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Autoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis: Benefit/risk following review of trial and post-marketing data.

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dc.contributor.authorColes, Alasdair J
dc.contributor.authorJones, Joanne L
dc.contributor.authorVermersch, Patrick
dc.contributor.authorTraboulsee, Anthony
dc.contributor.authorBass, Ann D
dc.contributor.authorBoster, Aaron
dc.contributor.authorChan, Andrew
dc.contributor.authorComi, Giancarlo
dc.contributor.authorFernandez, Oscar
dc.contributor.authorGiovannoni, Gavin
dc.contributor.authorKubala-Havrdova, Eva
dc.contributor.authorLaGanke, Christopher
dc.contributor.authorMontalban, Xavier
dc.contributor.authorOreja-Guevara, Celia
dc.contributor.authorPiehl, Fredrik
dc.contributor.authorWiendl, Heinz
dc.contributor.authorZiemssen, Tjalf
dc.date.accessioned2023-05-03T13:32:29Z
dc.date.available2023-05-03T13:32:29Z
dc.date.issued2021-10-18
dc.description.abstractDoes preexisting or treatment-emergent autoimmunity increase the risk of subsequent autoimmune disease in individuals with relapsing-remitting multiple sclerosis (MS) after alemtuzumab? In the extended phase 2/3 trials, 34/96 (35.4%) patients with and 395/1120 (35.3%) without preexisting autoimmunity developed non-MS autoimmunity. Thyroid autoimmunity after alemtuzumab courses 1 or 2 did not increase subsequent non-thyroid autoimmune adverse events. Therefore, autoimmune disease before or after alemtuzumab treatment does not predict autoimmunity after further courses, so should not preclude adequate alemtuzumab dosing to control MS. Finally, post-marketing safety data contribute toward a full record of the alemtuzumab benefit/risk profile for the MS field.
dc.description.versionSi
dc.identifier.citationColes AJ, Jones JL, Vermersch P, Traboulsee A, Bass AD, Boster A, et al. Autoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis: Benefit/risk following review of trial and post-marketing data. Mult Scler. 2022 Apr;28(5):842-846.
dc.identifier.doi10.1177/13524585211061335
dc.identifier.essn1477-0970
dc.identifier.pmcPMC8978465
dc.identifier.pmid34882037
dc.identifier.pubmedURLhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8978465/pdf
dc.identifier.unpaywallURLhttps://doi.org/10.1177/13524585211061335
dc.identifier.urihttp://hdl.handle.net/10668/20223
dc.issue.number5
dc.journal.titleMultiple sclerosis (Houndmills, Basingstoke, England)
dc.journal.titleabbreviationMult Scler
dc.language.isoen
dc.organizationHospital Universitario Regional de Málaga
dc.organizationFundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud-FIMABIS
dc.page.number842-846
dc.provenanceRealizada la curación de contenido 18/03/2025
dc.publisherSage Publications
dc.pubmedtypeJournal Article
dc.pubmedtypeReview
dc.pubmedtypeResearch Support, Non-U.S. Gov't
dc.relation.publisherversionhttps://journals.sagepub.com/doi/abs/10.1177/13524585211061335?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed
dc.rightsAttribution-NonCommercial 4.0 International
dc.rights.accessRightsopen access
dc.rights.urihttp://creativecommons.org/licenses/by-nc/4.0/
dc.subjectMultiple sclerosis
dc.subjectAlemtuzumab
dc.subjectAutoimmunity
dc.subjectPost-marketing
dc.subjectProduct surveillance
dc.subjectRisk assessment
dc.subjectTreatment outcome
dc.subject.decsAutoinmunidad
dc.subject.decsEnfermedades Autoinmunes
dc.subject.decsGlándula Tiroides
dc.subject.decsEsclerosis Múltiple Recurrente-Remitente
dc.subject.decsSeguridad
dc.subject.meshAlemtuzumab
dc.subject.meshAutoimmunity
dc.subject.meshClinical Trials, Phase II as Topic
dc.subject.meshClinical Trials, Phase III as Topic
dc.subject.meshHumans
dc.subject.meshMarketing
dc.subject.meshMultiple Sclerosis
dc.subject.meshMultiple Sclerosis, Relapsing-Remitting
dc.titleAutoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis: Benefit/risk following review of trial and post-marketing data.
dc.typeresearch article
dc.type.hasVersionVoR
dc.volume.number28
dspace.entity.typePublication

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