Sanofi Genzyme

Author Of 1 Presentation

Clinical Outcome Measures Poster Presentation

P0023 - Alemtuzumab Real World Evidence in a Private Practice Setting (ID 1858)

Presentation Number
Presentation Topic
Clinical Outcome Measures



Alemtuzumab significantly improved clinical, MRI, and disability outcomes compared to sub-cutaneous interferon β-1a in MS patients in two phase 3 clinical trials and provided efficacy and safety rationale for treating relapsing multiple sclerosis (RMS) patients in a clinical trial setting. The need for additional data illustrating the efficacy and safety of alemtuzumab use in MS patients outside the clinical trial setting and in the real world exists.


To describe patient characteristics and clinical outcomes in RMS patients who have received alemtuzumab in a single neurology center in the United States.


This retrospective, observational study included patients treated with alemtuzumab and had at least 24 months of follow-up. Patient characteristics and clinical outcomes [annualized relapse rate; disability progression, magnetic resonance imaging (MRI)] were analyzed. Patient data for at least 1 year prior and for up to 2 years after initiation of alemtuzumab was collected via chart reviews for all patients.


A total of 250 patients were included in the study. Mean (standard deviation) age at baseline was 49.7 (10.5). 85% of patients switched from natalizumab during the pre-index period primarily due to JCV positive status (57%). Annualized relapse rate was reduced from 0.088 (2-year pre-) to 0.004 (2-year post) index date (p<0.0001) and 0.164 (1-year pre-) to 0.004 (1-year post) index date (p<0.0003). At 2 years, more patients were stable on brain MRI (98.3% vs. 85.0%) and less patients demonstrated brain MRI worsening (1.27% vs. 14.2%) compared to index date (p <0.0001). Mean (95% Confidence Interval) observed EDSS was 3.58 (3.37, 3.79) at baseline and decreased to 3.03 (2.78, 3.28) and 2.82 (2.53, 3.11) at year 1 and year 2, respectively. The average follow-up time for EDSS was 3.72 years (range: 0 - 4.58 years). At 2 years, 84% of patients did not require ambulatory aid.


This study further supports clinical and radiological efficacy of alemtuzumab in RMS patients. After treatment with alemtuzumab, there was a significant reduction in annualized relapse rate, a significant increase in the proportion of patients with stable brain MRI, improvement in disability, and reduced usage of ambulatory aid. Long term follow-up of this cohort will help assess clinical efficacy in a real-world setting.