FRI0663 TREATMENT WITH BIOLOGIC DRUGS OF PREGNANT WOMEN WITH AUTOIMMUNE DISEASE, EXPERIENCE OF A REFERENCE CENTER IN HIGH RISK PREGNANCY AND AUTOIMMUNE DISEASES

Background Autoimmune diseases predominantly affect women of childbearing age. These women must be without clinical activity before conception, which is usually achieved thanks to immunosuppressive drugs. Also, information on new drugs does not include their possible effects on pregnancy because pregnant women are usually excluded from clinical trials. Objectives The aim of the study is to evaluate the safety of biological drugs (BD) in pregnant patients with different autoimmune diseases (AD). Methods Patients were prospectively followed in a reference Spanish center for high-risk pregnancies and AD. Follow-up was performed by a multidisciplinary team with at least one obstetrician and one expert clinician in autoimmune diseases. Females exposed to BD during the periconceptional period or during pregnancy were included in the study. Obstetric and neonatal outcomes were assessed. Results Between 2015 and 2018 we identified 37 exposed pregnancies in 35 women affected by different AD. At the start of pregnancy, 18 patients were taking infliximab, 11 adalimumab, 3 natalizumab, 2 rituximab, 1 etanercept y 1 tocilizumab. The AD that required BD were Crohn’s disease (20 patients, 54.1%), ulcerative colitis (7, 18.9%), rheumatoid arthritis (4, 10.8%), ankylosing spondylitis (3, 8.1%) and multiple sclerosis (3, 8.1%). Regarding pregnancies, 5 (13.5%) had left the BD just before the pregnancy. Of these, 1 remained stable and 4 (80%) had a flare during pregnancy requiring restart of BD. Of the 32 pregnancies who took the BD during pregnancy, 8 (25%) abandoned the treatment after knowing the pregnancy, meaning that 2 of them flared; 10 (31.5%) continued with the treatment until the end of the second trimester (week 25-26) and 14 (43.7%) continued during the third trimester, 4 of them kept the drug during the entire gestation due to disease activity In our study there was a positive correlation between preconceptional abandonment of the BD and the risk of presenting a flare (p=0.003), specially in the first and second trimesters (p=0.024). However, no relationship was found between BD and infections in the newborn (p>0.05), nor between each of the BD with the risk of infections. Preconceptional treatment reduced the risk of flare (OR 0.545, 95%CI) and the risk of maternal complications (OR 0.5, 95%CI). Indeed, the presence of a flare during pregnancy increased the risk of maternal complications (OR 2.0, 95%CI). Pregnancies under BD were compared to healthy controls adjusted by age finding no differences in the preterm delivery rate (p>0.05), in the induction rate of delivery (p>0.05) nor in the cesarean section rate (p>0.05). Conclusion In our series, the use of preconceptional BD and/or during pregnancy is not associated with an increase of maternal or fetal complications. However, fewer flares were observed. This may imply that BD can be a good tool for the treatment of women of childbearing age since control of the disease resulted in better maternal-fetal outcomes. However, more studies are needed to determine the usefulness and safety of these treatments during pregnancy. References [1] Gotestam Skorpen C, et al. The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Ann Rheum Dis. 2016 May;75(5):795-810. [2] Alijotas-Reig J, et al. Treatment with immunosuppressive and biologic drugs of pregnant women with systemic rheumatic or autoimmune disease. Med Clin (Barc). 2016 Oct 21;147(8):352-360. [3] Bazzani C, et al. Prospectively-followed pregnancies in patients with inflammatory arthritis taking biological drugs: an Italian multicentre study. Clin Exp Rheumatol. 2015 Sep-Oct;33(5):688-93. Disclosure of Interests None declared