Dupilumab Efficacy in Steroid-Dependent Severe Asthma by Baseline Oral Corticosteroid Dose.

Abstract

BACKGROUND:

Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin-4/-13, key and central drivers of type 2 inflammation in multiple diseases. In the phase 3 LIBERTY ASTHMA VENTURE (VENTURE) study (NCT02528214), dupilumab versus placebo reduced oral corticosteroid (OCS) dose and improved clinical outcomes in patients with OCS-dependent severe asthma. Dupilumab efficacy in patients with varying disease burden (defined by baseline OCS dose) has not been assessed.

OBJECTIVE:

This post hoc analysis of VENTURE evaluated dupilumab efficacy across subgroups defined by baseline OCS dose.

METHODS:

The OCS dose, proportion no longer needing OCS at week 24, annualized severe exacerbation rate, and least squares mean change from baseline in pre- and post-bronchodilator forced expiratory volume in 1 second at week 24 were evaluated in VENTURE patients with OCS-dependent severe asthma receiving dupilumab 300 mg every 2 weeks versus placebo, categorized by a baseline OCS dose of less than 10 mg/d or 10 or more mg/d.

RESULTS:

Dupilumab reduced daily OCS dose from baseline at week 24 in both dose groups. In dupilumab-/placebo-treated patients with a baseline OCS dose of less than 10 mg/d and 10 or more mg/d, 72%/42% and 37%/23% stopped OCS by week 24 (P < .01/P < .05), respectively. Dupilumab significantly reduced the annualized severe exacerbation rate by 71% and 48% (P < .01/P < .05). At week 24, dupilumab improved pre- and post-bronchodilator forced expiratory volume in 1 second in patients in both dose groups.

CONCLUSIONS:

In patients with OCS-dependent severe asthma receiving lower or higher baseline OCS doses, dupilumab significantly reduced the OCS dose and improved the likelihood of no longer requiring OCS while also reducing exacerbations and improving lung function.

• Authors: Christian Domingo, Jorge F Maspero, Mario Castro, Nicola A Hanania, Linda B Ford, David M G Halpin, David J Jackson, Nadia Daizadeh, Michel Djandji, Colin P Mitchell, Nora Crikelair, Juby A Jacob-Nara, Yamo Deniz, Paul J Rowe, Benjamin Ortiz
• Journal: The journal of allergy and clinical immunology. In practice (J Allergy Clin Immunol Pract) Vol. 10 Issue 7 Pg. 1835-1843 (07 2022) ISSN: 2213-2201 [Electronic] United States
• PMID: 35398549 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.

Chemical References

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

Topics

• Adrenal Cortex Hormones (therapeutic use)
• Anti-Asthmatic Agents
• Antibodies, Monoclonal, Humanized
• Asthma
• Bronchodilator Agents (therapeutic use)
• Double-Blind Method
• Humans
• Injections, Subcutaneous
• Steroids (therapeutic use)
• Treatment Outcome