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dc.contributor.authorSinger, Barry A
dc.contributor.authorAlroughani, Raed
dc.contributor.authorBroadley, Simon
dc.contributor.authorEichau, Sara
dc.contributor.authorHartung, Hans-Peter
dc.contributor.authorHavrdova, Eva Kubala
dc.contributor.authorKim, Ho Jin
dc.contributor.authorNakamura, Kunio
dc.contributor.authorNavas, Carlos
dc.contributor.authorPozzilli, Carlo
dc.contributor.authorRovira, Alex
dc.contributor.authorVermersch, Patrick
dc.contributor.authorWray, Sibyl
dc.contributor.authorChung, Luke
dc.contributor.authorDaizadeh, Nadia
dc.contributor.authoret al.
dc.description.abstractObjective: Evaluate efficacy/safety of alemtuzumab over 8 years (y) in CARE-MS II patients. Background: In CARE-MS II (NCT00548405), alemtuzumab (12 mg/day; baseline: 5 days; 12 months later: 3 days) significantly improved clinical/MRI outcomes versus SC IFNB-1a over 2 y in relapsing-remitting MS (RRMS) patients with inadequate response to prior therapy. Efficacy was maintained in a 4-y extension (NCT00930553), in which patients could receive additional, as-needed alemtuzumab (12 mg/day on 3 days; ≥12 months apart) for disease activity or other disease-modifying therapy (DMT) per investigator discretion. Following the initial 4-y extension, patients could continue in TOPAZ (NCT02255656), an additional 5-y extension. Design/Methods: Patients in TOPAZ can receive additional alemtuzumab (≥12 months apart) or other DMT (at any time), both per investigator’s discretion. Results: 300/435 patients (69%) completed Y2 of TOPAZ (Y8 after initiating alemtuzumab). 44% received neither additional alemtuzumab nor another DMT through Y8. At Y8, annualized relapse rate was 0.18; 85% were relapse-free. From core study baseline to Y8, 70% of patients had stable/improved EDSS scores; mean EDSS score change was +0.17. Through Y8, 64% of patients were free of 6-month confirmed disability worsening; 47% attained 6-month confirmed disability improvement. In Y8, 58% of patients achieved no evidence of disease activity, 70% were free of MRI disease activity, 89% were free of new Gd-enhancing lesions, and 70% were free of new/enlarging T2 hyperintense lesions. Median cumulative brain volume loss (BVL) from baseline through Y8 was −1.06%; annual BVL was ≤0.19% in Y3–8. Incidence of overall adverse events (AEs) and infections decreased through Y8. Thyroid AE incidence peaked at 17% in Y3, declining thereafter. Conclusions: Efficacy of alemtuzumab on clinical, MRI, and BVL outcomes was maintained over 8 y without continuous treatment in CARE-MS II patients, with a consistent and manageable safety profile.
dc.publisherLippincott Williams & Wilkins
dc.relation.ispartofconferencename71st Annual Meeting of the American-Academy-of-Neurology (AAN)
dc.relation.ispartoflocationPhiladelphia, PA
dc.relation.ispartofissue15 Supplement
dc.subject.fieldofresearchClinical Sciences
dc.subject.fieldofresearchCognitive Sciences
dc.subject.keywordsScience & Technology
dc.subject.keywordsLife Sciences & Biomedicine
dc.subject.keywordsClinical Neurology
dc.subject.keywordsNeurosciences & Neurology
dc.titleImproved Clinical and MRI Disease Activity Outcomes, Including Slowing of Brain Volume Loss, in Alemtuzumab-Treated RRMS Patients: 8-Year Follow-up of CARE-MS II (TOPAZ Study)
dc.typeConference output
dc.type.descriptionE3 - Conferences (Extract Paper)
dcterms.bibliographicCitationSinger, BA; Alroughani, R; Broadley, S; Eichau, S; Hartung, H-P; Havrdova, EK; Kim, HJ; Nakamura, K; Navas, C; Pozzilli, C; Rovira, A; Vermersch, P; Wray, S; Chung, L; et al.; Selmaj, KW, Improved Clinical and MRI Disease Activity Outcomes, Including Slowing of Brain Volume Loss, in Alemtuzumab-Treated RRMS Patients: 8-Year Follow-up of CARE-MS II (TOPAZ Study), Neurology, 2019, 92 (15)
gro.hasfulltextNo Full Text
gro.griffith.authorBroadley, Simon

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