Research Scientist Carelon Research Wilmington, United States
Background: Medication use during pregnancy represents a unique safety issue. Migraine is a condition that commonly afflicts women of reproductive age. Galcanezumab is an anti-calcitonin gene-related peptide (CGRP) monoclonal antibody for migraine prevention. As a result of its long half-life (27 days), a pregnancy occurring even 4.5 months after a galcanezumab injection could be considered exposed. Real-world database studies can be used to assess risk if an appropriate sample size is achieved. This study is targeting a sample size of more than 400 galcanezumab-exposed pregnancies linked to infants.
Objectives: To assess the number of HealthCore Integrated Research Database (HIRD) pregnancies exposed to galcanezumab. Additionally, to assess the number of these pregnancies linkable to infants and eligible for future comparative analyses (versus oral migraine preventives).
Methods: Galcanezumab exposure during pregnancy was monitored in the HIRD, a US commercial administrative claims database, for the study period 28 September 2018 – 30 November 2021. A pregnancy was considered exposed if a galcanezumab claim occurred up to 135 days (5 half-lives) prior to estimated last menstrual period (LMP) through end of pregnancy. Pregnancies were eligible for comparative analysis if the patient had migraine, was aged 15-49 years at LMP, had 6 months of baseline (pre-LMP) continuous enrollment in the HIRD, were not exposed to other non-galcanezumab CGRP antibodies or oral migraine preventives, and did not have baseline diagnoses for epilepsy or severe cardiovascular disease. In the subset of pregnancies with a live birth, infants with a shared subscriber identifier and a date of birth within 30 days of delivery were linked for the assessment of infant outcomes.
Results: During the study period, 523,250 eligible pregnancies were identified in the HIRD. Of these eligible pregnancies, 207 were exposed to galcanezumab and 137 were eligible for comparative analysis. Relevant galcanezumab exposures most frequently began prior to LMP (88.3%) with a few (10.9%) occurring during the first trimester. Of the 137 pregnancies eligible for comparative analysis, 92 had a documented end of pregnancy and 45 were ongoing or lost to follow-up. Of the 92 known completed pregnancies, 63 resulted in a live birth and 39 were linked to infant claims.
Conclusions: The HIRD is a large commercial claims database that includes 17% of the US population and approximately 3.9% of US births during the study period. However, even with this large database, only 39 galcanezumab-exposed pregnancies linked to infants were identified during the more than 3-year study period.
.jpg "Sarah R. Hoffman, PhD, MS, MPH (she/her/hers) photo")
