PMID- 21996342 OWN - NLM STAT- MEDLINE DCOM- 20120703 LR - 20220330 IS - 1097-6825 (Electronic) IS - 0091-6749 (Linking) VI - 129 IP - 1 DP - 2012 Jan TI - Epicutaneous allergen-specific immunotherapy ameliorates grass pollen-induced rhinoconjunctivitis: A double-blind, placebo-controlled dose escalation study. PG - 128-35 LID - 10.1016/j.jaci.2011.08.036 [doi] AB - 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. CI - Copyright (c) 2011 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved. FAU - Senti, Gabriela AU - Senti G AD - Clinical Trials Center, University Hospital Zurich, Zurich, Switzerland. FAU - von Moos, Seraina AU - von Moos S FAU - Tay, Fabian AU - Tay F FAU - Graf, Nicole AU - Graf N FAU - Sonderegger, Theodor AU - Sonderegger T FAU - Johansen, Pal AU - Johansen P FAU - Kundig, Thomas M AU - Kundig TM LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20111013 PL - United States TA - J Allergy Clin Immunol JT - The Journal of allergy and clinical immunology JID - 1275002 RN - 0 (Allergens) SB - IM MH - Administration, Cutaneous MH - Adult MH - Allergens/*immunology MH - Conjunctivitis, Allergic/immunology/*therapy MH - *Desensitization, Immunologic/adverse effects MH - Double-Blind Method MH - Female MH - Humans MH - Male MH - Middle Aged MH - Poaceae/*immunology MH - Pollen/*immunology MH - Treatment Outcome EDAT- 2011/10/15 06:00 MHDA- 2012/07/04 06:00 CRDT- 2011/10/15 06:00 PHST- 2011/03/31 00:00 [received] PHST- 2011/08/18 00:00 [revised] PHST- 2011/08/25 00:00 [accepted] PHST- 2011/10/15 06:00 [entrez] PHST- 2011/10/15 06:00 [pubmed] PHST- 2012/07/04 06:00 [medline] AID - S0091-6749(11)01404-7 [pii] AID - 10.1016/j.jaci.2011.08.036 [doi] PST - ppublish SO - J Allergy Clin Immunol. 2012 Jan;129(1):128-35. doi: 10.1016/j.jaci.2011.08.036. Epub 2011 Oct 13.