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dc.contributor.authorSinger, Barry A
dc.contributor.authorAlroughani, Raed
dc.contributor.authorBrassat, David
dc.contributor.authorBroadley, Simon
dc.contributor.authorHartung, Hans-Peter
dc.contributor.authorHavrdova, Eva
dc.contributor.authorKim, Ho Jin
dc.contributor.authorOreja-Guevara, Celia
dc.contributor.authorPozzilli, Carlo
dc.contributor.authorSelmaj, Krzysztof W
dc.contributor.authorVermersch, Patrick
dc.contributor.authorWray, Sibyl
dc.contributor.authorMargolin, David H
dc.contributor.authorChung, Luke
dc.contributor.authorDaizadeh, Nadia
dc.contributor.authorChirieac, Madalina
dc.contributor.authorColes, Alasdair J
dc.date.accessioned2021-05-18T06:09:17Z
dc.date.available2021-05-18T06:09:17Z
dc.date.issued2018
dc.identifier.issn0028-3878
dc.identifier.urihttp://hdl.handle.net/10072/404487
dc.description.abstractObjective: Evaluate efficacy/safety of alemtuzumab over 7 years (y) in relapsing-remitting MS (RRMS) patients from CARE-MS II. Background: In CARE-MS II (NCT00548405), alemtuzumab (12mg/day, baseline: 5 days; 12 months later: 3 days) significantly improved clinical/MRI outcomes versus SC IFNB-1a over 2 y in patients with inadequate response to prior therapy. Durable efficacy was observed in a 4-y extension (NCT00930553; 93% enrolled, 86% completed), in which patients could receive alemtuzumab retreatment as-needed for relapse/MRI activity or receive other disease-modifying therapies (DMTs) per investigator’s discretion. Patients completing the extension could enroll in TOPAZ (n=336), a 5-y study (NCT02255656), for further evaluation. Design/Methods: In TOPAZ, patients can receive alemtuzumab retreatment (≥12 months apart) or other DMTs at any time (both per investigator’s discretion). MRI scans are performed annually. Assessments: annualized relapse rate (ARR); 6-month confirmed disability worsening (CDW); 6-month confirmed disability improvement (CDI); no evidence of disease activity (NEDA); AEs. Results: 317 patients (94%) completed TOPAZ Y1 (Y7 after initiating alemtuzumab). ARR remained low (Y7: 0.14); 51% were relapse-free in Y3–7. The percentage of patients with stable/improved EDSS scores versus baseline remained high (Y7: 73%). At Y7, 69% were 6-month CDW-free, and 44% achieved 6-month CDI. The majority of patients achieved NEDA each year (Y7: 60%). 47% received no additional treatment (alemtuzumab or other DMT) after the initial 2 courses. Overall AE incidence, infusion-associated reactions, and infections decreased over time. Thyroid AE incidence peaked in Y3 (17%) and then declined. Conclusions: Alemtuzumab efficacy was maintained for 7 y in CARE-MS II patients, despite 47% receiving no additional treatment since the initial 2 courses. 44% of patients also showed improvement in disability. Alemtuzumab safety profile remained consistent; overall AE incidence decreased over time. Alemtuzumab may provide a unique treatment approach for patients, offering durable efficacy in the absence of continuous treatment.
dc.languageEnglish
dc.publisherLippincott Williams & Wilkins
dc.publisher.urihttps://n.neurology.org/content/90/15_Supplement/P6.369.abstract
dc.relation.ispartofconferencename70th Annual Meeting of the American Academy of Neurology (AAN)
dc.relation.ispartofconferencetitleNeurology
dc.relation.ispartofdatefrom2018-04-21
dc.relation.ispartofdateto2018-04-27
dc.relation.ispartoflocationLos Angeles, CA, USA
dc.relation.ispartofissue15 Supplement
dc.relation.ispartofvolume90
dc.subject.fieldofresearchClinical sciences
dc.subject.fieldofresearchNeurosciences
dc.subject.fieldofresearchCognitive and computational psychology
dc.subject.fieldofresearchcode3202
dc.subject.fieldofresearchcode3209
dc.subject.fieldofresearchcode5204
dc.subject.keywordsScience & Technology
dc.subject.keywordsLife Sciences & Biomedicine
dc.subject.keywordsClinical Neurology
dc.subject.keywordsNeurology
dc.titleDurable Clinical Outcomes With Alemtuzumab in Patients With Active RRMS in the Absence of Continuous Treatment: 7-Year Follow-up of CARE-MS II Patients (TOPAZ Study)
dc.typeConference output
dc.type.descriptionE3 - Conferences (Extract Paper)
dcterms.bibliographicCitationSinger, BA; Alroughani, R; Brassat, D; Broadley, S; Hartung, H-P; Havrdova, E; Kim, HJ; Oreja-Guevara, C; Pozzilli, C; Selmaj, KW; Vermersch, P; Wray, S; Margolin, DH; Chung, L; Daizadeh, N; Chirieac, M; Coles, AJ, Durable Clinical Outcomes With Alemtuzumab in Patients With Active RRMS in the Absence of Continuous Treatment: 7-Year Follow-up of CARE-MS II Patients (TOPAZ Study), Neurology, 2018, 90
dc.date.updated2021-05-18T05:59:40Z
gro.hasfulltextNo Full Text
gro.griffith.authorBroadley, Simon


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