Efficacy and safety of nintedanib in Asian patients with systemic sclerosis-associated interstitial lung disease: Subgroup analysis of the SENSCIS trial

Abstract

Background and objective: In the SENSCIS trial in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD), nintedanib reduced the rate of decline in forced vital capacity (FVC) (mL/year) over 52 weeks by 44% in comparison with placebo, with manageable adverse events in most patients. We analyzed the efficacy and safety of nintedanib in patients of Asian race.

Methods: Patients with SSc-ILD were randomized to receive nintedanib or placebo. The outcomes over 52 weeks were analyzed in Asian versus non-Asian patients.

Results: Of the 288 patients in each treatment group, 62 (21.5%) in the nintedanib group and 81 (28.1%) in the placebo group were Asian; 90.2% of the Asian patients were enrolled in Asian countries. In the placebo group, the rate of FVC decline over 52 weeks was consistent between Asian and non-Asian patients (-99.9 and -90.6 mL/year, respectively). The effect of nintedanib on reducing the rate of FVC decline over 52 weeks was consistent between Asian (difference, 44.3 mL/year [95% CI: -32.8, 121.4]) and non-Asian patients (difference, 39.0 mL/year [95% CI: -5.1, 83.1]) (treatment-by-time-by-subgroup interaction, p = 0.91). Diarrhea was the most frequent adverse event and was reported in similar proportions of Asian and non-Asian patients in the nintedanib group (80.6% and 74.3%, respectively) and placebo group (28.4% and 32.9%, respectively).

Conclusions: In patients with SSc-ILD, nintedanib had a consistent benefit on slowing the progression of SSc-ILD in Asian and non-Asian patients, with a similar adverse event profile.

Trial registration: ClinicalTrials.gov NCT02597933.

Keywords: Clinical trial; Rheumatic diseases; Tyrosine kinase; Vital capacity.

Conflict of interest statement

Conflict of Interest AA reports honoraria (≥500,000 JPY annually) from Boehringer Ingelheim and travel fees, gifts, and others (≥500,000 JPY annually) from Boehringer Ingelheim. LC reports employment/leadership position/advisory role (≥1,000,000 JPY annually) from Boehringer Ingelheim, Eicos, Mitsubishi Tanabe and Reata Pharmaceuticals; honoraria (≥500,000 JPY annually) from Boehringer Ingelheim; and research funding (≥1,000,000 JPY annually) from Boehringer Ingelheim and United Therapeutics. YK reports honoraria (≥500,000 JPY annually) from Boehringer Ingelheim. TO reports honoraria (≥500,000 JPY annually) from Boehringer Ingelheim and Shionogi; and research funding (≥1,000,000 JPY annually) from Boehringer Ingelheim. MO reports honoraria (≥500,000 JPY annually) from Boehringer Ingelheim. XM, MG and MA are employees of Boehringer Ingelheim. MK reports employment/leadership position/advisory role (≥1,000,000 JPY annually) from Boehringer Ingelheim, Chugai and Corbus; patent royalties/licensing fees (≥1,000,000 JPY annually) from MBL; honoraria (≥500,000 JPY annually) from AbbVie, Actelion, Astellas, Bayer, Boehringer Ingelheim, Chugai, Eisai, GlaxoSmithKline, Ono Pharmaceuticals, Mitsubishi Tanabe and Pfizer; research funding (≥1,000,000 JPY) annually from Boehringer Ingelheim and Ono Pharmaceuticals; and subsidies or donations (≥1,000,000 JPY annually) from AbbVie, Boehringer Ingelheim, Chugai, Eisai, Ono Pharmaceuticals and Mitsubishi Tanabe. DB, MC, RS, XZ and HZ have nothing to disclose.

Copyright © 2020 The Authors. Published by Elsevier B.V. All rights reserved.