@article{2997434,
    title = "Long-term efficacy and safety of alemtuzumab in patients with RRMS: 12-year follow-up of CAMMS223",
    author = "Steingo, B. and Al Malik, Y. and Bass, A.D. and Berkovich, R. and Carraro, M. and Fernández, Ó. and Ionete, C. and Massacesi, L. and Meuth, S.G. and Mitsikostas, D.D. and Pardo, G. and Simm, R.F. and Traboulsee, A. and Choudhry, Z. and Daizadeh, N. and Compston, D.A.S. and the CAMMS223, CAMMS03409, and TOPAZ Investigators",
    journal = "Egyptian Journal of Neurology, Psychiatry and Neurosurgery",
    year = "2020",
    volume = "267",
    number = "11",
    pages = "3343-3353",
    publisher = "Springer Science and Business Media Deutschland GmbH",
    doi = "10.1007/s00415-020-09983-1",
    keywords = "alemtuzumab;  peginterferon beta1a;  alemtuzumab;  beta1a interferon;  monoclonal antibody, adult;  Article;  autoimmune disease;  controlled study;  disease activity;  drug efficacy;  drug fatality;  drug safety;  drug withdrawal;  Expanded Disability Status Scale;  female;  follow up;  human;  idiopathic thrombocytopenic purpura;  incidence;  infection;  major clinical study;  male;  malignant neoplasm;  multiple sclerosis;  nuclear magnetic resonance imaging;  open study;  phase 2 clinical trial;  priority journal;  randomized controlled trial;  recurrence risk;  thyroid disease;  unspecified side effect;  diagnostic imaging, Alemtuzumab;  Antibodies, Monoclonal, Humanized;  Follow-Up Studies;  Humans;  Interferon beta-1a;  Multiple Sclerosis, Relapsing-Remitting",
    abstract = "Background: 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). Methods: 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. Results: 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. Conclusions: 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. © 2020, The Author(s)."
}