Steingo, BrianAl-Malik, YaserBass, Ann DBerkovich, ReginaCarraro, MatthewFernandez, OscarIonete, CarolinaMassacesi, LucaMeuth, Sven GMitsikostas, Dimos DPardo, GabrielSimm, Renata FariaTraboulsee, AnthonyChoudhry, ZiaDaizadeh, NadiaCompston, D Alastair S2023-02-092023-02-092020-06-24Steingo 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):3343-3353http://hdl.handle.net/10668/15820In 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.enAttribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/AlemtuzumabDisease-modifying therapyEfficacyLong-termMultiple sclerosisSafetyAlemtuzumabAntibodies, Monoclonal, HumanizedFollow-Up StudiesHumansInterferon beta-1aMultiple Sclerosis, Relapsing-Remittingresearch article32583052open accessIncidenciaRecurrenciaInterferón beta-1aGlándula TiroidesPúrpura trombocitopénica idiopática10.1007/s00415-020-09983-11432-1459PMC7578137https://link.springer.com/content/pdf/10.1007/s00415-020-09983-1.pdfhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7578137/pdf