title: A double-blind placebo-controlled evaluation of sublingual immunotherapy with a standardized ragweed extract in patients with seasonal rhinitis. Evidence for a dose-response relationship.
abstract: BACKGROUND
  There is a growing consensus on the benefits of sublingual-swallow immunotherapy in the treatment of allergic diseases.
  
  
  METHODS
  This randomized, double-blind placebo-controlled study was undertaken to assess the efficacy and safety of sublingual immunotherapy with standardized ragweed pollen extract tablets, in patients with an allergic rhinitis. A total of 110 outpatients were randomized (immunotherapy [I]: 55; placebo [P]: 55), of whom 99 were analyzable for efficacy (I: 48; P: 51) and 106 analyzable for safety (I: 53; P: 53). After a 28-day progression phase, the patients received a maintenance treatment during 6.5 months. Efficacy variables included a global assessment of efficacy (patient/ investigator), symptoms and medication scores as well as the frequency of asthma attacks.
  
  
  RESULTS
  In the active treatment group, 43 patients completed the study, versus 49 on placebo. During the whole period of pollination, the difference favoring immunotherapy was highly significant for the global assessment by the patient (p = 0.004) and by the investigator (p = 0.005). Adverse reactions were reported more often in the active treatment but mild or moderate, and they abated after dose adjustment. A subgroup analysis of those patients receiving the highest dose of immunotherapy (3 tablets 3 times a week) showed a highly significant response for rhinitis and conjunctivitis total scores by comparison to lower dosages.
  
  
  CONCLUSIONS
  This study confirms the efficacy and safety of sublingual immunotherapy and strongly suggests a dose-response relationship.
authors.affiliation: Département Scientifique et Médical, Stallergènes S.A., Antony, France. candre@stallergenes.fr
authors.forename: C
authors.initials: C
authors.lastname: André
authors.forename: M
authors.initials: M
authors.lastname: Perrin-Fayolle
authors.forename: M
authors.initials: M
authors.lastname: Grosclaude
authors.forename: P
authors.initials: P
authors.lastname: Couturier
authors.forename: D
authors.initials: D
authors.lastname: Basset
authors.forename: J
authors.initials: J
authors.lastname: Cornillon
authors.forename: D
authors.initials: D
authors.lastname: Piperno
authors.forename: B
authors.initials: B
authors.lastname: Girodet
authors.forename: R
authors.initials: R
authors.lastname: Sanchez
authors.forename: C
authors.initials: C
authors.lastname: Vallon
authors.forename: P
authors.initials: P
authors.lastname: Bellier
authors.forename: M
authors.initials: M
authors.lastname: Nasr
mesh_terms: D000286:Administration, Sublingual; D000293:Adolescent; D000328:Adult; D000485:Allergens / Q000008:administration & dosage* / Q000276:immunology; D031164:Ambrosia / Q000276:immunology; D003888:Desensitization, Immunologic / Q000379:methods; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010936:Plant Extracts / Q000008:administration & dosage* / Q000627:therapeutic use; D011058:Pollen / Q000276:immunology; D006255:Rhinitis, Allergic, Seasonal / Q000276:immunology / Q000628:therapy*; D013607:Tablets; D016896:Treatment Outcome
chemical_list: D000485:Allergens; D010936:Plant Extracts; D013607:Tablets