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Intrathecal treatme...
Intrathecal treatment trial of rituximab in progressive MS: An open-label phase 1b study
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- Bergman, Joakim (författare)
- Uppsala universitet,Umeå universitet,Klinisk neurovetenskap,Umea Univ, Dept Pharmacol & Clin Neurosci, Umea, Sweden,Neurologi
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Burman, J. (författare)
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- Gilthorpe, Jonathan D. (författare)
- Umeå universitet,Klinisk neurovetenskap,Umea Univ, Dept Pharmacol & Clin Neurosci, Umea, Sweden
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- Zetterberg, Henrik, 1973 (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för psykiatri och neurokemi,Institute of Neuroscience and Physiology, Department of Psychiatry and Neurochemistry,Gothenburg Univ, Inst Neurosci & Physiol, Dept Psychiat & Neurochem, Sahlgrenska Acad, Gothenburg, Sweden;Sahlgrens Univ Hosp, Clin Neurochem Lab, Molndal, Sweden;UCL Inst Neurol, Dept Mol Neurosci, Queen Sq, London, England;UCL, UK Dementia Res Inst, London, England
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- Jiltsova, E. (författare)
- Uppsala Univ, Dept Neurosci, Uppsala, Sweden
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- Bergenheim, Tommy (författare)
- Umeå universitet,Klinisk neurovetenskap,Umea Univ, Dept Pharmacol & Clin Neurosci, Umea, Sweden
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- Svenningsson, Anders (författare)
- Karolinska Institutet,Umeå universitet,Klinisk neurovetenskap,Umea Univ, Dept Pharmacol & Clin Neurosci, Umea, Sweden;Karolinska Inst, Dept Clin Sci, Danderyd Hosp, Stockholm, Sweden
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(creator_code:org_t)
- Wolters Kluwer, 2018
- 2018
- Engelska.
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Ingår i: Neurology. - : Wolters Kluwer. - 1526-632X .- 0028-3878. ; 91:20
- Relaterad länk:
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https://doi.org/10.1...
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https://urn.kb.se/re...
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https://urn.kb.se/re...
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http://kipublication...
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Abstract
Ämnesord
Stäng
- OBJECTIVES: To perform a phase 1b assessment of the safety and feasibility of intrathecally delivered rituximab as a treatment for progressive multiple sclerosis (PMS) and to evaluate the effect of treatment on disability and CSF biomarkers during a 1-year follow-up period. METHODS: Three doses of rituximab (25 mg with a 1-week interval) were administered in 23 patients with PMS via a ventricular catheter inserted into the right frontal horn and connected to a subcutaneous Ommaya reservoir. Follow-ups were performed at 1, 3, 6, 9, and 12 months. RESULTS: Mild to moderate vertigo and nausea were common but temporary adverse events associated with intrathecal rituximab infusion, which was otherwise well tolerated. The only severe adverse event was a case of low-virulent bacterial meningitis that was treated effectively. Of 7 clinical assessments, only 1 showed statistically significant improvement 1 year after treatment. No treatment effect was observed during the follow-up period among 6 CSF biomarkers. CONCLUSIONS: Intrathecal administration of rituximab was well tolerated. However, it may involve a risk for injection-related infections. The lack of a control group precludes conclusions being drawn regarding treatment efficacy. CLINICALTRIALSGOV IDENTIFIER: NCT01719159. CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that intrathecal rituximab treatment is well tolerated and feasible in PMS but involves a risk of severe infections. © 2018 American Academy of Neurology.
Ämnesord
- 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)
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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