Autoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis: Benefit/risk following review of trial and post-marketing data

Alasdair J. Coles; Joanne L. Jones; Patrick Vermersch; Anthony Traboulsee; Ann D. Bass; Aaron Boster; Andrew Chan; Giancarlo Comi; Óscar Fernández; Gavin Giovannoni; Eva Kubala Havrdova; Christopher LaGanke; Xavier Montalban; Celia Oreja-Guevara; Fredrik Piehl; Heinz Wiendl; Tjalf Ziemssen

doi:10.1177/13524585211061335

Autoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis: Benefit/risk following review of trial and post-marketing data

Alasdair J. Coles^*, Joanne L. Jones, Patrick Vermersch, Anthony Traboulsee, Ann D. Bass, Aaron Boster, Andrew Chan, Giancarlo Comi, Óscar Fernández, Gavin Giovannoni, Eva Kubala Havrdova, Christopher LaGanke, Xavier Montalban, Celia Oreja-Guevara, Fredrik Piehl, Heinz Wiendl, Tjalf Ziemssen

^*Autor corresponent d’aquest treball

Departament de Medicina

Producció científica: Contribució a revista › Article › Recerca › Avaluat per experts

23 Cites (Scopus)

3 Descàrregues (Pure)

Resum

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.

Idioma original	Anglès
Pàgines (de-a)	842-846
Nombre de pàgines	5
Revista	Multiple Sclerosis Journal
Volum	28
Número	5
DOIs	https://doi.org/10.1177/13524585211061335
Estat de la publicació	Publicada - d’abr. 2022

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10.1177/13524585211061335

https://ddd.uab.cat/record/275789

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Coles, A. J., Jones, J. L., Vermersch, P., Traboulsee, A., Bass, A. D., Boster, A., Chan, A., Comi, G., Fernández, Ó., Giovannoni, G., Kubala Havrdova, E., LaGanke, C., Montalban, X., Oreja-Guevara, C., Piehl, F., Wiendl, H., & Ziemssen, T. (2022). Autoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis: Benefit/risk following review of trial and post-marketing data. Multiple Sclerosis Journal, 28(5), 842-846. https://doi.org/10.1177/13524585211061335

@article{bbe6b88ce0cf48f8903a5f3647114df1,

title = "Autoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis: Benefit/risk following review of trial and post-marketing data",

abstract = "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.",

keywords = "Multiple sclerosis, alemtuzumab, autoimmunity, post-marketing, product surveillance, risk assessment, treatment outcome",

author = "Coles, \{Alasdair J.\} and Jones, \{Joanne L.\} and Patrick Vermersch and Anthony Traboulsee and Bass, \{Ann D.\} and Aaron Boster and Andrew Chan and Giancarlo Comi and {\'O}scar Fern{\'a}ndez and Gavin Giovannoni and \{Kubala Havrdova\}, Eva and Christopher LaGanke and Xavier Montalban and Celia Oreja-Guevara and Fredrik Piehl and Heinz Wiendl and Tjalf Ziemssen",

note = "Publisher Copyright: {\textcopyright} The Author(s), 2021.",

year = "2022",

month = apr,

doi = "10.1177/13524585211061335",

language = "English",

volume = "28",

pages = "842--846",

journal = "Multiple Sclerosis Journal",

issn = "1352-4585",

publisher = "SAGE Publications Ltd",

number = "5",

}

Coles, AJ, Jones, JL, Vermersch, P, Traboulsee, A, Bass, AD, Boster, A, Chan, A, Comi, G, Fernández, Ó, Giovannoni, G, Kubala Havrdova, E, LaGanke, C, Montalban, X, Oreja-Guevara, C, Piehl, F, Wiendl, H & Ziemssen, T 2022, 'Autoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis: Benefit/risk following review of trial and post-marketing data', Multiple Sclerosis Journal, vol. 28, núm. 5, pàg. 842-846. https://doi.org/10.1177/13524585211061335

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 et al.
In: Multiple Sclerosis Journal, Vol. 28, Núm. 5, 04.2022, pàg. 842-846.

Producció científica: Contribució a revista › Article › Recerca › Avaluat per experts

TY - JOUR

T1 - Autoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis

T2 - Benefit/risk following review of trial and post-marketing data

AU - Coles, Alasdair J.

AU - Jones, Joanne L.

AU - Vermersch, Patrick

AU - Traboulsee, Anthony

AU - Bass, Ann D.

AU - Boster, Aaron

AU - Chan, Andrew

AU - Comi, Giancarlo

AU - Fernández, Óscar

AU - Giovannoni, Gavin

AU - Kubala Havrdova, Eva

AU - LaGanke, Christopher

AU - Montalban, Xavier

AU - Oreja-Guevara, Celia

AU - Piehl, Fredrik

AU - Wiendl, Heinz

AU - Ziemssen, Tjalf

PY - 2022/4

Y1 - 2022/4

N2 - 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.

AB - 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.

KW - Multiple sclerosis

KW - alemtuzumab

KW - autoimmunity

KW - post-marketing

KW - product surveillance

KW - risk assessment

KW - treatment outcome

UR - https://www.scopus.com/pages/publications/85121289744

U2 - 10.1177/13524585211061335

DO - 10.1177/13524585211061335

M3 - Article

C2 - 34882037

AN - SCOPUS:85121289744

SN - 1352-4585

VL - 28

SP - 842

EP - 846

JO - Multiple Sclerosis Journal

JF - Multiple Sclerosis Journal

IS - 5

ER -

Autoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis: Benefit/risk following review of trial and post-marketing data

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