OPEN-LABEL SAFETY TRIAL OF HOUSE DUST MITE SUBLINGUAL IMMUNOTHERAPY TABLET IN ADOLESCENTS WITH ALLERGIC RHINITIS/RHINOCONJUNCTIVITIS

Abstract

<h3>Introduction</h3> The HDM sublingual immunotherapy (SLIT) tablet is a treatment option for allergic rhinitis with/without conjunctivitis (AR/C) approved in adults worldwide and in adolescents in some countries. The MT-18 trial was conducted specifically in adolescents per FDA request to supplement existing adolescent safety data of the HDM SLIT tablet. <h3>Methods</h3> MT-18 (EudraCT:2020-000446-34) was a phase 3, open-label, single-arm, multi-center, 28-day safety trial of daily HDM SLIT tablet (12 SQ-HDM dose) conducted in European adolescents (12-17 y; N=253) with HDM-associated AR/C, with or without asthma. The primary endpoint was at least 1 treatment-emergent adverse event (TEAE). Secondary endpoints were at least 1 solicited TEAE, at least 1 treatment-related adverse event (TRAE), and at least 1 serious TEAE. <h3>Results</h3> The percentage of adolescents reporting any TEAE was 88%, the percentage reporting any TRAE was 86%, and there were no serious TEAEs. Two subjects (1%) discontinued due to AEs. The most common TRAEs were local application site reactions. Most TRAEs were mild in severity and were typically experienced during the first 1-2 days of treatment. The most common TRAEs recurred for <10 days in MT-18. No treatment-related anaphylaxis, epinephrine administrations, severe local swellings, severe mouth or throat edema, or eosinophilic esophagitis occurred in the trial. <h3>Conclusions</h3> There were no new or unexpected safety findings in MT-18 compared with previous safety data. The HDM SLIT tablet was well tolerated in European adolescents with HDM AR/C, similar to previous data in North American adolescents.