AB0290 Certolizumab Pegol Exposure in Rheumatoid Arthritis Pregnancies: A Case Series

BackgroundTNF alpha (TNFα) has a dual role during pregnancy course: in its first phase, promotes embryo implantation and endometrial vascular differentiation via cyclo-oxygenase and subsequent prostaglandins production; at the end of the third trimester, it contributes to the labor onset by regulating uterine contractions [1]. TNFα increased levels, although, have been associated to pregnancy complications. Among anti-TNFα agents indicated for RA treatment is included certolizumab pegol (CTZ). A double peak of incidence of RA in the female gender is linked to the hormonal status changes: the majority of women becomes ill during the post-menopausal age, but a percentage around 10% experiences the disease during the reproductive age [2]. Even if pregnancy has always been considered having a positive impact on RA symptoms [3], disease flares are occasionally observed, raising the challenge of RA management before/in the early stages of pregnancy.ObjectivesTo assess the CTZ use safety during RA pregnancies.MethodsIn cooperation with the Obstetrics and Gynecology Division, we retrospectively considered, since 2010, 7 RA patients, diagnosed according to the 2010 ACR/EULAR criteria and exposed to CTZ just at the beginning (1st trimester) or during the whole pregnancy. Local ethic committee previously approved this rescue treatment and all patients signed an informed consent regarding the potential risk of biologic agents on fetus.ResultsThe totality of patients was free from taking any potentially teratogenic drug like methotrexate or leflunomide, that were been stopped in the view of pregnancy. In 5/7 patients, thanks to an improvement of RA symptoms and laboratory tests, CTZ treatment was stopped during the first trimester of pregnancy. In 2 cases, on the opposite, the high disease activity required a prosecution of biologic administration until the end of the second trimester. All patients were treated by low-dose of oral prednisone (average 5±2.5 mg daily); two subjects were on sulfasalazine administration (both on 500 mg three times daily) and two others on hydroxychloroquine (200 mg, twice daily). Mean maternal age at conception was 31.6±3.4 years; mean disease duration dated of 51±26 months. Mean gestation period was 39±0.8 weeks and mean birth weight 3.037±0.58 grams. Three patients deliveries required cesarean section, while the others experienced a normal vaginal delivery (2 labor were induced by intravenous oxytocin). Mean APGAR scores after 1, 5 and 1