The long-term effect of dupilumab on dyspnea, sleep, and activity in oral corticosteroid-dependent severe asthma

Lawrence D Sher; Giovanni Passalacqua; Camille Taillé; Lauren Cohn; Nadia Daizadeh; Nami Pandit-Abid; Xavier Soler; Angela Khodzhayev; Juby A Jacob-Nara; Yamo Deniz; Paul J Rowe; Arpita Nag; Yi Zhang

doi:10.1016/j.anai.2022.12.002

The long-term effect of dupilumab on dyspnea, sleep, and activity in oral corticosteroid-dependent severe asthma

Ann Allergy Asthma Immunol. 2023 Mar;130(3):298-304. doi: 10.1016/j.anai.2022.12.002. Epub 2022 Dec 9.

Authors

Affiliations

¹ Peninsula Research Associates, Rolling Hills Estates, Los Angeles, California. Electronic address: lawrence.sher@peninsularesearch.com.
² Allergy and Respiratory Diseases, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) San Martino, University of Genoa, Genoa, Italy.
³ Service de Pneumologie et Centre de Référence des Maladies Pulmonaires Rares, Assistance Publique-Hôpitaux de Paris, Université de Paris, Paris, France.
⁴ Yale Center for Asthma and Airway Diseases, Yale School of Medicine, New Haven, Connecticut; Veteran Affairs Connecticut Health Care System, West Haven, Connecticut.
⁵ Immunology, Sanofi, Cambridge, Massachusetts.
⁶ Immunology, Sanofi, Bridgewater, New Jersey.
⁷ Medical Affairs, Regeneron Pharmaceuticals, Incorporated, Tarrytown, New York.

PMID: 36509407
DOI: 10.1016/j.anai.2022.12.002

Abstract

Background: Severe asthma impacts quality of life (QoL), including dyspnea, sleep, and activity limitation. Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukins-4 and -13, which are key and central drivers of type 2 inflammation. Phase 3 LIBERTY ASTHMA VENTURE (NCT02528214) and LIBERTY ASTHMA TRAVERSE open-label extension (NCT02134028) evaluated dupilumab 300 mg vs placebo every 2 weeks for 24 weeks (VENTURE) and dupilumab only for an additional 48 to 96 weeks (TRAVERSE) in patients with oral corticosteroid (OCS)-dependent severe asthma.

Objective: To assess dupilumab's impact on Asthma QoL Questionnaire (AQLQ) items related to breathing symptoms, sleep, and activity limitation, and on OCS reduction.

Methods: The proportion of patients with AQLQ scores of 6 or 7 for breathing symptoms-, sleeping-, and activity-related items in VENTURE and TRAVERSE, together with OCS dose reductions in VENTURE.

Results: In VENTURE, significantly greater proportions of dupilumab- vs placebo-treated patients achieved scores of 6 or 7 by week 24 in breathing symptoms-related (42.7%-60.2% vs 22.4%-39.3%), sleeping-related (45.6%-65.0% vs 27.1%-47.7%), and activity-related (44.7%-51.5% vs 22.4%-34.6%) AQLQ items. Improvements were maintained through TRAVERSE in the dupilumab/dupilumab group and increased to dupilumab treatment levels in the placebo/dupilumab group. Significant OCS dose reductions were observed in VENTURE; up to 90% and 60% of dupilumab-treated vs 65% and 41% of placebo-treated patients with AQLQ scores of 6 or 7 in breathing symptoms-, sleeping-, and activity-related items achieved greater than or equal to 50% dose reduction and eliminated OCS at week 24, respectively.

Conclusion: In patients with severe OCS-dependent asthma, dupilumab improved QoL related to breathing symptoms, sleep, and activity limitation, and reduced OCS use.

Trial registration: ClinicalTrials.gov Identifiers: NCT02528214 and NCT02134028.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Adrenal Cortex Hormones / therapeutic use
Asthma* / drug therapy
Double-Blind Method
Dyspnea / drug therapy
Humans
Injections, Subcutaneous
Quality of Life*
Sleep
Treatment Outcome

Substances

dupilumab
Adrenal Cortex Hormones

Associated data

ClinicalTrials.gov/NCT02134028
ClinicalTrials.gov/NCT02528214