OP0041 Pregnancy Outcomes for Systemic Lupus Erythematosus (SLE) Subjects with Conception during Belimumab Intravenous (IV) and Subcutaneous (SC) Placebo-Controlled Clinical Trials and Long Term Extension Trials

Abstract

Background SLE is an autoimmune disease typically affecting women of childbearing age that can be associated with significant maternal and fetal morbidity. Belimumab is a biologic approved as adjunctive therapy for SLE. Although pregnant women were excluded from belimumab clinical trials and treatment was discontinued if a pregnancy occurred, pregnancy outcomes were collected when a pregnancy was identified. Objectives To describe pregnancy outcomes of women who conceived while participating in belimumab phase 2-4 clinical trial studies. Methods Cumulative pregnancy outcome data with autoantibody status (when available) were collected from women who conceived while participating in belimumab SLE phase 2-4 clinical trials. Results As of 08 March 2013, 66 pregnancies with known outcomes in subjects who received belimumab and 6 who received placebo had been reported in the IV and SC SLE studies (Table). A lower frequency of fetal loss was noted in subjects treated with belimumab (27%; 18 of 66) compared to the placebo group (50%; 3 of 6). Live births were noted in 33 of 66 pregnancies (50%) in the belimumab group, 3 of which were associated with congenital anomalies (1 case of Dandy Walker syndrome, 1 case of bilateral enlarged kidneys in a pregnancy also exposed to a known teratogenic drug, and an unbalanced translocation involving chromosomes 11 and 13 that was linked to the mother). In the group receiving belimumab, anticardiolipin antibodies were present at baseline in 21% (7 of 33) of subjects who had live births and in 44% (8 of 18) of subjects with fetal loss. Conclusions Total fetal loss in belimumab-treated subjects was similar to background estimates in SLE patients (∼25%), although data remain limited. Valuable clinical information can be obtained through the Belimumab Pregnancy Registry (BPR), an international, prospective cohort study with voluntary participation. The BPR will add to current clinical experience with belimumab and assist clinicians and patients regarding potential risks and benefits of treating SLE patients who are contemplating pregnancy or are pregnant. GSK1550188; eTrack Study #201182 References Andrade R, Sanchez ML, Alarcon GS, et al. Adverse pregnancy outcomes in women with systemic lupus erythematosus from a multiethnic US cohort: LUMINA (LU1). Clin Exp Rheumatol. 2008;26:268-74. Clowse ME, Magder LS, Witter F et al. The impact of increased lupus activity on obstetric outcomes. Arthritis Rheum. 2005;52:514-21. Rahman P, Gladman DD, Urowitz MB. Clinical predictors of fetal outcome in systemic lupus erythematosus. J Rheumatol. 1998; 25.8:1526-30. Disclosure of Interest M. Powell Shareholder of: GlaxoSmithKline, Employee of: GlaxoSmithKline, D. Hill Shareholder of: GlaxoSmithKline, Employee of: GlaxoSmithKline, A. Eudy Employee of: GlaxoSmithKline, H. Landy Consultant for: GlaxoSmithKline, M. Petri Consultant for: GlaxoSmithKline DOI 10.1136/annrheumdis-2014-eular.4484

Immunosuppressives and biologics during pregnancy and lactation

“…No teratogenicity has been observed in animal models. Presently available human data on slightly more than 150 pregnancies derive from registries and case reports [87–89]. …”

The use of biologics for autoimmune rheumatic diseases in fertility and pregnancy

“…Exact information on DMARDs was not available; there were two cases of malformations -one Dandy-Walker syndrome, and one bilaterally enlarged kidneys. 72 Presumably belimumab was discontinued upon confirmation of pregnancy; a large number of women also elected to have their pregnancy terminated. 72 Two additional published case reports that described the use of belimumab beyond the first trimester of pregnancy did not demonstrate any adverse outcomes in either mother or neonate.…”

“…72 Presumably belimumab was discontinued upon confirmation of pregnancy; a large number of women also elected to have their pregnancy terminated. 72 Two additional published case reports that described the use of belimumab beyond the first trimester of pregnancy did not demonstrate any adverse outcomes in either mother or neonate. 73,71 There is a single published case report of maternal use of belimumab till 26 weeks' gestation for severe systemic lupus erythematosus (SLE).…”

Biologikatherapie beim systemischen Lupus erythematodes

“…Zudem gibt es ein weltweites Register für unter Belimumab eingetretene Schwangerschaften (NCT01532310), das bislang keine fetotoxischen oder andere Komplikationen bei den derzeit vorliegenden Erfahrungen von 80 Graviditäten berichten konnte [40].…”