TY - JOUR
T1 - Alemtuzumab CARE-MS I 5-year follow-up
T2 - Durable efficacy in the absence of continuous MS therapy
AU - Havrdova, Eva
AU - Arnold, Douglas L.
AU - Cohen, Jeffrey A.
AU - Hartung, Hans-Peter
AU - Fox, Edward J.
AU - Giovannoni, Gavin
AU - Schippling, Sven
AU - Selmaj, Krzysztof W.
AU - Traboulsee, Anthony
AU - Compston, D. Alastair S.
AU - Margolin, David H.
AU - Thangavelu, Karthinathan
AU - Rodriguez, Claudio E.
AU - Jody, Darlene
AU - Hogan, Richard J.
AU - Xenopoulos, Panos
AU - Panzara, Michael A.
AU - CARE-MS I CAMMS03409 Investigators
AU - Hupperts, Raymond
AU - Coles, Alasdair J.
PY - 2017/9/12
Y1 - 2017/9/12
N2 - 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 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).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: 20.59%, 20.25%, 20.19%, 20.15%, and 20.20%). 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.
AB - 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 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).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: 20.59%, 20.25%, 20.19%, 20.15%, and 20.20%). 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.
KW - MULTIPLE-SCLEROSIS PATIENTS
KW - CONTROLLED PHASE-3 TRIAL
KW - LONG-TERM DISABILITY
KW - BRAIN ATROPHY
KW - INTERFERON-BETA
U2 - 10.1212/WNL.0000000000004313
DO - 10.1212/WNL.0000000000004313
M3 - Article
C2 - 28835401
VL - 89
SP - 1107
EP - 1116
JO - Neurology
JF - Neurology
SN - 0028-3878
IS - 11
ER -