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| |  Subcutaneous Immunotherapy With Optimised Allergen to Aluminium Hydroxide Ratio Well Tolerated: Presented at EAACI By Sara Freeman LONDON -- June 8, 2010 -- A new subcutaneous immunotherapy (SCIT) product (Avanz) that has been optimised for its allergen to aluminium hydroxide content is well tolerated, according to data presented at the 29th Congress of the European Academy of Allergy and Clinical Immunology (EAACI). Kirsten Jung, MD, Erfurt Dermatology Clinic, Erfurt, Germany, presented results from a randomised, controlled, parallel-group, phase 2 study here on June 6. Aluminium hydroxide (alum) is commonly used as a slow-release carrier for allergens used in SCIT and a "has an adjuvant effect, improving the immune response," Dr. Jung explained. As a result, the maximum dose of a SCIT product with an optimised allergen to alum ratio can be lowered and may be associated with shorter (5 injection) up-dosing schedules. Compared with another SCIT product used to treat allergic rhinitis caused by grass pollen (Alutard SQ), the new SCIT therapy (Avanz) has 50% of the alum and 15% of the allergen content. The safety and tolerability of the new SCIT therapy was evaluated in 400 adults with rhinoconjunctivitis due to grass pollen. Therapy was initiated utilising an up-dosing phase with 5 injections (300/600/3,000/6,000/15,000 SQ+) with weekly intervals in group 1 and 3 to 4 day intervals in group 2 and was continued by 2 maintenance injections of 15,000 SQ+ with 14- and 28-day intervals. The trial was completed according to the injection schedule by 358 patients (mean age, 35.5 years; 50% male). The mean duration of symptoms was 16.4 years, 27.8% had asthma, and 17.8% had other concomitant allergic disease. Fewer local and systemic reactions were observed with the weekly injection schedule versus administration every 3 to 4 days in the up-dosing phase. One-third (33.8%) of patients given weekly injections compared with 46.7% of those given the injection every 3 to 4 days experienced local adverse reactions (P = .0107). Corresponding figures for systemic reactions were 20.4% and 31.7%, respectively (P = .0121). The main local reactions were swelling and pruritus at the injection site, with some patients experiencing injection-site erythema, pain, or warmth. Systemic reactions of note included urticaria, skin pruritus, and angio-oedema. In maintenance phase there was a nonsignificant difference in adverse events between the 2 groups, with a trend towards more local (11.5% vs 8.5%) but fewer systemic (2.1% vs 3.4%) reactions in the weekly as compared with the every 3 to 4 days dosing group. No serious adverse events (SAEs) were reported in the patients who received weekly injections. Two SAEs were reported in 2 patients given the injection every 3 to 4 days during the up-dosing period. Funding for this study was provided by ALK-Abelló. [Presentation title: Subcutaneous Immunotherapy With a Preparation With Optimised Allergen Aluminium Hydroxide Ratio: A Randomised Parallel-Group Clinical Trial Investigating Safety and Tolerability. Abstract 9]
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