{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T18:42:16Z","timestamp":1792608136658,"version":"4.5.0"},"reference-count":33,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T00:00:00Z","timestamp":1791590400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T00:00:00Z","timestamp":1791590400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"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":["headachejournal.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Headache"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>This study was conducted to describe pregnancy outcomes reported following maternal or paternal exposure to galcanezumab in clinical trials and postmarketing surveillance.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Galcanezumab is a calcitonin gene\u2010related peptide\u2010inhibiting monoclonal antibody indicated for the preventive treatment of migraine. This long\u2010acting injectable medication has a half\u2010life of 27\u2009days. Despite high migraine prevalence in women during their childbearing years, information on the use of migraine preventive medications during pregnancy is limited.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This is a pooled analysis of clinical trial data with a descriptive case series from a pharmacovigilance database. First, all completed phase 1\u20133 galcanezumab clinical trials were searched for cases of pregnancy. Additionally, the manufacturer's worldwide safety database was searched for all postmarketing reports of galcanezumab\u2010exposed pregnancy through September 27, 2024. Maternal and fetal outcomes, trimester of exposure, and maternal risk factors were evaluated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In all, 52 pregnancies with maternal or paternal exposure were identified in 12 clinical trials, and 426 were identified in postmarketing reports. In clinical trials, pregnancy exposure to the full therapeutic galcanezumab concentration did not exceed the first trimester. Because of its long half\u2010life, subtherapeutic galcanezumab concentrations persisted into the second trimester in 16 of 30 maternal exposures. The exposure pattern was similar in postmarketing reports when information on the timing of dosing and conception was available, with 88 of 108 confirmed maternal exposures at therapeutic concentrations during the first trimester only, and 34 of 47 confirmed maternal exposures at subtherapeutic concentrations during the first and second trimester. Among pregnancies with reported outcomes, live births were recorded in 22 of 34 clinical trial pregnancies and 62 of 108 postmarketing pregnancies. Among pregnancies with available fetal outcome data, normal fetal outcomes were reported in 21 of 22 clinical trial pregnancies and 56 of 76 postmarketing pregnancies. Preexisting maternal risk factors were identified in 11 of 14 preterm births (three from clinical trials and 11 from postmarketing) and 23 of 44 spontaneous abortions (three from clinical trials and 41 from postmarketing). Nine cases of major congenital anomaly were identified among postmarketing cases, with none identified in clinical trials. Among these nine cases, no consistent pattern of system organ class involvement was observed, and five of the nine anomalies had a one or more relevant maternal risk factor.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Based on the available data from this pooled analysis, this review did not identify any qualitative safety signal suggesting a causal relationship between galcanezumab exposure and adverse maternal or fetal outcomes. Because exposure durations were often limited and follow\u2010up information was unavailable for many cases, no definitive conclusions can be drawn regarding the safety of galcanezumab during pregnancy.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/head.70242","type":"journal-article","created":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T08:10:48Z","timestamp":1791619848000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Pregnancy outcomes following exposure to galcanezumab: Analysis of cases from the galcanezumab clinical trials and postmarketing database"],"prefix":"10.1111","author":[{"given":"Irene","family":"Boz","sequence":"first","affiliation":[{"name":"Eli Lilly and Company  Indianapolis Indiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan Lewis","family":"Brandes","sequence":"additional","affiliation":[{"name":"Nashville Neuroscience Group  Nashville Tennessee USA"},{"name":"Department of Neurology Vanderbilt University School of Medicine  Nashville Tennessee USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher","family":"Robinson","sequence":"additional","affiliation":[{"name":"Charleston Maternal Fetal Medicine  Charleston South Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Fernanda","family":"Scantamburlo Fernandes","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company  Indianapolis Indiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Lipsius","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company  Indianapolis Indiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"LaRonda","family":"Morford","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company  Indianapolis Indiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Enemona Emmanuel","family":"Adaji","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company  Indianapolis Indiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anaclara","family":"Prada Jardim","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company  Indianapolis Indiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Holland C.","family":"Detke","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company  Indianapolis Indiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,10,10]]},"reference":[{"key":"e_1_2_13_2_1","unstructured":"World Health Organization.Migraine and other headache disorders.2024. Accessed June 17 2025.https:\/\/www.who.int\/news\u2010room\/fact\u2010sheets\/detail\/headache\u2010disorders."