Xiao Yu, Yang Wanying, Wang Muyang
Department of Dermatology, The People's Hospital of Longhua, Shenzhen, Guangdong, China.
Front Med (Lausanne). 2024 Aug 8;11:1435370. doi: 10.3389/fmed.2024.1435370. eCollection 2024.
Dupilumab was approved for the treatment of several dermatologic immune-mediated inflammatory diseases, such as atopic dermatitis and bullous pemphigoid; whereas omalizumab is the first biological agent which was approved to treat chronic spontaneous urticaria. None of the published meta-analyses has provided the sufficient data regarding the safety of these two biologics, especially regarding their potential serious adverse events (SAEs). The aim of this study was, to comprehensively evaluate the safety of the two biologics dupilumab and omalizumab. In this study, we included 32 randomized trials, and performed meta-analyses on 113 types of SAEs regarding dupilumab and 61 types of SAEs regarding omalizumab. We identified that: (1) use of dupilumab was significantly associated with the lower incidence of atopic dermatitis, while use of omalizumab was significantly associated with the lower incidence of asthma; and (2) use of dupilumab was not significantly associated with the incidences of 112 other kinds of SAEs including various infectious diseases, while use of omalizumab was not significantly associated with the incidences of 60 other kinds of SAEs including various infectious diseases. This meta-analysis for the first time assessed the association between use of dupilumab or omalizumab and incidences of various SAEs, and identified that neither dupilumab use nor omalizumab use was associated with the increased risks of any SAEs including various infectious diseases. These findings further confirm the general safety of the two biologics dupilumab and omalizumab. This informs clinicians that there is no need to worry too much about the safety issues of these two biologics.
度普利尤单抗已被批准用于治疗多种皮肤免疫介导的炎症性疾病，如特应性皮炎和大疱性类天疱疮；而奥马珠单抗是首个被批准用于治疗慢性自发性荨麻疹的生物制剂。已发表的荟萃分析均未提供关于这两种生物制剂安全性的充分数据，尤其是关于其潜在严重不良事件（SAE）的数据。本研究的目的是全面评估度普利尤单抗和奥马珠单抗这两种生物制剂的安全性。在本研究中，我们纳入了32项随机试验，并对度普利尤单抗的113种SAE和奥马珠单抗的61种SAE进行了荟萃分析。我们发现：（1）使用度普利尤单抗与特应性皮炎的较低发病率显著相关，而使用奥马珠单抗与哮喘的较低发病率显著相关；（2）使用度普利尤单抗与包括各种传染病在内的其他112种SAE的发病率无显著相关性，而使用奥马珠单抗与包括各种传染病在内的其他60种SAE的发病率无显著相关性。这项荟萃分析首次评估了使用度普利尤单抗或奥马珠单抗与各种SAE发病率之间的关联，并确定使用度普利尤单抗和奥马珠单抗均与包括各种传染病在内的任何SAE的风险增加无关。这些发现进一步证实了度普利尤单抗和奥马珠单抗这两种生物制剂的总体安全性。这告知临床医生无需过度担心这两种生物制剂的安全性问题。
