House dust mite sublingual immunotherapy tablet safety in adolescents with allergic rhinoconjunctivitis

• DOI: 10.1016/j.anai.2023.03.006
• Publication Date: 2023-03-15T02:03:31Z
• Authors: Andreas Horn; David I. Bernstein; Kimihiro Okubo; Terrie Dalgaard; Ole Hels; Helle Frobøse Sør...; Marianne Henriksen; Ryuji Azuma; Jan Mikler; Hendrik Nolte
• Keywords: Sublingual Immunotherapy; Dust mites

BackgroundThe house dust mite (HDM) sublingual immunotherapy (SLIT)-tablet is a treatment option for allergic rhinitis with/without conjunctivitis (AR/C) approved in adults worldwide and adolescents some countries.ObjectiveTo supplement existing adolescent HDM SLIT-tablet safety data by conducting the MT-18 trial adolescents.MethodsMT-18 (EudraCT:2020-000446-34) was phase 3, open-label, single-arm, 28-day of daily (12 SQ-HDM dose) European (12-17 years) with AR/C, or without asthma. The primary end point at least 1 treatment-emergent adverse event (TEAE). results were compared 12 subpopulation from previously described 1-year 3 trials conducted North America (P001; clinicaltrials.gov:NCT01700192) Japan (TO-203-3-2; JapicCTI:121848).ResultsNo treatment-related anaphylaxis, epinephrine administrations, severe local swellings, mouth throat edema, eosinophilic esophagitis occurred trials. For (N = 253), P001 189), TO-203-3-2 206), percentage treated reporting any TEAE 88%, 95%, 93%, respectively, AE (TRAE) 86%, 66%, respectively. most common TRAEs application site reactions. Most mild intensity typically experienced first to 2 days treatment. There no asthma-related TEAEs SLIT-tablet. profile appears similar between asthma baseline.ConclusionThe well tolerated European, American, Japanese indicating insensitive age geographic region.Trial registrationClinicalTrials.gov Identifier: (P001: NCT01700192); EudraCT: (MT-18; 2020-000446-34); JapicCTI: 121848)