Pregnancy outcomes in patients exposed to baricitinib in clinical trials and during postmarketing surveillance

Author:

Bergamini Bianca1,Seneschal Julien2,Meyers Kristin J1,Durand Frederick1,Haladyj Ewa1,Espinosa Gerard3ORCID,Thyssen Jacob P4

Affiliation:

1. Eli Lilly and Company , Indianapolis, IN , USA

2. Department of Dermatology, National Reference Center for Rare Skin Disorders, CNRS, UMR5164, ImmunoConCept, University of Bordeaux, Bordeaux , France

3. Department of Autoimmune Diseases, Hospital Clinic, Universitat de Barcelona , Barcelona, Catalonia , Spain

4. Department of Dermatology, Bispebjerg Hospital, University of Copenhagen , Copenhagen , Denmark

Abstract

Information is needed to manage pregnancies with inadvertent exposure to baricitinib. A total of 117 pregnancies with exposure to baricitinib were identified among patients treated with baricitinib for rheumatoid arthritis, atopic dermatitis, or alopecia areata during clinical trials or in the postmarketing setting, and retrieved from the Eli Lilly global safety database. The clinical outcomes of the pregnancies with reported exposure to baricitinib appear to be comparable to those previously reported with other targeted therapies for immune-mediated diseases or in the general population.

Funder

Eli Lilly and Company

Publisher

Oxford University Press (OUP)

Subject

Dermatology

Reference8 articles.

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3. Secukinumab in pregnancy: outcomes in psoriasis, psoriatic arthritis, and ankylosing spondylitis from the global safety database;Warren;Br J Dermatol,2018

4. Exposure to infliximab during pregnancy: post-marketing experience;Geldhof;Drug Saf,2020

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