Carelon Research, Wilmington, Delaware, USA.
Eli Lilly and Company, Indianapolis, Indiana, USA.
Pharmacoepidemiol Drug Saf. 2024 Oct;33(10):e70015. doi: 10.1002/pds.70015.
Galcanezumab is a calcitonin gene-related peptide monoclonal antibody indicated for migraine prevention in adults. Due to the long half-life of galcanezumab and the prevalence of migraine in women of childbearing age, galcanezumab exposure may occur during pregnancy. However, real-world use and safety of galcanezumab during pregnancy has not been fully described. To help fill this gap, galcanezumab has two ongoing pregnancy safety studies, one of which is an insurance claims database study.
This database study is actively identifying and following pregnancies exposed to galcanezumab using commercial claims from the Healthcare Integrated Research Database (HIRD). Patient accrual is planned from September 2018 to June 2026, with a final study report planned for December 2027. This study requires 430 galcanezumab-exposed pregnancies with linked infants to reach power for comparative analysis of major congenital malformations.
Recent monitoring of patient accrual, including data from 28 September 2018 to 31 January 2023, identified 207 galcanezumab-exposed pregnancies in women with migraine in the HIRD, of which 110 were live births and 73 of which were linked to an infant. This represents an annual accrual rate of approximately 17 pregnancies linked to infants, which is substantially lower than the 55 required annually to reach target size within current regulatory-committed study timelines.
The accrual of a sufficient number of galcanezumab-exposed pregnancies represents a substantial, but not uncommon, barrier to conducting comparative analyses in pregnancy studies. Potential solutions that would allow for timely dissemination of important safety information to patients and providers may be available.
加兰他敏是一种降钙素基因相关肽单克隆抗体，用于预防成人偏头痛。由于加兰他敏半衰期长，且生育年龄的女性偏头痛患病率高，因此加兰他敏可能在怀孕期间暴露。然而，加兰他敏在怀孕期间的实际使用情况和安全性尚未得到充分描述。为了帮助填补这一空白，加兰他敏正在进行两项妊娠安全性研究，其中一项是保险索赔数据库研究。
这项数据库研究正在使用医疗保健综合研究数据库（HIRD）中的商业索赔积极识别和跟踪暴露于加兰他敏的妊娠情况。患者入组计划从 2018 年 9 月至 2026 年 6 月进行，最终研究报告计划于 2027 年 12 月完成。这项研究需要 430 例暴露于加兰他敏且与婴儿相关联的妊娠，以达到对主要先天畸形进行比较分析的效力。
最近对患者入组情况的监测，包括 2018 年 9 月 28 日至 2023 年 1 月 31 日的数据，确定了 HIRD 中 207 例偏头痛女性的 207 例暴露于加兰他敏的妊娠，其中 110 例为活产，73 例与婴儿相关联。这代表每年约有 17 例与婴儿相关联的妊娠入组，大大低于目前监管承诺的研究时间内每年需要 55 例才能达到目标规模。
足够数量的暴露于加兰他敏的妊娠的入组是进行妊娠研究中比较分析的一个重大但并非不常见的障碍。可能存在允许及时向患者和提供者传播重要安全信息的潜在解决方案。
