{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T19:37:14Z","timestamp":1777491434339,"version":"3.51.4"},"reference-count":25,"publisher":"SAGE Publications","issue":"8","license":[{"start":{"date-parts":[[2022,3,10]],"date-time":"2022-03-10T00:00:00Z","timestamp":1646870400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/100002429","name":"Amgen","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100002429","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Cephalalgia"],"published-print":{"date-parts":[[2022,7]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Immunogenicity of erenumab, a human anti-calcitonin gene-related peptide receptor monoclonal antibody developed for migraine prevention, has been evaluated throughout clinical development.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Integrated post hoc analysis assessing immunogenicity of erenumab across six clinical trials in patients with episodic and chronic migraine (N\u2009=\u20092985). Anti-erenumab antibody incidence and potential impact on pharmacokinetics, efficacy, and safety were evaluated in short-term (double-blind treatment phase 12\u201324 weeks) and long-term (double-blind treatment phase plus extensions of up to 5 years) analyses.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Anti-erenumab binding antibody incidence was low with few patients developing neutralizing antibodies. Antibody responses were mostly transient with low magnitude. Binding antibodies developed as early as 2\u20134 weeks after the first dose; the majority developed within the first 6 months and very few after the first year. Serum concentrations of erenumab in antibody-positive patients were generally lower than, but within the range of, antibody-negative patients. There was no impact of anti-erenumab antibodies on erenumab efficacy or safety with no differences between antibody-positive and antibody-negative patients in change in monthly migraine days or adverse event rates.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This pooled analysis showed that immunogenicity had no meaningful clinical impact on efficacy or safety of erenumab in patients with migraine. Clinical Trial Registration: ClinicalTrials.gov, NCT01952574; ClinicalTrials.gov, NCT02456740; Clinicaltrials.gov NCT02483585; Clinicaltrials.gov, NCT02174861; Clinicaltrials.gov, NCT02630459; Clinicaltrials.gov, NCT03812224<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/03331024221075621","type":"journal-article","created":{"date-parts":[[2022,3,11]],"date-time":"2022-03-11T00:46:11Z","timestamp":1646959571000},"page":"749-760","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":9,"title":["Immunogenicity of erenumab: A pooled analysis of six placebo-controlled trials with long-term extensions"],"prefix":"10.1177","volume":"42","author":[{"given":"Yanchen","family":"Zhou","sequence":"first","affiliation":[{"name":"Clinical Immunology, Amgen Inc., South San Francisco, CA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Feng","family":"Zhang","sequence":"additional","affiliation":[{"name":"Global Biostatistical Sciences, Amgen, Inc. Thousand Oaks, CA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marta","family":"Starcevic Manning","sequence":"additional","affiliation":[{"name":"Translational Safety and Bioanalytical Sciences, Amgen, Inc. Thousand Oaks, CA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zheng","family":"Hu","sequence":"additional","affiliation":[{"name":"Translational Safety and Bioanalytical Sciences, Amgen, Inc. Thousand Oaks, CA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cheng-Pang","family":"Hsu","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology, Amgen, Inc. Thousand Oaks, CA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Po-Wei","family":"Chen","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology, Amgen, Inc. Thousand Oaks, CA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cheng","family":"Peng","sequence":"additional","affiliation":[{"name":"Global Biostatistical Sciences, Amgen, Inc. Thousand Oaks, CA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brett","family":"Loop","sequence":"additional","affiliation":[{"name":"Global Safety, Amgen Inc., Thousand Oaks, CA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel T","family":"Mytych","sequence":"additional","affiliation":[{"name":"Clinical Immunology, Amgen, Inc. Thousand Oaks, CA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8073-719X","authenticated-orcid":false,"given":"Gabriel","family":"Paiva da Silva Lima","sequence":"additional","affiliation":[{"name":"Global Development, Neuroscience, Amgen, Inc. Thousand Oaks, CA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2022,3,10]]},"reference":[{"key":"bibr1-03331024221075621","unstructured":"US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER). Guidance for Industry Immunogenicity Assessment for Therapeutic Protein Products. https:\/\/www.fda.gov\/media\/85017\/download2014 (2014, accessed August 2021)."