title: SQ house dust mite sublingually administered immunotherapy tablet (ALK) improves allergic rhinitis in patients with house dust mite allergic asthma and rhinitis symptoms.
abstract: BACKGROUND
  House dust mite (HDM) allergy is associated with persistent allergic rhinitis (AR) and allergic asthma.
  
  
  OBJECTIVE
  To investigate the efficacy and safety of a SQ HDM sublingually administered immunotherapy tablet (ALK, Hørsholm, Denmark) in adults and adolescents with HDM respiratory allergic disease and report the AR results.
  
  
  METHODS
  Six hundred four subjects at least 14 years old with HDM AR and mild to moderate HDM allergic asthma were randomized 1:1:1:1 to double-blinded daily treatment with 1, 3, 6 SQ-HDM or placebo. End-of-treatment rhinoconjunctivitis symptoms and medication score were predefined extrapulmonary end points. A subgroup analysis was conducted post hoc in subjects with a total combined rhinitis score (TCRS) > 0 (ie, with AR symptoms and/or AR medication use during the 4-week baseline period). The subgroup was comprised of 498 subjects (82%).
  
  
  RESULTS
  In the subgroup, the absolute difference in end-of-treatment TCRS between 6 SQ-HDM and placebo was -0.78 (95% confidence interval -1.47 to -0.07, relative difference 28.8%, P = .0357). Furthermore, a significant difference was found for the total score of the Rhinitis Quality of Life Questionnaire with Standardized Activities RQLQ(S) and for the individual domains: activities, sleep, non-nose and non-eye symptoms, and nasal symptoms. For the TCRS and Rhinitis Quality of Life Questionnaire score, a dose response was seen, with numerically lower, nonsignificant differences for 1 and 3 SQ-HDM. The predefined analysis for the entire trial population showed no statistically significant difference between the placebo and actively treated groups. No safety concerns were observed.
  
  
  CONCLUSIONS
  Efficacy in mild to severe AR of 6 SQ-HDM compared with placebo was demonstrated by statistically significant improvements in TCRS and Rhinitis Quality of Life Questionnaire score in subjects with AR present at baseline. The treatment was well tolerated.
  
  
  BACKGROUND
  EudraCT, no 2006-001795-20; ClinicalTrials.gov, identifier NCT00389363.
authors.affiliation: Allergy Clinic, Copenhagen University Hospital Gentofte, Hellerup, Denmark. Electronic address: hmos0006@geh.regionh.dk.
authors.forename: Holger
authors.initials: H
authors.lastname: Mosbech
authors.affiliation: Allergy and Respiratory Disease Clinic, University of Genova-IRCCS AOU San Martino, San Martino, Italy.
authors.forename: G Walter
authors.initials: GW
authors.lastname: Canonica
authors.affiliation: Bispebjerg University Hospital, Copenhagen, Denmark.
authors.forename: Vibeke
authors.initials: V
authors.lastname: Backer
authors.affiliation: Chest Diseases Department, Strasbourg University Hospital, University of Strasbourg, Strasbourg, France.
authors.forename: Frederic
authors.initials: F
authors.lastname: de Blay
authors.affiliation: Center for Rhinology and Allergology, Wiesbaden, Germany.
authors.forename: Ludger
authors.initials: L
authors.lastname: Klimek
authors.affiliation: ALK, Hørsholm, Denmark.
authors.forename: Louise
authors.initials: L
authors.lastname: Broge
authors.affiliation: ALK, Hørsholm, Denmark.
authors.forename: Christian
authors.initials: C
authors.lastname: Ljørring
mesh_terms: D000293:Adolescent; D000818:Animals; D039741:Antigens, Dermatophagoides / Q000008:administration & dosage / Q000276:immunology / Q000627:therapeutic use*; D001249:Asthma / Q000276:immunology; D003233:Conjunctivitis, Allergic / Q000276:immunology / Q000628:therapy*; D040002:Dermatophagoides pteronyssinus / Q000276:immunology*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D010919:Placebos; D011788:Quality of Life; D065631:Rhinitis, Allergic / Q000276:immunology / Q000628:therapy*; D063729:Sublingual Immunotherapy / Q000009:adverse effects / Q000379:methods*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D039741:Antigens, Dermatophagoides; D010919:Placebos