1 research outputs found
Supplementary Material for: The SQ House Dust Mite SLIT-Tablet Is Well Tolerated in Patients with House Dust Mite Respiratory Allergic Disease
<p><b><i>Background:</i></b> The SQ house dust mite (HDM) SLIT-tablet
(ALK, Denmark) addresses the underlying cause of HDM respiratory
allergic disease, and a clinical effect has been demonstrated for both
HDM allergic rhinitis and allergic asthma. Here, we present pooled
safety data from an adult population with HDM respiratory allergy, with
particular focus on the impact of asthma on the SQ HDM SLIT-tablet
tolerability profile. <b><i>Methods:</i></b> Safety data from 2
randomised double-blind, placebo-controlled clinical trials were
included: MT-04: 834 adults with HDM allergic asthma not well controlled
by inhaled corticosteroids and with HDM allergic rhinitis, and MT-06:
992 adults with moderate-to-severe HDM allergic rhinitis despite the use
of allergy pharmacotherapy and with or without asthma. <b><i>Results:</i></b>
The proportion of subjects experiencing adverse events (AEs) was
greater in the active treatment group (12 SQ-HDM; 73% of subjects)
compared to placebo (53%). The most common treatment-related AEs were
local allergic reactions. No AEs were reported as systemic allergic
reactions. Regardless of asthma status, most AEs were mild or moderate
(>97% of AEs) and the frequency of serious AEs was low. Subgroup
analysis revealed no statistically significant difference in the risk of
experiencing moderate or severe treatment-related AEs for subjects with
asthma compared to subjects without asthma (<i>p</i> = 0.88). In
addition, subjects with partly controlled or uncontrolled asthma were no
more likely to experience moderate or severe treatment-related AEs than
subjects with controlled asthma (<i>p</i> = 0.42). <b><i>Conclusion:</i></b>
The SQ HDM SLIT-tablet is well tolerated, and the safety profile was
comparable for subjects with HDM respiratory allergic disease
irrespective of asthma status.</p