese patients was similar to that of the overall population.

Methods: Using data from 108 Japanese patients with PF-ILDs who had received at least 1 dose of study medication in the INBUILD trial, we evaluated the effect of nintedanib on disease progression and assessed the safety profile over the whole trial period (i.e., a longer duration than the prior analysis) compared with placebo. ILD progression was defined as an absolute decline in FVC ≥10% predicted vs baseline.

Results: Over the whole trial, in Japanese patients with PF-ILDs, nintedanib numerically lowered the risk of progression of ILD or death (hazard ratio [HR], 0.66; 95% confidence intervals [CI]: 0.37, 1.16), acute exacerbation of ILD or death (HR, 0.28; 95% CI: 0.09, 0.83), and death (HR, 0.41; 95% CI: 0.11, 1.51). The most common adverse event over the whole trial in nintedanib-treated Japanese patients was diarrhea, which was manageable for most patients by dose reduction and interruption. The safety profile of nintedanib in this longer duration analysis was consistent with that previously reported.

Conclusions: In this analysis of data from Japanese patients with PF-ILDs, nintedanib nominally reduced the risk of clinically meaningful outcomes reflecting disease progression, including death, over the whole trial, and no new safety concerns were observed.

Clinical trial registration: ClinicalTrials.gov NCT02999178.

Keywords: Forced vital capacity; Interstitial lung disease progression; Nintedanib; Progressive fibrosing interstitial lung disease; Safety.

Conflict of interest statement

Conflict of interest TO has received research funding and lecture fees from Nippon Boehringer Ingelheim Co., Ltd. and lecture fees from Shionogi & Co., Ltd. TS has received research funding and lecture fees from Nippon Boehringer Ingelheim Co., Ltd. and lecture fees from AstraZeneca K.K. NI has nothing to declare. YN has received lecture fees from Boehringer Ingelheim Co., Ltd. AA has received lecture fees and travel expense from Boehringer Ingelheim Co., Ltd. MO has received lecture fees from Boehringer Ingelheim Co., Ltd. AT and TI are employees of Nippon Boehringer Ingelheim Co., Ltd. KBR is an employee of Boehringer Ingelheim International GmbH. YI was a member of the Industry Advisory Committee for Asahi Kasei Corporation, Shionogi & Co., Ltd., Taiho Pharmaceutical Co., Ltd., and SAVARA Inc, and a member of the Clinical Trial Steering Committee for Boehringer Ingelheim Co., Ltd. and Roche Products Ltd.

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