Alemtuzumab CARE-MS II 5-year follow-up: Efficacy and Safety Findings  

Oleh:

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

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: Neurology (Official Journal of The American Academy of Neurology) vol. 89 no. 11 (Sep. 2017), page 1117-1126.
Topik: Alemtuzumab; CARE-MS II
Fulltext: N11 v89 n11 p1117 kelik2017.pdf (837.65KB)

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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 patients with active relapsing-remitting multiple sclerosis and inadequate response to prior therapy. Methods: In the 2-year Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis (CARE-MS) II study (NCT00548405), alemtuzumab-treated patients received 2 courses (baseline and 12 months later). Patients could enter an extension (NCT00930553), with as-needed alemtuzumab retreatment for relapse or MRI activity. 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) were assessed. Results: Most alemtuzumab-treated patients (92.9%) who completed CARE-MS II entered the extension; 59.8% received no alemtuzumab retreatment. ARR was low in each extension year (years 3–5: 0.22, 0.23, 0.18). Through 5 years, 75.1% of patients were free of 6-month CDW; 42.9% achieved 6-month CDI. In years 3, 4, and 5, proportions with NEDA were 52.9%, 54.2%, and 58.2%, respectively. Median yearly BVL remained low in the extension (years 1–5: -0.48%, -0.22%, -0.10%, -0.19%, -0.07%). AE exposure-adjusted incidence rates in the extension were lower than in the core study. Thyroid disorders peaked at year 3, declining thereafter. Conclusions: Alemtuzumab provides durable efficacy through 5 years in patients with an inadequate response to prior therapy in the absence of continuous treatment. Classification of evidence: This study provides Class III evidence that alemtuzumab provides efficacy and slowing of brain atrophy through 5 years.

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