SQ HOUSE DUST MITE SUBLINGUAL IMMUNOTHERAPY TABLET IS WELL TOLERATED IN SUBJECTS WITH ALLERGIC ASTHMA

Abstract

Introduction Asthma is a risk factor for systemic allergic reactions to subcutaneous immunotherapy. The safety of SQ house dust mite (HDM) sublingual immunotherapy (SLIT)-tablet in subjects with or without asthma was evaluated. Methods Safety data from 6 phase II/III double-blind, placebo-controlled trials of SQ HDM SLIT-tablet for the treatment of allergic rhinitis or mild-to-moderate asthma were pooled and compared between subjects with and without reported asthma. IRB approval was obtained. Data for the 12 SQ-HDM dose approved in Europe/US are presented. Results In all, 3473 subjects were randomized to 12 SQ-HDM (n=1663) or placebo (n=1810), 2036 (59%) of whom had reported asthma. Most asthma was moderate according to GINA criteria (66%, 12 SQ-HDM; 70%, placebo). The proportion of subjects reporting treatment-emergent adverse events (AEs) was similar between subjects with and without asthma (86% vs 85%, respectively) in the 12 SQ-HDM group and in the placebo group (70% vs 64%, respectively). The frequencies of treatment-related AEs, discontinuations due to AEs, severe AEs, and serious AEs were generally similar for subjects with and without asthma. One treatment-related systemic allergic reaction was reported; this event occurred in a subject without asthma. The frequency of asthma events in subjects with asthma was 11% with 12 SQ-HDM and 10% with placebo; in subjects without asthma the frequency was Conclusions SQ HDM SLIT-tablet was well tolerated and did not appear to increase asthma events in patients with mild-to-moderate asthma. The safety profile was comparable for subjects with HDM-induced respiratory allergy irrespective of asthma status. Asthma is a risk factor for systemic allergic reactions to subcutaneous immunotherapy. The safety of SQ house dust mite (HDM) sublingual immunotherapy (SLIT)-tablet in subjects with or without asthma was evaluated. Safety data from 6 phase II/III double-blind, placebo-controlled trials of SQ HDM SLIT-tablet for the treatment of allergic rhinitis or mild-to-moderate asthma were pooled and compared between subjects with and without reported asthma. IRB approval was obtained. Data for the 12 SQ-HDM dose approved in Europe/US are presented. In all, 3473 subjects were randomized to 12 SQ-HDM (n=1663) or placebo (n=1810), 2036 (59%) of whom had reported asthma. Most asthma was moderate according to GINA criteria (66%, 12 SQ-HDM; 70%, placebo). The proportion of subjects reporting treatment-emergent adverse events (AEs) was similar between subjects with and without asthma (86% vs 85%, respectively) in the 12 SQ-HDM group and in the placebo group (70% vs 64%, respectively). The frequencies of treatment-related AEs, discontinuations due to AEs, severe AEs, and serious AEs were generally similar for subjects with and without asthma. One treatment-related systemic allergic reaction was reported; this event occurred in a subject without asthma. The frequency of asthma events in subjects with asthma was 11% with 12 SQ-HDM and 10% with placebo; in subjects without asthma the frequency was SQ HDM SLIT-tablet was well tolerated and did not appear to increase asthma events in patients with mild-to-moderate asthma. The safety profile was comparable for subjects with HDM-induced respiratory allergy irrespective of asthma status.