Abstract

<h3>Objective:</h3> To evaluate the effectiveness and safety of Alemtuzumab in a real-world clinical setting over 7 years follow up. <h3>Background:</h3> Alemtuzumab, a humanized anti-CD52 monoclonal antibody (mAb), has been approved as a treatment in patients with active relapsing–remitting multiple sclerosis (RRMS). It is used in Kuwait since 2015. Real-world data in middle east is very limited. <h3>Design/Methods:</h3> 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. <h3>Results:</h3> Data of seventy-three patients was analyzed, of which 53 (72.6%) were females. Mean age and mean disease duration were 34.25±7.62 and 9.23±6.20 years respectively. Alemtuzumab was started in 32 (43.8%) patients due to highly active disease and disease breakthrough in 25 (34.2). Mean follow-up period was 4±1.67 years. In the last follow-up visits, most of our cohort was relapse free (79.5% versus. 17.8%; <i>p</i> &lt;0.001) compared to baseline while EDSS score was significantly reduced (2.21±2.15 versus 2.41±1.85; <i>p</i>&lt; 0.059). The proportion of patients with MRI activity (new T2/Gd-enhancing) (15.1% versus. 82.2%; <i>p</i> &lt;0.001) lesions were significantly reduced compared to baseline MRI. NEDA-3 was achieved in 57.5% of patients. NEDA-3 was significantly better in naïve patients (78% versus. 41.5%; <i>p</i> &lt;0.002) and in patients with disease duration l≤ 5 years, (82.6% versus 43.2%; <i>p</i> &lt;0.002). Infusion reactions (75.3%), autoimmune thyroiditis (16.4%) and glomerulonephritis (2.7%) were reported. <h3>Conclusions:</h3> The effectiveness and safety profile of Alemtuzumab in this cohort were consistent with data of clinical trials. Early initiation of Alemtuzumab is associated with favorable outcome. <b>Disclosure:</b> Dr. Alroughani has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen, Bayer, Novartis, Merck, Roche, Sanofi. Dr. Alroughani has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Bayer, Biogen, Novartis, Merck, Roche, Sanofi. Dr. AlMojel has nothing to disclose. Dr. Al-Hashel has nothing to disclose. Dr. Ahmed has nothing to disclose.

Full Text
Published version (Free)

Talk to us

Join us for a 30 min session where you can share your feedback and ask us any queries you have

Schedule a call