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| |  Ultra-Short Course of Subcutaneous Immunotherapy Well Tolerated in Patients With Seasonal Allergic Rhinoconjunctivitis: Presented at EAACI By Judith Moser, MD WARSAW, Poland -- June 12, 2009 -- Patients with moderate to severe seasonal allergic rhinoconjunctivitis caused by grass pollen who receive an ultra-short treatment course with a subcutaneously administered 13 grass pollen allergoid show an excellent compliance and mainly local adverse events, according to a study presented here at the 28th Congress of the European Academy of Allergy and Clinical Immunology (EAACI). Tom Holdich, MBBS, Research & Development, Allergy Therapeutics, Worthing, United Kingdom, presented the results at an oral presentation on June 9. The randomised, placebo-controlled G301 study included 1,028 patients, who were recruited at 84 centres in North America and Europe, and was designed to assess an ultra-short course of subcutaneous immunotherapy (uSCIT) with a 13 grass pollen allergoid in an L-tyrosine depot plus 50 mcg monophosphoryl lipid A (Grass MATA MPL) adjuvant per injection. Patients were randomised to receive either Grass MATA MPL administered in 4 dose-escalating injections or placebo (n = 514 each) weekly in advance of the start of the grass pollen season. Local and systemic reactions to treatment were recorded during the 24 hours following each injection and for up to 2 weeks after completion of the treatment course. Patient diaries were completed daily throughout the grass pollen season. "Compliance and completion rates were extremely high," Dr. Holdich reported. Overall, 97.5% of the patients in the placebo group and 95.3% of those in the Grass MATA MPL group completed the course of treatment. More patients in the active treatment group reported at least 1 adverse event during the treatment period and up to 2 weeks after the last injection (70.2% vs 47.0%; P < .0001), but adverse events leading to withdrawal were scarce (1.0% vs 0.2%), and their frequency did not differ significantly between the 2 groups (P = .22). After the treatment period, 43.0% of patients in the active treatment group and 40.7% of those in the placebo group experienced adverse events (P = .49). Of those, only 1.9% and 1.6% were regarded as treatment-related, respectively. "On average, 65% of patients had no adverse events within 24 hours after each Grass MATA MPL injection," Dr. Holdich said. The majority of adverse events occurred at the injection site, particularly pain (32.3% in the Grass MATA MPL group and 16.4% in the placebo group), pruritus (30.0% vs 3.3%), and swelling (25.1% vs 1.8%). Local reactions were mostly mild to moderate and resolved without treatment. There were no cases of treatment-related anaphylaxis. The frequency of systemic events like headache and upper respiratory tract infections did not differ between the groups. "Adverse events reported after the uSCIT treatment period were similar in nature and frequency to those in the placebo group," Dr. Holdich said. Funding for this study was provided by Allergy Therapeutics. [Presentation title: Safety and Tolerability of an Ultra Short Course Subcutaneous Immunotherapy Formulation in a Large Randomised Phase III Trial. Abstract 161]
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