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

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

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 e...

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Published in:Respiratory investigation Vol. 59; no. 2; pp. 252 - 259
Main Authors: Azuma, Arata, Chung, Lorinda, Behera, Digambar, Chung, Melody, Kondoh, Yasuhiro, Ogura, Takashi, Okamoto, Masaki, Swarnakar, Rajesh, Zeng, Xiaofeng, Zou, Heijan, Meng, Xianhua, Gahlemann, Martina, Alves, Margarida, Kuwana, Masataka
Format: Journal Article
Language:English
Published: Netherlands Elsevier B.V 01-03-2021
Subjects:
Clinical trial
Rheumatic diseases
Tyrosine kinase
Vital capacity
Tyrosine kinase
Clinical trial
Vital capacity
Rheumatic diseases
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Summary: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. Patients with SSc-ILD were randomized to receive nintedanib or placebo. The outcomes over 52 weeks were analyzed in Asian versus non-Asian patients. 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). 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. ClinicalTrials.gov NCT02597933.
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ISSN:2212-5345
2212-5353
DOI:10.1016/j.resinv.2020.10.005