Publications

Broad and focused studies are required to have an insight of safety for small molecules, such as JAK inhibitors in the case of accidental exposure before or during pregnancy.This case study’s objective describes a case report of a 43-year-old woman affected by RA who became pregnant during BARI treatment. She has had two previous pregnancies at term without complications. After failure of bDMARDs due to loss of efficacy and adverse drug reactions, the patient was started on BARI when it became available on the market. During the fifth week of treatment, the patient confirmed her pregnancy. Therefore, she had been exposed to several weeks of BARI before conception and during the first trimester until the 17th week of gestation. BARI treatment was promptly discontinued, and the patient was regularly monitored. Throughout the pregnancy and ultrasound examinations, foetal growth was normal and there was no detection of macroscopic abnormality. This is the first reported BARI exposure during pregnancy outside the drug registration study program. This study reports the positive pregnancy outcomes of a continuous exposure to BARI during the first 17 weeks of pregnancy without evidence of teratogenic effects. This case study may be useful when counselling women who inadvertently get pregnant during BARI use. However, more broad and focused studies are required in order to have an insight of safety for this class of drugs during pregnancy and lactation.