(121) Pregnancy and Fetal Outcomes Following Paternal Exposure to Glatiramer Acetate

Publication Number: 1116

Background: Information about pregnancy and fetal outcomes following paternal exposure to glatiramer acetate (GA) is limited.

Objectives: To assess pregnancy and fetal outcomes following paternal exposure to GA

Methods: Postmarketing reports were extracted between January 1, 2001 to June 30, 2022 from Teva global safety database using the following criteria: (1) pregnancy report in a female whose partner is a male treated with GA, (2) paternal exposure to GA within 30 days prior to conception, (3) conception occurring during treatment.
Pregnancy exposure data acquired prior to the knowledge of the pregnancy outcome or prior to the detection of a congenital malformation at prenatal examination were considered prospective pregnancy reports. Pregnancy cases were classified as retrospective when data of pregnancy exposure were acquired after knowledge of the pregnancy outcome or after detection of a congenital malformation at a prenatal test.
Major congenital malformations were classified based on the Metropolitan Atlanta Congenital Defects Program (MACDP) classification as well as the European Concerted Action on Congenital Anomalies and Twins (EUROCAT) and adjudicated by a medical physician. Other endpoints included spontaneous abortion ( < 22 weeks gestation), pregnancy termination ( < 22 weeks gestation), fetal death (≥22 weeks gestation), preterm birth ( < 37 weeks), and low birth weight ( < 2500 gram). The rates of major congenital malformations and other endpoints were compared to the general population rates.

Results: Of 466 paternal GA-exposed pregnancies, pregnancy outcome was known for 349 (74.9%) pregnancies at the cutoff date. There were 316 (90.5%) live births, 28 (8.0%) spontaneous abortions, 3 (0.9%) terminations due to medical reasons, and 2 (0.6%) stillbirths. Preterm birth was reported in 6.3% (7/111) of prospective cases.
The median birth weight reported (n=97) was 3.31 (range 1.80 to 4.82) kg. Among 115 prospective live births, low birth weight was reported in 4.3% (n=5), hospitalization in neonatal intensive care unit was reported in 1.7% (n=2). The total prevalence of MCM among prospective cases was 1.7% (n=2) according to either MACDP or EUROCAT classifications, slightly below the total prevalence of 3% according to MACDP or 2.1% according to EUROCAT.

Conclusions: These findings did not indicate any adverse pregnancy and fetal outcomes following paternal exposure to GA. While this analysis is subject to over-reporting and underreporting, the results provide additional information for healthcare professionals, male patients and their female partners who wish to become pregnant regarding the safety of GA.