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#Post#: 967--------------------------------------------------
(ECTRIMS abst.) Long-term follow-up of early cohorts
(alemtuzumab in MS)
DIR By: agate
Date: October 11, 2015, 1:17 pm
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Presented at the ECTRIMS conference in Barcelona, October 7-10,
2015:
--- Quote ---
> Alemtuzumab in multiple sclerosis: long-term follow-up of the
early cohorts
>
> J.W.L. Brown1,2, O. Tuohy1, O. Kousin-Ezewu1, L. Azzopardi1,
T. Button1, C. Mccarthy1, T. Alli3, C. Callan3, M. Folks3, S.
Heller3, H. Laidley3, B. Nourallah3, C. O’Neill3, D. Obute3, R.
Piper3, O. Prankerd Smith3, H. Wickham3, X. Zheng3, K. May1, A.
Gerritz1, D.A.S. Compston1, J.L. Jones1, A.J. Coles1
>
> 1Department of Clinical Neurosciences, University of
Cambridge, Cambridge, 2University College London Institute of
Neurology, Queen Square Multiple Sclerosis Centre, NMR Research
Unit, London, 3University of Cambridge School of Clinical
Medicine, Cambridge, United Kingdom
>
> Background:
>
> In relapsing remitting multiple sclerosis (RRMS) alemtuzumab
is highly effective at reducing relapses and disability accrual,
and is now widely licensed. We present the efficacy and safety
data from two early single-arm studies of alemtuzumab in RRMS
(median follow-up 10.1 years), and contrast the findings with a
secondary progressive (SPMS) cohort (median follow-up 19.8
years). These cohorts informed the design of subsequent clinical
trials.
>
> Methods:
>
> We treated 86 patients with highly active RRMS (median two
relapses per year before treatment; median (standard deviation
(SD)) Expanded Disability Status Scale (EDSS) score at baseline:
3.5 (2.0)) plus 36 patients with SPMS (baseline EDSS: 6 (0.9)).
Relapses, change in disability and adverse events were recorded.
Univariate and logistic regression analyses were used to
identify baseline variables associated with a higher risk of
disability progression.
>
> Results:
>
> RRMS
>
> After 10.1 years, 39/86 patients (45%) remained relapse-free.
Forty-one patients (48%) required two cycles of alemtuzumab (the
standard treatment course), while relapses triggered
re-treatment to a total of three cycles (in 33 patients (38%)),
four cycles (in nine patients (10%)) and five cycles (in three
patients (3%)). The EDSS remained largely unchanged 10.1 years
later (3.5, SD 2.2; p NS). One patient died, unrelated to
multiple sclerosis.
>
> SPMS
>
> Patients received one (n=28), two (n=7) or three (n=1) cycles
of alemtuzumab. After 19.8 years, the median EDSS had
significantly increased from 6 (SD 0.9) to 8.75 (SD 1.4), p<
0.0001, and 13 patients had died.
>
> Adverse events
>
> Secondary clinical autoimmunity occurred in 41/86 (48%) of the
RRMS cohort and 16/36 (44%) of the SPMS cohort, a median 18.0
and 28.5 months respectively after the last alemtuzumab
treatment. The thyroid gland was most commonly affected.
>
> Conclusions:
>
> Alemtuzumab causes long-lasting disease stabilization in
highly active RRMS, but has no effect on disability progression
in SPMS. Secondary clinical autoimmunity occurs in approximately
half of patients.
>
> __________________
> Disclosure
>
> J William L Brown: nothing to disclose;
> Orla Tuohy: nothing to disclose;
> Onajite Kousin-Ezewu: nothing to disclose;
> Laura Azzopardi: nothing to disclose;
> Tom Button: nothing to disclose;
> Claire McCarthy: nothing to disclose;
> Theo Alli: nothing to disclose;
> Caitriona Callan: nothing to disclose;
> Matthew Folks: nothing to disclose;
> Simon Heller: nothing to disclose;
> Hannah Laidley: nothing to disclose;
> Basil Nourallah: nothing to disclose;
> Cormac O’Neill: nothing to disclose;
> Daniel Obute: nothing to disclose;
> Robert Piper: nothing to disclose;
> Olivia Prankerd Smith: nothing to disclose;
> Helena Wickham: nothing to disclose;
> Xueying Zheng: nothing to disclose;
> Karen May: nothing to disclose;
> Anna Gerritz: nothing to disclose;
> D Alastair S Compston has received lecture fees and travel
reimbursements from Genzyme (a Sanofi company) on behalf of
himself and the University of Cambridge; and he is a paid
scientific adviser to the Lundbeck Foundation;
> Joanne L Jones has received consulting fees and lecture fees
from Genzyme (a Sanofi company).
> Alasdair J Coles has received honoraria and travel expenses
and the department has received research grants, from Genzyme (a
Sanofi company).
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