Treating a pregnant patient with chronic spontaneous urticaria (CSU) can be quite challenging. According to recent findings, most CSU treatments for pregnant patients involved the use of second-generation H1-antihistamines (sgAHs), while information on the safety of Omalizumab is limited.
A study found Omalizumab to be a safe treatment option for pregnant women with a history of chronic spontaneous urticaria. This study was led by Cataldo Patruno and colleagues and was published in Clinical and Experimental Dermatology.

This study assessed the effectiveness and safety of Omalizumab for individuals with severe chronic spontaneous urticaria (CSU) who are either pregnant during treatment or initiate the medication during pregnancy in a typical clinical practice setting.
A team of researchers performed a retrospective analysis on women who were 18 years old or older, pregnant, and had received one or more doses of Omalizumab at any point during their pregnancy or were taking Omalizumab at the time of conception or within the eight weeks before conception.
Key findings are:
Twenty-nine pregnant patients were evaluated. There were two groups, A and B.
In group A, 23 patients, constituting 79.31%, conceived during omalizumab therapy.
In group B, six patients, constituting 20.69%, initiated omalizumab therapy during pregnancy.
Among group A, 23 births and one miscarriage were reported.
15/23 patients discontinued Omalizumab after discovering the pregnancy state, while 8/23 patients were exposed to Omalizumab during the entire pregnancy period.
In group B, Omalizumab was introduced at 10.83 ± 3.60 weeks of gestation. The patients in this group were exposed to it until the end of pregnancy. This group had seven live-born infants, including five singletons and one twin pair.
No adverse events, complications or congenital anomalies were reported.
The objective of this retrospective study was to evaluate the efficacy and safety of Omalizumab in a cohort of 29 pregnant women who had severe chronic spontaneous urticaria and were resistant to second-generation H1-antihistamines.
They said Omalizumab for managing CSU before and during pregnancy does not negatively affect maternal and fetal outcomes.
Reference:
Cataldo Patruno et al. Safety of Omalizumab for chronic urticaria during pregnancy: a real-life study, Clinical and Experimental Dermatology, 2023; llad386.