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Minocycline reduces the relative risk of multiple sclerosis in people experiencing their first clinical demyelinating event by 44.6%: results of a phase III double-blind placebo controlled Canadian multicentre clinical trial
Author(s): ,
L.M. Metz
Affiliations:
University of Calgary, Calgary, AB
,
D. Li
Affiliations:
University of British Columbia, Vancouver, BC
,
A. Traboulsee
Affiliations:
University of British Columbia, Vancouver, BC
,
P. Duquette
Affiliations:
University of Montreal, Montreal, QC, Canada
,
V.W. Yong
Affiliations:
University of Calgary, Calgary, AB
,
M. Eliasziw
Affiliations:
Tufts University, Boston, MA, United States
,
G. Cerchiaro
Affiliations:
University of Calgary, Calgary, AB
,
J. Greenfield
Affiliations:
University of Calgary, Calgary, AB
,
A. Riddehough
Affiliations:
University of British Columbia, Vancouver, BC
,
M. Yeung
Affiliations:
University of Calgary, Calgary, AB
,
M. Kremenchutzky
Affiliations:
Western University, London, ON
,
G. Vorobeychik
Affiliations:
Fraser Health MS Clinic, Burnaby, BC
,
M.S. Freedman
Affiliations:
University of Ottawa, Ottawa, ON
,
V. Bhan
Affiliations:
Dalhousie University, Halifax, NS
,
G. Blevins
Affiliations:
University of Alberta, Edmonton, AB
,
J.J. Marriott
Affiliations:
University of Manitoba, Winnipeg, MB
,
F. Grand'Maison
Affiliations:
Clinique Neuro Rive-Sud, Greenfield Park, QC
,
L. Lee
Affiliations:
University of Toronto, Toronto, ON
,
M. Thibault
Affiliations:
CHA-Hôpital Enfant-Jésus, Québec, QC, Canada
M. Hill
Affiliations:
University of Calgary, Calgary, AB
(Abstract release date: Oct 7, 2015) ECTRIMS Online Library. Metz L. Oct 10, 2015; 116700
Luanne Metz
Luanne Metz
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Abstract: 227

Type: Oral LB

Abstract Category: Invited / Oral LB / Poster LB

Background: Current proven therapies for patients experiencing their first clinical demyelinating event show benefit the earlier they are introduced. However, payment coverage varies throughout the world, often delaying treatment until patients have demonstrated a second clinical attack. Furthermore, current oral therapies may not be ideal options because of safety concerns. Minocycline is an inexpensive oral antibiotic with a recognized safety profile. It is widely available, often in generic formulation. Preclinical and preliminary clinical studies suggest it may be a therapeutic option in MS as both monotherapy and as an add-on treatment.

Methods:
Subjects between age 18 and 60, with onset of their first demyelinating symptoms within the previous 180 days, and at least two T2 hyperintense lesions on brain MRI were randomized to oral minocycline 100 mg bid or identical placebo. Treatment continued for up to 24 months or until MS by 2005 McDonald criteria was confirmed. Follow up visits were scheduled at 1, 3, 6, 9, 12, 15, 18, 21, and 24 months and MRI scans were scheduled at screen, month 3, 6, 12, 24 and at early end of study. The primary outcome was the proportion of participants who reached MS by 6 months. Risk estimates, absolute risk reductions and relative risk reductions were calculated from actuarial life table analysis.

Results:
Starting in December 2008, over 4.5 years, 236 patients were screened at 12 Canadian sites; 143 were randomized. Intention to treat analysis included 142 subjects as one subject was randomized in error; 72 received minocycline. Mean age was 35.8 years; 68.3% were women. Onset was monofocal in 76.8%, median EDSS was 1.5, mean duration since onset of demyelinating symtoms was 84.5 days, 69% had >8 T2 lesions, and 34.5% had enhancing lesions at screen. The risk of conversion to MS by 6 months based on the 2005 McDonald MS criteria was 61.4% in the placebo group and 34.0% in the minocycline group. The absolute risk reduction was 27.4%, the relative risk reduction was 44.6%, and the number needed to treat (NNT) was 4 (log rank p value = 0.002). At 12 months the absolute risk reduction was 25.1%, the relative risk reduction was 37.6%, and the NNT was 4 (p=0.002).

Conclusions:
Minocycline 100 mg bid reduces conversion of the first clinical demyelinating event to MS. Given its' known safety and low cost, minocycline should be considered for initial treatment as well as for combination therapy trials.

Disclosure: This study was funded by the Multiple Sclerosis Society of Canada.

LM Metz has nothing to disclose.

D Li has nothing to disclose.

A Traboulsee has nothing to disclose.

P Duquette has nothing to disclose.

VW Yong has nothing to disclose.

M Eliasziw has nothing to disclose.

G Cerchiaro has nothing to disclose.

J Greenfield has nothing to disclose.

A Riddehough has nothing to disclose.

M Yeung has nothing to disclose.

M Kremenchutzky has nothing to disclose.

G Vorobeychik has nothing to disclose.

MS Freedman has nothing to disclose.

V Bhan has nothing to disclose.

G Blevins has nothing to disclose.

JJ Marriott has nothing to disclose.

F Grand´Maison has nothing to disclose.

L Lee has nothing to disclose.

M Thibault has nothing to disclose.

M Hill has nothing to disclose.
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