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Autoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis: Benefit/risk following review of trial and post-marketing data
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 autoimmunit...
| Autores principales: | , , , , , , , , , , , , , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
SAGE Publications
2021
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8978465/ https://www.ncbi.nlm.nih.gov/pubmed/34882037 http://dx.doi.org/10.1177/13524585211061335 |
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| author | Coles, Alasdair J Jones, Joanne L Vermersch, Patrick Traboulsee, Anthony Bass, Ann D Boster, Aaron Chan, Andrew Comi, Giancarlo Fernández, Óscar Giovannoni, Gavin Kubala Havrdova, Eva LaGanke, Christopher Montalban, Xavier Oreja-Guevara, Celia Piehl, Fredrik Wiendl, Heinz Ziemssen, Tjalf |
| author_facet | Coles, Alasdair J Jones, Joanne L Vermersch, Patrick Traboulsee, Anthony Bass, Ann D Boster, Aaron Chan, Andrew Comi, Giancarlo Fernández, Óscar Giovannoni, Gavin Kubala Havrdova, Eva LaGanke, Christopher Montalban, Xavier Oreja-Guevara, Celia Piehl, Fredrik Wiendl, Heinz Ziemssen, Tjalf |
| author_sort | Coles, Alasdair J |
| collection | PubMed |
| description | 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. |
| format | Online Article Text |
| id | pubmed-8978465 |
| institution | National Center for Biotechnology Information |
| language | English |
| publishDate | 2021 |
| publisher | SAGE Publications |
| record_format | MEDLINE/PubMed |
| spelling | pubmed-89784652022-04-05 Autoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis: Benefit/risk following review of trial and post-marketing data Coles, Alasdair J Jones, Joanne L Vermersch, Patrick Traboulsee, Anthony Bass, Ann D Boster, Aaron Chan, Andrew Comi, Giancarlo Fernández, Óscar Giovannoni, Gavin Kubala Havrdova, Eva LaGanke, Christopher Montalban, Xavier Oreja-Guevara, Celia Piehl, Fredrik Wiendl, Heinz Ziemssen, Tjalf Mult Scler Short Report 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. SAGE Publications 2021-12-09 2022-04 /pmc/articles/PMC8978465/ /pubmed/34882037 http://dx.doi.org/10.1177/13524585211061335 Text en © The Author(s), 2021 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage). |
| spellingShingle | Short Report Coles, Alasdair J Jones, Joanne L Vermersch, Patrick Traboulsee, Anthony Bass, Ann D Boster, Aaron Chan, Andrew Comi, Giancarlo Fernández, Óscar Giovannoni, Gavin Kubala Havrdova, Eva LaGanke, Christopher Montalban, Xavier Oreja-Guevara, Celia Piehl, Fredrik Wiendl, Heinz Ziemssen, Tjalf Autoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis: Benefit/risk following review of trial and post-marketing data |
| title | Autoimmunity and long-term safety and efficacy of alemtuzumab for
multiple sclerosis: Benefit/risk following review of trial and post-marketing
data |
| title_full | Autoimmunity and long-term safety and efficacy of alemtuzumab for
multiple sclerosis: Benefit/risk following review of trial and post-marketing
data |
| title_fullStr | Autoimmunity and long-term safety and efficacy of alemtuzumab for
multiple sclerosis: Benefit/risk following review of trial and post-marketing
data |
| title_full_unstemmed | Autoimmunity and long-term safety and efficacy of alemtuzumab for
multiple sclerosis: Benefit/risk following review of trial and post-marketing
data |
| title_short | Autoimmunity and long-term safety and efficacy of alemtuzumab for
multiple sclerosis: Benefit/risk following review of trial and post-marketing
data |
| title_sort | autoimmunity and long-term safety and efficacy of alemtuzumab for
multiple sclerosis: benefit/risk following review of trial and post-marketing
data |
| topic | Short Report |
| url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8978465/ https://www.ncbi.nlm.nih.gov/pubmed/34882037 http://dx.doi.org/10.1177/13524585211061335 |
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