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Alemtuzumab CARE-MS II 5-year follow-up: Efficacy and safety findings
Alasdair J Coles1, Jeffrey A Cohen2, Edward J Fox2
1From the Department of Clinical Neurosciences (A.J.C., D.A.S.C.), University of Cambridge, UK; Mellen Center (J.A.C.), Cleveland Clinic, OH; MS Clinic of Central Texas (E.J.F.), Central Texas Neurology Consultants, Round Rock; Queen Mary University of London (G.G.), Barts and the London School of Medicine, UK; Department of Neurology and Center for Neuropsychiatry (H.-P.H.), Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany; Department of Neurology and Center for Clinical Neuroscience (E.H.), First Faculty of Medicine, Charles University and General Hospital in Prague, Czech Republic; Neuroimmunology and Multiple Sclerosis Research, Department of Neurology (S.S.), University Hospital Zürich and University of Zürich, Switzerland; Department of Neurology (K.W.S.), Medical University of Łódź, Poland; The University of British Columbia (A.T.), Vancouver, Canada; Sanofi (D.H.M., K.T., M.C.C., D.J., M.A.P.), Cambridge, MA; Envision Scientific Solutions (P.X.), Philadelphia, PA; Envision Scientific Solutions (R.J.H.), Sydney, NSW, Australia; NeuroRx Research (D.L.A.), Montréal; Department of Neurology and Neurosurgery (D.L.A.), Montréal Neurological Institute, McGill University, Québec, Canada. M.A.P. is currently affiliated with Wave Life Sciences, Cambridge, MA. ajc1020@medschl.cam.ac.uk.
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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