Safety of omalizumab for chronic urticaria during pregnancy: a real-life study

Background: Managing a pregnant patient with chronic spontaneous urticaria (CSU) is often challenging. Recent data showed that most CSU treatments in pregnant patients were second-generation H1-antihistamines (sgAHs), while data on safety of omalizumab are scant. Objectives: To evaluate the efficacy and safety of omalizumab in patients with severe CSU refractory to sgAHs, either becoming pregnant during treatment or starting the drug during pregnancy, in a routine clinical practice setting. Methods: We conducted a retrospective study on women aged ≥18 years, pregnant, receiving 1 or more doses of omalizumab at any time during pregnancy, or taking omalizumab at the time of conception or during the 8 weeks before conception. Results: Twenty-nine pregnant patients were evaluated in the study: 23 (79.31%) conceived a child during omalizumab therapy (group A), while 6 (20.69%) started omalizumab therapy during pregnancy (group B). Among group A, we observed 23 births (21 live-born singletons and 1 live-born twin pair) and 1 miscarriage. Fifteen out of 23 (65.22%) patients discontinued omalizumab after discovering the pregnancy state, while 8/23 patients (34.78%) were exposed to omalizumab during the entire pregnancy. In the group B, omalizumab was introduced at 10.83 ± 3.60 weeks of gestation and all patients were exposed to it until the end of pregnancy. In this group, there were 7 live-born infants (5 singletons and 1 twin pair). No AEs, pregnancy complications or congenital anomalies of newborns were recorded in both groups. Conclusions: Omalizumab for CSU treatment before and during pregnancy does not seem to negatively affect maternal or fetal outcomes.