RT Journal Article
T1 Autoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis: Benefit/risk following review of trial and post-marketing data.
A1 Coles, Alasdair J
A1 Jones, Joanne L
A1 Vermersch, Patrick
A1 Traboulsee, Anthony
A1 Bass, Ann D
A1 Boster, Aaron
A1 Chan, Andrew
A1 Comi, Giancarlo
A1 Fernandez, Oscar
A1 Giovannoni, Gavin
A1 Kubala-Havrdova, Eva
A1 LaGanke, Christopher
A1 Montalban, Xavier
A1 Oreja-Guevara, Celia
A1 Piehl, Fredrik
A1 Wiendl, Heinz
A1 Ziemssen, Tjalf
K1 Multiple sclerosis
K1 Alemtuzumab
K1 Autoimmunity
K1 Post-marketing
K1 Product surveillance
K1 Risk assessment
K1 Treatment outcome
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.
PB Sage Publications
YR 2021
FD 2021-10-18
LK http://hdl.handle.net/10668/20223
UL http://hdl.handle.net/10668/20223
LA en
NO Coles AJ, Jones JL, Vermersch P, Traboulsee A, Bass AD, Boster A, et al. Autoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis: Benefit/risk following review of trial and post-marketing data. Mult Scler. 2022 Apr;28(5):842-846.
DS RISalud
RD Apr 19, 2025