Real-Life Study with Alemtuzumab, Kuwait Experience

Background To assess the efficacy and safety of Alemtuzumab Efficacy in Multiple Sclerosis in a real-world clinical setting over 7 years follow up. Material(s) and Method(s) This observational, prospective study assessed MS patients who were treated with Alemtuzumab. Baseline patient clinical and radiological characteristics recorded within one year prior to Alemtuzumab initiation. The relapse rate, disability measures, radiological activity and adverse events at last follow-up visits were assessed. Result(s) A total of seventy-three patients, 53 (72.6%) were females, mean age 34.25±7.62 years old, mean disease duration 9.23 +6.20. Mean pre-treatment EDSS was 2.41 +1.85. Most patients (n=32; 43.8%) were naïve to any treatment. Mean follow- up time was 4.00 +1.67years. In the last follow-up visits, most of our cohort was relapse free (55 (82.1)% versus 13 (17.8); P<0.001) and few had new T2 lesions (13 (17.8)% versus 57 (78.1)%; P<0.001 and gadolinium enhancement 14 (19.2)% versus 65 (83.6)%; P<0.001) in MRI compared to baseline. ARR was significantly reduced 0.21+ 0.48versus 0.85 +0.47; P<0.0001). Most of this cohort 94 % has no progression of disability. NEDA-3 was achieved in 52.1% patients. With respect to subgroup analysis, naïve patients showed more relapse free compared to those who received prior DMT(93.1% versus73.7%; P<0.038). Autoimmune thyroiditis (n=12; 15.1%) and Glomerulonephritis (n=2; 2.7%) were reported. Conclusion(s) The effectiveness and safety profile of Alemtuzumab in this cohort were consistent with data of clinical trials. To assess the efficacy and safety of Alemtuzumab Efficacy in Multiple Sclerosis in a real-world clinical setting over 7 years follow up. This observational, prospective study assessed MS patients who were treated with Alemtuzumab. Baseline patient clinical and radiological characteristics recorded within one year prior to Alemtuzumab initiation. The relapse rate, disability measures, radiological activity and adverse events at last follow-up visits were assessed. A total of seventy-three patients, 53 (72.6%) were females, mean age 34.25±7.62 years old, mean disease duration 9.23 +6.20. Mean pre-treatment EDSS was 2.41 +1.85. Most patients (n=32; 43.8%) were naïve to any treatment. Mean follow- up time was 4.00 +1.67years. In the last follow-up visits, most of our cohort was relapse free (55 (82.1)% versus 13 (17.8); P<0.001) and few had new T2 lesions (13 (17.8)% versus 57 (78.1)%; P<0.001 and gadolinium enhancement 14 (19.2)% versus 65 (83.6)%; P<0.001) in MRI compared to baseline. ARR was significantly reduced 0.21+ 0.48versus 0.85 +0.47; P<0.0001). Most of this cohort 94 % has no progression of disability. NEDA-3 was achieved in 52.1% patients. With respect to subgroup analysis, naïve patients showed more relapse free compared to those who received prior DMT(93.1% versus73.7%; P<0.038). Autoimmune thyroiditis (n=12; 15.1%) and Glomerulonephritis (n=2; 2.7%) were reported. The effectiveness and safety profile of Alemtuzumab in this cohort were consistent with data of clinical trials.