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 . 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.
- 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.
- Nybo Andersen AM, et al. 2000;320:1708-12.
- American College of Obstetricians and Gynecologists’ Committee on Practice Bulletins. Obstet Gynecol. 2018;132:e197-207.
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Table of Contents: SPIN 2022
Letter from the Editor
SPIN 2022 Highlights Podcast
IMIDs in Adults and Children: New Developments
Therapies for atopic dermatitis: still moving forward
Children with AD: high risk of bacterial infections in carriers of a filaggrin gene variant
Men on biologics report fewer adverse events than women
Conceptual framework of adverse drug reactions may improve treatment of patients with IMIDs
Psoriasis: The Beat Goes On
Systemic treatment for psoriasis: what is on the horizon?
Topical therapy in psoriasis: an important partner in combination therapy
GPP flares: pronounced undertreatment is common
IL-17A/F inhibitor bimekizumab shows higher response and maintenance rates compared with secukinumab
Paediatric psoriasis: ixekizumab beneficial in difficult-to-treat areas
Psoriasis patients see great benefit in achieving complete skin clearance
The Future Is Bright for Vitiligo
Predilection sites for skin signs of vitiligo disease activity determined
Where Are We Now in Hidradenitis Suppurativa
IHS4 better suited as an outcome measure in HS trials?
New treatments for HS: IL-17 inhibitors next in practice?
New Treatment Options in Alopecia Areata
Alopecia areata: light at the end of the tunnel
Alopecia areata pathogenesis: known genetic background, unknown environmental triggers
Best of the Posters
Psoriasis treatment: no elevation of MACE and VTE on deucravacitinib
Comorbid anxiety and depression may benefit from psoriasis treatment with certolizumab
Dose tapering in psoriasis is associated with a low relapse rate
DLQI scores underestimated during lockdowns?
Favourable safety profile of long-term use of ixekizumab
Treating psoriasis during pregnancies