},{"key":"bibr2-03331024221075621","doi-asserted-by":"publisher","DOI":"10.2174\/1389201023378175"},{"key":"bibr3-03331024221075621","doi-asserted-by":"publisher","DOI":"10.1007\/s00415-004-1202-9"},{"key":"bibr4-03331024221075621","doi-asserted-by":"publisher","DOI":"10.1208\/s12248-014-9599-2"},{"key":"bibr5-03331024221075621","doi-asserted-by":"publisher","DOI":"10.1208\/s12248-015-9857-y"},{"key":"bibr6-03331024221075621","doi-asserted-by":"publisher","DOI":"10.1177\/1060028019835166"},{"key":"bibr7-03331024221075621","unstructured":"US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER). Immunogenicity testing of therapeutic protein products \u2014 developing and validating assays for anti-drug antibody detection. https:\/\/www.fda.gov\/media\/119788\/download2019 (2019, accessed August 2021)."},{"key":"bibr8-03331024221075621","unstructured":"European Medicine Agency - Committee for Medicinal Products for Human Use (CHMP). Guideline on validation of bioanalytical methods.\n                      EMEA\/CHMP\/EWP\/192217\/2009 Rev 1 Corr 2.\n                      https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-bioanalytical-method-validation_en.pdf (2011, accessed August 2021)."},{"key":"bibr9-03331024221075621","unstructured":"European Medicine Agency - Committee for Medicinal Products for Human Use (CHMP). Guideline on Immunogenicity assessment of therapeutic proteins. https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-immunogenicity-assessment-therapeutic-proteins-revision-1_en.pdf2017 (2017, accessed August 2021)."},{"key":"bibr10-03331024221075621","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(16)00019-3"},{"key":"bibr11-03331024221075621","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1705848"},{"key":"bibr12-03331024221075621","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(17)30083-2"},{"key":"bibr13-03331024221075621","doi-asserted-by":"publisher","DOI":"10.1177\/0333102418759786"},{"key":"bibr14-03331024221075621","doi-asserted-by":"publisher","DOI":"10.1111\/head.14138"},{"key":"bibr15-03331024221075621","doi-asserted-by":"publisher","DOI":"10.1111\/head.13652"},{"key":"bibr16-03331024221075621","doi-asserted-by":"publisher","DOI":"10.1111\/head.14096"},{"key":"bibr17-03331024221075621","doi-asserted-by":"publisher","DOI":"10.4155\/bio-2017-0185"},{"key":"bibr18-03331024221075621","doi-asserted-by":"publisher","DOI":"10.1208\/s12248-012-9340-y"},{"key":"bibr19-03331024221075621","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2013-203296"},{"key":"bibr20-03331024221075621","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2012-202220"},{"key":"bibr21-03331024221075621","doi-asserted-by":"publisher","DOI":"10.1016\/j.jid.2018.04.019"},{"key":"bibr22-03331024221075621","doi-asserted-by":"publisher","DOI":"10.1007\/s00277-010-0908-2"},{"key":"bibr23-03331024221075621","doi-asserted-by":"publisher","DOI":"10.1177\/0333102420920642"},{"key":"bibr24-03331024221075621","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-020-01211-5"},{"key":"bibr25-03331024221075621","doi-asserted-by":"publisher","DOI":"10.1208\/s12248-017-0059-7"}],"container-title":["Cephalalgia"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/03331024221075621","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/03331024221075621","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/03331024221075621","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T14:49:27Z","timestamp":1777387767000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/03331024221075621"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,3,10]]},"references-count":25,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2022,7]]}},"alternative-id":["10.1177\/03331024221075621"],"URL":"https:\/\/doi.org\/10.1177\/03331024221075621","relation":{},"ISSN":["0333-1024","1468-2982"],"issn-type":[{"value":"0333-1024","type":"print"},{"value":"1468-2982","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,3,10]]}}}