杭州浙大迪迅生物基因工程有限公司Release date：2019-05-17
JACI [IF:13.1]
Double-blind, randomized, placebo-controlled trial of allergen-specific immunotherapy with the major allergen Alt a 1
https://doi.org/10.1016/j.jaci.2019.02.029
Abstract:
Background
There have been few studies conducted on the efficacy and safety of specific immunotherapy with allergen extracts of fungi compared with other allergen extracts, and there are no data on the major allergen Alt a 1 of the fungus Alternaria alternata.
Objectives
We sought to evaluate the efficacy and safety of subcutaneous immunotherapy with 2 different doses of Alt a 1 in patients with rhinoconjunctivitis caused by sensitization to A alternata.
Method
We performed a multicenter, randomized, double-blind, placebo-controlled trial with Alt a 1 administered subcutaneously in patients with allergic rhinoconjunctivitis with or without controlled asthma aged 12 to 65 years. Three groups were included: the placebo group and active groups receiving 0.2 or 0.37 μg of Alt a 1 per dose. The main end point was the combined symptom and medication score. Secondary end points were cutaneous reactivity and serum IgE and IgG4 levels to Alt a 1. Recorded adverse reactions were graded according to World Allergy Organization criteria.
Results
There were significant reductions in the combined symptom and medication score for the 0.37-μg dose of Alt a 1 compared with placebo at 12 months of treatment. Reduced cutaneous reactivity and IgE levels, together with increased IgG4 levels, were demonstrated for the 2 active groups versus the placebo group. A similar safety profile was found for both active groups compared with the placebo group. No serious adverse drug reactions were reported.
Conclusion
Immunotherapy with Alt a 1 was efficacious and safe, reducing the symptoms and medication consumption associated with rhinoconjunctivitis after only 1 year of treatment. The clinical benefits were associated with reduced skin reactivity and specific IgE levels and increased IgG4 levels.
All Author:
Ana Isabel Tabar Luis Prieto Pilar Alba Antonio Nieto Miguel Torrecillas
Mercedes Rodríguez Beatriz Huertas Elisa Gómez Francisco Javier Fernández Ricardo Palacios Miguel Blanca David Rodríguez
xMartin Lloyd HibberdSearch for articles by this authorAffiliations
· Genome Institute of Singapore, Agency for Science, Technology and Research Singapore, Singapore
2019-5-2 Artical
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