Epicutaneous allergen-specific immunotherapy ameliorates grass pollen–induced rhinoconjunctivitis: A double-blind, placebo-controlled dose escalation study - 24/12/11
, Seraina von Moos, MD a, , Fabian Tay, MD a, Nicole Graf, PhD a, Theodor Sonderegger, MSc c, Pål Johansen, PhD b, Thomas M. Kündig, MD b, ⁎ 
Corresponding author: Thomas M. Kündig, MD, Department of Dermatology, University Hospital Zurich, Gloriastrasse 31, 8091 Zurich, Switzerland.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.
Conclusion |
Epicutaneous immunotherapy is safe and efficacious in a dose-dependent manner after 6 patches only.
El texto completo de este artículo está disponible en PDF.Key words : Epicutaneous allergen-specific immunotherapy, epicutaneous immunotherapy, patch immunization
Abbreviations used : AE, CPT, EPIT, HEP, SIT, SPT, VAS
Esquema
| This academic investigator–initiated study was financially supported by the Swiss National Science Foundation (SNSF), the University of Zurich, Medanz Medical GmbH (Starnberg, Germany), and Allergy Innovations (Munich, Germany). |
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| Disclosure of potential conflict of interest: G. Senti and T. M. Kundig are named as inventors on a patent on epicutaneous immunotherapy; the patent is owned by the University of Zurich. The rest of the authors declare that they have no relevant conflicts of interest. |
Vol 129 - N° 1
P. 128-135 - janvier 2012 Regresar al número
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