Predictors of long-term disability accrual in relapse-onset multiple sclerosis.

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Abstract

To identify predictors of 10-year Expanded Disability Status Scale (EDSS) change after treatment initiation in patients with relapse-onset multiple sclerosis.

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Most cited references 34

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Effect of relapses on development of residual deficit in multiple sclerosis.

Gary R Cutter, Monika Baier, Fred Lublin (2003)

To determine the percentage of patients with residual deficits following multiple sclerosis (MS) exacerbations and the magnitude of those deficits using a database of pooled placebo patients from clinical trials. A database of patients assigned to the placebo group in several randomized clinical trials was queried to determine those patients with Expanded Disability Status Scale (EDSS) and Scripps Neurologic Rating Scale assessments prior to, at the time of, and after an acute exacerbation of MS. The extent of deficit present at these time points was compared to determine the acute effect of exacerbations and the degree of persistent disability. Forty-two percent of patients had residual deficit of at least 0.5 and 28% had residual of >or=1.0 EDSS units, at an average of 64 days after an exacerbation. The results were reproduced across subsequent exacerbations and were sustained over time. The subgroup of patients with measurable change in EDSS during the exacerbation had more extensive residual impairment on the follow-up visits. Similar results were seen when the Scripps score was examined. MS exacerbations produce a measurable and sustained effect on disability.

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Defining reliable disability outcomes in multiple sclerosis.

Tomas Kalincik, Gary R Cutter, Tim Spelman … (2015)

Prevention of irreversible disability is currently the most important goal of disease modifying therapy for multiple sclerosis. The disability outcomes used in most clinical trials rely on progression of Expanded Disability Status Scale score confirmed over 3 or 6 months. However, sensitivity and stability of this metric has not been extensively evaluated. Using the global MSBase cohort study, we evaluated 48 criteria of disability progression, testing three definitions of baseline disability, two definitions of progression magnitude, two definitions of long-term irreversibility and four definitions of event confirmation period. The study outcomes comprised the rates of detected progression events per 10 years and the proportions of the recorded events persistent at later time points. To evaluate the ratio of progression frequency and stability for each criterion, we calculated the proportion of events persistent over the five subsequent years once progression was achieved. Finally, we evaluated the clinical and demographic determinants characterising progression events and, for those that regressed back to baseline, determinants of their subsequent regression. The study population consisted of 16 636 patients with the minimum of three recorded disability scores, totalling 112 584 patient-years. The progression rates varied between 0.41 and 1.14 events per 10 years, with the length of required confirmation interval as the most important determinant of the observed variance. The concordance among all tested progression criteria was only 17.3%. Regression of disability occurred in 11-34% of the progression events over the five subsequent years. The most important determinant of progression stability was the length of the confirmation period. For the most accurate set of the progression criteria, the proportions of 3-, 6-, 12- or 24-month confirmed events persistent over 5 years reached 70%, 74%, 80% and 89%, respectively. Regression post progression was more common in younger patients, relapsing-remitting disease course, and after a smaller change in disability, and was inflated by higher visit frequency. These results suggest that the disability outcomes based on 3-6-month confirmed disability progression overestimate the accumulation of permanent disability by up to 30%. This could lead to spurious results in short-term clinical trials, and the issue may be magnified further in cohorts consisting predominantly of younger patients and patients with relapsing-remitting disease. Extension of the required confirmation period increases the persistence of progression events.

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Long-term subcutaneous interferon beta-1a therapy in patients with relapsing-remitting MS.

J-P Erälinna, M Sandberg, B Stubinski … (2006)

