Efficacy and safety of nintedanib in Asian patients with systemic sclerosis-associated interstitial lung disease: Subgroup analysis of the SENSCIS trial.
Clinical trial
Rheumatic diseases
Tyrosine kinase
Vital capacity
Journal
Respiratory investigation
ISSN: 2212-5353
Titre abrégé: Respir Investig
Pays: Netherlands
ID NLM: 101581124
Informations de publication
Date de publication:
Mar 2021
Mar 2021
Historique:
received:
14
09
2020
accepted:
14
10
2020
pubmed:
24
11
2020
medline:
21
8
2021
entrez:
23
11
2020
Statut:
ppublish
Résumé
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.
Sections du résumé
BACKGROUND AND OBJECTIVE
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
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
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
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
BACKGROUND
ClinicalTrials.gov NCT02597933.
Identifiants
pubmed: 33223487
pii: S2212-5345(20)30156-8
doi: 10.1016/j.resinv.2020.10.005
pii:
doi:
Substances chimiques
Indoles
0
nintedanib
G6HRD2P839
Banques de données
ClinicalTrials.gov
['NCT02597933']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
252-259Informations de copyright
Copyright © 2020 The Authors. Published by Elsevier B.V. All rights reserved.
Déclaration de conflit d'intérêts
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.