title: Epicutaneous allergen-specific immunotherapy ameliorates grass pollen-induced rhinoconjunctivitis: A double-blind, placebo-controlled dose escalation study.
abstract: BACKGROUND
  Epicutaneous allergen administration using a patch may be an alternative to subcutaneous or sublingual immunotherapy.
  
  
  OBJECTIVE
  To optimize treatment dose and to demonstrate the efficacy and safety of epicutaneous immunotherapy.
  
  
  METHODS
  This monocentric, placebo-controlled, double-blind trial included 132 patients with grass pollen-induced rhinoconjunctivitis. In February 2008, patients were randomly allocated to receive placebo or 3 different doses of allergen. Before and during the pollen season 2008, patients received 6 weekly patches. Efficacy was assessed 4 to 5 months later (n = 110) and during the pollen season of the treatment-free follow-up year in 2009 (n = 93). The primary outcome was patient-reported changes in hay fever symptoms assessed by a visual analog scale. Secondary outcome measures were weekly visual analog scale symptom scores during pollen season, use of rescue medication, changes in conjunctival and skin reactivity, as well as safety.
  
  
  RESULTS
  Hay fever symptoms during the pollen season were reduced by more than 30% in 2008 and by 24% in 2009 in the high-dose group as compared with that in the placebo group, and the alleviation of symptoms in the follow-up year was dependent on the treatment dose. Higher allergen doses were associated with drug-related adverse events (AEs), predominantly manifested by pruritus, erythema, wheal, or eczema. Eleven systemic AEs of grades 1 to 2 required treatment and led to study exclusion. The dropout rate due to AEs was 8.3%. No drug-related serious AE was recorded.
  
  
  CONCLUSIONS
  Epicutaneous immunotherapy is safe and efficacious in a dose-dependent manner after 6 patches only.
authors: Clinical Trials Center, University Hospital Zurich, Zurich, Switzerland.
authors: Gabriela
authors: G
authors: Senti
authors: Seraina
authors: S
authors: von Moos
authors: Fabian
authors: F
authors: Tay
authors: Nicole
authors: N
authors: Graf
authors: Theodor
authors: T
authors: Sonderegger
authors: Pål
authors: P
authors: Johansen
authors: Thomas M
authors: TM
authors: Kündig
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000485:Allergens / Q000276:immunology*; D003233:Conjunctivitis, Allergic / Q000276:immunology / Q000628:therapy*; D003888:Desensitization, Immunologic / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D006109:Poaceae / Q000276:immunology*; D011058:Pollen / Q000276:immunology*; D016896:Treatment Outcome
chemical_list: D000485:Allergens