{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T19:19:38Z","timestamp":1791659978135,"version":"4.3.4"},"reference-count":28,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2024,10,7]],"date-time":"2024-10-07T00:00:00Z","timestamp":1728259200000},"content-version":"vor","delay-in-days":6,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004312","name":"Eli Lilly and Company","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004312","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2024,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>Galcanezumab is a calcitonin gene\u2010related peptide monoclonal antibody indicated for migraine prevention in adults. Due to the long half\u2010life of galcanezumab and the prevalence of migraine in women of childbearing age, galcanezumab exposure may occur during pregnancy. However, real\u2010world 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>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\u2010exposed pregnancies with linked infants to reach power for comparative analysis of major congenital malformations.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Recent monitoring of patient accrual, including data from 28 September 2018 to 31 January 2023, identified 207 galcanezumab\u2010exposed 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\u2010committed study timelines.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The accrual of a sufficient number of galcanezumab\u2010exposed 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.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.70015","type":"journal-article","created":{"date-parts":[[2024,10,8]],"date-time":"2024-10-08T06:05:42Z","timestamp":1728367542000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Monitoring Pregnancies Exposed to Galcanezumab for Migraine in a United States Administrative Claims Database"],"prefix":"10.1002","volume":"33","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5629-160X","authenticated-orcid":false,"given":"Sarah R.","family":"Hoffman","sequence":"first","affiliation":[{"name":"Carelon Research  Wilmington Delaware USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francis","family":"Mawanda","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company  Indianapolis Indiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher L.","family":"Crowe","sequence":"additional","affiliation":[{"name":"Carelon Research  Wilmington Delaware USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dustin D.","family":"Ruff","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company  Indianapolis Indiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephan","family":"Lanes","sequence":"additional","affiliation":[{"name":"Carelon Research  Wilmington Delaware USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0589-2613","authenticated-orcid":false,"given":"Krista","family":"Schroeder","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company  Indianapolis Indiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,10,7]]},"reference":[{"key":"e_1_2_10_2_1","unstructured":"U.S. Department of Health and Human ServicesandFood and Drug Administration \u201cPostapproval Pregnancy Safety Studies Guidance for Industry \u201daccessed October 16 2023 https:\/\/www.fda.gov\/media\/124746\/download."},{"key":"e_1_2_10_3_1","unstructured":"Eli Lilly and Company \u201cEMGALITY (Galcanezumab\u2010gnlm) Injection for Subcutaneous Use \u201daccessed October 16 2023 https:\/\/pi.lilly.com\/us\/emgality\u2010uspi.pdf."},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.13966"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1517\/14740338.2010.505601"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.7759\/cureus.36828"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10072\u2010019\u201003792\u20109"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1186\/s10194\u2010023\u201001613\u20101"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2018.1212"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102418779543"},{"issue":"2","key":"e_1_2_10_11_1","first-page":"251","article-title":"Characteristics of Linked and Unlinked Mother\u2010Infant in the HealthCore Integrated Research Database (Abstract 559)","volume":"31","author":"Jamal\u2010Allial A.","year":"2022","journal-title":"Pharmacoepidemiology and Drug Safety"},{"key":"e_1_2_10_12_1","first-page":"380","article-title":"Drug Safety in Pregnancy: Review of Study Approaches Requested by Regulatory Agencies","volume":"6","author":"Margulis A. 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