Background Previous research shows that high disease activity is associated with an increased prevalence of fetal loss in systemic lupus erythematosus (SLE) pregnancies1.
Objectives To analyze the association of SLE disease severity with pregnancy outcomes in a single center, prospective cohort.
Methods A secondary analysis of prospectively collected data. Physician's global assessment (PGA) of disease activity measured every 4-6 weeks during pregnancy by a single rheumatologist. High disease activity was defined as the first occurrence of PGA score ≥2 in the observation period of 6 months prior to conception through pregnancy outcome. Outcomes of interest included birth defects diagnosed at birth, spontaneous miscarriage, stillbirth and live birth (preterm birth and small for gestational age). We evaluated whether high disease activity was associated with adverse pregnancy outcomes.
Results The analysis included 410 pregnancies; 38% black, 56% white, 7% other race, 80% <35 years old at last menstrual period (LMP), median age at LMP: 30 years, median disease duration from SLE diagnosis to LMP: 6 years. Pregnancy outcomes included 351 live births (86%), 16 stillbirths (4%), 39 spontaneous miscarriages (10%), 7 birth defects diagnosed at birth (2%), 107 preterm births (26%), and 37 small for gestational age births (9%). During the observation period, 18% (n=73) of pregnant women with SLE had high disease activity (PGA ≥2) and 82% had low disease activity (n=337). Pregnancies with high disease activity had an increased frequency of preterm births (44% vs. 22%; p=0.0001) and stillbirths (10% vs. 3%; p=0.006) compared to pregnancies with low disease activity. While the frequency of spontaneous miscarriages was not significantly different for the two disease activity groups, we observed a higher frequency of spontaneous miscarriages in women who first demonstrated high disease activity in the preconception period compared to the first trimester (63% vs. 37%). We observed a higher frequency of disease activity in the 2nd and 3rd trimesters for preterm births, SGA, stillbirths and birth defects at birth (see table).
Conclusions High disease activity during the preconception period and 2nd and 3rd trimesters was associated with selected adverse pregnancy outcomes in women with SLE. Data reported in this cohort will complement analyses planned for the Belimumab Pregnancy Registry, an international, prospective cohort study of women exposed to commercially-supplied belimumab within four months prior to and/or during pregnancy (clinicaltrials.gov ID NCT01532310). WEUKBRE5887
Molad Y, Borkowski T, Monselise A, et al. Maternal and fetal outcome of lupus pregnancy: a prospective study of 29 pregnancies. Lupus 2005;14:145-51
Disclosure of Interest D. Hill Shareholder of: GlaxoSmithKline, Employee of: GlaxoSmithKline, A. Eudy Employee of: GlaxoSmithKline, M. Powell Shareholder of: GlaxoSmithKline, Employee of: GlaxoSmithKline, Q. Fu Shareholder of: GlaxoSmithKline, Employee of: GlaxoSmithKline, M. Petri Grant/research support: GlaxoSmithKline, Consultant for: GlaxoSmithKline
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