},{"key":"e_1_2_13_3_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102418779543"},{"key":"e_1_2_13_4_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2018.1212"},{"key":"e_1_2_13_5_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000006640"},{"key":"e_1_2_13_6_1","doi-asserted-by":"publisher","DOI":"10.1080\/03007995.2022.2059975"},{"key":"e_1_2_13_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1813440"},{"key":"e_1_2_13_8_1","volume-title":"Prescribing information","author":"EMGALITY \u2013 galcanezumab\u2010glnm injection, solution","year":"2025"},{"key":"e_1_2_13_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.1511"},{"key":"e_1_2_13_10_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12883-018-1193-2"},{"key":"e_1_2_13_11_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102420905321"},{"key":"e_1_2_13_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(14)70128-0"},{"key":"e_1_2_13_13_1","doi-asserted-by":"publisher","DOI":"10.1080\/14740338.2021.1866536"},{"key":"e_1_2_13_14_1","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-022-01458-0"},{"key":"e_1_2_13_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(20)30279-9"},{"key":"e_1_2_13_16_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12325-021-01911-7"},{"key":"e_1_2_13_17_1","doi-asserted-by":"publisher","DOI":"10.1177\/03331024221103509"},{"key":"e_1_2_13_18_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2017.3859"},{"key":"e_1_2_13_19_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000206831"},{"key":"e_1_2_13_20_1","first-page":"573","article-title":"Maternal plasma levels of endothelial dysfunction mediators including AM, CGRP, sICAM\u20101 and tHcy in pre\u2010eclampsia","volume":"21","author":"Fei X","year":"2012","journal-title":"Adv Clin Exp Med"},{"key":"e_1_2_13_21_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00404-014-3303-8"},{"key":"e_1_2_13_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.npep.2010.12.002"},{"key":"e_1_2_13_23_1","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-024-01715-4"},{"key":"e_1_2_13_24_1","doi-asserted-by":"publisher","DOI":"10.1177\/03331024231158083"},{"key":"e_1_2_13_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(21)00682-6"},{"key":"e_1_2_13_26_1","unstructured":"United States Department of Health and Human Services (DHHS) Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).Pregnancy lactation and reproductive potential: Labeling for human prescription drug and biological products\u2014content and format. Guidance for Industry.2020. Accessed June 15 2025.https:\/\/www.fda.gov\/media\/90160\/download"},{"key":"e_1_2_13_27_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00431-023-04865-w"},{"issue":"1","key":"e_1_2_13_28_1","first-page":"1","article-title":"Update on overall prevalence of major birth defects\u2014Atlanta, Georgia, 1978\u20102005","volume":"57","author":"Centers for Disease Control and Prevention","year":"2008","journal-title":"MMWR Morb Mortal Wkly Rep"},{"key":"e_1_2_13_29_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijms242316772"},{"key":"e_1_2_13_30_1","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2008.71"},{"key":"e_1_2_13_31_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.70015"},{"key":"e_1_2_13_32_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.2602"},{"key":"e_1_2_13_33_1","unstructured":"European Medicines Agency.Prospective pregnancy study to assess maternal and fetal outcomes following exposure to galcanezumab (I5Q\u2010MC\u2010B005). EU PAS number: EUPAS28151. HMA\u2010EMA Catalogues of real\u2010world data sources and studies. March 21 2024. Accessed July 22 2025.https:\/\/catalogues.ema.europa.eu\/node\/2790\/administrative\u2010details"},{"key":"e_1_2_13_34_1","unstructured":"European Medicines Agency.Observational Cohort Study of Exposure to Galcanezumab during Pregnancy (I5Q\u2010MC\u2010B003). EU PAS number: EUPAS27574. HMA\u2010EMA Catalogues of real\u2010world data sources and studies. January 3 2025. Accessed July 22 2025.https:\/\/catalogues.ema.europa.eu\/node\/3326\/administrative\u2010details"}],"container-title":["Headache: The Journal of Head and Face Pain"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/headachejournal.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/head.70242","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/headachejournal.onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/head.70242","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/headachejournal.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/head.70242","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T18:13:09Z","timestamp":1792606389000},"score":1,"resource":{"primary":{"URL":"https:\/\/headachejournal.onlinelibrary.wiley.com\/doi\/10.1111\/head.70242"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,10,10]]},"references-count":33,"alternative-id":["10.1111\/head.70242"],"URL":"https:\/\/doi.org\/10.1111\/head.70242","archive":["Portico"],"relation":{},"ISSN":["0017-8748","1526-4610"],"issn-type":[{"value":"0017-8748","type":"print"},{"value":"1526-4610","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,10,10]]},"assertion":[{"value":"2025-08-08","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-08-25","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-10-10","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"head.70242"}}