Double‐blind, placebo‐controlled study of Alternaria alternata immunotherapy: Clinical efficacy and safety

Abstract

Allergen-specific immunotherapy (ASIT) with fungal extracts has been beset by safety and efficacy problems, which result mainly from qualitative and quantitative variations. Little has been published on the safety and efficacy of these extracts. The objective was to analyze the safety and efficacy of ASIT with an Alternaria alternata extract. A total of 28 patients were selected with rhinitis and/or bronchial asthma because of Alternaria allergy and monosensitization to molds. The patients were randomized to an active ASIT or placebo group, both groups on a conventional immunotherapy schedule (increasing weekly doses until maintenance dose and then monthly doses). Adverse reactions were classified with the European Academy of Allergology and Clinical Immunology system. Clinical efficacy was analyzed for a year with symptom/medication diary cards, peak expiratory flow (PEF) measures, clinical severity score, severity of symptoms (visual analog scale), subjective evaluation of treatment by the patient and the physician, and a quality of life questionnaire. Twenty-three patients completed the study; all reached the established maintenance dose with only two mild adverse reactions in the whole sample. Significant improvements were found after 6 months in respiratory symptoms in the active treatment group, and in all symptoms in both groups. PEF increased significantly in the active treatment group but not in the placebo group. The severity of asthma decreased in the active treatment group, and the severity of rhinitis decreased in both groups. Visual analog scale scores for severity of symptoms improved in all phases in the active treatment group, but only after 12 months in the placebo group. Physicians judged the disease course as significantly better in the active treatment group. ASIT with the A. alternata extract was safe, with clinical improvements after one year of treatment.

Specific allergen immunotherapy for the treatment of allergic asthma: a review of current evidence

“…As for Alternaria allergy, very common in warm weather, one study showed that the severity of asthma decreased in patients that received SCIT compared to placebo, and physicians judged the disease course as significantly better in the active treatment group [106]. Regarding animal dander, it has been shown that SCIT produces immunological [107] and clinical responses [108,109] in cat allergic patients and horse allergic patients [110].…”

Evidence of effect of subcutaneous immunotherapy in children: complete and updated review from 2006 onward

“…The study was underpowered, but also the treatment might have been poorly effective in view of the very low maintenance dose of allergen included in the extract: of the variables analyzed some improved more in the active and others more in the placebo group. 30 Kuna et al (G4, J5) 31 showed convincing improvement of asthma and rhinoconjunctivitis in a study that used a highdose (8 g of Alt a 1 for 6 weeks) Alternaria depot extract. After a baseline run-in season, symptom and medication scores reduced progressively during 3 years in favor of the active treatment group, accompanied by improved quality of life (P Ͻ .05).…”

“…There were 4 DBPC trials in which specific immunotherapy was only given to the active group. 18,30,31,45 Two involved Alternaria extracts, one of high (8 g of Alt a 1) 31 and one of low allergen content (0.1 g of Alt a 1), 30 although no difference in the number of systemic reactions was observed; no conclusions can be drawn in view of the low numbers. The other 2 DBPC trials reported a higher rate of adverse events.…”

Clinical practice

“…Validated SIT compounds are available for tree pollen, grass pollen, insect venom, and house dust mite. For allergies to fur-bearing animals (cats, dogs), molds, and latex, SIT products are on the market [11,12,56,77,137,138], but safety and efficacy data in children are scarcely available. Hence, most allergological societies do not recommend the use of these extracts [2,17,25,27,30,69,70,83,84,100,158].…”