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. 2024 Mar 21;49(4):344-347.
doi: 10.1093/ced/llad386.

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

Cataldo Patruno  1 , Fabrizio Guarneri  2 , Eustachio Nettis  3 , Laura Bonzano  4 , Federica Filippi  5   6 , Simone Ribero  7 , Caterina Foti  8 , Pietro Rubegni  9 , Anna Balato  10 , Andrea Miniello  3 , Alfonso Motolese  2 , Bianca Maria Piraccini  5   6 , Pietro Quaglino  7 , Paolo Romita  8 , Laura Lazzeri  9 , Dario Buononato  10 , Stefano Dastoli  1 , Flavia Raia  11 , Maddalena Napolitano  11
Affiliations

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

Cataldo Patruno et al. Clin Exp Dermatol. .

Abstract

Background: Managing a pregnant patient with chronic spontaneous urticaria (CSU) is often challenging. Recent data have shown that most CSU treatments in pregnant patients are second-generation H1 antihistamines (sgAHs), while data on the safety of omalizumab are scant.

Objectives: To evaluate, in a routine clinical practice setting, the efficacy and safety of omalizumab in patients with severe CSU refractory to sgAHs who either became pregnant during treatment or who started the drug during pregnancy.

Methods: We conducted a retrospective study of women aged ≥ 18 years who were pregnant, who received one or more doses of omalizumab at any time during their pregnancy or who were taking omalizumab at the time of, or in the 8 weeks before, conception.

Results: Twenty-nine pregnant patients were evaluated: 23 (79%) conceived a child while taking omalizumab (group A), while 6 (21%) started omalizumab treatment during pregnancy (group B). Among patients in group A, we observed 23 births (21 liveborn singletons and 1 liveborn twin pair) and 1 miscarriage. Fifteen (65%) patients discontinued omalizumab after confirming their pregnancy, while eight (35%) were exposed to omalizumab during their entire pregnancy. In group B, omalizumab was introduced at a mean (SD) 10.83 (3.60) weeks' gestation and all patients were exposed to it until the end of pregnancy. In this group, there were seven liveborn infants (five singletons and one twin pair). No adverse events, pregnancy complications or congenital anomalies in newborns were recorded in either group.

Conclusions: Omalizumab for CSU treatment before and during pregnancy does not appear to have negative effects on maternal or fetal outcomes.

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Conflict of interest statement

Conflicts of interest C.P. has received consulting fees from AbbVie, Eli Lilly, LEO Pharma, Pfizer, Sanofi and Pierre Fabre; and payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from AbbVie, Eli Lilly, LEO Pharma, Pfizer, Sanofi, Novartis and Pierre Fabre. C.F. has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from AbbVie, Almirall, LEO Pharma, Lilly, Novartis and Sanofi. A.B. has served as a speaker and/or consultant for AbbVie, Amgen, Boehringer Ingelheim, Eli Lilly, Novartis and UCB. M.N. has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Sanofi, AbbVie, LEO Pharma, Eli Lilly and Amgen, outside the submitted work. The other authors declare no conflicts of interest.