Header

UZH-Logo

Maintenance Infos

Epicutaneous allergen-specific immunotherapy ameliorates grass pollen-induced rhinoconjunctivitis: A double-blind, placebo-controlled dose escalation study


Senti, Gabriela; von Moos, Seraina; Tay, Fabian; Graf, Nicole; Sonderegger, Theodor; Johansen, Pål; Kündig, Thomas M (2012). Epicutaneous allergen-specific immunotherapy ameliorates grass pollen-induced rhinoconjunctivitis: A double-blind, placebo-controlled dose escalation study. Journal of Allergy and Clinical Immunology, 129(1):128-135.

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.

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.

Statistics

Citations

74 citations in Web of Science®
82 citations in Scopus®
Google Scholar™

Altmetrics

Downloads

503 downloads since deposited on 10 Apr 2012
82 downloads since 12 months
Detailed statistics

Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Dermatology Clinic
04 Faculty of Medicine > Institute for Regenerative Medicine (IREM)
Dewey Decimal Classification:570 Life sciences; biology
610 Medicine & health
Date:January 2012
Deposited On:10 Apr 2012 08:31
Last Modified:10 Dec 2017 19:33
Publisher:Elsevier
ISSN:0091-6749
Free access at:Publisher DOI. An embargo period may apply.
Publisher DOI:https://doi.org/10.1016/j.jaci.2011.08.036
PubMed ID:21996342

Download