Safety of omalizumab in the treatment of children with allergic diseases / 中国药房

ABSTRACT

OBJECTIVE To analyze the safety of omalizumab in the treatment of allergic diseases in children. METHODS Clinical data of children with allergic diseases who were prescribed omalizumab therapy were collected from our hospital during February 2019 to July 2023， including the children’s basic conditions， allergen test results， serum levels of total immunoglobulin E （IgE）， omalizumab application and the occurrence of adverse events. The information on telephone follow-up was collected among the children who had completed treatment 12th month after drug withdrawal. At the same time， the causal relationship between adverse events and omalizumab was also evaluated by using the Naranjo assessment scale. RESULTS A total of 30 children were enrolled and received subcutaneous injections of omalizumab 245 times， accumulating 473 times. Four children suffered from four times of immediate-type hypersensitivity reactions （degree Ⅰ and Ⅱ every two times）， with an incidence of 13.3%； among them， two cases occurred after the first injection， one after the third injection， and one after the fifth injection； the results of the causality evaluation showed that two cases were “very likely” and two cases were “likely”. The telephone follow-up of 21 children showed that the children were in good health and there were no adverse events， such as malignant tumors， worm infections， serum disease- like reactions and arterial thromboembolism. CONCLUSIONS Omalizumab in children with allergic diseases is of good safety with a low incidence of adverse reactions， which are mainly mild immediate-type hypersensitivity reactions with a high long-term safety profile.