{"doi":"10.1111/all.70073","title":"<scp>SQ</scp> House Dust Mite Sublingual Immunotherapy Tablet in Children With Allergic Asthma: A Randomised Phase <scp>III</scp> Trial","abstract":"BACKGROUND: In children, house dust mite (HDM) sensitisation is a contributing factor for developing allergic asthma. HDM allergen immunotherapy has demonstrated efficacy and safety in adults with allergic asthma; however, evidence for its use in children is limited. MT-11 evaluated the efficacy and safety of the SQ HDM sublingual immunotherapy (SLIT) tablet in children (5-17 years) with HDM allergic asthma. METHODS: This phase III, randomised, double-blind, placebo-controlled trial randomised 533 children with a recent history of asthma exacerbations, despite treatment with inhaled corticosteroids and/or long-acting beta-agonists, to daily treatment with SQ HDM SLIT-tablet or placebo for 24-30 months. The primary endpoint was the annualised rate of clinically relevant asthma exacerbations. Adverse events (AEs) were reported throughout the trial. RESULTS: The rate ratio for the annualised rate of clinically relevant asthma exacerbations was 0.89 (95% CI: 0.60, 1.31), in favour of the SQ HDM-SLIT tablet; superiority over placebo was not established. Most treatment-related AEs (TRAEs) were of mild or moderate severity, and few subjects discontinued due to TRAEs (< 2%). The most common TRAEs were local application site reactions (oral pruritus, throat irritation, ear pruritus, and upper abdominal pain). There was no increased incidence of asthma-related events, and no anaphylaxis or adrenaline use in the SQ HDM SLIT-tablet group. CONCLUSION: As a result of the coronavirus disease 2019 pandemic, asthma exacerbation rates were much lower than expected, contributing to the primary endpoint not being met. The SQ HDM SLIT-tablet was well tolerated in a paediatric population with inadequately controlled HDM allergic asthma. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT03654976; EudraCT number: 2016-004363-39.","journal":"Allergy","year":2025,"id":527128,"datarank":0.20794415416798362,"base_score":1.3862943611198906,"endowment":1.3862943611198906,"self_citation_contribution":0.20794415416798362,"citation_network_contribution":0.0,"self_endowment_contribution":0.20794415416798362,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":3,"citer_count":3,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.957,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT03654976"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2025-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1403275,"name":"J. Just","orcid":"0000-0002-5646-2429","position":1,"is_corresponding":false},{"id":254805,"name":"Hendrik Nolte","orcid":"0000-0003-1560-5099","position":2,"is_corresponding":false},{"id":1403788,"name":"Ole Hels","orcid":null,"position":3,"is_corresponding":false},{"id":254036,"name":"Andrzej Emeryk","orcid":"0000-0003-1853-8696","position":4,"is_corresponding":false},{"id":1403276,"name":"Carmen Vidal","orcid":"0000-0002-2844-2754","position":5,"is_corresponding":false},{"id":247765,"name":"Graham Roberts","orcid":"0000-0003-2252-1248","position":0,"is_corresponding":true}],"reference_count":36,"raw_metadata":null,"created_at":"2026-07-19T02:50:34.851930Z","pmid":"41064908","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}