BACKGROUND
There have been few studies conducted on the efficacy and safety of specific immunotherapy with allergen extracts of fungi compared to other allergen extracts and there are no data on major allergen Alt a 1 of the fungus Alternaria alternata.
OBJECTIVE
To evaluate the efficacy and safety of subcutaneous immunotherapy with two different doses of Alt a 1 in patients with rhinoconjunctivitis due to sensitisation to Alternaria alternata.
METHODS
Multicentre, randomised, double-blind, placebo-controlled trial with Alt a 1 administered subcutaneously in patients with allergic rhinoconjunctivitis, with or without controlled asthma, aged 12-65 years. Three groups were included: placebo, and 0.2 μg, and 0.37 μg Alt a 1/doses. The main endpoint was the combined symptom and medication score. Secondary endpoints were cutaneous reactivity and serum IgE and IgG4 to Alt a 1. Recorded adverse reactions were graded according to WAO criteria.
RESULTS
There were significant reductions in the combined symptom and medication score for the dose of Alt a 1 0.37 μg compared with placebo at 12 months of treatment. Reduced cutaneous reactivity and IgE levels, together with increased IgG4 levels, were demonstrated for the two active groups versus placebo. A similar safety profile was found for both active groups compared with placebo. No serious ADR were reported.
CONCLUSIONS
Immunotherapy with Alt a 1 was efficacious and safe, reducing the symptoms and medication associated with rhinoconjunctivitis after only one year of treatment. The clinical benefits were associated with reduced skin reactivity and specific IgE, and increased IgG4