[Chinese expert consensus on the use of Omalizumab in allergic asthma (2021 version)].

As the first targeted biotherapy for asthma, Omalizumab, was officially approved in China in August 2017, and was applied in clinical practice since March, 2018. Dozens of experts in Respirology and Allergy from China fully discussed the important clinical issues on the use of Omalizumab in allergic asthma by referring to the relevant publications over the world and the first version of consensus published in March 2018. Until now, over 30, 000 allergic asthma patients have received the treatment of Omalizumab. Therefore, with the latest evidence of clinical and basic research around the world, we updated the consensus with the following issues: (1) The mechanisms and available evidence on anti-IgE treatment; (2) Selection and exclusion criteria for patients using Omalizumab; (3) Cautions on the administration of Omalizumab and highlights of the use of Omalizumab with various vaccines, including novel Coronavirus vaccines, and key points to note during a Novel Coronavirus pandemic; (4) Long-term use and safety; (5) The use of Omalizumab in specific populations; (6) Clinical applications of omalizumab with other targeted therapies and allergen-specific immunotherapy. Omalizumab, combining to the Cε3 area of IgE, reduces the free IgE level, and downregulates the expression of FcεRⅠ, which inhibits the release of inflammatory mediators of mast cell sources, and leads to reduced asthma exacerbation, decreased rate of emergency visit and hospitalization, improved symptoms and quality of life, as well as less concomitant moderate to severe asthma, poorly controlled after at least 3 months treatment of ICS/LABA, and confirmed with allergic status through skin prick test or serum total IgE or specific IgE. Conditions that exclude the use of Omalizumab include patients who are suspected to be allergic to drug ingredients. Omalizumab is administered based on dosing tables by subcutaneous injection. Omalizumab should be administered by a health care professional (doctor or nurse) in a medical institution equipped with facilities for post-injection observation and rescue treatment for anaphylactic shock. After the injection, the patient should be closely monitored whether there is an anaphylactic reaction. The duration of Omalizumab treatment should be at least 16 weeks to judge its effectiveness, after 16 weeks, Omalizumab treatment will be continued or withdrawn based on the overall asthma control evaluation. Patients should be followed every 3 months to assess the disease control and dosing adjustment. The common adverse reactions were injection sites reactions. Based on the latest evidence around the word, we focused on updating the relevant treatment course, administration method and use of specific populations, in order to guide clinicians in the use of Omalizumab. The use of Omalizumab in China still requires long-term observation and further research. With the increase of clinical evidence, this consensus will be continuously improved and supplemented.奥马珠单抗是全球哮喘领域第一个生物靶向治疗药物，于2017年8月在我国正式获批，2018年3月起正式在我国进入临床使用。中华医学会呼吸病学分会哮喘学组的数十位专家结合国内外循证医学证据，就奥马珠单抗治疗过敏性哮喘的相关重要的临床问题进行了充分的讨论，于2018年制定了奥马珠单抗治疗过敏性哮喘的第一版中国专家共识。迄今为止，已有逾3万例中国患者接受过奥马珠单抗的治疗。在此基础上，我们根据近2年国内外新的循证医学、临床实践和基础研究的证据，在第一版专家共识的基础上做了更新，本共识主要内容包括：（1）抗IgE治疗的基本原理和循证证据；（2）奥马珠单抗适用对象的筛选标准及排除条件；（3）奥马珠单抗使用的注意事项，与各种疫苗（包括新型冠状病毒疫苗）接种的重点说明以及新型冠状病毒流行期间的注意要点；（4）奥马珠单抗的疗程及安全性；（5）奥马珠单抗在特殊人群中的使用；（6）奥马珠单抗与其他生物靶向药物和变应原免疫治疗的联合临床应用。奥马珠单抗通过与IgE的Cε3区域特异性结合，降低游离IgE水平，下调FcεRⅠ受体表达，可减少哮喘急性发作、降低急诊及住院率，改善症状及生活质量、减少糖皮质激素的使用。奥马珠单抗的适用患者为确诊为中重度过敏性哮喘，经吸入性糖皮质激素（ICS）/长效β2受体激动剂（LABA）标准治疗控制不佳，且排除对奥马珠单药物成分过敏的患者。奥马珠单抗需根据注射剂量表确定剂量后进行皮下注射，应在具备留观条件和抢救过敏性休克相关医疗设施的医疗机构，由护士或医生进行注射，注射完成后应密切观察是否发生过敏反应。奥马珠单抗治疗应至少使用16周以判断其有效性，根据总体哮喘控制效果判断是否继续应用奥马珠单抗，并需每3个月随访评估病情变化及调整剂量。常见不良反应为注射部位的不良反应。基于最新国内外证据，本版共识重点更新了有关疗程、给药方式以及特殊人群使用等部分，以期更好指导奥马珠单抗的临床使用。奥马珠单抗在我国的使用仍需长期的观察和进一步的研究，基于循证医学证据的增加，本共识将不断完善和补充。.