{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,24]],"date-time":"2026-08-24T09:29:38Z","timestamp":1787563778011,"version":"build-2736575974"},"reference-count":32,"publisher":"SAGE Publications","issue":"2","license":[{"start":{"date-parts":[[2026,1,3]],"date-time":"2026-01-03T00:00:00Z","timestamp":1767398400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,1,3]],"date-time":"2026-01-03T00:00:00Z","timestamp":1767398400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Mult Scler"],"published-print":{"date-parts":[[2026,2]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>\n                      Gilenya\n                      <jats:sup>\u00ae<\/jats:sup>\n                      (fingolimod), a sphingosine-1-receptor agonist, is an effective treatment for multiple sclerosis (MS). However, increased relapse activity has been observed after transitioning to generic fingolimod despite prior prolonged disease stability.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>\n                      To quantify the clinical and radiological impact of transitioning from Gilenya\n                      <jats:sup>\u00ae<\/jats:sup>\n                      to generic fingolimod in people with MS (PwMS).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>\n                      Retrospective data were evaluated from a single tertiary MS care center. Time to magnetic resonance imaging (MRI) activity and clinical relapse was assessed during Gilenya\n                      <jats:sup>\u00ae<\/jats:sup>\n                      and generic fingolimod treatment. Differences in absolute lymphocyte count (ALC) and side effects were also measured by treatment group.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      The cohort included 88 PwMS (71 female; 76 White, mean age when starting Gilenya\n                      <jats:sup>\u00ae<\/jats:sup>\n                      was 39.6\u2009years (standard deviation (SD)\u2009=\u200910.6\u2009years), and mean age when starting generic fingolimod was 46.9 years (SD\u2009=\u200911.2 years)). A shorter time to MRI activity (\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u2009=\u20090.0026) and time to relapse (\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u2009=\u20090.0027) was observed during generic fingolimod treatment. The ALC increased by 8.81% after generic fingolimod treatment, relative to Gilenya\n                      <jats:sup>\u00ae<\/jats:sup>\n                      (95% CI\u2009=\u2009(2.00%, 16.08%),\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u2009=\u20090.01), with an intersubject variability of 1.97%. A 2.45-fold increase in side effects was observed with generic fingolimod relative to Gilenya\n                      <jats:sup>\u00ae<\/jats:sup>\n                      (95% CI\u2009=\u2009(1.38, 4.36),\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u2009=\u20090.002).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>Measures of disease stability appear less optimal with generic fingolimod based on serological, clinical, and radiological measures.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/13524585251401404","type":"journal-article","created":{"date-parts":[[2026,1,3]],"date-time":"2026-01-03T11:15:29Z","timestamp":1767438929000},"page":"192-201","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":1,"title":["Clinical and radiological outcomes of directed treatment transitions from Gilenya\n                    <sup>\u00ae<\/sup>\n                    to generic fingolimod"],"prefix":"10.1177","volume":"32","author":[{"ORCID":"https:\/\/orcid.org\/0009-0002-8245-2336","authenticated-orcid":false,"given":"Mahi A","family":"Patel","sequence":"first","affiliation":[{"name":"College of Osteopathic Medicine, Kansas City University, Kansas City, MO, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-2969-2360","authenticated-orcid":false,"given":"Tom G","family":"Punnen","sequence":"additional","affiliation":[{"name":"School of Medicine, The University of Texas Southwestern Medical Center, Dallas, TX, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin S","family":"Shan","sequence":"additional","affiliation":[{"name":"School of Medicine, The University of Texas Southwestern Medical Center, Dallas, TX, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8378-460X","authenticated-orcid":false,"given":"Morgan C","family":"McCreary","sequence":"additional","affiliation":[{"name":"Department of Neurology, The University of Texas Southwestern Medical Center, Dallas, TX, USA; Peter O\u2019Donnell Jr. Brain Institute, The University of Texas Southwestern Medical Center, Dallas, TX, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Crystal M","family":"Wright","sequence":"additional","affiliation":[{"name":"Department of Neurology, The University of Texas Southwestern