Determinants of efficacy and safety in epicutaneous allergen immunotherapy: summary of three clinical trials

Allergy. 2015 Jun;70(6):707-10. doi: 10.1111/all.12600. Epub 2015 Mar 13.


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.

Keywords: allergen-specific antibodies; allergic rhinoconjunctivitis; epicutaneous allergen-specific immunotherapy; needle-free immunisation; patch immunisation.

Publication types

  • Clinical Trial, Phase I
  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Conjunctivitis, Allergic / drug therapy*
  • Conjunctivitis, Allergic / immunology
  • Desensitization, Immunologic / methods*
  • Double-Blind Method
  • Female
  • Humans
  • Immunoglobulin E / immunology
  • Immunoglobulin G / immunology
  • Male
  • Middle Aged
  • Plant Extracts / therapeutic use*
  • Poaceae / immunology*
  • Pollen / immunology*
  • Rhinitis, Allergic / drug therapy*
  • Rhinitis, Allergic / immunology
  • Rhinitis, Allergic, Seasonal / drug therapy*
  • Rhinitis, Allergic, Seasonal / immunology
  • Transdermal Patch
  • Treatment Outcome
  • Young Adult


  • Immunoglobulin G
  • Plant Extracts
  • Immunoglobulin E