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Campo DC | Valor | Lengua/Idioma |
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dc.contributor.author | Hartung, Hans-Peter | - |
dc.contributor.author | Derfuss, Tobias | - |
dc.contributor.author | Cree, Bruce A.C. | - |
dc.contributor.author | Sormani, Maria Pia | - |
dc.contributor.author | Selmaj, Krysztof | - |
dc.contributor.author | Stutters, Jonathan | - |
dc.contributor.author | Prados Carrasco, Ferran | - |
dc.contributor.author | MacManus, David | - |
dc.contributor.author | Schneble, Hans-Martin | - |
dc.contributor.author | Lambert, Estelle | - |
dc.contributor.author | Porchet, Hervé | - |
dc.contributor.author | Glanzman, Robert | - |
dc.contributor.author | Warne, David | - |
dc.contributor.author | Curtin, Francois | - |
dc.contributor.author | Kornmann, Gabrielle | - |
dc.contributor.author | Buffet, Bénédicte | - |
dc.contributor.author | Kremer, David | - |
dc.contributor.author | Küry, Patrick | - |
dc.contributor.author | Leppert, David | - |
dc.contributor.author | Rückle, Thomas | - |
dc.contributor.author | Barkhof, Frederik | - |
dc.contributor.other | Universitat Oberta de Catalunya (UOC) | - |
dc.contributor.other | Universitat Oberta de Catalunya. eHealth Center | - |
dc.date.accessioned | 2022-02-10T19:27:41Z | - |
dc.date.available | 2022-02-10T19:27:41Z | - |
dc.date.issued | 2021-07-09 | - |
dc.identifier.citation | Hartung, H. P., Derfuss, T., Cree, B. A., Sormani, M. P., Selmaj, K., Stutters, J., Prados, F., MacManus, D., Schneble, H. M., Lambert, E., Porchet, H., Glanzman, R., Warne, D., Curtin, F., Kornmann, G., Buffet, B., Kremer, D., Küry, P., Leppert, D., Rückle, T., Barkhof, F. (2021). Efficacy and safety of temelimab in multiple sclerosis: Results of a randomized phase 2b and extension study. Multiple sclerosis (Houndmills, Basingstoke, England), 13524585211024997. Advance online publication. https://doi.org/10.1177/13524585211024997 | - |
dc.identifier.issn | 1352-4585MIAR | - |
dc.identifier.uri | http://hdl.handle.net/10609/139251 | - |
dc.description.abstract | Background: The envelope protein of human endogenous retrovirus W (HERV-W-Env) is expressed by macrophages and microglia, mediating axonal damage in chronic active MS lesions. Objective and Methods: This phase 2, double-blind, 48-week trial in relapsing-remitting MS with 48-week extension phase assessed the efficacy and safety of temelimab; a monoclonal antibody neutralizing HERV-W-Env. The primary endpoint was the reduction of cumulative gadolinium-enhancing T1-lesions in brain magnetic resonance imaging (MRI) scans at week 24. Additional endpoints included numbers of T2 and T1-hypointense lesions, magnetization transfer ratio, and brain atrophy. In total, 270 participants were randomized to receive monthly intravenous temelimab (6, 12, or 18 mg/kg) or placebo for 24 weeks; at week 24 placebo-treated participants were re-randomized to treatment groups. Results: The primary endpoint was not met. At week 48, participants treated with 18 mg/kg temelimab had fewer new T1-hypointense lesions (p = 0.014) and showed consistent, however statistically non-significant, reductions in brain atrophy and magnetization transfer ratio decrease, as compared with the placebo/comparator group. These latter two trends were sustained over 96 weeks. No safety issues emerged. Conclusion: Temelimab failed to show an effect on features of acute inflammation but demonstrated preliminary radiological signs of possible anti-neurodegenerative effects. Current data support the development of temelimab for progressive MS. | - |
dc.language.iso | eng | - |
dc.publisher | Multiple Sclerosis Journal | - |
dc.rights.uri | http://creativecommons.org/licenses/by-nc/3.0/es/ | - |
dc.subject | timelimab | en |
dc.subject | MRI | en |
dc.subject | clinical trial | en |
dc.subject | atrophy | en |
dc.title | Efficacy and safety of temelimab in multiple sclerosis: Results of a randomized phase 2b and extension study | - |
dc.type | info:eu-repo/semantics/article | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.doi | https://doi.org/10.1177/13524585211024997 | - |
dc.gir.id | AR/0000009050 | - |
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Efficacy and safety of temelimab in multiple sclerosis.pdf | 1,43 MB | Adobe PDF | Visualizar/Abrir |
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