American Academy of Allergy, Asthma & Immunology/American College of Allergy, Asthma and Immunology joint task force report on omalizumab-associated anaphylaxis
American Academy of Allergy, Asthma & Immunology/American College of Allergy, Asthma and Immunology joint task force report on omalizumab-associated anaphylaxis
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DOI：
10.1016/j.jaci.2007.09.032
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发表时间：
2007-12-01
影响因子：
14.2
通讯作者：
Wallace, Dana V.
中科院分区：
文献类型：
--
作者：
Cox, Linda;Platts-Mills, Thomas A. E.;Wallace, Dana V.
美国过敏、哮喘和免疫学学会和美国过敏、哮喘和免疫学学会执行委员会成立了奥马珠单抗联合工作组，目的是审查Genentech Xolair（奥马珠单抗）临床试验和过敏反应和类过敏反应的上市后监测数据。使用2005年多学科研讨会上提出的过敏反应定义，奥马珠单抗联合工作组得出结论，在2003年6月1日至2005年12月31日期间，35名患者发生了41次与Xolair（奥马珠单抗）给药相关的过敏反应。在同一时间段内有39，510例患者接受Xolair（奥马珠单抗），这相当于0.09%的患者过敏反应报告率。在已知反应时间的36起事件中，22起（61%）反应发生在前3次给药之一后的前2小时内。第四次或更高剂量后的5起（14%）事件发生在30分钟内。考虑到这36起事件的发生时间，前3次注射的观察期为2小时，后续注射的观察期为30分钟，将捕获75%的速发过敏反应。OJTF报告为开Xolair（奥马珠单抗）处方的医生提供了以下建议：（1）给药后建议的等待时间和（2）关于过敏反应的患者教育。
The American Academy of Allergy, Asthma & Immunology and the American College of Allergy, Asthma and Immunology Executive Committees formed the Omalizumab Joint Task Force with the purpose of reviewing the Genentech Xolair (omalizumab) clinical trials and postmarketing surveillance data on anaphylaxis and anaphylactoid reactions. Using the definition of anaphylaxis proposed at a 2005 multidisciplinary symposia, the Omalizumab Joint Task Force concluded that 35 patients had 41 episodes of anaphylaxis associated with Xolair (omalizumab) administration between June 1, 2003, and December 31, 2005. With 39,510 patients receiving Xolair (omalizumab) during the same period of time, this would correspond to an anaphylaxis-reporting rate of 0.09% of patients. Of those 36 events for which the time of reaction was known, 22 (61%) reactions occurred in the first 2 hours after one of the first 3 doses. Five (14%) of the events after the fourth or later doses occurred within 30 minutes. Considering the timing of these 36 events, an observation period of 2 hours for the first 3 injections and 30 minutes for subsequent injections would have captured 75% of the anaphylactic reactions. The OJTF report provides recommendations for physicians who prescribe Xolair (omalizumab) on (1) the suggested wait periods after administration and (2) patient education regarding anaphylaxis.