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| |  Sublingual Immunotherapy Tablets Reduce Need for Rescue Medication in Patients With Allergic Rhinitis: Presented at EAACI By Sara Freeman LONDON -- June 7, 2010 – The sublingual recombinant allergen tablet rBet v 1 reduces the symptoms of allergic rhinitis and the need for rescue medication, according to phase 2 data presented here at the 29th Congress of the European Academy of Allergy and Clinical Immunology (EAACI). These data represent the first placebo-controlled evidence of clinically relevant efficacy with a recombinant allergen sublingual tablet, said Sabina Rak, MD, Sahlgrenska University Hospital, Gothenburg, Sweden, on June 6. The multinational, double-blind study involved 483 adult patients with rhinoconjunctivitis caused by exposure to birch pollen. The aim of the study was to compare the efficacy and safety of 3, once-daily doses of the sublingual immunotherapy (SLIT) with placebo. After a 6-week selection period, patients were randomised to treatment with rBet v 1 at doses of 12 mcg (n = 123), 25 mcg (n = 120), or 50 mcg (n = 120) or placebo. Treatment was given once a day for 5 months, starting 4 months before the birch pollen season began. Patients were then followed up for 2 weeks after the end of the month-long pollen season. Patients in all active-treatment groups showed a greater improvement in the primary endpoint of the Average Adjusted Symptom Score (AAdSS) compared with placebo-treated patients. Dr. Rak noted that the AAdSS score assesses 6 recognised symptoms of rhinoconjunctivitis -- sneezing, rhinorrhoea, nasal pruritus, nasal congestion, ocular pruritus, and watery eyes -- and takes into account the use of rescue medication. Higher AAdSS scores, denoting worse allergic rhinitis symptoms, were observed in the placebo-treated patients. The median AAdSS during the entire pollen season was 6.9 for placebo, 5.0 for the 12-mcg dose of rBet v 1, 5.0 for the 25-mcg dose, and 4.9 for the 50-mcg dose. Similar results were seen during the peak pollen season, with relative decreases of -33%, -39%, and -20% versus placebo for each increasing dose of the recombinant allergen tablet. "There was a marked reduction in the use of rescue medications," Dr. Rak reported. The use of rescue medications decreased by 50% to 60% comparing the active treatment with placebo. The most common side effects of active therapy were oral pruritus and throat irritation. A dose response was seen in the development of side effects, with more treatment-related side effects with the 50-mcg dose. Overall, the 12.5-mcg dose had the best efficacy and safety profile in the study. Funding for this study was provided by Stallergenes. [Presentation title: Efficacy and Safety of Recombinant Bet v 1 (rBet v 1) Tablets in Sublingual Immunotherapy. Abstract 7]
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