title: Sustained 3-year efficacy of pre- and coseasonal 5-grass-pollen sublingual immunotherapy tablets in patients with grass pollen-induced rhinoconjunctivitis.
abstract: BACKGROUND
  Seasonal allergic rhinoconjunctivitis affects millions of persons. The efficacy of allergen sublingual immunotherapy (SLIT) was demonstrated in previous short-term studies.
  
  
  OBJECTIVE
  We sought to evaluate the sustained efficacy of 2 dosing regimens of a pre- and coseasonal treatment with 300 IR (index of reactivity) 5-grass-pollen SLIT tablets (Oralair) compared with placebo assessed by using the average adjusted symptom score (AAdSS) at season 3 in adults with grass pollen-induced rhinoconjunctivitis.
  
  
  METHODS
  Six hundred thirty-three patients were treated for either 2 or 4 months before and then during the grass pollen season with active or placebo treatment for 3 consecutive seasons. The primary outcome was the AAdSS, a symptom score adjusted for rescue medication use, after 3 consecutive treatment seasons. Secondary outcomes were symptoms and rescue medication score, quality-of-life, and safety assessments.
  
  
  RESULTS
  The mean AAdSS was reduced by 36.0% and 34.5% at season 3 in the 2- and 4-month pre- and coseasonal active treatment groups, respectively, compared with that in the placebo group (P < .0001 for both). Reductions were observed in total symptom scores and ISSs and the medication score, with a marked improvement in quality of life for both active groups compared with the placebo group at season 3. Most treatment-emergent adverse events were local reactions expected with SLIT, decreasing in number and intensity in each treatment season.
  
  
  CONCLUSIONS
  Sustained efficacy of 2- and 4-month pre- and coseasonal treatment with the 300 IR tablet over 3 pollen seasons was demonstrated, with reduction in symptoms and rescue medication use. The treatment was well tolerated. Adverse events decreased in number and intensity over the 3 seasons.
authors.affiliation: Rangueil-Larrey Hospital, Respiratory Diseases Department, Toulouse, France. didier.a@chu-toulouse.fr
authors.forename: Alain
authors.initials: A
authors.lastname: Didier
authors.forename: Margitta
authors.initials: M
authors.lastname: Worm
authors.forename: Friedrich
authors.initials: F
authors.lastname: Horak
authors.forename: Gordon
authors.initials: G
authors.lastname: Sussman
authors.forename: Olivier
authors.initials: O
authors.lastname: de Beaumont
authors.forename: Martine
authors.initials: M
authors.lastname: Le Gall
authors.forename: Michel
authors.initials: M
authors.lastname: Melac
authors.forename: Hans-Jorgen
authors.initials: HJ
authors.lastname: Malling
mesh_terms: D000286:Administration, Sublingual; D000293:Adolescent; D000328:Adult; D000485:Allergens / Q000008:administration & dosage / Q000276:immunology*; D003233:Conjunctivitis, Allergic / Q000628:therapy*; D003888:Desensitization, Immunologic / Q000009:adverse effects / Q000379:methods; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D006109:Poaceae / Q000276:immunology*; D011058:Pollen / Q000276:immunology*; D006255:Rhinitis, Allergic, Seasonal / Q000628:therapy*; D012621:Seasons; D013607:Tablets / Q000008:administration & dosage; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000485:Allergens; D013607:Tablets