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dc.contributor.authorHolmøy, Trygveen_US
dc.contributor.authorFevang, Børreen_US
dc.contributor.authorOlsen, David Beneeen_US
dc.contributor.authorSpigset, Olaven_US
dc.contributor.authorBø, Larsen_US
dc.date.accessioned2020-05-13T08:34:12Z
dc.date.available2020-05-13T08:34:12Z
dc.date.issued2019-08-12
dc.PublishedHolmøy T, Fevang B, Olsen, Spigset O, Bø L. Adverse events with fatal outcome associated with alemtuzumab treatment in multiple sclerosis. BMC Research Notes. 2019;12:497eng
dc.identifier.issn1756-0500
dc.identifier.urihttps://hdl.handle.net/1956/22216
dc.description.abstractObjective: Sporadic fatal adverse events have been reported during treatment of multiple sclerosis with alemtuzumab. To provide a systematic overview, we searched the centralized European Medicines Agency database of suspected adverse reactions related to medicinal products (EudraVigilance) for fatal adverse events associated with treatment with alemtuzumab (Lemtrada®) for multiple sclerosis. Four independent reviewers with expertise on MS, clinical immunology, infectious diseases and clinical pharmacology reviewed the reports, and scored the likelihood for causality. Results: We identified nine cases with a probable and one case with a possible causal relationship between alemtuzumab treatment and a fatal adverse event. Six of these patients died within one month after treatment; one from intracerebral hemorrhage, two from acute multiple organ failure and septic shock, one from listeriosis, one from pneumonia and one from agranulocytosis. Four patients died several months after administration of alemtuzumab from either autoimmune hepatitis, immune-mediated thrombocytopenia, autoimmune hemolytic anemia or agranulocytosis. Four of the 10 cases had been published previously in case reports or congress abstracts. Fatal adverse events related to treatment with alemtuzumab occur more frequently than previously published in the literature. A significant proportion occurs in the first month after treatment.en_US
dc.language.isoengeng
dc.publisherBMCeng
dc.rightsAttribution CC BYeng
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/eng
dc.subjectMultiple sclerosiseng
dc.subjectTreatmenteng
dc.subjectAlemtuzumabeng
dc.subjectAdverse eventeng
dc.titleAdverse events with fatal outcome associated with alemtuzumab treatment in multiple sclerosisen_US
dc.typePeer reviewed
dc.typeJournal article
dc.date.updated2019-12-13T13:07:41Z
dc.description.versionpublishedVersionen_US
dc.rights.holderCopyright 2019 The Author(s)
dc.identifier.doihttps://doi.org/10.1186/s13104-019-4507-6
dc.identifier.cristin1722039
dc.source.journalBMC Research Notes


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