Efficacy and safety of multiple doses of QGE031 (ligelizumab) versus omalizumab and placebo in inhibiting allergen-induced early asthmatic responses

Publication date: Available online 7 April 2016
Source:Journal of Allergy and Clinical Immunology
Author(s): Gail M. Gauvreau, Jonathan P. Arm, Louis-Philippe Boulet, Richard Leigh, Donald W. Cockcroft, Beth E. Davis, Irvin Mayers, J. Mark FitzGerald, Barbro Dahlen, Kieran J. Killian, Michel Laviolette, Christopher Carlsten, Nikolaos Lazarinis, Richard M. Watson, Joanne Milot, Veronica Swystun, Miranda Bowen., Linda Hui, Ann-Sofie Lantz, Karin Meiser, Suzanne Maahs, Philip J. Lowe, Andrej Skerjanec, Anton Drollmann, Paul M. O'Byrne
BackgroundOmalizumab is an established anti-IgE therapy for treatment of allergic diseases that prevents IgE from binding to its receptor. QGE031 is an investigational anti-IgE antibody which binds IgE with higher affinity than omalizumab.ObjectiveThis study compared the effects of QGE031 with those of omalizumab on clinical efficacy, IgE levels and FcεR1 expression in a clinical model of allergic asthma.Methods37 subjects with mild allergic asthma were randomized to subcutaneous omalizumab, placebo, or QGE031 at 24, 72 or 240 mg every two weeks for 10 weeks in a double-blind, parallel-group multi-center study. Inhaled allergen challenges and skin tests were conducted before dosing and at weeks 6, 12 and 18, and blood was collected until 24 weeks after the first dose.ResultsQGE031 elicited a concentration- and time-dependent change in the provocative concentration of allergen causing at 15% decrease in forced expiratory volume (allergen PC15) that was maximal and approximately 3-fold greater than that of omalizumab (p=0.10) and 16-fold greater than placebo (p=0.0001) at week 12 in the 240 mg cohort. Skin responses reached 85% suppression at week 12 in the 240 mg cohort, and were maximal at week 18. The top doses of QGE031 consistently suppressed skin test responses among subjects but had a variable effect on allergen PC15 (2-fold to 500-fold change). QGE031 was well tolerated.ConclusionQGE031 has greater efficacy than omalizumab on inhaled and skin allergen responses in subjects with mild allergic asthma. These data support the clinical development of QGE031 as treatment of asthma.

Teaser

This study suggests QGE031 as an alternative anti-IgE treatment to omalizumab because it has potential for greater efficacy against allergic responses in the airways and skin.


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