Baricitinib exposure during pregnancy in rheumatoid arthritis

Abstract

We here describe the case of a 43-year-old White woman who was diagnosed with rheumatoid arthritis treated with anti-tumour necrosis factor drugs that caused an adverse drug reaction. The objective of this study was to describe the outcome of a pregnancy under baricitinib, a JAK-inhibitor drug, in a woman affected by rheumatoid arthritis. Scant data are available about the safety of JAK inhibitors during pregnancy. A case report and review of literature about JAK-inhibitor exposure during pregnancy were conducted. After the failure of biologic disease-modifying antirheumatic drugs due to a loss of efficacy and adverse drug reaction, the patient was started on baricitinib when it was marketed. During the fifth month of this treatment, she reported missing her period and a pregnancy was confirmed, despite a previous recommendation of adequate contraception. Thus, she had been exposed to baricitinib for several weeks before conception and during the whole first-trimester until the 17th week of gestation. The treatment with baricitinib was promptly discontinued and she was regularly examined. Foetal growth was normal throughout pregnancy and ultrasound examination did not detect any macroscopic abnormality. This is the first report of exposure to baricitinib during pregnancy outside the drug registration study program. We report the positive pregnancy outcome of a continuous exposure to baricitinib during the first 17 weeks of pregnancy. Small molecules, such as JAK inhibitors, are increasingly being used in clinical practice in rheumatoid arthritis and in other diseases. Hence, more broad and focused studies are required to have an insight of safety for this drug class in the case of accidental exposure before or during pregnancy.

Contraception and reproductive planning during the COVID-19 pandemic

“…Baricitinib: A Phase I trial with 20 healthy women studied how the body absorbs and breaks down a COC with 30 µg ethinyl estradiol (EE) and 150 µg LNG when it is given with baricitinib showed slight reductions of serum levels of EE and LNG that probably does not reduce its effectiveness [45]. Although there is a case report of a 43-year-old woman with rheumatoid arthritis treated with baricitinib that got pregnant during the fifth month of this treatment, she did not follow the recommendation of using adequate contraception [46]. Clevudine: We found no data regarding clevudine and contraception.…”

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“…An Italian group has published 1 report of a normal pregnancy outcome while taking baricitinib for rheumatoid arthritis, although it was unintentionally given during the pregnancy. 71 Similarly, Mahadavan et al reported in this journal the outcomes of tofacitinib exposure in pregnancy to be similar to reference populations in nonexposed patients. 72 A PubMed search regarding the use of upadacitinib and pregnancy outcomes did not yield any results.…”