Autoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis: Benefit/risk following review of trial and post-marketing data
Jazyk angličtina Země Anglie, Velká Británie Médium print-electronic
Typ dokumentu časopisecké články, přehledy, práce podpořená grantem
PubMed
34882037
PubMed Central
PMC8978465
DOI
10.1177/13524585211061335
Knihovny.cz E-zdroje
- Klíčová slova
- Multiple sclerosis, alemtuzumab, autoimmunity, post-marketing, product surveillance, risk assessment, treatment outcome,
- MeSH
- alemtuzumab škodlivé účinky MeSH
- autoimunita MeSH
- klinické zkoušky, fáze II jako téma MeSH
- klinické zkoušky, fáze III jako téma MeSH
- lidé MeSH
- marketing MeSH
- relabující-remitující roztroušená skleróza * farmakoterapie MeSH
- roztroušená skleróza * chemicky indukované farmakoterapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- přehledy MeSH
- Názvy látek
- alemtuzumab MeSH
Does preexisting or treatment-emergent autoimmunity increase the risk of subsequent autoimmune disease in individuals with relapsing-remitting multiple sclerosis (MS) after alemtuzumab? In the extended phase 2/3 trials, 34/96 (35.4%) patients with and 395/1120 (35.3%) without preexisting autoimmunity developed non-MS autoimmunity. Thyroid autoimmunity after alemtuzumab courses 1 or 2 did not increase subsequent non-thyroid autoimmune adverse events. Therefore, autoimmune disease before or after alemtuzumab treatment does not predict autoimmunity after further courses, so should not preclude adequate alemtuzumab dosing to control MS. Finally, post-marketing safety data contribute toward a full record of the alemtuzumab benefit/risk profile for the MS field.
Barts and The London School of Medicine Queen Mary University of London London UK
Bern University Hospital and University of Bern Bern Switzerland
Boster MS Center Columbus OH USA
Department of Clinical Neuroscience School of Medicine University of Cambridge Cambridge UK
Department of Neurology 1st Medical Faculty Charles University Prague Czech Republic
Fundacion IMABIS Hospital Universitario Carlos Haya Málaga Spain
Neuroimmunology Unit Department of Clinical Neuroscience Karolinska Institutet Stockholm Sweden
Neurology Center of San Antonio San Antonio TX USA
North Central Neurology Associates Cullman AL USA
The University of British Columbia Vancouver BC Canada
Univ Lille INSERM UMR S1172 Lille Neuroscience et Cognition CHU Lille FHU Precise Lille France
Zobrazit více v PubMed
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Multiple sclerosis: time for early treatment with high-efficacy drugs
ClinicalTrials.gov
NCT00050778, NCT00530348, NCT00548405, NCT00930553, NCT02255656
