Author Of 2 Presentations
P0023 - Alemtuzumab Real World Evidence in a Private Practice Setting (ID 1858)
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.
P0139 - Real World Clinical and Imaging Outcomes in Relapsing MS Patients treated with Alemtuzumab in a US Regional MS Center (ID 362)
Additional data on alemtuzumab use including clinical, imaging and safety outcomes in a real-world setting can improve patient care.
To examine clinical, imaging and safety outcomes in relapsing multiple sclerosis (MS) patients who received at least 2 courses of alemtuzumab.
This retrospective, single-center study included patients treated with at least 2 courses of alemtuzumab and at least 12 months of follow-up. Demographic, clinical (annualized relapse rate; disability progression); imaging characteristics (brain and spine MRI); previous treatment; co-morbidities and adverse events were analyzed. Patient data for 2 years prior to course 1 (index date) and for up to 4 years after initiation of alemtuzumab was available for all patients.
74 patients were included. Mean age (SD) at baseline was 41.8 (9.9), diagnosis duration 11.5 (7.8) years. 33 patients needed help with ambulation; of which 11 were wheelchair-bound. 45% of patients switched from natalizumab and 23% from fingolimod primarily due to MS worsening. After Alemtuzumab treatment, ARR was significantly decreased from 1.231 (1-year pre-) to 0.392 (1-year post-) index date (P < 0.0001) and to 0.313, 0.240 and 0.291 during each of following 3 years respectively. Comparing one year prior to and 2-years post- treatment: more patients had stable spinal cord MRI (94.3% vs 62.5%) and fewer showed worsening (37.5% vs 5.7%) (p = 0.0017). On brain MRI, more patients were stable (87.7% vs. 52.1%) and fewer patients showed worsening (48.0% vs. 9.6%) (p<0.0001). On disability, 69% of patients remained stable; 3 of 11 wheelchair-bound patients became ambulatory. Safety outcomes will be available for presentation.
This real-world data suggests alemtuzumab is clinically and radiographically safe and effective in a wide spectrum of MS patients including those with severe disability, longer disease duration and multiple comorbidities. Long term follow-up of this cohort will help assess the clinical efficacy of alemtuzumab in a real-world setting.