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Fel d 1‐derived synthetic peptide immuno‐regulatory epitopes show a long‐term treatment effect in cat allergic subjects
Author(s) -
Couroux P.,
Patel D.,
Armstrong K.,
Larché M.,
Hafner R. P.
Publication year - 2015
Publication title -
clinical and experimental allergy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.462
H-Index - 154
eISSN - 1365-2222
pISSN - 0954-7894
DOI - 10.1111/cea.12488
Subject(s) - placebo , medicine , clinical endpoint , allergen , allergy , gastroenterology , randomized controlled trial , immunology , pathology , alternative medicine
Summary Background Cat‐ PAD , the first in a new class of synthetic peptide immuno‐regulatory epitopes ( SPIRE s), was shown to significantly improve rhinoconjunctivitis symptoms in subjects with cat allergy up to 1 year after the start of a short course of treatment. Objective To evaluate the long‐term effects of Cat‐ PAD on rhinoconjunctivitis symptoms following standardized allergen challenge 2 years after treatment. Methods In a randomized, double‐blind, placebo‐controlled, parallel group study, subjects were exposed to cat allergen in an environmental exposure chamber ( EEC ) before and after treatment with two regimens of Cat‐ PAD (either eight doses of 3 nmol or four doses of 6 nmol) given intradermally over a 3‐month period. In this follow‐up study, changes from baseline in rhinoconjunctivitis symptoms were reassessed 2 years after the start of treatment. Results The primary endpoint showed a mean reduction in total rhinoconjunctivitis symptom scores of 3.85 units in the 4 × 6 nmol Cat‐ PAD group compared to placebo 2 years after the start of treatment ( P = 0.13), and this difference was statistically significant in the secondary endpoint at the end of day 4 when the cumulative allergen challenge was greatest ( P = 0.02). Consistent reductions in nasal symptoms of between 2 and 3 units were observed for 4 × 6 nmol Cat‐ PAD compared to placebo between the 2 and 3 h time points on days 1–4 of EEC challenge at 2 years ( P < 0.05). The 8 × 3 nmol dose did not show a meaningful effect in this study. Conclusion and Clinical Relevance A persistent, clinically meaningful reduction in rhinoconjunctivitis symptoms was observed on EEC challenge 2 years after the start of a short course of treatment with 4 × 6 nmol Cat‐ PAD . This study is the first to provide evidence of a long‐term therapeutic effect with this new class of SPIRE s.