Pregnancy and fetal outcomes following paternal exposure to glatiramer acetate

Abstract

Objectives

This study aimed to examine pregnancy and fetal outcomes following paternal exposure to glatiramer acetate (GA).

Methods

Pregnancy reports of paternal GA-exposure at time of conception from 2001 to 2022 were extracted from Teva Global Pharmacovigilance database. Pregnancy reports obtained prior to (prospective) or after (retrospective) knowledge of the pregnancy outcome were included. The primary endpoint was major congenital malformation (MCM) in the offspring according to the US Metropolitan Atlanta Congenital Defects Program (MACDP) and European Surveillance of Congenital Anomalies and Twins (EUROCAT) classification. Other pregnancy and fetal outcomes, including spontaneous abortion, pregnancy termination, fetal death, preterm birth, and low birth weight, were assessed.

Results

A total of 466 paternal GA-exposed pregnancies were retrieved, 232 prospective cases and 234 retrospective cases. Of 349 (74.9%) pregnancies with known outcomes, 316 (90.5%) were live births, 28 (8.0%) were spontaneous abortions, 3 (0.9%) were elective pregnancy terminations, and 2 (0.6%) were stillbirths. In prospective live birth cases, there were 7/111 (6.3%) preterm births and 5/115 (4.3%) neonates with a low birth weight. The prevalence of total MCM among prospective cases was 1.7% (2 cases of 116 live births and fetal death/stillbirth), which is slightly lower than the background rates from MACDP (3%) and EUROCAT (2.1%).

Conclusions

This study did not indicate an increase in the rate of adverse pregnancy and fetal outcomes after paternal exposure to GA. These results provide additional information regarding pregnancy outcomes following paternal exposure to GA for healthcare professionals, male patients and their female partners who are considering pregnancy while their male partner is using GA.

PLAIN LANGUAGE SUMMARY

This research aimed to look at how pregnancies and babies were affected when fathers with multiple sclerosis have been prescribed and taken the medication, glatiramer acetate (GA). Researchers looked at reports of pregnancies where the father had taken GA around the time of conception, from 2001 to 2022. They got this information from the Teva Global Pharmacovigilance database. They included reports where the pregnancy was known about either before (prospective) or after (retrospective) the outcome was known. They looked at outcomes like major birth defects, miscarriages, pregnancy terminations, fetal deaths, premature births, and low birth weight. The study found a total of 466 pregnancies where the father had taken GA. Of these pregnancies, the final outcome of pregnancy was found for 349 pregnancies. Most of these pregnancies (90.5%) resulted in live births, 8.0% ended in miscarriage, 0.9% in termination, and 0.6% in stillbirth. Among prospective live births, 6.3% were premature, and 4.3% had low birth weight. The amount of major birth defects was 1.7%, which was slightly lower than usual. The study did not suggest that exposure of the father to GA negatively affects the pregnancy or the baby. These findings can help healthcare providers, male patients taking GA, and their partners who are thinking about pregnancy while the male partner is taking GA.

Keywords:

• Glatiramer acetate
• multiple sclerosis
• paternal exposure
• pregnancy outcome

Transparency

Declaration of financial/other relationships

All authors are employees of Teva Pharmaceutical Industries Ltd. and/or its affiliates. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

SK: conceptualization, study supervision, analysis, interpretation of data, drafting the manuscript. CD: study supervision, interpretation of data. AG: data acquisition, analysis, interpretation of data. All authors critically revised the manuscript for important intellectual content.

Acknowledgments

An abstract of this manuscript has been presented at the 39th International Conference on Pharmacoepidemiology & Therapeutic Risk Management, Halifax, Nova Scotia, Canada, 25–27 August 2023.

Data availability statement

The original contributions presented in the analysis are included in this published article.

Additional information

Funding

This analysis was funded by Teva Pharmaceutical Industries Ltd and/or its affiliates. The sponsor had a role in the design and conduct of the study; study supervision, management, analysis, and interpretation of the data; preparation, review, and approval of the manuscript; and decision to submit the manuscript for publication.