No adverse pregnancy outcomes in patients exposed to baricitinib

Atopic dermatitis and alopecia areata may present in women of childbearing age. Therefore, data on unintentional exposure during pregnancy is important. According to an analysis of a pharmacovigilance system, pregnancies with reported exposure to the JAK inhibitor baricitinib showed similar clinical outcomes compared with pregnancies in the general population.

All JAK inhibitors are contraindicated during pregnancy, and women of childbearing age should use effective contraception. But many pregnancies are not recognised in time to avoid drug exposure. Therefore, an analysis of phase 3 randomised-controlled trials (RCTs) and post-marketing sources, including the use of baricitinib in rheumatoid arthritis, alopecia areata, and atopic dermatitis during pregnancy, was performed to shed some light on a possible deleterious effect [1]. All pregnancy events identified in RCTs and post-marketing sources, including spontaneous reports to the global Lilly pharmacovigilance system through 13 August 2021, were included.

Clinical outcomes of pregnancy included live births, spontaneous abortions, elective terminations, and pregnancies with pending outcomes at the time of cut-off data and patients lost to follow-up. Overall, 91 pregnancies could be identified, 77 with maternal exposure to baricitinib and 14 with paternal exposure. Of the pregnancies with maternal exposure to baricitinib, 8.1% in the post-marketing data and 22% in the RCT ended in spontaneous abortion. This falls in the range of the estimated 10–20% of clinically recognised pregnancies in the general population that end in miscarriage or spontaneous abortion [2,3]. Most spontaneous abortions (83%) occurred during the first trimester (2 out of 3 in the post-marketing population and 8 out of 9 in the RCTs). Only 2 congenital malformations were reported in the analysis, both in the post-marketing sample: 1 anencephaly, resulting in spontaneous abortion, and 1 hip dysplasia ending in a live birth.

The authors concluded that the clinical outcomes of pregnancies with reported exposure to baricitinib seem comparable to those observed in the general population in Europe and the US. However, due to the low number of cases, especially regarding paternal exposure, and scarce information, risk assessment is challenging. Therefore, pregnancy outcomes in patients treated with baricitinib will be monitored through ongoing surveillance. In addition, prescribers should follow guidance on contraception during the use of baricitinib in women of childbearing age.

1. Thyssen JP, et al. Pregnancy outcomes in patients exposed to baricitinib in randomised clinical trials and during post-marketing surveillance. P031, SPIN 2022 Congress, 06–08 July, Paris, France.
2. Nybo Andersen AM, et al. 2000;320:1708-12.
3. American College of Obstetricians and Gynecologists' Committee on Practice Bulletins. Obstet Gynecol. 2018;132:e197-207.

 

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Posted on 26 August 202217 May 2024