title: SQ HDM SLIT-tablet (ALK) in treatment of asthma--post hoc results from a randomised trial.
abstract: BACKGROUND
  In a double-blind, placebo-controlled trial (EudraCT identifier: 2006-001795-20), the standardised quality (SQ) house dust mite (HDM) sublingual immunotherapy (SLIT)-tablet (ALK, Denmark) was investigated.
  
  
  METHODS
  The trial included 604 subjects, ≥14 years, with mild-moderate HDM allergic asthma. Subjects were randomised 1:1:1:1 to 1, 3 or 6 SQ-HDM or placebo once daily. The primary endpoint was reduction in inhaled corticosteroid (ICS) after one year. ICS reduction, asthma quality of life questionnaire (AQLQ) and asthma control questionnaire (ACQ) score was analysed post hoc in a subgroup with daily ICS use of 400-800 μg and ACQ score of 1-1.5, corresponding to partly controlled asthma (N = 108).
  
  
  RESULTS
  The trial met its primary endpoint. In the subgroup, the difference between placebo and 6 SQ-HDM in change from baseline in daily ICS use was 327 μg (p < 0.0001), while it was 0.52 (p = 0.010) for AQLQ. The treatment effect on ICS reduction and AQLQ was increased for the subgroup versus the residual population (ICS reduction: p < 0.001); AQLQ: p = 0.044).
  
  
  CONCLUSIONS
  In this subgroup, including only patients with partly controlled asthma, the benefit of 1 year of treatment with SQ HDM SLIT-tablet was significantly higher than for the less severe full population, both in terms of increased asthma control and improved quality of life.
authors.affiliation: Chest Disease Department, University Hospital of Strasbourg, Federation of Translational Medicine, EA 3072, 67091 Strasbourg University, France. Electronic address: Frederic.DEBLAY@chru-strasbourg.fr.
authors.forename: F
authors.initials: F
authors.lastname: de Blay
authors.affiliation: Division of Internal Medicine, Asthma and Allergy, Barlicki University Hospital, Medical University of Lodz, ul. Kopcińskiego 22, 90-153 Łódź, Poland.
authors.forename: P
authors.initials: P
authors.lastname: Kuna
authors.affiliation: Departamento de Medicina, Universidad de Valencia, Av. Blásco Ibáñez, 15, 46010 Valencia, Spain.
authors.forename: L
authors.initials: L
authors.lastname: Prieto
authors.affiliation: Private Practice, Vorgebirgsstraße 43, 53119 Bonn, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Ginko
authors.affiliation: Global Clinical Development, ALK, Bøge Allé 6-8, 2970 Hørsholm, Denmark.
authors.forename: D
authors.initials: D
authors.lastname: Seitzberg
authors.affiliation: Global Clinical Development, ALK, Bøge Allé 6-8, 2970 Hørsholm, Denmark.
authors.forename: B
authors.initials: B
authors.lastname: Riis
authors.affiliation: Allergy & Respiratory Dis. Clinic, DIMI, University of Genova, IRCCS AOU San Martino, Largo R. Benzi 10, 16132 Genova, Italy.
authors.forename: G W
authors.initials: GW
authors.lastname: Canonica
mesh_terms: D000328:Adult; D000818:Animals; D001249:Asthma / Q000188:drug therapy / Q000276:immunology*; D019819:Budesonide / Q000008:administration & dosage; D004311:Double-Blind Method; D005938:Glucocorticoids / Q000008:administration & dosage; D006801:Humans; D039981:Pyroglyphidae / Q000276:immunology*; D011788:Quality of Life; D063729:Sublingual Immunotherapy / Q000379:methods*; D011795:Surveys and Questionnaires; D013607:Tablets / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D005938:Glucocorticoids; D013607:Tablets; D019819:Budesonide
keywords: Asthma; Asthma quality of life; House dust mite; ICS reduction; SLIT-tablet