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Ann Clin Transl Neurol. 2015 May;2(5):479-91. doi: 10.1002/acn3.187. Epub 2015 Mar 27.

Predictors of disability worsening in clinically isolated syndrome.

Author information

1
Department of Medicine (RMH), The University of Melbourne Parkville, Australia.
2
Department of Neurology, Royal Melbourne Hospital Parkville, Australia.
3
Hospital Universitario Virgen Macarena Sevilla, Spain.
4
Neuro Rive-Sud, Hôpital Charles LeMoyne Quebec, Canada.
5
Hôpital Notre Dame Montreal, Canada.
6
MS Center, Department of Neuroscience and Imaging, University "G. d'Annunzio" Chieti, Italy.
7
Centre de réadaptation déficience physique Chaudière-Appalache Levis, Canada.
8
Orbis Medical Centre Sittard, The Netherlands.
9
CIREN Havana, Cuba.
10
University Hospital San Carlos Madrid, Spain.
11
Karadeniz Technical University Trabzon, Turkey.
12
Ospedale di Macerata Macerata, Italy.
13
Hospital Universitario Virgen de Valme Seville, Spain.
14
Ospedali Riuniti di Salerno Salerno, Italy.
15
John Hunter Hospital Newcastle, Australia.
16
Groene Hart ziekenhuis Gouda, The Netherlands.
17
Cliniques Universitaires Saint-Luc Brussels, Belgium.
18
JZU Clinic for Neurology Skopje, Republic of Macedonia.
19
FLENI Buenos Aires, Argentina.
20
Jewish General Hospital Montreal, Canada.
21
Hospital Italiano Buenos Aires, Argentina.
22
Amiri Hospital Kuwait City, Kuwait.
23
Neurological Institute IRCCS Mondino Pavia, Italy.
24
Brain and Mind Research Institute Sydney, Australia.
25
Flinders University and Medical Centre Adelaide, Australia.
26
Mater Dei Hospital Msida, Malta.
27
New York University Langone Medical Center New York, New York.
28
Geelong Hospital Geelong, Australia.
29
INEBA Buenos Aires, Argentina.
30
Department of Neurology University of Florence Florence, Italy.
31
Melbourne EpiCentre, University of Melbourne and Melbourne Health Melbourne, Australia.
32
Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari Bari, Italy.
33
Department of Medicine (RMH), The University of Melbourne Parkville, Australia ; Department of Neurology, Royal Melbourne Hospital Parkville, Australia.

Abstract

OBJECTIVE:

To assess demographic, clinical, magnetic resonance imaging, and treatment exposure predictors of time to 3 or 12-month confirmed disability worsening in clinically isolated syndrome (CIS) and early multiple sclerosis (MS).

METHODS:

We utilized the MSBase Incident Study (MSBasis), a prospective cohort study of outcome after CIS. Predictors of time to first 3 and 12-month confirmed expanded disability status scale worsening were analyzed using Cox proportional hazards regression.

RESULTS:

About 1989 patients were analyzed, the largest seen-from-onset cohort reported to-date. A total of 391 patients had a first 3-month confirmed disability worsening event, of which 307 were sustained for 12 months. Older age at CIS onset (adjusted hazard ratio: aHR 1.17, 95% 1.06, 1.30), pyramidal (aHR 1.45, 95% CI 1.13, 1.89) and ambulation (HR 1.60, 95% CI 1.09, 2.34) system dysfunction, annualized relapse rate (aHR 1.20, 95% CI 1.18, 1.22), and lower proportion of observation time on treatment were associated with 3-month confirmed worsening. Predictors of time to 12-month sustained worsening included pyramidal system dysfunction (Hazard ratio: aHR 1.38, 95% CI 1.05, 1.83), and older age at CIS onset (aHR 1.17, 95% CI 1.04, 1.31). Greater proportion of follow-up time exposed to treatment was associated with greater reductions in the rate of worsening.

INTERPRETATION:

This study provides class IV evidence for a strong protective effect of disease-modifying treatment to reduce disability worsening events in patients with CIS and early MS, and confirms age and pyramidal dysfunction at onset as risk factors.

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