Safety of Biologics for Atopic Diseases During Pregnancy

J Allergy Clin Immunol Pract. 2022 Dec;10(12):3149-3155. doi: 10.1016/j.jaip.2022.08.013. Epub 2022 Aug 18.


The high prevalence of atopic diseases in women of childbearing age reveals the need to determine the safety of biologics during pregnancy. This review summarizes the effects of 7 Food and Drug Administration-approved biologics (omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, tezepelumab, and tralokinumab) on maternal and fetal outcomes. For this purpose, we reviewed English-language publications to investigate whether the use of biologics for atopic diseases during pregnancy increased the risk of preterm delivery, stillbirth, low birth weight, or congenital malformations. Most publications found were case reports, case series, or observational studies reporting outcomes in a total of 313 pregnancies. No randomized controlled studies were identified. We found that biologics do not seem to influence maternal or fetal outcomes. Indeed, worsening of the underlying atopic disease during pregnancy appears to be more detrimental to the viability of the pregnancy. Given the small sample size and scarcity of studies, future research should include prospective studies with comparable control groups without exposure to biologics and multicenter registries for long-term follow-up.

Keywords: Asthma; Atopic dermatitis; Atopic diseases; Benralizumab; Biologics; Birth weight; Chronic urticaria; Congenital malformations; Dupilumab; Mepolizumab; Omalizumab; Pregnancy; Preterm; Reslizumab; Safety; Stillbirth; Tezepelumab; Tralokinumab.

Publication types

  • Review

MeSH terms

  • Anti-Asthmatic Agents* / therapeutic use
  • Asthma* / drug therapy
  • Biological Products* / therapeutic use
  • Female
  • Humans
  • Infant, Newborn
  • Multicenter Studies as Topic
  • Omalizumab / therapeutic use
  • Pregnancy
  • Prospective Studies


  • Biological Products
  • Omalizumab
  • Anti-Asthmatic Agents