title: Determinants of efficacy and safety in epicutaneous allergen immunotherapy: summary of three clinical trials.
abstract: The results of our third trial on epicutaneous allergen-specific immunotherapy (EPIT) will be presented and discussed in the context of our previous trials. This monocentric, placebo-controlled, double-blind phase I/IIa trial included 98 patients with grass pollen rhinoconjunctivitis. Prior to the pollen season 2009, patients received six patches (allergen extract: n = 48; placebo: n = 50) with weekly intervals, administered onto tape-stripped skin. Allergen EPIT produced a median symptom improvement of 48% in 2009 and 40% in the treatment-free follow-up year 2010 as compared to 10% and 15% improvement after placebo EPIT (P = 0.003). After allergen EPIT but not placebo EPIT, conjunctival allergen reactivity was significantly decreased and allergen-specific IgG4 responses were significantly elevated (P < 0.001). In conclusion, our three EPIT trials found that allergen EPIT can ameliorate hay fever symptoms. Overall, treatment efficacy appears to be determined by the allergen dose. Local side-effects are determined by the duration of patch administration, while risk of systemic allergic side-effects is related to the degree of stratum corneum disruption.
authors.affiliation: Clinical Trials Center, University of Zurich, Zurich, Switzerland.
authors.forename: G
authors.initials: G
authors.lastname: Senti
authors.affiliation: Department of Internal Medicine, University Hospital Zurich, Zurich, Switzerland.
authors.forename: S
authors.initials: S
authors.lastname: von Moos
authors.affiliation: Clinical Trials Center, University of Zurich, Zurich, Switzerland.
authors.forename: F
authors.initials: F
authors.lastname: Tay
authors.affiliation: Graf Biostatistics, Winterthur, Switzerland.
authors.forename: N
authors.initials: N
authors.lastname: Graf
authors.affiliation: Department of Dermatology, University Hospital Zurich, Zurich, Switzerland.
authors.forename: P
authors.initials: P
authors.lastname: Johansen
authors.affiliation: Department of Dermatology, University Hospital Zurich, Zurich, Switzerland.
authors.forename: T M
authors.initials: TM
authors.lastname: Kündig
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D003233:Conjunctivitis, Allergic / Q000188:drug therapy* / Q000276:immunology; D003888:Desensitization, Immunologic / Q000379:methods*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007073:Immunoglobulin E / Q000276:immunology; D007074:Immunoglobulin G / Q000276:immunology; D008297:Male; D008875:Middle Aged; D010936:Plant Extracts / Q000627:therapeutic use*; D006109:Poaceae / Q000276:immunology*; D011058:Pollen / Q000276:immunology*; D065631:Rhinitis, Allergic / Q000188:drug therapy* / Q000276:immunology; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy* / Q000276:immunology; D057968:Transdermal Patch; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D007074:Immunoglobulin G; D010936:Plant Extracts; D007073:Immunoglobulin E
keywords: allergen-specific antibodies; allergic rhinoconjunctivitis; epicutaneous allergen-specific immunotherapy; needle-free immunisation; patch immunisation