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document
Epicutaneous allergen-specific immunotherapy ameliorates grass pollen-induced rhinoconjunctivitis : A double-blind , placebo-controlled dose escalation study . 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 .
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Intervention_Physical
allergen-specific immunotherapy
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Outcome_Physical
patient-reported changes in hay fever symptoms assessed by a visual analog scale
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Outcome_Physical
weekly visual analog scale symptom scores during pollen season , use of rescue medication , changes in conjunctival and skin reactivity
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Outcome_Other
safety
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Outcome_Physical
Hay fever symptoms
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Outcome_Adverse-effects
drug-related adverse events ( AEs )
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Outcome_Adverse-effects
by pruritus , erythema , wheal , or eczema
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Outcome_Adverse-effects
systemic AEs
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Outcome_Other
dropout rate
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Outcome_Adverse-effects
serious AE
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Participant_Sample-size
132
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Participant_Condition
grass pollen-induced rhinoconjunctivitis