COMBAT-MS: A Population-Based Observational Cohort Study Addressing the Benefit-Risk Balance of Multiple Sclerosis Therapies Compared with Rituximab

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COMBAT-MS : A Population-Based Observational Cohort Study Addressing the Benefit-Risk Balance of Multiple Sclerosis Therapies Compared with Rituximab

Piehl, Fredrik (författare): Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Department of Neurology, Karolinska University Hospital, Stockholm, Sweden; Academic Specialist Center, Stockholm Health Services, Stockholm, Sweden

Alping, Peter (författare): Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden

Virtanen, Suvi (författare): Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden

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Englund, Simon (författare): Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden

Burman, Joachim (författare): Department of Neurology, Uppsala University Hospital, and Department of Medical Sciences, Uppsala University, Uppsala, Sweden

Fink, Katharina (författare): Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Department of Neurology, Karolinska University Hospital, Stockholm, Sweden

Fogdell-Hahn, Anna (författare): Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden

Gunnarsson, Martin, 1973- (författare): Örebro universitet,Institutionen för medicinska vetenskaper,Region Örebro län,Department of Neurology

Hillert, Jan (författare): Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden

Langer-Gould, Annette (författare): Clinical and Translational Neuroscience, Southern California Permanente Medical Group, Kaiser Permanente, Los Angeles, CA, USA

Lycke, Jan (författare): Department of Neurology, Sahlgrenska University Hospital, and Department of Clinical Neuroscience, University of Gothenburg, Gothenburg, Sweden

Mellergård, Johan (författare): Department of Neurology in Linköping, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden

Nilsson, Petra (författare): Department of Neurology, Skåne University Hospital, and Department of Clinical Sciences/Neurology, Lund University, Lund, Sweden

Olsson, Tomas (författare): Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden

Salzer, Jonatan (författare): Department of Neurology, Umeå University Hospital, and Department of Clinical Science, Neurosciences, Umeå University, Umeå, Sweden

Svenningsson, Anders (författare): Department of Neurology, Danderyd Hospital, and Department of Clinical Sciences, Karolinska Institutet, Stockholm, Sweden

Frisell, Thomas (författare): Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden

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2024
2024
Engelska.
Ingår i: Annals of Neurology. - : John Wiley & Sons. - 0364-5134 .- 1531-8249.

Relaterad länk:: https://doi.org/10.1...; visa fler...; https://urn.kb.se/re...; https://doi.org/10.1...; visa färre...

Tidskriftsartikel (refereegranskat)

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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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Av författaren/redakt...: Piehl, Fredrik; Alping, Peter; Virtanen, Suvi; Englund, Simon; Burman, Joachim; Fink, Katharina; visa fler...; Fogdell-Hahn, An ...; Gunnarsson, Mart ...; Hillert, Jan; Langer-Gould, An ...; Lycke, Jan; Mellergård, Joha ...; Nilsson, Petra; Olsson, Tomas; Salzer, Jonatan; Svenningsson, An ...; Frisell, Thomas; visa färre...

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Artiklar i publikationen: Annals of Neurol ...

Av lärosätet: Örebro universitet

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COMBAT-MS : A Population-Based Observational Cohort Study Addressing the Benefit-Risk Balance of Multiple Sclerosis Therapies Compared with Rituximab

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