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| |  Favourable Study Results With High-Dose Hypoallergenic Immunotherapy Confirmed in Daily Practice: Presented at EAACI By Judith Moser, MD WARSAW, Poland -- June 10, 2009 -- Subcutaneous immunotherapy (SCIT) with a high-dose hypoallergenic preparation is well tolerated and effective in daily practice, according to a postmarketing observational study presented here at the 28th Congress of the European Academy of Allergy and Clinical Immunology (EAACI). Eike Martin, Allergopharma Joachim Ganzer KG, Reinbek, Germany, presented the results here at a poster presentation on June 8. It is widely accepted that the specific immunotherapy exerts its effects in a dose-dependent manner. Hypoallergenic preparations (allergoids) can provide high major allergen doses for effective immune modulation without increasing the risk of adverse events. The safety and efficacy of a SCIT with the high-dose hypoallergenic pollen preparation was documented in several randomised clinical trials. A prospective postmarketing observational study conducted between 2001 and 2005 aimed to confirm the study results in daily practice. Two hundred twenty-one office-based specialists participated in the survey. Effectiveness and safety data of 2,931 patients with immunoglobulin E-mediated allergies and clinical symptoms within the relevant pollen season were collected via structured questionnaires. Patients assessed their condition on a 1 (very good) to 10 (very bad) visual analogue scale (VAS). Additionally, physicians evaluated patients' health and tolerability of treatment. Clinical assessments took place at baseline and within the first pollen season after the SCIT course. The present analysis includes only forms relating to the first year of therapy. After only 1 treatment cycle, an improvement in VAS with a median of 3 scale points was shown in the first pollen season, indicating very good effectiveness. "Two-thirds of patients reported improved well-being," said Martin. A clinically relevant improvement of 2 or more scale points was achieved in 86.3% of treatments. As Martin stressed, 68.7% of patients reduced their frequency of intake of symptomatic medication. Patients with severe symptoms showed a trend for a higher reduction in medication use. "The number of adverse events was low, and the recorded reactions were mostly local," Martin said. Adverse effects occurred after 8.2% of the total number of injections (27,109), and 98.9% of them were local reactions. Three-quarters of patients did not display any adverse reactions. The risk of local or general reactions was not increased in children aged up to 14 years. Compliance was excellent with patients wanting to continue their SCIT in 95% of cases. "It can be said that the high-dose hypoallergenic pollen preparation is effective and safe in daily routine and is met by a great patient acceptance," Martin concluded. Funding for this study was provided by Allergopharma Joachim Ganzer KG. Presentation title: Subcutaneous High Dose Hypoallergenic Preparations in Daily Practice in More Than 2,900 Allergic Subjects - Effective, Safe and Accepted by Patients. Abstract 889
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