Medical Center, Dallas, TX, USA; Peter O\u2019Donnell Jr. Brain Institute, The University of Texas Southwestern Medical Center, Dallas, TX, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-4747-9610","authenticated-orcid":false,"given":"Shanan B","family":"Munoz","sequence":"additional","affiliation":[{"name":"Department of Neurology, The University of Texas Southwestern Medical Center, Dallas, TX, USA; Peter O\u2019Donnell Jr. Brain Institute, The University of Texas Southwestern Medical Center, Dallas, TX, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paula","family":"Hardeman","sequence":"additional","affiliation":[{"name":"Department of Neurology, The University of Texas Southwestern Medical Center, Dallas, TX, USA; Peter O\u2019Donnell Jr. Brain Institute, The University of Texas Southwestern Medical Center, Dallas, TX, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katy W","family":"Burgess","sequence":"additional","affiliation":[{"name":"Department of Neurology, The University of Texas Southwestern Medical Center, Dallas, TX, USA; Peter O\u2019Donnell Jr. Brain Institute, The University of Texas Southwestern Medical Center, Dallas, TX, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2091-8201","authenticated-orcid":false,"given":"Benjamin M","family":"Greenberg","sequence":"additional","affiliation":[{"name":"Department of Neurology, The University of Texas Southwestern Medical Center, Dallas, TX, USA; Peter O\u2019Donnell Jr. Brain Institute, The University of Texas Southwestern Medical Center, Dallas, TX, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6040-1947","authenticated-orcid":false,"given":"Lindsay A","family":"Horton","sequence":"additional","affiliation":[{"name":"Department of Neurology, The University of Texas Southwestern Medical Center, Dallas, TX, USA; Peter O\u2019Donnell Jr. Brain Institute, The University of Texas Southwestern Medical Center, Dallas, TX, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1825-575X","authenticated-orcid":false,"given":"Peter V","family":"Sguigna","sequence":"additional","affiliation":[{"name":"Department of Neurology, The University of Texas Southwestern Medical Center, Dallas, TX, USA; Peter O\u2019Donnell Jr. Brain Institute, The University of Texas Southwestern Medical Center, Dallas, TX, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0214-633X","authenticated-orcid":false,"given":"Lauren M","family":"Tardo","sequence":"additional","affiliation":[{"name":"Department of Neurology, The University of Texas Southwestern Medical Center, Dallas, TX, USA; Peter O\u2019Donnell Jr. Brain Institute, The University of Texas Southwestern Medical Center, Dallas, TX, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0469-6872","authenticated-orcid":false,"given":"Olaf","family":"St\u00fcve","sequence":"additional","affiliation":[{"name":"Department of Neurology, The University of Texas Southwestern Medical Center, Dallas, TX, USA; Peter O\u2019Donnell Jr. Brain Institute, The University of Texas Southwestern Medical Center, Dallas, TX, USA; Neurology Section, Dallas Veterans Affairs Medical Center, Dallas, TX, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6499-1523","authenticated-orcid":false,"given":"Darin T","family":"Okuda","sequence":"additional","affiliation":[{"name":"Department of Neurology, The University of Texas Southwestern Medical Center, Dallas, TX, USA; Peter O\u2019Donnell Jr. Brain Institute, The University of Texas Southwestern Medical Center, Dallas, TX, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,1,3]]},"reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1146\/annurev.neuro.30.051606.094313"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(23)00281-8"},{"key":"e_1_3_2_4_2","doi-asserted-by":"publisher","DOI":"10.1002\/ana.26555"},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2023.2815"},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2024.4164"},{"key":"e_1_3_2_7_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0907839"},{"key":"e_1_3_2_8_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0909494"},{"key":"e_1_3_2_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(14)70049-3"},{"key":"e_1_3_2_10_2","first-page":"1","article-title":"Efficacy and safety of 2 fingolimod doses vs glatiramer acetate for the treatment of patients with relapsing-remitting multiple sclerosis: A randomized clinical trial","volume":"78","author":"Cree BAC","year":"2020","unstructured":"Cree BAC, Goldman MD, Corboy JR, et al. Efficacy and safety of 2 fingolimod doses vs glatiramer acetate for the treatment of patients with relapsing-remitting multiple sclerosis: A randomized clinical trial. JAMA Neurol 2020; 78: 1\u201313.","journal-title":"JAMA Neurol"},{"key":"e_1_3_2_11_2","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000001462"},{"key":"e_1_3_2_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.msard.2023.105134"},{"key":"e_1_3_2_13_2","volume-title":"European Medicines Agency recommends precautionary recall of batches of clopidogrel-containing medicines from Acino Pharma GmbH","author":"European Medicines Agency","year":"2010","unstructured":"European Medicines Agency. European Medicines Agency recommends precautionary recall of batches of clopidogrel-containing medicines from Acino Pharma GmbH. Amsterdam: European Medicines Agency, 2010."