Abstract Details

Title Pregnancy outcomes in patients with multiple sclerosis and exposure to branded glatiramer acetate

Topic Multiple Sclerosis

Presentation(s) P4 - Poster Session 4 (5:30 PM-6:30 PM)

Poster/Presentation
Number 15-096

Objective

To assess the overall impact of branded GA exposure and all cases of confirmed exposure during all three trimesters on pregnancy outcomes

Background Multiple sclerosis is not associated with an increase in spontaneous abortions, stillbirth, cesarean delivery, premature birth, or birth defects. Limited information is available on the association of disease-modifying therapies with adverse pregnancy outcomes. Accordingly, these treatments are often discontinued for women with MS who intend to become or are confirmed pregnant.

Design/Methods Rates of pregnancy loss (spontaneous abortions, still births and fetal demise) and birth defects were calculated from Teva’s global safety database and compared with MACDP (Metropolitan Atlanta Congenital Defects Program) rates.

Results From all prospectively reported pregnancies, a primary cohort (n=2061) with confirmed GA exposure and known outcomes was analyzed. Outcomes included 1760 (85%) live births, 227 (11%) pregnancy loss, 63 (3%) elective pregnancy terminations, 3 (0.15%) molar and 15 (0.7%) ectopic pregnancies. The 227 pregnancy loss cases include 208 spontaneous abortions, 11 fetal deaths and 8 still births. In comparison to MACDP rates, GA-exposed pregnancies show no increase in the percentage of pregnancy loss (17% and 11 %, respectively). All 216 cases in the sub-cohort of exposure during all 3 trimesters resulted in live births. Seven cases of congenital anomalies were reported (3.2%), which is similar to that in the general population (2.8%). Full term (i.e gestational age >37 weeks), normal birthweight, and Caesarean delivery rates were all similar to rates in the general population (85.6% vs. 90.4%, 89.7% vs. 90.6% and 32.9% vs. 32.0%, respectively).

Conclusions Analysis of 2061 cases with confirmed exposure to branded GA demonstrated no increased risk for pregnancy loss. Among 216 cases where exposure throughout all three trimesters of pregnancy was confirmed, GA did not increase the risk of congenital anomalies or alter the normal course of pregnancy.

Authors/Disclosures
PRESENTER	No disclosure on file
Sigal Melamed-Gal	No disclosure on file
	No disclosure on file

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