Alemtuzumab CARE-MS II 5-year follow-up: Efficacy and safety findings

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11110%2F17%3A10362900" target="_blank" >RIV/00216208:11110/17:10362900 - isvavai.cz</a>

Alternative codes found

RIV/00064165:_____/17:10362900

Result on the web

<a href="http://dx.doi.org/10.1212/WNL.0000000000004354" target="_blank" >http://dx.doi.org/10.1212/WNL.0000000000004354</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1212/WNL.0000000000004354" target="_blank" >10.1212/WNL.0000000000004354</a>

Result language

angličtina

Original language name

Alemtuzumab CARE-MS II 5-year follow-up: Efficacy and safety findings

Original language description

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 5 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: 20.48%, 20.22%, 20.10%, 20.19%, 20.07%). 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.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

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OECD FORD branch

30103 - Neurosciences (including psychophysiology)

Project

—

Continuities

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2017

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Neurology

ISSN

0028-3878

e-ISSN

—

Volume of the periodical

89

Issue of the periodical within the volume

11

Country of publishing house

US - UNITED STATES

Number of pages

10

Pages from-to

1117-1126

UT code for WoS article

000410051500008

EID of the result in the Scopus database

2-s2.0-85030615813