},{"key":"e_1_3_2_14_2","volume-title":"Class 3 medicines recall: Glenmark pharmaceuticals Europe Ltd, fingolimod 0.5 mg hard capsules (EL (24) A\/39)","author":"Medicines and Healthcare Products Regulatory Agency (MHRA)","year":"2024","unstructured":"Medicines and Healthcare Products Regulatory Agency (MHRA). Class 3 medicines recall: Glenmark pharmaceuticals Europe Ltd, fingolimod 0.5 mg hard capsules (EL (24) A\/39). London: Medicines and Healthcare Products Regulatory Agency (MHRA), 2024."},{"key":"e_1_3_2_15_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.diagmicrobio.2009.06.012"},{"key":"e_1_3_2_16_2","doi-asserted-by":"publisher","DOI":"10.1185\/03007990802207874"},{"key":"e_1_3_2_17_2","doi-asserted-by":"publisher","DOI":"10.1177\/17562864241300047"},{"key":"e_1_3_2_18_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(17)30470-2"},{"issue":"64","key":"e_1_3_2_19_2","first-page":"213","article-title":"A mechanistically novel, first oral therapy for multiple sclerosis: The development of fingolimod (FTY720, Gilenya)","volume":"12","author":"Chun J","year":"2011","unstructured":"Chun J, Brinkmann V. A mechanistically novel, first oral therapy for multiple sclerosis: The development of fingolimod (FTY720, Gilenya). Discov Med 2011; 12(64): 213\u2013228.","journal-title":"Discov Med"},{"key":"e_1_3_2_20_2","doi-asserted-by":"publisher","DOI":"10.1007\/s40120-019-00160-9"},{"key":"e_1_3_2_21_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.msard.2017.11.018"},{"key":"e_1_3_2_22_2","doi-asserted-by":"publisher","DOI":"10.1177\/1352458513500551"},{"key":"e_1_3_2_23_2","doi-asserted-by":"publisher","DOI":"10.1212\/NXI.0000000000000397"},{"key":"e_1_3_2_24_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.msard.2023.104692"},{"key":"e_1_3_2_25_2","volume-title":"Bottle of lies: The inside story of the generic drug boom","author":"Eban K","year":"2019","unstructured":"Eban K. Bottle of lies: The inside story of the generic drug boom. New York: HarperCollins, 2019."},{"key":"e_1_3_2_26_2","doi-asserted-by":"publisher","DOI":"10.2147\/DDDT.S106802"},{"key":"e_1_3_2_27_2","first-page":"319201","article-title":"Adding to the burden: Gastrointestinal symptoms and syndromes in multiple sclerosis","volume":"2013","author":"Levinthal DJ","year":"2013","unstructured":"Levinthal DJ, Rahman A, Nusrat S, et al. Adding to the burden: Gastrointestinal symptoms and syndromes in multiple sclerosis. Mult Scler Int 2013; 2013: 319201.","journal-title":"Mult Scler Int"},{"key":"e_1_3_2_28_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.xphs.2017.12.021"},{"key":"e_1_3_2_29_2","first-page":"1449","article-title":"Excipients and additives: Hidden hazards in drug products and in product substitution","volume":"131","author":"Napke E","year":"1984","unstructured":"Napke E, Stevens DG. Excipients and additives: Hidden hazards in drug products and in product substitution. Can Med Assoc J 1984; 131: 1449\u20131452.","journal-title":"Can Med Assoc J"},{"key":"e_1_3_2_30_2","doi-asserted-by":"publisher","DOI":"10.1126\/scitranslmed.aau6753"},{"key":"e_1_3_2_31_2","unstructured":"U.S. Food and Drug Administration. Generic drugs. https:\/\/www.fda.gov\/drugs\/buying-using-medicine-safely\/generic-drugs"},{"key":"e_1_3_2_32_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.msard.2023.105077"},{"key":"e_1_3_2_33_2","doi-asserted-by":"publisher","DOI":"10.1177\/1060028019881692"}],"container-title":["Multiple Sclerosis Journal"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/13524585251401404","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/13524585251401404","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/13524585251401404","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,2]],"date-time":"2026-05-02T04:20:03Z","timestamp":1777695603000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/13524585251401404"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,1,3]]},"references-count":32,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2026,2]]}},"alternative-id":["10.1177\/13524585251401404"],"URL":"https:\/\/doi.org\/10.1177\/13524585251401404","relation":{},"ISSN":["1352-4585","1477-0970"],"issn-type":[{"value":"1352-4585","type":"print"},{"value":"1477-0970","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,1,3]]}}}