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| |  Recombinant Bet v 1 Sublingual Tablets in Birch Allergy Well Tolerated Up to 50 mcg: Presented at EAACI By Judith Moser, MD WARSAW, Poland -- June 11, 2009 -- In patients with birch pollen allergic rhinitis, the optimal tolerance range of a sublingual immunotherapy with recombinant Bet v 1 (rBet v 1) was 12.5 to 50 mcg with or without a titration phase, according to findings of 2 single-centre, randomised, double-blind studies presented here at the 28th European Academy of Allergology and Clinical Immunology (EAACI) Congress. "We used both constant-dose regimens and regimens with a dose-increase phase to assess whether side effects could be reduced," explained Lone Winther, MD, National University Hospital, Copenhagen, Denmark, on June 9. Two placebo-controlled, parallel-group, phase 1 clinical studies investigated the safety and tolerability of 2-week regimens of recombinant rBet v 1 sublingual tablets in subjects with birch pollen allergic rhinitis for at least 2 years. The use of sublingual immunotherapy (SLIT) with standardised recombinant allergen vaccines enabled a more reproducible clinical response. The first study investigated higher doses of rBet v 1 SLIT (50-300 mcg), and the second study investigated 12.5- to 100-mcg doses. Ten doses of SLIT or placebo were administered. "No serious adverse events were reported and most side effects were local," noted Dr. Winther A total of 402 treatment-emergent adverse events (TEAEs) were observed in 101 of the 112 enrolled subjects. Of the TEAEs, 81% were SLIT related, the most common being throat irritation (86%), ear pruritus (40%), and pharyngeal oedema (31%). Doses between 50 and 300 mcg did not appear suitable for treatment because they were accompanied by too many side effects. The inclusion of a dose-increase phase did not seem to improve the results. "Sublingual immunotherapy with rBet v 1 seems to be well tolerated up to around 50 mcg with or without a titration phase, whereas incremental doses up to 300 mcg and constant doses of 150 mcg were not that tolerable," concluded Dr. Winther. Further efficacy studies should include doses ranging from 12.5 to 50 mcg. Funding for this study was provided by Stallergenes GmbH. [Presentation title: Safety and Tolerability of Recombinant Bet v 1 (rBet v1) Tablets in Sublingual Immunotherapy (SLIT). Abstract 341]
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