Epicutaneous allergen-specific immunotherapy ameliorates grass pollen-induced rhinoconjunctivitis: A double-blind, placebo-controlled dose escalation study. 2012

Gabriela Senti, and Seraina von Moos, and Fabian Tay, and Nicole Graf, and Theodor Sonderegger, and Pål Johansen, and Thomas M Kündig
Clinical Trials Center, University Hospital Zurich, Zurich, Switzerland.

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. CONCLUSIONS Epicutaneous immunotherapy is safe and efficacious in a dose-dependent manner after 6 patches only.

UI MeSH Term Description Entries
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D011058 Pollen The fertilizing element of plants that contains the male GAMETOPHYTES. Male Gametes, Plant,Male Gametophytes,Microspores, Plant,Plant Microspores,Pollen Grains,Gamete, Plant Male,Gametes, Plant Male,Gametophyte, Male,Gametophytes, Male,Grain, Pollen,Grains, Pollen,Male Gamete, Plant,Male Gametophyte,Microspore, Plant,Plant Male Gamete,Plant Male Gametes,Plant Microspore,Pollen Grain
D003233 Conjunctivitis, Allergic Conjunctivitis due to hypersensitivity to various allergens. Allergic Conjunctivitis,Conjunctivitis, Atopic,Conjunctivitis, Giant Papillary,Conjunctivitis, Vernal,Keratoconjunctivitis, Vernal,Allergic Conjunctivitides,Atopic Conjunctivitides,Atopic Conjunctivitis,Conjunctivitides, Allergic,Conjunctivitides, Atopic,Conjunctivitides, Giant Papillary,Conjunctivitides, Vernal,Giant Papillary Conjunctivitides,Giant Papillary Conjunctivitis,Keratoconjunctivitides, Vernal,Papillary Conjunctivitides, Giant,Papillary Conjunctivitis, Giant,Vernal Conjunctivitides,Vernal Conjunctivitis,Vernal Keratoconjunctivitides,Vernal Keratoconjunctivitis
D003888 Desensitization, Immunologic Immunosuppression by the administration of increasing doses of antigen. Though the exact mechanism is not clear, the therapy results in an increase in serum levels of allergen-specific IMMUNOGLOBULIN G, suppression of specific IgE, and an increase in suppressor T-cell activity. Allergen Immunotherapy,Allergy Shots,Hyposensitization Therapy,Immunotherapy, Allergen,Venom Immunotherapy,Immunologic Desensitization,Therapy, Hyposensitization,Allergen Immunotherapies,Allergy Shot,Desensitizations, Immunologic,Hyposensitization Therapies,Immunologic Desensitizations,Immunotherapy, Venom,Shot, Allergy,Venom Immunotherapies
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D005260 Female Females
D006109 Poaceae A large family of narrow-leaved herbaceous grasses of the order Cyperales, subclass Commelinidae, class Liliopsida (monocotyledons). Food grains (EDIBLE GRAIN) come from members of this family. RHINITIS, ALLERGIC, SEASONAL can be induced by POLLEN of many of the grasses. Alopecurus,Arundo,Gramineae,Grasses,Imperata,Grass,Imperata cylindrica
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000279 Administration, Cutaneous The application of suitable drug dosage forms to the skin for either local or systemic effects. Cutaneous Drug Administration,Dermal Drug Administration,Drug Administration, Dermal,Percutaneous Administration,Skin Drug Administration,Transcutaneous Administration,Transdermal Administration,Administration, Dermal,Administration, Transcutaneous,Administration, Transdermal,Cutaneous Administration,Cutaneous Administration, Drug,Dermal Administration,Drug Administration, Cutaneous,Skin Administration, Drug,Administration, Cutaneous Drug,Administration, Dermal Drug,Administration, Percutaneous,Administrations, Cutaneous,Administrations, Cutaneous Drug,Administrations, Dermal,Administrations, Dermal Drug,Administrations, Percutaneous,Administrations, Transcutaneous,Administrations, Transdermal,Cutaneous Administrations,Cutaneous Administrations, Drug,Cutaneous Drug Administrations,Dermal Administrations,Dermal Drug Administrations,Drug Administrations, Cutaneous,Drug Administrations, Dermal,Drug Skin Administrations,Percutaneous Administrations,Skin Administrations, Drug,Skin Drug Administrations,Transcutaneous Administrations,Transdermal Administrations

Related Publications

Gabriela Senti, and Seraina von Moos, and Fabian Tay, and Nicole Graf, and Theodor Sonderegger, and Pål Johansen, and Thomas M Kündig
January 2016, Respiratory research,
Gabriela Senti, and Seraina von Moos, and Fabian Tay, and Nicole Graf, and Theodor Sonderegger, and Pål Johansen, and Thomas M Kündig
July 2001, Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology,
Gabriela Senti, and Seraina von Moos, and Fabian Tay, and Nicole Graf, and Theodor Sonderegger, and Pål Johansen, and Thomas M Kündig
February 1984, The Journal of allergy and clinical immunology,
Gabriela Senti, and Seraina von Moos, and Fabian Tay, and Nicole Graf, and Theodor Sonderegger, and Pål Johansen, and Thomas M Kündig
January 2001, Journal of investigational allergology & clinical immunology,
Gabriela Senti, and Seraina von Moos, and Fabian Tay, and Nicole Graf, and Theodor Sonderegger, and Pål Johansen, and Thomas M Kündig
March 2007, Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation,
Gabriela Senti, and Seraina von Moos, and Fabian Tay, and Nicole Graf, and Theodor Sonderegger, and Pål Johansen, and Thomas M Kündig
January 1998, Allergologia et immunopathologia,
Gabriela Senti, and Seraina von Moos, and Fabian Tay, and Nicole Graf, and Theodor Sonderegger, and Pål Johansen, and Thomas M Kündig
January 1996, Journal of investigational allergology & clinical immunology,
Gabriela Senti, and Seraina von Moos, and Fabian Tay, and Nicole Graf, and Theodor Sonderegger, and Pål Johansen, and Thomas M Kündig
March 2008, Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology,
Gabriela Senti, and Seraina von Moos, and Fabian Tay, and Nicole Graf, and Theodor Sonderegger, and Pål Johansen, and Thomas M Kündig
November 2007, Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology,
Gabriela Senti, and Seraina von Moos, and Fabian Tay, and Nicole Graf, and Theodor Sonderegger, and Pål Johansen, and Thomas M Kündig
January 2004, Allergy,
Copied contents to your clipboard!