SQ house dust mite sublingual immunotherapy tablet subgroup efficacy and local application site reaction duration

Publication date: Available online 12 April 2018
Source:Annals of Allergy, Asthma & Immunology
Author(s): David I. Bernstein, Joerg Kleine-Tebbe, Harold S. Nelson, Jose A. Bardelas, Gordon L. Sussman, Susan Lu, Dorte Rehm, Bodil Svanholm Fogh, Hendrik Nolte
BackgroundAllergic rhinitis with or without conjunctivitis (AR/C) is common, necessitating evaluation of SQ house dust mite (HDM) sublingual immunotherapy (SLIT)-tablet efficacy in various subgroups.ObjectiveTo evaluate 12 SQ-HDM efficacy and safety across subgroups, and the onset, duration, and recurrence of local application site reactions.MethodsSubgroup (age, gender, race, asthma status, and allergen sensitization) efficacy was assessed using pooled data from two previously described trials of daily 12 SQ-HDM vs placebo for AR/C (N=2138). Efficacy was measured by average total combined rhinitis score (TCRS; rhinitis daily symptom plus medication score) during the last 8 weeks of treatment. Safety in subgroups and local application site reaction onset, duration, and recurrence were evaluated using pooled data from five previously described trials of SQ HDM SLIT-tablet (N=2923).ResultsThere was significant (based on 95% CIs) reduction in TCRS with 12 SQ-HDM relative to placebo across all subgroups, with TCRS improvements ranging from 15%-25%. The AE profile was generally similar within subgroups. Approximately 95% of local application site reactions were mild-to-moderate in severity. Median duration on day 1 of treatment for the most common local application site reactions (throat irritation, oral pruritus, ear pruritus, and lip swelling) ranged from 30-60 minutes; median first day of onset ranged from days 1-4 of treatment; median days that reactions recurred ranged from 3-12 days.ConclusionTreatment with 12 SQ-HDM consistently improved symptoms and was well tolerated in relevant subgroups of subjects with HDM AR/C. Local application site reactions to 12 SQ-HDM were typically mild-to-moderate and transient.



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