Safety of house dust mite sublingual immunotherapy standardized quality tablet in children allergic to house dust mites.
BACKGROUND Sublingual immunotherapy (SLIT) tablets could be an important alternative to subcutaneous immunotherapy for house dust mite (HDM) allergy in children. OBJECTIVE To characterize the safety, tolerability, and duration of local adverse events (AEs) of an HDM SLIT tablet (MK 8237; Merck, ALK Abello, and Torii) in North American children 12 to 17 years old with HDM allergic rhinitis with and without conjunctivitis and with or without asthma. METHODS In this phase 1, multicenter, double blinded, randomized trial (NCT01678807) children received placebo, HDM SLIT tablet 6 standardized quality (SQ) HDM, or 12 SQ HDM once daily for 28 days. The primary end point was the proportion of subjects with treatment emergent AEs receiving active treatment vs placebo. The secondary end point was the proportion of subjects who discontinued owing to AEs. RESULTS In total 195 subjects were randomized. The 2 HDM SLIT tablet doses were well tolerated. No anaphylactic reactions, systemic allergic reactions, AEs requiring epinephrine, serious AEs, or local swellings in the mouth or throat assessed as severe were reported. The proportion of subjects with treatment emergent AEs was 54% with 6 SQ HDM and 57% with 12 SQ HDM (nonsignificant vs 43% with placebo) Local AEs were the most commonly reported treatment emergent AEs. On day 1, the median duration of individual local AEs ranged from 1 to 43 minutes. The proportion of subjects who discontinued owing to AEs was 0% 6.2% and 6.2% and who experienced treatment related AEs was 25% 45% and 52% for the placebo, 6 SQ HDM, and 12 SQ HDM groups, respectively. CONCLUSION The 6 and 12 SQ HDM doses of the HDM SLIT tablet MK 8237 were well tolerated, and local AEs were of short duration. TRIAL REGISTRATION ClinicalTrials.gov, identifier NCT01678807.
Annals of allergy, asthma immunology official publication of the American College of Allergy, Asthma, Immunology