SQ house dust mite sublingual immunotherapy tablet subgroup efficacy and local application site reaction duration
David I Bernstein, Joerg Kleine-Tebbe, Harold S Nelson, Jose A Bardelas Jr, Gordon L Sussman, Susan Lu, Dorte Rehm, Bodil Svanholm Fogh, Hendrik Nolte, David I Bernstein, Joerg Kleine-Tebbe, Harold S Nelson, Jose A Bardelas Jr, Gordon L Sussman, Susan Lu, Dorte Rehm, Bodil Svanholm Fogh, Hendrik Nolte
Abstract
Background: Allergic 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.
Objective: To evaluate 12 SQ-HDM efficacy and safety across subgroups, and the onset, duration, and recurrence of local application site reactions.
Methods: Subgroup (age, sex, race, asthma status, and allergen sensitization) efficacy was assessed using pooled data from 2 previously described trials of daily 12 SQ-HDM vs placebo for AR/C (n = 2,138). 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 5 previously described trials of SQ HDM SLIT-tablet (n = 2,923).
Results: Significant (based on 95% confidence intervals [CIs]) reduction in TCRS was seen with 12 SQ-HDM relative to placebo across all subgroups, with TCRS improvements ranging from 15% to 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 to 60 minutes; median first day of onset ranged from days 1 to 4 of treatment; median days that reactions recurred ranged from 3 to 12 days.
Conclusion: Treatment 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.
Trial registration: ClinicalTrials.gov NCT01700192 NCT01454544 NCT00389363 NCT01644617.
Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.
Source: PubMed