RT Journal Article
SR Electronic
T1 Alemtuzumab treatment of multiple sclerosis: long-term safety and efficacy
JF Journal of Neurology, Neurosurgery & Psychiatry
JO J Neurol Neurosurg Psychiatry
FD BMJ Publishing Group Ltd
SP 208
OP 215
DO 10.1136/jnnp-2014-307721
VO 86
IS 2
A1 Orla Tuohy
A1 Lisa Costelloe
A1 Grant Hill-Cawthorne
A1 Ingunn Bjornson
A1 Katharine Harding
A1 Neil Robertson
A1 Karen May
A1 Tom Button
A1 Laura Azzopardi
A1 Onajite Kousin-Ezewu
A1 Michael T Fahey
A1 Joanne Jones
A1 D Alastair S Compston
A1 Alasdair Coles
YR 2015
UL http://jnnp.bmj.com/content/86/2/208.abstract
AB Objectives Alemtuzumab is a newly licensed treatment of active relapsing-remitting multiple sclerosis (RRMS) in Europe, which in phase II and III studies demonstrated superior efficacy over β-interferon in reducing disability progression over 2–3 years. In this observational cohort study, we sought to describe our longer-term experience of the efficacy and safety of alemtuzumab in active RRMS. Methods Clinical and laboratory data including serial Expanded Disability Status Scale (EDSS) assessments, from all 87 patients treated with alemtuzumab on investigator-led studies in Cambridge, UK, from 1999 to 2012, were collected. The occurrence of adverse events including secondary autoimmunity, malignancy and death, and pregnancy outcomes was recorded. Baseline variables including age, disease duration and relapse rate were compared in univariate and logistic regression analyses between groups with different disability outcomes. Results Over a median 7-year follow-up (range 33–144 months), most patients (52%) required just two cycles of alemtuzumab. In the remaining patients, relapses triggered re-treatment to a total of three cycles (36%), four cycles (8%) or five cycles (1%). Using a 6-month sustained accumulation of disability definition, 59/87 (67.8%) of patients had an improved or unchanged disability compared with baseline. By an area under the curve analysis, 52/87 (59.8%) patients had an overall improvement or stabilisation of disability. Higher baseline relapse rate was associated with worse long-term disability outcomes, with trends for longer disease duration and older age at first treatment. Secondary autoimmunity was the most frequent adverse event occurring in 41/86 (47.7%) patients, most commonly involving the thyroid gland. Conclusions Alemtuzumab is associated with disease stabilisation in the majority of patients with highly active RRMS over an average seven-year follow-up. No new safety concerns arose over this extended follow-up.