Abstract
BackgroundIn 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).MethodsIn 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.ResultsOf 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.ConclusionsAlemtuzumab 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.
Highlights
Multiple sclerosis (MS) is a lifelong potentially debilitating disorder of the central nervous system that usually evolves over several decades and requires long-term treatment to slow the accumulation of disability and disease progression [1,2,3]
In a 3-year phase 2 trial (CAMMS223; NCT00050778), patients with active relapsing–remitting MS (RRMS) who were treatment-naive at baseline demonstrated significantly greater improvements in clinical and radiological outcomes with alemtuzumab compared with subcutaneous interferon beta1a (SC IFNB-1a; R ebif®; EMD Serono Inc., Rockland, MA, USA) [6]
Of the 108 patients who received alemtuzumab 12 mg/day in the CAMMS223 core study, 60 (56%) enrolled in the CAMMS03409 extension study, and had further follow-up in TOPAZ; 54 (50%) patients remained on study at Year 12 (Fig. 1)
Summary
Multiple sclerosis (MS) is a lifelong potentially debilitating disorder of the central nervous system that usually evolves over several decades and requires long-term treatment to slow the accumulation of disability and disease progression [1,2,3]. In a 3-year phase 2 trial (CAMMS223; NCT00050778), patients with active RRMS who were treatment-naive at baseline demonstrated significantly greater improvements in clinical and radiological outcomes with alemtuzumab compared with subcutaneous interferon beta1a (SC IFNB-1a; R ebif®; EMD Serono Inc., Rockland, MA, USA) [6]. Alemtuzumab demonstrated significant efficacy versus SC IFNB-1a over 2 years in phase 3 clinical trials (CARE-MS I [NCT00530348] and II [NCT00548405]) [7, 8], and efficacy was maintained in two consecutive extension studies (CAMMS03409 [NCT00930553]; TOPAZ [NCT02255656]) [9,10,11,12,13]. 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. The safety profile in this cohort was consistent with other alemtuzumab clinical trials
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