title: Effective treatment of house dust mite-induced allergic rhinitis with 2 doses of the SQ HDM SLIT-tablet: Results from a randomized, double-blind, placebo-controlled phase III trial.
abstract: BACKGROUND
  The SQ HDM SLIT-tablet (ALK) has been developed for treatment of house dust mite (HDM)-induced respiratory allergic disease.
  
  
  OBJECTIVE
  This trial investigated the efficacy and safety of the SQ HDM SLIT-tablet in adults with moderate-to-severe HDM-induced allergic rhinitis (AR).
  
  
  METHODS
  The trial was a randomized, double-blind, placebo-controlled phase III trial conducted in 12 European countries including 992 adults with moderate-to-severe HDM-induced AR despite treatment with pharmacotherapy. Subjects were randomized 1:1:1 to 1 year of daily treatment with placebo, 6 SQ-HDM, or 12 SQ-HDM. The primary end point was the total combined rhinitis score (ie, the sum of rhinitis symptom and medication scores) during the efficacy assessment period (approximately the last 8 weeks of the treatment period). Key secondary end points were rhinitis symptoms, medication scores, quality of life, and the combined rhinoconjunctivitis score.
  
  
  RESULTS
  Analysis of the primary end point (observed data) demonstrated absolute reductions in total combined rhinitis score of 1.18 (P = .002) and 1.22 (P = .001) compared with placebo for 6 SQ-HDM and 12 SQ-HDM, respectively. The statistically significant treatment effect was evident from 14 weeks of treatment onward. For all key secondary end points, efficacy was confirmed for 12 SQ-HDM, with statistically significant reductions of rhinitis symptoms and medication scores, improved quality of life, and a reduced combined rhinoconjunctivitis score in the efficacy assessment period compared with placebo. The treatment was well tolerated.
  
  
  CONCLUSIONS
  The trial confirmed the efficacy and favorable safety profile of both 6 SQ-HDM and 12 SQ-HDM in adults with HDM-induced AR. The treatment effect was present from 14 weeks of treatment onward.
authors: Department of Pulmonology, Division of Allergy, Hôpital Arnaud de Villeneuve, University Hospital of Montpellier, Paris, France. Electronic address: pascal.demoly@inserm.fr.
authors: Pascal
authors: P
authors: Demoly
authors: Allergy Outpatient Clinic, Rennweg, Vienna, Austria.
authors: Waltraud
authors: W
authors: Emminger
authors: ALK, Hørsholm, Denmark.
authors: Dorte
authors: D
authors: Rehm
authors: Department of Respiratory Medicine, Bispebjerg University Hospital, Copenhagen, Denmark.
authors: Vibeke
authors: V
authors: Backer
authors: ALK, Hørsholm, Denmark.
authors: Lene
authors: L
authors: Tommerup
authors: Allergy & Asthma Center Westend, Outpatient Clinic & Research Center, Berlin, Germany.
authors: Jörg
authors: J
authors: Kleine-Tebbe
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000485:Allergens / Q000008:administration & dosage / Q000276:immunology*; D000818:Animals; D039741:Antigens, Dermatophagoides / Q000276:immunology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D039981:Pyroglyphidae / Q000276:immunology*; D065631:Rhinitis, Allergic / Q000276:immunology* / Q000628:therapy*; D012307:Risk Factors; D063729:Sublingual Immunotherapy / Q000379:methods; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000485:Allergens; D039741:Antigens, Dermatophagoides
keywords: Allergy immunotherapy; Rhinitis Quality of Life Questionnaire; allergen immunotherapy; allergic rhinitis; allergy; house dust mite; rhinoconjunctivitis; sublingual immunotherapy; sublingual immunotherapy tablet; total combined rhinitis score