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Background <p>Administrative claims databases may complement pregnancy registries for post-marketing utilization assessment and safety surveillance.</p> Objective <p>To assess patterns of utilization of disease-modifying therapies (DMT) indicated for treatment of multiple sclerosis among women with live-birth deliveries across pregnancy and over time.</p> Methods <p>We conducted a retrospective administrative claims-based utilization analysis from January 1, 2001, to December 31, 2020 in the Sentinel Distributed Database. We described use across the pregnancy period and over time among pregnancies ending in a live-birth delivery and matched non-pregnant episodes.</p> Results <p>Among 2,142,706 pregnancies resulting in live-birth deliveries, 1,362 pregnancies were exposed to DMTs (&lt; 0.1%). Glatiramer acetate was the most prevalent DMT any time in pregnancy (48.9%), followed by interferon beta 1a (22.4%), dimethyl fumarate (10.7%), and natalizumab (8.4%). The highest use was observed six months prior to pregnancy start, while the lowest use was in the second trimester.</p> Conclusions <p>In our analysis, exposure to DMT was low and varied across the pregnancy period. Use among pregnant patients was highest in the six months prior to pregnancy start and remained lower than pre-pregnancy levels after delivery.</p>

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Use of multiple sclerosis drugs among pregnant individuals with live-birth deliveries in the FDA’s Sentinel Distributed Database

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月9日

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  • Danijela Stojanovic,
  • Lockwood Taylor,
  • Mayura Shinde,
  • Nicole Haug,
  • Mohamed Mohamoud,
  • Leyla Sahin,
  • Amanda Carruth,
  • Rebecca Hawrusik,
  • Jennifer G. Lyons

摘要

Background

Administrative claims databases may complement pregnancy registries for post-marketing utilization assessment and safety surveillance.

Objective

To assess patterns of utilization of disease-modifying therapies (DMT) indicated for treatment of multiple sclerosis among women with live-birth deliveries across pregnancy and over time.

Methods

We conducted a retrospective administrative claims-based utilization analysis from January 1, 2001, to December 31, 2020 in the Sentinel Distributed Database. We described use across the pregnancy period and over time among pregnancies ending in a live-birth delivery and matched non-pregnant episodes.

Results

Among 2,142,706 pregnancies resulting in live-birth deliveries, 1,362 pregnancies were exposed to DMTs (< 0.1%). Glatiramer acetate was the most prevalent DMT any time in pregnancy (48.9%), followed by interferon beta 1a (22.4%), dimethyl fumarate (10.7%), and natalizumab (8.4%). The highest use was observed six months prior to pregnancy start, while the lowest use was in the second trimester.

Conclusions

In our analysis, exposure to DMT was low and varied across the pregnancy period. Use among pregnant patients was highest in the six months prior to pregnancy start and remained lower than pre-pregnancy levels after delivery.