(281) Progress Towards Enrollment in a US Pregnancy Registry for Galcanezumab and Lasmiditan

Background: The US Lilly Migraine Pregnancy Registry (MPR) has been implemented as part of a broader pharmacovigilance plan to assess the safety of galcanezumab and Lasmiditan use during pregnancy, as there is currently not adequate information about the safety of either of these medications during pregnancy. Recruitment into pregnancy registries, such as the MPR, is challenging and can be informed by databases such as the Sentinel Initiative database, a national electronic system that monitors the safety of FDA-regulated medical products, which recently reported the utilization of various medical products during pregnancies ending in live birth delivery from 01-Jan-2008 through 30-Jun-2022.

Objectives: To compare the number of exposed pregnancies enrolled in the US Lilly Migraine Pregnancy Registry (MPR), a multi-drug registry combining efforts for galcanezumab (approved for preventive use Sep-2018) and lasmiditan (approved for acute use Oct-2019), to the number of galcanezumab and lasmiditan exposed pregnancies reported in the Sentinel database.

Methods: The MPR, opened to enrollment in May 2021, aims to recruit a minimum of 420 galcanezumab and 420 lasmiditan-exposed pregnancies as well as 420 patients into each comparator group of patients with migraine to allow for detection of a 2.5-fold difference in risk of major congenital malformations. Ongoing recruitment/awareness activities including active website listings, scientific abstracts, and mass Health Care Provider (HCP) emails. Additional planned efforts include a social media campaign and direct patient/HCP recruitment through EMR queries and MyChart in partnership with the OMNY Health Network. The number of galcanezumab and lasmiditan exposed pregnancies in a recent report of an FDA-initiated query using Sentinel are also reported. The Sentinel cohort study covers 6% of the US births during the study period.

Results: The MPR is ongoing with final study reports due in December 2033 (galcanezumab) and December 2034 (lasmiditan) for submission to FDA. After more than 2 years of enrollment, only 8 galcanezumab and 0 lasmiditan-exposed pregnancies have been enrolled. The Sentinel reported only 144 pregnancy episodes with galcanezumab use over the 3.5-year period from 01-Jan-2019 to 30-June-2022, while no data were presented for lasmiditan due to a small sample size between 01-Jan-2020 and 30-June-2022.

Conclusions: While MPR recruitment including upcoming social media and direct recruitment through EMR/MyChart may help increase enrollment, results from the Sentinel database report suggest that US pregnancy exposures to galcanezumab and lasmiditan are not extensive.