TY - JOUR
TI - Long-term efficacy and safety of alemtuzumab in patients with RRMS: 12-year follow-up of CAMMS223
AU - Steingo, B.
AU - Al Malik, Y.
AU - Bass, A.D.
AU - Berkovich, R.
AU - Carraro, M.
AU - Fernández, Ó.
AU - Ionete, C.
AU - Massacesi, L.
AU - Meuth, S.G.
AU - Mitsikostas, D.D.
AU - Pardo, G.
AU - Simm, R.F.
AU - Traboulsee, A.
AU - Choudhry, Z.
AU - Daizadeh, N.
AU - Compston, D.A.S.
AU - the CAMMS223, CAMMS03409,
AU - TOPAZ Investigators
JO - Egyptian Journal of Neurology, Psychiatry and Neurosurgery
PY - 2020
VL - 267
TODO - 11
SP - 3343-3353
PB - Springer Science and Business Media Deutschland GmbH
SN - null
TODO - 10.1007/s00415-020-09983-1
TODO - 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
TODO - 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).
ER -