To conduct systematic long-term follow-up (LTFU) of patients in the Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis (PRISMS) study to provide up to 8 years of safety, clinical and MRI outcomes on subcutaneous (s.c.) interferon (IFN) beta-1a in relapsing-remitting multiple sclerosis (RRMS). The original cohort of 560 patients was randomized to IFNbeta-1a, 44 or 22 microg three times weekly (TIW) or to placebo; after 2 years, patients on placebo were rerandomized to active treatment and the blinded study continued for a further 4 years. The LTFU visit was scheduled 7 to 8 years after baseline. LTFU was attended by 68.2% of the original PRISMS study cohort (382/560 patients). 72.0% (275/382) were still receiving IFNbeta-1a s.c. TIW. Patients originally randomized to IFNbeta-1a 44 microg s.c. TIW showed lower Expanded Disability Status Scale progression, relapse rate and T2 burden of disease up to 8 years compared with those in the late treatment group. Brain parenchymal volume did not show differences by treatment group. Overall, 19.7% of patients progressed to secondary progressive MS between baseline and LTFU (75/381). No new safety concerns were identified and treatment was generally well tolerated. Despite the limitations inherent in any long-term study (for example, potential differences between returning and nonreturning patients), these results indicate that patients with relapsing-remitting multiple sclerosis can experience sustained benefit over many years from early interferon beta-1a subcutaneous therapy three times weekly compared with patients whose treatment is delayed. This effect was more apparent in the patients receiving the higher dose.

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Author and article information

Journal

Journal ID (iso-abbrev): Ann. Neurol.

Title: Annals of neurology

Publisher: Wiley-Blackwell

ISSN (Electronic): 1531-8249

ISSN (Print): 0364-5134

Publication date (Electronic): Jul 2016

Volume: 80

Issue: 1

Affiliations

[1 ] Department of Medicine and Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Melbourne, Victoria, Australia.

[2 ] Department of Neurology, Royal Melbourne Hospital, Melbourne, Victoria, Australia.

[3 ] Department of Neurology and Center of Clinical Neuroscience, First Faculty of Medicine, General University Hospital and Charles University in Prague, Prague, Czech Republic.

[4 ] Centre Hospitalier de l'Université de Montréal, Notre Dame Hospital, Montreal, Quebec, Canada.

[5 ] Hospital Universitario Virgen Macarena, Seville, Spain.

[6 ] Centre de réadaptation déficience physique Chaudière-Appalache, Lévis, Quebec, Canada.

[7 ] Cliniques Universitaires Saint-Luc, Brussels, Belgium.

[8 ] Neurology Unit, Azienda Sanitaria Unica Regionale Marche AV3, Macerata, Italy.

[9 ] Neuro Rive-Sud, Charles LeMoyne Hospital, Greenfield Park, Quebec, Canada.

[10 ] Zuyderland Ziekenhuis, Sittard, The Netherlands.

[11 ] University of Parma, Parma, Italy.

[12 ] Nuovo Ospedale Civile S.Agostino/Estense, Modena, Italy.

[13 ] C. Mondino National Neurological Institute, Pavia, Italy.

[14 ] Ospedali Riuniti di Salerno, Salerno, Italy.

[15 ] Azienda Ospedaliera di Rilievo Nazionale San Giuseppe Moscati, Avellino, Italy.

[16 ] Karadeniz Technical University, Trabzon, Turkey.

[17 ] Department of Neurology, Liverpool Hospital, Liverpool, New South Wales, Australia.

[18 ] Donostia Hospital, San Sebastián, Spain.

[19 ] Groene Hart Ziekenhuis, Gouda, The Netherlands.

[20 ] Centre for Clinical Research, University of Queensland, Brisbane, Queensland, Australia.

[21 ] Kommunehospitalet, Arhus C, Denmark.

[22 ] Jahn Ferenc Teaching Hospital, Budapest, Hungary.

[23 ] John Hunter Hospital, University of Newcastle, Newcastle, New South Wales, Australia.

[24 ] Instituto de Neurociencias Buenos Aires, Buenos Aires, Argentina.

[25 ] MS Center, Department of Neuroscience, Imaging and Clinical Sciences, G. d'Annunzio University, Chieti, Italy.

[26 ] Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari, Bari, Italy.

[27 ] Department of Neurology, Box Hill Hospital, Monash University, Box Hill, Victoria, Australia.

[28 ] Department of Biomedical and Neuromotor Sciences (DIBINEM), Alma Mater Studiorum-University of Bologna, Bologna, Italy.

[29 ] IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.

Article

DOI: 10.1002/ana.24682

PubMed ID: 27145331

SO-VID: d651eb57-4c92-4eed-b3fa-89ea291bf853

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Predictors of long-term disability accrual in relapse-onset multiple sclerosis.

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Journal of Disability Research

Effect of relapses on development of residual deficit in multiple sclerosis.

Defining reliable disability outcomes in multiple sclerosis.

Long-term subcutaneous interferon beta-1a therapy in patients with relapsing-remitting MS.

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