REGN1908/1909 prevented cat allergen-induced early asthmatic responses in an environmental exposure unit
Frederic J de Blay, Alina Gherasim, Nathalie Domis, Pretty Meier, Furat Shawki, Claire Q Wang, Jamie M Orengo, Michelle DeVeaux, Divya Ramesh, Jessica J Jalbert, Mohamed A Kamal, Hisham Abdallah, Robert Dingman, Lorah Perlee, David M Weinreich, Gary Herman, George D Yancopoulos, Meagan P O'Brien, Frederic J de Blay, Alina Gherasim, Nathalie Domis, Pretty Meier, Furat Shawki, Claire Q Wang, Jamie M Orengo, Michelle DeVeaux, Divya Ramesh, Jessica J Jalbert, Mohamed A Kamal, Hisham Abdallah, Robert Dingman, Lorah Perlee, David M Weinreich, Gary Herman, George D Yancopoulos, Meagan P O'Brien
Abstract
Background: The dominant allergen in cat dander, Felis domesticus allergen 1 (Fel d 1), is a persistent trigger for allergic rhinitis and asthma symptoms.
Objective: We evaluated the efficacy of Fel d 1 monoclonal antibodies (REGN1908/1909) in preventing cat allergen-induced early asthmatic responses (EARs) in cat-allergic patients with mild asthma.
Methods: Patients were randomized to single-dose REGN1908/1909 600 mg (n = 29) or placebo (n = 27). The FEV1 was measured for up to 4 hours in a cat allergen environmental exposure unit up to 85 days after dosing. Assessments included between-group differences in change from baseline in FEV1 area under the curve (AUC; 0-2 hours) and incidence of EAR (FEV1 reduction ≥20%).
Trial registration: NCT03838731.
Results: Single-dose REGN1908/1909 significantly prevented reductions in FEV1 on days 8, 29, 57, and 85. Most REGN1908/1909 patients did not have an EAR by 4 hours (the last time point tested). In contrast, placebo-treated patients experienced a ≥20% mean FEV1 reduction on days 8, 29, 57, and 85 after dosing, with most experiencing an EAR within 1 hour. REGN1908/1909-treated patients tolerated 3-fold higher allergen quantities (P < .05 at all time points) versus placebo. REGN1908/1909 substantially reduced skin test reactivity to cat allergen versus placebo at all time points tested (nominal P < .001). REGN1908/1909 was generally well tolerated; no serious adverse events or deaths were reported.
Conclusion: Single-dose REGN1908/1909 significantly prevented reductions in FEV1 in cat-allergic patients with mild asthma on cat allergen environmental exposure unit exposure at 8 days and up to 85 days after dose.
Keywords: Cat allergy; Fel d 1; IgG monoclonal antibodies; allergic rhinitis; asthma; immune system diseases; passive immunotherapy.
Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.
Source: PubMed