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Are stable MS patients who stop their disease-modifying therapy (DMT) at increased risk for relapses and disability progression compared to patients who continue on DMTs? A propensity-score matched analysis of the MSBase registrants
Author(s): ,
I. Kister
Affiliations:
Neurology, New York University School of Medicine, New York, NY, United States
,
T. Spelman
Affiliations:
Royal Melbourne Hospital, Parkville, VIC, Australia
,
R. Alroughani
Affiliations:
Amiri Hospital, Kuwait City, Kuwait
,
J. Lechner-Scott
Affiliations:
John Hunter Hospital, Newcastle, NSW, Australia
,
P. Duquette
Affiliations:
Hôpital Notre Dame, Montreal
,
F. Grand'Maison
Affiliations:
Hôpital Charles LeMoyne, Greenfield Park, QC, Canada
,
M. Slee
Affiliations:
Flinders University and Flinders Medical Centre, Bedford Park, SA, Australia
,
A. Lugaresi
Affiliations:
University 'G. d'Annunzio', Chieti, Italy
,
M. Barnett
Affiliations:
University of Sydney, Sydney, NSW, Australia
,
P. Grammond
Affiliations:
Centre De Réadaptation En Déficience Physique Chaudière-Appalaches, Charny, QC, Canada
,
G. Iuliano
Affiliations:
Ospedali Riuniti di Salerno, Salerno, Italy
,
R. Hupperts
Affiliations:
Orbis Medical Centre, Sittard-Geleen, The Netherlands
,
M. Trojano
Affiliations:
University of Bari, Bari, Italy
,
H. Butzkueven
Affiliations:
The University of Melbourne, Parkville, VIC, Australia
MSBase Study Group
MSBase Study Group
Affiliations:
(Abstract release date: Sep 23, 2015) ECTRIMS Online Library. Kister I. Oct 8, 2015; 116635
Dr. Ilya Kister
Dr. Ilya Kister
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Abstract: 82

Type: Oral

Abstract Category: Long-term treatment monitoring

Objectives: To compare relapse and sustained disability progression rates in previously stable MS patients who discontinued their disease-modifying therapy ('DMTs stoppers') and propensity-score matched MS patients who continued their therapy ('DMT stayers').

Background: It is not known how disease course in previously stable MS patients who discontinue DMT compares to disease course who stay on DMT. The large international MSBase Registry that prospectively follows MS patients in real-world clinical setting affords an opportunity for a prospective comparative study of patients who elected to stop DMT and those who did not.

Methods: Patients were included in the 'DMT stoppers' group if they had diagnosis of MS; no relapses and no change in Expanded Disability Status Scale (EDSS) for ≥5 years at the time of DMD discontinuation; had continuous treatment with DMD for ≥3 years; were followed for ≥3 years after stopping DMD; did not restart DMD for ≥3 months after discontinuation. DMT stayers were matched 1:1 according to age, gender, disease duration, EDSS and proportion of time on prior treatment. Pairwise analysis of DMT stoppers and stayers from the international MSBase registry data was conducted using propensity-score matching. The groups were compared with respect to risk of relapses and sustained disability progression using Cox marginal model, using simultaneous censoring of the matched pair.

Results: The cohort consisted of 140 DMT stoppers and 140 propensity-scored matched DMT stayers. 73% were women, mean age was 48 year; mean disease duration - 16 years; mean baseline EDSS - 5.5; and proportion of disease duration on treatment of 0.4. Patients were followed for a median (IQR) duration of 4.0 years (2.2, 6.7) from baseline. A total of 77 first relapse events and 38 sustained disability progression event were observed across the follow-up period. DMT stoppers had a non-significantly decreased risk of relapse compared to stayers (HR 0.61, 95% CI 0.35, 1.06, p=0.078), and a non-significantly increased risk of sustained disability progression (HR 1.53, 95% CI 0.80, 2.95, p=0.2)

Disclosure:

Ilya Kister served on scientific advisory board for Biogen Idec and received research support from Guthy- Jackson Charitable Foundation, National Multiple Sclerosis Society, Biogen-Idec, Serono, and Navartis.

Tim Spelman received compensation for travel from Biogen Idec.

Raed Alroughani received honoraria from Bayer, Biologix, GSK, Merck Sorono, and Novartis and served on advisory boards for Biologix, Merck Sorono, and Novartis.

Jeannette Lechner-Scott has accepted travel compensation from Novartis, Biogen and Merck Serono. Her institution receives the honoraria for talks and advisory board commitment and also clinic support as well as research grants from Bayer Health Care, Biogen Idec, CSL, Genzyme Sanofi, Merck Serono and Novartis.

Helmut Butzkueven received compensation for serving on scientific advisory boards and as a consultant for Biogen Idec and Novartis; speaker honoraria from Biogen Idec Australia, Merck Serono Australia, and Novartis Australia; travel support from Biogen Idec Australia and Merck Serono Australia; research support from CASS Foundation (Australia), Merck Serono Australia, the Royal Melbourne Hospital Friends of the Neurosciences Foundation, and the University of Melbourne.

Pierre Duquette - nothing to disclose.

Francois Grand'Maison received honoraria from Biogen Idec, Genzyme, Novartis, and Roche.

Mark Slee has nothing to disclose.

Alessandra Lugaresi has served as a Bayer, Biogen Idec, Genzyme/Sanofi, Merck Serono, Novartis Advisory Board Member. She received travel grants and honoraria from Bayer, Biogen Idec, Genzyme, Merck Serono, Novartis, Sanofi and Teva and her institution received research grants from Bayer, Biogen Idec, Merck Serono, Novartis, Sanofi and Teva.

Prof Lugaresi has also received travel and research grants from the Associazione Italiana Sclerosi Multipla and was a Consultant of 'Fondazione Cesare Serono'.

Michael Barnett has served on scientific advisory boards for Biogen-Idec, Novartis and Genzyme and has received and has served on steering committees for trials conducted by Novartis. He has received conference travel support from Biogen-Idec and Novartis; and his institution has received research support from Biogen-Idec, Merck-Serono and Novartis.

Pierre Grammond is a Biogen Idec, Novartis, and Teva-Neuroscience advisory board member; a consultant for Merck Serono; received payments for lectures from the Canadian Multiple Sclerosis Society, Merck Serono, and Teva-Neuroscience; and received grants for travel from Novartis and Teva- Neuroscience.

Gerardo Iuliano had travel/accommodations/meeting expenses funded by Bayer Schering, Biogen Idec, Merck Serono, Novartis, Sanofi, and Teva.

Raymond Hupperts received honoraria as a consultant on scientific advisory boards from Biogen Idec, Merck Serono, Sanofi-Genzyme, and Teva; research funding from Biogen Idec and Merck Serono; and speaker honoraria from Sanofi-Genzyme.

Maria Trojano received speaking honoraria from Bayer Schering, Biogen Idec, Merck Serono, Novartis, Sanofi, and Teva, as well as research grants from Biogen Idec, Merck Serono, and Novartis.

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