Author Of 2 Presentations
P0023 - Alemtuzumab Real World Evidence in a Private Practice Setting (ID 1858)
Abstract
Background
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.
Objectives
To describe patient characteristics and clinical outcomes in RMS patients who have received alemtuzumab in a single neurology center in the United States.
Methods
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.
Results
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.
Conclusions
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.
P0143 - Real-World Experience in RRMS and SPMS Patients with Higher Disability and Substantial Lymphopenia Switching from Prior DMTs to Teriflunomide (ID 1818)
Abstract
Background
Teriflunomide is a once-daily oral immunomodulator approved for the treatment of relapsing forms of multiple sclerosis (MS).
Objectives
To describe the patient characteristics and examine the effectiveness and safety of teriflunomide in patients who switched from other disease modifying therapies (DMTs).
Methods
A retrospective, observational, cohort study was conducted using medical charts on patients ≥ 18 years of age with diagnosis of RRMS or SPMS, who switched to teriflunomide from a prior DMT at a single MS center in the US. Data were extracted at 12 months prior (M-12), at baseline (M0), at 12 months post (M12), and at 24 months post (M24) initiating teriflunomide. Descriptive statistics were conducted for all outcome measures, including relapses, disability, MRI, and cognitive assessment.
Results
Eighty patients (60% RRMS, 40% SPMS) were included in this analysis with a mean age of 44.0 ± 14.55, disease duration of 9.35 ± 6.37 years, baseline EDSS of 3.88 ± 1.76, and 30% with lymphopenia (ALC < 1000/mm3). The most common prior DMTs were dimethyl fumarate (22.5%), glatiramer acetate (18.8%), and natalizumab (16.3%). Mean number of relapses were reduced from 0.26 ±0.44 in the year prior to study entry to 0.18± 0.38 (M12) and 0.05 ± 0.22 (M24). Over the 24 months, mean (95% confidence interval) number of relapses decreased by -0.21 (-0.32, -0.11; P<0.0001), representing an 80.8% reduction. MRI was stable or improved in more patients at M12 (95.1%) and at M24 (97.6%), compared to baseline (92.5%). Mean EDSS score, Montreal Cognitive Assessment (MoCA) test score, and timed 25-foot walk (T25FW) remained stable throughout the study. The percent of patients with lymphopenia was reduced from 30.0% (M0) to 6.3% (M12) and 1.3% (M24). No unexpected or serious AEs were reported.
Conclusions
his real-world study evaluated a more challenging MS cohort with higher EDSS, including a substantial proportion with SPMS, and comorbidities including lymphopenia. Patients who switched to teriflunomide from a prior DMT demonstrated a significant decrease in relapses, and MRI was stable or improved in more patients after initiating teriflunomide compared to baseline. Mean EDSS, T25FW, and MoCA remained stable. In patients previously treated with other DMTs, the proportion of patients with lymphopenia substantially decreased with teriflunomide.