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Assessing the long-term effectiveness of interferon-beta and glatiramer acetate in multiple sclerosis : final ten year results from the UK multiple sclerosis risk sharing scheme
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Palace, Jacqueline, Duddy, Martin, Lawton, Michael, Bregenzer, Thomas, Zhu, Feng, Boggild, Mike, Piske, Benjamin, Robertson, Neil P, Oger, Joel, Tremlett, Helen, Tilling, Kate, Ben-Shlomo, Yoav, Lilford, Richard and Dobson, Charles (2019) Assessing the long-term effectiveness of interferon-beta and glatiramer acetate in multiple sclerosis : final ten year results from the UK multiple sclerosis risk sharing scheme. Journal of Neurology, Neurosurgery and Psychiatry, 90 (3). pp. 251-260. doi:10.1136/jnnp-2018-318360 ISSN 0022-3050.
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Official URL: https://doi.org/10.1136/jnnp-2018-318360
Abstract
Background
Because multiple sclerosis (MS) is a chronic disease causing disability over decades, it is crucial to know if the short-term effects of disease-modifying therapies reported in randomised controlled trials reduce long-term disability. This 10-year prospective observational study of disability outcomes (Expanded Disability Status Scale (EDSS) and utility) was set up, in conjunction with a risk-sharing agreement between payers and producers, to investigate this issue.
Methods
The outcomes of the UK treated patients were compared with a modelled untreated control based on the British Columbia MS data set to assess the long-term effectiveness of these treatments. Two complementary analysis models were used: a multilevel model (MLM) and a continuous Markov model.
Results
4862 patients with MS were eligible for the primary analysis (mean and median follow-up times 8.7 and 10 years). EDSS worsening was reduced by 28% (MLM), 7% (Markov) and 24% time-adjusted Markov in the total cohort, and by 31% (MLM) and 14% (Markov) for relapsing remitting patients. The utility worsening was reduced by 23%–24% in the total cohort and by 24%–31% in the RR patients depending on the model used. All sensitivity analyses showed a treatment effect. There was a 4-year (CI 2.7 to 5.3) delay to EDSS 6.0. An apparent waning of treatment effect with time was seen. Subgroup analyses suggested better treatment effects in those treated earlier and with lower EDSS scores.
Conclusions
This study supports a beneficial effect on long-term disability with first-line MS disease-modifying treatments, which is clinically meaningful. However the waning effect noted requires further study.
| Item Type: | Journal Article | ||||||||||||||||||
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| Subjects: | R Medicine > RC Internal medicine | ||||||||||||||||||
| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences > Population, Evidence & Technologies (PET) Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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| Library of Congress Subject Headings (LCSH): | Multiple sclerosis -- Treatment, Interferon | ||||||||||||||||||
| Journal or Publication Title: | Journal of Neurology, Neurosurgery and Psychiatry | ||||||||||||||||||
| Publisher: | B M J Group | ||||||||||||||||||
| ISSN: | 0022-3050 | ||||||||||||||||||
| Official Date: | 14 February 2019 | ||||||||||||||||||
| Dates: |
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| Volume: | 90 | ||||||||||||||||||
| Number: | 3 | ||||||||||||||||||
| Page Range: | pp. 251-260 | ||||||||||||||||||
| DOI: | 10.1136/jnnp-2018-318360 | ||||||||||||||||||
| Status: | Peer Reviewed | ||||||||||||||||||
| Publication Status: | Published | ||||||||||||||||||
| Access rights to Published version: | Open Access (Creative Commons) | ||||||||||||||||||
| Date of first compliant deposit: | 1 April 2019 | ||||||||||||||||||
| Date of first compliant Open Access: | 2 April 2019 | ||||||||||||||||||
| RIOXX Funder/Project Grant: |
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