RT Journal Article
T1 Long-term efficacy and safety of alemtuzumab in patients with RRMS: 12-year follow-up of CAMMS223.
A1 Steingo, Brian
A1 Al-Malik, Yaser
A1 Bass, Ann D
A1 Berkovich, Regina
A1 Carraro, Matthew
A1 Fernandez, Oscar
A1 Ionete, Carolina
A1 Massacesi, Luca
A1 Meuth, Sven G
A1 Mitsikostas, Dimos D
A1 Pardo, Gabriel
A1 Simm, Renata Faria
A1 Traboulsee, Anthony
A1 Choudhry, Zia
A1 Daizadeh, Nadia
A1 Compston, D Alastair S
K1 Alemtuzumab
K1 Disease-modifying therapy
K1 Efficacy
K1 Long-term
K1 Multiple sclerosis
K1 Safety
AB In the phase 2 CAMMS223 trial (NCT00050778), alemtuzumab significantly improved clinical and MRI outcomes versus subcutaneous interferon beta-1a over 3 years in treatment-naive patients with relapsing-remitting MS. Here, we assess efficacy and safety of alemtuzumab over 12 years in CAMMS223 patients who enrolled in the CAMMS03409 extension (NCT00930553), with available follow-up through the subsequent TOPAZ extension (NCT02255656). In CAMMS223, patients received 2 alemtuzumab courses (12 mg/day; baseline: 5 days; 12 months later: 3 days); 22% received a third course. In the open-label, nonrandomized extensions, patients could receive as-needed additional alemtuzumab or other disease-modifying therapies. Of 108 alemtuzumab-treated patients in CAMMS223, 60 entered the CAMMS03409 extension; 33% received a total of 2 alemtuzumab courses, and 73% received no more than 3 courses through Year 12. Over 12 years, annualized relapse rate was 0.09, 71% of patients had stable or improved Expanded Disability Status Scale scores, and 69% were free of 6-month confirmed disability worsening. In Year 12, 73% of patients were free of MRI disease activity. Cumulatively throughout the extensions (Years 7-12), 34% of patients had no evidence of disease activity. Adverse event (AE) incidence declined through Year 12. Infusion-associated reactions peaked at first course and declined thereafter. Cumulative thyroid AE incidence was 50%; one immune thrombocytopenia event occurred, and there were no autoimmune nephropathy cases. Alemtuzumab efficacy was maintained over 12 years in CAMMS223 patients, with 73% receiving no more than three courses. The safety profile in this cohort was consistent with other alemtuzumab clinical trials.
PB Springer
YR 2020
FD 2020-06-24
LK http://hdl.handle.net/10668/15820
UL http://hdl.handle.net/10668/15820
LA en
NO Steingo B, Al Malik Y, Bass AD, Berkovich R, Carraro M, Fernández Ó, et al.  Long-term efficacy and safety of alemtuzumab in patients with RRMS: 12-year follow-up of CAMMS223. J Neurol. 2020 Nov;267(11):3343-3353
DS RISalud
RD Apr 19, 2025