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| |  Icatibant Effective and Well Tolerated in Treatment for Acute Laryngeal Hereditary Angio-oedema Attacks: Presented at ACAAI By Carole VanSickle Ellis PHOENIX, Ariz -- November 15, 2010 -- Icatibant use continues to be effective and well tolerated in attacks of acute laryngeal hereditary angio-oedema (HAE), according to the results of phase 3 trials presented here at the 2010 Annual Meeting of the American College of Allergy, Asthma and Immunology (ACAAI). Icatibant was approved in the European Union in 2008 for the treatment of acute attacks of HAE in adults with C1-esterase-inhibitor (INH) deficiency. The drug has been assessed for safety and efficacy in 2 phase 3 registration trials, and this study analysed the results of 78 laryngeal attacks in 38 patients during the these 2 trials. The 38 patients were gathered from 15 sites across Argentina, France, Canada, Germany, Israel, Poland, and the United States, said Alejandro Malbrán, MD, Hospital Británico de Buenos Aires, Buenos Aires, Argentina, speaking here on November 14. In all, 24 of the patients were treated for a single laryngeal attack while 14 were treated for multiple attacks (2 in 7 patients, 3 in 4 patients, 5 in 1 patient, 7 in 1 patient, and 16 in 1 patient). The Investigator’s Global Assessments showed rapid improvements in severity of the attacks after icatibant treatment, with attacks becoming less severe over 4 hours and the majority being reported at that time as mild or absent, irrespective of baseline severity. Reductions in severity were most notable in the 21 “severe” and “very severe” baseline attacks, and Dr. Malbrán noted that rescue medication (C1-INH concentrate infusion, n = 4; 3 x 1,000 U and 1 x 500 U and an additional icatibant injection, n = 1) was administered to 5 patients with 5 laryngeal attacks. There were no treatment-related adverse effects and no discontinuations, reported the group, though almost all patients reported injection-site reactions including erythema, swelling, burning, itching, and cutaneous pain. These reactions were, however, generally mild to moderate in intensity and resolved without additional medical intervention. The group concluded that their data also supported the efficacy and safety of icatibant for the treatment of acute laryngeal angio-oedema in patients with HAE types I and II. This study was a part of the For Angioedema Subcutaneous Treatment (FAST) trials, which were funded by Shire Human Genetic Therapies, Inc., and, in part, by a grant from the National Institutes of Health. [Presentation title: Treatment of Laryngeal Hereditary Angioedema Attacks With Icatibant: Results From Two Phase III Clinical Trials. Abstract P322]
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