%0 Journal Article
%A Steingo, Brian
%A Al-Malik, Yaser
%A Bass, Ann D
%A Berkovich, Regina
%A Carraro, Matthew
%A Fernandez, Oscar
%A Ionete, Carolina
%A Massacesi, Luca
%A Meuth, Sven G
%A Mitsikostas, Dimos D
%A Pardo, Gabriel
%A Simm, Renata Faria
%A Traboulsee, Anthony
%A Choudhry, Zia
%A Daizadeh, Nadia
%A Compston, D Alastair S
%T Long-term efficacy and safety of alemtuzumab in patients with RRMS: 12-year follow-up of CAMMS223.
%D 2020
%U http://hdl.handle.net/10668/15820
%X 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.
%K Alemtuzumab
%K Disease-modifying therapy
%K Efficacy
%K Long-term
%K Multiple sclerosis
%K Safety
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