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Rituximab in multip...
Rituximab in multiple sclerosis : a retrospective observational study on safety and efficacy
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- Salzer, Jonatan (author)
- Umeå universitet,Klinisk neurovetenskap
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- Svenningsson, Rasmus (author)
- Umeå universitet,Klinisk neurovetenskap,Department of Clinical Neuroscience, Danderyd Hospital, Karolinska Institutet, Stockholm
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- Alping, Peter (author)
- Karolinska Institutet
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Novakova, Lenka (author)
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Björck, Anna (author)
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- Fink, Katharina (author)
- Karolinska Institutet
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- Islam-Jakobsson, Protik (author)
- Umeå universitet,Klinisk neurovetenskap
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Malmeström, Clas (author)
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Axelsson, Markus (author)
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- Vågberg, Mattias (author)
- Umeå universitet,Klinisk neurovetenskap
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- Sundström, Peter (author)
- Umeå universitet,Klinisk neurovetenskap
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Lycke, Jan (author)
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- Piehl, Fredrik (author)
- Karolinska Institutet
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- Svenningsson, Anders (author)
- Karolinska Institutet,Umeå universitet,Klinisk neurovetenskap,Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm
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(creator_code:org_t)
- 2016
- 2016
- English.
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In: Neurology. - 0028-3878 .- 1526-632X. ; 87:20, s. 2074-2081
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Abstract
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- Objective: To investigate the safety and efficacy of rituximab in multiple sclerosis (MS). Methods: In this retrospective uncontrolled observational multicenter study, off-label rituximab-treated patients with MS were identified through the Swedish MS register. Outcome data were collected from the MS register and medical charts. Adverse events (AEs) grades 2-5 according to the Common Terminology Criteria for Adverse Events were recorded. Results: A total of 822 rituximab-treated patients with MS were identified: 557 relapsing-remitting MS (RRMS), 198 secondary progressive MS (SPMS), and 67 primary progressive MS (PPMS). At baseline, 26.2% had contrast-enhancing lesions (CELs). Patients were treated with 500 or 1,000 mg rituximab IV every 6-12 months, during a mean 21.8 (SD 14.3) months. During treatment, the annualized relapse rates were 0.044 (RRMS), 0.038 (SPMS), and 0.015 (PPMS), and 4.6% of patients displayed CELs. Median Expanded Disability Status Scale remained unchanged in RRMS (p = 0.42) and increased by 0.5 and 1.0 in SPMS and PPMS, respectively (p = 0.10 and 0.25). Infusion-related AEs occurred during 7.8% of infusions and most were mild. A total of 89 AEs grades >= 2 (of which 76 infections) were recorded in 72 patients. No case of progressive multifocal leukoencephalopathy was detected. Conclusions: This is the largest cohort of patients with MS treated with rituximab reported so far. The safety, clinical, and MRI findings in this heterogeneous real-world cohort treated with different doses of rituximab were similar to those reported in previous randomized controlled trials on B-cell depletion therapy in MS. Classification of evidence: This study provides Class IV evidence that for patients with MS, rituximab is safe and effective.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Neurovetenskaper (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Neurosciences (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Neurologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Neurology (hsv//eng)
Publication and Content Type
- ref (subject category)
- art (subject category)
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Neurology
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- By the author/editor
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Salzer, Jonatan
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Svenningsson, Ra ...
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Alping, Peter
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Novakova, Lenka
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Björck, Anna
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Fink, Katharina
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Islam-Jakobsson, ...
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Malmeström, Clas
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Axelsson, Markus
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Vågberg, Mattias
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Sundström, Peter
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Lycke, Jan
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Piehl, Fredrik
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Svenningsson, An ...
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Basic Medicine
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and Neurosciences
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Neurology
- Articles in the publication
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Neurology
- By the university
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Umeå University
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Karolinska Institutet