Alemtuzumab CARE-MS I 5-year follow-up: Durable Efficacy in The Absence of Continuous MS Therapy  

Oleh:

Havrdova, Eva ; Arnold, Douglas L. ; Cohen, Jeffrey A. ; Hartung, Hans-Peter ; Fox, Edward J. ; Giovannoni, Gavin ; Schippling, Sven ; Selmaj, Krzysztof W. ; Traboulsee, Anthony ; Compston, D. Alastair S. ; Margolin, David H. ; Thangavelu, Karthinathan ; Rodriguez, Claudio E. ; Jody, Darlene ; Hogan, Richard J. ; Xenopoulos, Panos ; Panzara, Michael A. ; Coles, Alasdair J.

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: Neurology (Official Journal of The American Academy of Neurology) vol. 89 no. 11 (Sep. 2017), page 1107-1116.
Topik: Alemtuzumab; CARE-MS I
Fulltext: N11 v89 n11 p1107 kelik2017.pdf (613.4KB)

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Perpustakaan FK Nomor Panggil: N11.K Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

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Isi artikel

Objective: To evaluate 5-year efficacy and safety of alemtuzumab in treatment-naive patients with active relapsing-remitting MS (RRMS) (CARE-MS I; NCT00530348). Methods: Alemtuzumab-treated patients received treatment courses at baseline and 12 months later; after the core study, they could enter an extension (NCT00930553) with as-needed alemtuzumab retreatment for relapse or MRI activity. Assessments included annualized relapse rate (ARR), 6-month confirmed disability worsening (CDW; =1-point Expanded Disability Status Scale [EDSS] score increase [=1.5 if baseline EDSS = 0]), 6-month confirmed disability improvement (CDI; =1-point EDSS decrease [baseline score =2.0]), no evidence of disease activity (NEDA), brain volume loss (BVL), and adverse events (AEs). Results: Most alemtuzumab-treated patients (95.1%) completing CARE-MS I enrolled in the extension; 68.5% received no additional alemtuzumab treatment. ARR remained low in years 3, 4, and 5 (0.19, 0.14, and 0.15). Over years 0–5, 79.7% were free of 6-month CDW; 33.4% achieved 6-month CDI. Most patients (61.7%, 60.2%, and 62.4%) had NEDA in years 3, 4, and 5. Median yearly BVL improved over years 2–4, remaining low in year 5 (years 1–5: -0.59%, -0.25%, -0.19%, -0.15%, and -0.20%). Exposure-adjusted incidence rates of most AEs declined in the extension relative to the core study. Thyroid disorder incidences peaked at year 3 and subsequently declined. Conclusions: Based on these data, alemtuzumab provides durable efficacy through 5 years in the absence of continuous treatment, with most patients not receiving additional courses.

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