{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,29]],"date-time":"2026-05-29T10:23:03Z","timestamp":1780050183031,"version":"3.53.1"},"reference-count":34,"publisher":"SAGE Publications","issue":"10","license":[{"start":{"date-parts":[[2022,4,1]],"date-time":"2022-04-01T00:00:00Z","timestamp":1648771200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100006259","name":"Teva Pharmaceutical Industries","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006259","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Mult Scler"],"published-print":{"date-parts":[[2022,9]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Safety data on disease-modifying therapies (DMTs) for relapsing multiple sclerosis (RMS) during breastfeeding are limited.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>\n                      Assess safety outcomes for offspring breastfed by mothers undergoing glatiramer acetate (GA; Copaxone\n                      <jats:sup>\u00ae<\/jats:sup>\n                      ) treatment.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>This non-interventional, retrospective study used German Multiple Sclerosis and Pregnancy Registry data. Participants had RMS, a live birth, and received GA or no DMT during breastfeeding.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>GA cohort: 58 mothers\/60 offspring; matched controls: 60 mothers\/60 offspring; 86.7% (GA) and 25% (control) of offspring were born to mothers who had GA at some point during pregnancy. Maternal demographics and disease activity were comparable. Annualized number of hospitalizations was similar for breastfed offspring: 0.20 (95% confidence interval: 0.09\u20130.31; GA) and 0.25 (0.12\u20130.38, controls). Proportion of offspring requiring hospitalization was comparable between cohorts (18.33% vs. 20.00%). Annualized number of antibiotic uses was similar in both cohorts (0.22, 0.10\u20130.33 (GA) vs. 0.17, 0.06\u20130.27 (controls)) The proportion of offspring requiring antibiotics was 15.00% (both cohorts). More developmental delays were identified in controls versus the GA cohort (3 (5.36%) vs. 0). Growth parameters were comparable between cohorts.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>Maternal intake of GA during breastfeeding did not adversely affect offspring safety outcomes assessed during the first 18\u2009months of life.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/13524585221083982","type":"journal-article","created":{"date-parts":[[2022,4,1]],"date-time":"2022-04-01T08:18:26Z","timestamp":1648801106000},"page":"1641-1650","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":16,"title":["Eighteen-month safety analysis of offspring breastfed by mothers receiving glatiramer acetate therapy for relapsing multiple sclerosis \u2013 COBRA study"],"prefix":"10.1177","volume":"28","author":[{"given":"Andrea Ines","family":"Ciplea","sequence":"first","affiliation":[{"name":"Department of Neurology, St. Josef Hospital \u2013 Katholisches Klinikum Bochum, Ruhr University Bochum, Bochum, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Kurzeja","sequence":"additional","affiliation":[{"name":"European Medical Affairs, Teva Pharmaceuticals Europe B.V., Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandra","family":"Thiel","sequence":"additional","affiliation":[{"name":"Department of Neurology, St. Josef Hospital \u2013 Katholisches Klinikum Bochum, Ruhr University Bochum, Bochum, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabrina","family":"Haben","sequence":"additional","affiliation":[{"name":"Department of Neurology, St. Josef Hospital \u2013 Katholisches Klinikum Bochum, Ruhr University Bochum, Bochum, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessica","family":"Alexander","sequence":"additional","affiliation":[{"name":"Teva Pharmaceutical Industries Ltd, West Chester, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Evelyn","family":"Adamus","sequence":"additional","affiliation":[{"name":"Department of Neurology, St. Josef Hospital \u2013 Katholisches Klinikum Bochum, Ruhr University Bochum, Bochum, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4467-9011","authenticated-orcid":false,"given":"Kerstin","family":"Hellwig","sequence":"additional","affiliation":[{"name":"Department of Neurology, St. Josef Hospital \u2013 Katholisches Klinikum Bochum, Ruhr University Bochum, Bochum, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2022,4,1]]},"reference":[{"issue":"7","key":"bibr1-13524585221083982","volume":"11","author":"Saleem 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Product information, https:\/\/www.copaxone.com (2020, accessed 17 March 2021)."},{"key":"bibr15-13524585221083982","unstructured":"Copaxone Summary of product characteristics, https:\/\/www.medicines.org.uk\/emc\/product\/183#gref (2020, accessed 21 April 2021)."},{"key":"bibr16-13524585221083982","doi-asserted-by":"publisher","DOI":"10.7224\/1537-2073.2016-079"},{"key":"bibr17-13524585221083982","doi-asserted-by":"publisher","DOI":"10.1177\/1352458515623366"},{"key":"bibr18-13524585221083982","doi-asserted-by":"publisher","DOI":"10.1212\/NXI.0000000000000757"},{"key":"bibr19-13524585221083982","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2015.1806"},{"key":"bibr20-13524585221083982","doi-asserted-by":"publisher","DOI":"10.3390\/nu13020606"},{"key":"bibr21-13524585221083982","doi-asserted-by":"publisher","DOI":"10.1097\/GRF.0000000000000142"},{"key":"bibr22-13524585221083982","first-page":"6527458","volume":"2016","author":"Almas S","year":"2016","journal-title":"Mult 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