COMBAT-MS : A Population-Based Observational Cohort Study Addressing the Benefit–Risk Balance of Multiple Sclerosis Therapies Compared with Rituximab
(2024) In Annals of Neurology- Abstract
Objective: To assess comparative effectiveness, safety, and tolerability of off-label rituximab, compared with frequently used therapies approved for multiple sclerosis (MS). Methods: A Swedish cohort study of persons with relapsing–remitting MS, age 18 to 75 years at inclusion and with a first therapy start or a first therapy switch between 2011 and 2018. Low-dose rituximab was compared with MS-approved therapies. Primary outcomes were proportions with 12 months confirmed disability worsening and change in MS Impact Scale-29 (MSIS-29) scores, respectively. Secondary endpoints included relapses, therapy discontinuation, and serious adverse events. Analyses used an intention-to-treat approach and were adjusted for demographics, MS... (More)
Objective: To assess comparative effectiveness, safety, and tolerability of off-label rituximab, compared with frequently used therapies approved for multiple sclerosis (MS). Methods: A Swedish cohort study of persons with relapsing–remitting MS, age 18 to 75 years at inclusion and with a first therapy start or a first therapy switch between 2011 and 2018. Low-dose rituximab was compared with MS-approved therapies. Primary outcomes were proportions with 12 months confirmed disability worsening and change in MS Impact Scale-29 (MSIS-29) scores, respectively. Secondary endpoints included relapses, therapy discontinuation, and serious adverse events. Analyses used an intention-to-treat approach and were adjusted for demographics, MS features, and health characteristics. Results: We included 2,449 participants as first therapy start and 2,463 as first therapy switch. Proportions with disability worsening at 3 years were 9.1% for rituximab as first therapy and 5.1% after therapy switch, with no differences to MS-approved comparators. Worsening on rituximab was mostly independent of relapses. MSIS-29 with rituximab at 3 years improved by 1.3/8.4 points (physical/psychological) for first disease-modifying therapy (DMT) and 0.4/3.6 for DMT switch, and was mostly similar across therapies. Rituximab had lower relapse rates and higher therapy persistence in both groups. The rate of hospital-treated infections was higher with rituximab after a therapy switch, but not as a first therapy. Interpretation: This population-based real-world cohort study found low rates of disability progression, mostly independent of relapses, and without significant differences between rituximab and MS-approved comparators. Rituximab led to lower rates of inflammatory activity and higher treatment persistence, but was associated with an increased rate of serious infections. ANN NEUROL 2024.
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- author
- organization
- publishing date
- 2024
- type
- Contribution to journal
- publication status
- in press
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- in
- Annals of Neurology
- publisher
- John Wiley & Sons Inc.
- external identifiers
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- pmid:38923558
- scopus:85196800733
- ISSN
- 0364-5134
- DOI
- 10.1002/ana.27012
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- English
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- yes
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- 0d12c461-d947-41a9-8ea5-a652d5e00ca0
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- 2024-09-04 14:09:32
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@article{0d12c461-d947-41a9-8ea5-a652d5e00ca0,
abstract = {{<p>Objective: To assess comparative effectiveness, safety, and tolerability of off-label rituximab, compared with frequently used therapies approved for multiple sclerosis (MS). Methods: A Swedish cohort study of persons with relapsing–remitting MS, age 18 to 75 years at inclusion and with a first therapy start or a first therapy switch between 2011 and 2018. Low-dose rituximab was compared with MS-approved therapies. Primary outcomes were proportions with 12 months confirmed disability worsening and change in MS Impact Scale-29 (MSIS-29) scores, respectively. Secondary endpoints included relapses, therapy discontinuation, and serious adverse events. Analyses used an intention-to-treat approach and were adjusted for demographics, MS features, and health characteristics. Results: We included 2,449 participants as first therapy start and 2,463 as first therapy switch. Proportions with disability worsening at 3 years were 9.1% for rituximab as first therapy and 5.1% after therapy switch, with no differences to MS-approved comparators. Worsening on rituximab was mostly independent of relapses. MSIS-29 with rituximab at 3 years improved by 1.3/8.4 points (physical/psychological) for first disease-modifying therapy (DMT) and 0.4/3.6 for DMT switch, and was mostly similar across therapies. Rituximab had lower relapse rates and higher therapy persistence in both groups. The rate of hospital-treated infections was higher with rituximab after a therapy switch, but not as a first therapy. Interpretation: This population-based real-world cohort study found low rates of disability progression, mostly independent of relapses, and without significant differences between rituximab and MS-approved comparators. Rituximab led to lower rates of inflammatory activity and higher treatment persistence, but was associated with an increased rate of serious infections. ANN NEUROL 2024.</p>}},
author = {{Piehl, Fredrik and Alping, Peter and Virtanen, Suvi and Englund, Simon and Burman, Joachim and Fink, Katharina and Fogdell-Hahn, Anna and Gunnarsson, Martin and Hillert, Jan and Langer-Gould, Annette and Lycke, Jan and Mellergård, Johan and Nilsson, Petra and Olsson, Tomas and Salzer, Jonatan and Svenningsson, Anders and Frisell, Thomas}},
issn = {{0364-5134}},
language = {{eng}},
publisher = {{John Wiley & Sons Inc.}},
series = {{Annals of Neurology}},
title = {{COMBAT-MS : A Population-Based Observational Cohort Study Addressing the Benefit–Risk Balance of Multiple Sclerosis Therapies Compared with Rituximab}},
url = {{http://dx.doi.org/10.1002/ana.27012}},
doi = {{10.1002/ana.27012}},
year = {{2024}},
}