Background Biologic DMARDs fall within the FDA category B or C. However many case series and registry data are available about women exposed during pregnancy.
Objectives to extend information on this topic by the contribution of a tertiary single centre case series
Methods Data were collected from a single-centre cohort of outpatients followed between 2006 and 2016. Women with rheumatic diseases (RD) exposed to biological (BE) agent during pregnancy or in the 3 months before conception were included. Outcomes in the BE group were compared with an age-matched group of pregnant women with RD non-exposed to biological agent (NE). Demographic and clinical data,obstetric outcome and neonatal complications were recorded.
Results 34 pregnancies in 28 patients were included: 14 Rheumatoid Arthritis (RA), 6 ankylosing spondylitis (AS), 2 Psoriatic arthritis (PsA), 4 Undifferentiated spondyloarthritis (uSpA), 1 Dermatomyositis (DM), 1 Adult Onset Still's disease (AOSD); all were exposed to a biologic agent: 16 Etanercept (ETA), 7 Adalimumab (ADA), 4 Infliximab (IFX), 1 Certolizumab (CTZ), 5 Rituximab (RTX), 1 Anakinra (ANK). Median age was 34 yrs (range 24–50). All patients treated with TNFi and ANK withdrew therapy in early pregnancy (<10 weeks gestational age). 2 RA patients had 2 pregnancies each, during ETA treatment. A RA woman became pregnant 4 times during RTX therapy. 10 patients were also on csDMARDs therapy at the time of conceptions: 7 Hydroxycloroquine (HCQ),1 HCQ + Sulphasalazine (SSZ), 1 Cyclosporine A (CYA), which was continued, and 1 with Methotrexate which was immediately withdrawn. 1 RA patient started SSZ from the 24th week. 15 patients (7 RA, 2 PsA, 2 AS, 2 uSpA, 1 DM) started or increased oral and/or intra-articular steroids because of disease flare. A control group of 45 pregnancies observed in 42 patients not exposed to biologics was selected=“selected” (19 RA, 12 uSpA, 3 Juvenile Idiopatic Arthritis (JIA), 5 PsA, 1 AS, 1 DM, 1 AOSD), median age 35 (range 22–42). 18 patients were treated with csDMARDs during pregnancy (8 HCQ; 4 SSZ; 2 CYA+HCQ; 4 SSZ+HCQ). No other drugs were taken at the time of conception, apart from low dose of steroids in 24 cases; in 1 case intra-articular steroids were given because of disease flare.
Pregnancy outcomes are summarized in tab.1: therapeutic abortions were performed for an extrauterine pregnancy occurred twice in the patient with RA who became pregnant 4 times during RTX treatment, after the 5th and the 6th retreatment. After the 4th retreatment she had an early spontaneous abortion. Previously, she delivered 2 healthy children after exposure to ETA and 3 treatment cycles of RTX. No serious perinatal complication occurred, excluding very preterm baby delivery at 28th weeks, who needed neonatal intensive care. No congenital malformations were observed. Klinefelter syndrome was diagnosed in 1 case.
Conclusions In our case series no significant differences did occur in pregnancy outcome between BE and NE group, according to the most recent data published in literature. Additional data from larger numbers of pregnacy exposed to biological agents are required.
Disclosure of Interest None declared