Efficacy of dupilumab in patients with uncontrolled, moderate-to-severe asthma recruited from Japanese centers in the phase 3 LIBERTY ASTHMA TRAVERSE study

Yuji Tohda; Yoichi Nakamura; Takao Fujisawa; Motohiro Ebisawa; Jerome Msihid; Michel Djandji; Benjamin Ortiz; Juby A Jacob-Nara; Yamo Deniz; Paul J Rowe; Masato Ishida; Kazuhiko Arima

doi:10.1016/j.alit.2022.07.008

Efficacy of dupilumab in patients with uncontrolled, moderate-to-severe asthma recruited from Japanese centers in the phase 3 LIBERTY ASTHMA TRAVERSE study

Allergol Int. 2023 Jan;72(1):89-99. doi: 10.1016/j.alit.2022.07.008. Epub 2022 Sep 13.

Authors

Affiliations

¹ Kindai University Hospital, Osakasayama, Japan. Electronic address: tohda@med.kindai.ac.jp.
² Yokohama City Minato Red Cross Hospital, Yokohama, Japan.
³ Allergy Center, National Hospital Organization Mie National Hospital, Tsu, Japan.
⁴ Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.
⁵ Sanofi, Chilly-Mazarin, France.
⁶ Sanofi, Cambridge, MA, USA.
⁷ Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
⁸ Sanofi, Bridgewater, NJ, USA.
⁹ Sanofi, Tokyo, Japan.

PMID: 36114102
DOI: 10.1016/j.alit.2022.07.008

Abstract

Background: Safety and efficacy data for dupilumab beyond 1 year are lacking for patients from Japan with moderate-to-severe asthma.

Methods: The TRAVERSE open-label extension (OLE) study (NCT02134028) assessed the safety and efficacy of dupilumab 300 mg every 2 weeks up to 96 weeks in 2282 patients who completed a previous dupilumab asthma study. The primary endpoint was incidence of treatment-emergent adverse events (TEAEs). Secondary endpoints included annualized severe exacerbation rate and change from parent study baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV₁), asthma control, quality of life, and blood eosinophil levels. Anti-drug antibodies (ADA) were evaluated. We report results in 160 (7.8% of exposed population) patients recruited from Japanese centers with non-oral corticosteroid (OCS)-dependent asthma rolled over from two parent studies, and in subgroups with a type 2 inflammatory phenotype.

Results: TEAEs were consistent with the parent studies and the known safety profile of dupilumab. One patient permanently discontinued treatment due to TEAEs. Exacerbation rates remained low and were sustained to Week 96, as were improvements in pre-bronchodilator FEV₁. Rapid, sustained improvements were observed in dupilumab-treated patients who previously received placebo in a parent study, while further improvements in exacerbation rates, asthma control, and asthma-related quality of life were observed in those continuing dupilumab. Blood eosinophil levels decreased progressively while on treatment. Treatment-emergent ADA responses were highest in patients who had previously received placebo. Efficacy results were consistent in patients with a type 2 phenotype.

Conclusions: Long-term dupilumab treatment was well tolerated and efficacious in patients with non-OCS-dependent, moderate-to-severe asthma recruited from Japan. (Funded by Sanofi and Regeneron Pharmaceuticals, Inc.; ClinicalTrials.gov identifier, NCT02134028).

Keywords: Asthma; Dupilumab; Japan; Long-term safety; Lung function.

MeSH terms

Adrenal Cortex Hormones / therapeutic use
Anti-Asthmatic Agents*
Antibodies, Monoclonal / therapeutic use
Asthma* / chemically induced
Asthma* / drug therapy
Bronchodilator Agents / therapeutic use
Double-Blind Method
Humans
Japan
Quality of Life
Treatment Outcome

Substances

Adrenal Cortex Hormones
Anti-Asthmatic Agents
Antibodies, Monoclonal
Bronchodilator Agents
dupilumab

Associated data

ClinicalTrials.gov/NCT02134028