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

被引：16

作者：

Coles, Alasdair J. ^{[1
]}

Jones, Joanne L. ^{[1
]}

Vermersch, Patrick ^{[2
]}

Traboulsee, Anthony ^{[3
]}

Bass, Ann D. ^{[4
]}

Boster, Aaron ^{[5
]}

Chan, Andrew ^{[6
,7
]}

Comi, Giancarlo ^{[8
]}

Fernandez, Oscar ^{[9
]}

Giovannoni, Gavin ^{[10
]}

Kubala Havrdova, Eva ^{[11
]}

LaGanke, Christopher ^{[12
]}

Montalban, Xavier ^{[13
]}

Oreja-Guevara, Celia ^{[14
,15
]}

Piehl, Fredrik ^{[16
]}

Wiendl, Heinz ^{[17
]}

Ziemssen, Tjalf ^{[18
]}

机构：

[1] Univ Cambridge, Sch Med, Dept Clin Neurosci, Cambridge, England

[2] Univ Lille, CHU Lille, FHU Precise, INSERM,UMR S 1172 Lille,Neurosci & Cognit, Lille, France

[3] Univ British Columbia, Vancouver, BC, Canada

[4] Neurol Ctr San Antonio, San Antonio, TX USA

[5] Boster MS Ctr, Columbus, OH USA

[6] Bern Univ Hosp, Bern, Switzerland

[7] Univ Bern, Bern, Switzerland

[8] Univ Vita Salute San Raffaele, Milan, Italy

[9] Hosp Univ Carlos Haya, Fdn IMABIS, Malaga, Spain

[10] Queen Mary Univ London, Barts & London Sch Med, London, England

[11] Charles Univ Prague, Med Fac 1, Dept Neurol, Prague, Czech Republic

[12] North Cent Neurol Associates, Cullman, AL USA

[13] Hosp Univ Vall dHebron, Ctr Esclerosi Multiple Catalunya Cemcat, Dept Neurol Neuroimmunol, Barcelona, Spain

[14] Hosp Clin San Carlos, IdISSC, Dept Neurol, Madrid, Spain

[15] Univ Complutense Madrid, Fac Med, Dept Med, Madrid, Spain

[16] Karolinska Inst, Dept Clin Neurosci, Neuroimmunol Unit, Stockholm, Sweden

[17] Univ Munster, Munster, Germany

[18] Tech Univ Dresden, Carl Gustav Carus Univ Hosp, Dept Neurol, Ctr Clin Neurosci, Dresden, Germany

来源：

MULTIPLE SCLEROSIS JOURNAL | 2022年 / 28卷 / 05期

基金：

英国惠康基金;

关键词：

Multiple sclerosis; alemtuzumab; autoimmunity; treatment outcome; risk assessment; product surveillance; post-marketing;

D O I：

10.1177/13524585211061335

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

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.

引用

页码：842 / 846

页数：5

共 10 条

[1]

[Anonymous], Surveillance, Epidemiology, and End Results Program

[2] Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial [J].

Cohen, Jeffrey A. ;

Coles, Alasdair J. ;

Arnold, Douglas L. ;

Confavreux, Christian ;

Fox, Edward J. ;

Hartung, Hans-Peter ;

Havrdova, Eva ;

Selmaj, Krzysztof W. ;

Weiner, Howard L. ;

Fisher, Elizabeth ;

Brinar, Vesna V. ;

Giovannoni, Gavin ;

Stojanovic, Miroslav ;

Ertik, Bella I. ;

Lake, Stephen L. ;

Margolin, David H. ;

Panzara, Michael A. ;

Compston, D. Alastair S. .

LANCET, 2012, 380 (9856) :1819-1828

[3]

Coles AJ, 2008, NEW ENGL J MED, V359, P1786, DOI 10.1056/NEJMoa0802670

[4]

Coles Alasdair J, 2021, Ther Adv Neurol Disord, V14, p1756286420982134, DOI 10.1177/1756286420982134

[5] Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial [J].

Coles, Alasdair J. ;

Twyman, Cary L. ;

Arnold, Douglas L. ;

Cohen, Jeffrey A. ;

Confavreux, Christian ;

Fox, Edward J. ;

Hartung, Hans-Peter ;

Havrdova, Eva ;

Selmaj, Krzysztof W. ;

Weiner, Howard L. ;

Miller, Tamara ;

Fisher, Elizabeth ;

Sandbrink, Rupert ;

Lake, Stephen L. ;

Margolin, David H. ;

Oyuela, Pedro ;

Panzara, Michael A. ;

Compston, D. Alastair S. .

LANCET, 2012, 380 (9856) :1829-1839

[6]

Genzyme Corporation, LEMTRADA REMS RISK E

[7]

Kochanek Kenneth D, 2019, Natl Vital Stat Rep, V68, P1

[8]

Sanofi Genzyme, 2020, LEMTRADA AL SUMM PRO

[9]

Senior P, 2016, NEUROLOGY, V86

[10] Efficacy and Safety of Alemtuzumab Through 9 Years of Follow-up in Patients with Highly Active Disease: Post Hoc Analysis of CARE-MS I and II Patients in the TOPAZ Extension Study [J].

Ziemssen, Tjalf ;

Bass, Ann D. ;

Berkovich, Regina ;

Comi, Giancarlo ;

Eichau, Sara ;

Hobart, Jeremy ;

Hunter, Samuel F. ;

LaGanke, Christopher ;

Limmroth, Volker ;

Pelletier, Daniel ;

Pozzilli, Carlo ;

Schippling, Sven ;

Sousa, Livia ;

Traboulsee, Anthony ;

Uitdehaag, Bernard M. J. ;

Van Wijmeersch, Bart ;

Choudhry, Zia ;

Daizadeh, Nadia ;

Singer, Barry A. .

CNS DRUGS, 2020, 34 (09) :973-988

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