RT Journal Article
SR Electronic
T1 Alemtuzumab CARE-MS II 5-year follow-up
JF Neurology
JO Neurology
FD Lippincott Williams & Wilkins
SP 1117
OP 1126
DO 10.1212/WNL.0000000000004354
VO 89
IS 11
A1 Coles, Alasdair J.
A1 Cohen, Jeffrey A.
A1 Fox, Edward J.
A1 Giovannoni, Gavin
A1 Hartung, Hans-Peter
A1 Havrdova, Eva
A1 Schippling, Sven
A1 Selmaj, Krzysztof W.
A1 Traboulsee, Anthony
A1 Compston, D. Alastair S.
A1 Margolin, David H.
A1 Thangavelu, Karthinathan
A1 Chirieac, Madalina C.
A1 Jody, Darlene
A1 Xenopoulos, Panos
A1 Hogan, Richard J.
A1 Panzara, Michael A.
A1 Arnold, Douglas L.
YR 2017
UL http://n.neurology.org/content/89/11/1117.abstract
AB 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.AE=adverse event; ARR=annualized relapse rate; BPF=brain parenchymal fraction; BVL=brain volume loss; CARE-MS II=Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis II; CDI=confirmed disability improvement; CDW=confirmed disability worsening; CI=confidence interval; DMT=disease-modifying therapy; EAIR=exposure-adjusted incidence rate; EDSS=Expanded Disability Status Scale; Gd=gadolinium; IAR=infusion-associated reaction; IFN-β-1a=interferon β-1a; ITP=immune thrombocytopenia; MS=multiple sclerosis; NEDA=no evidence of disease activity; RRMS=relapsing-remitting multiple sclerosis; SC=subcutaneous