AUTHOR=Eichau Sara , López Ruiz Rocío , Ruíz de Arcos María , Ruiz-Peña Juan Luis , Navarro Guillermo , Calleja Miguel Ángel , Moreno-Amador José Luis , Dotor García-Soto Julio 

TITLE=Results of treatment with alemtuzumab in a Spanish cohort of patients with multiple sclerosis in the real world: The RealMS study

JOURNAL=Frontiers in Neurology

VOLUME=Volume 14 - 2023

YEAR=2023

URL=https://www.frontiersin.org/journals/neurology/articles/10.3389/fneur.2023.1112193

DOI=10.3389/fneur.2023.1112193

ISSN=1664-2295

ABSTRACT=Background: Alemtuzumab (ALZ) is a humanized monoclonal antibody approved for highly active relapsing-remitting multiple sclerosis (RRMS) administered in two annual courses. The objective of this study was to describe the effectiveness and safety data of alemtuzumab and to report the health resource utilization in patients receiving this treatment.
Methods: In this retrospective, non-interventional study, information was retrieved from patients’ medical charts at one center in Spain. Included patients were age ≥18 and initiated ALZ treatment between March 1, 2015, and March 31, 2019, according to routine clinical practice and local labeling. 
Results: Of 123 patients, 78% were women. Mean age at diagnosis was 40.3 (9.1) years, and time since diagnosis was 13.8 (7.3) years. Patients were previously treated with a median number of 2 (2.0–3.0) disease-modifying treatments (DMT). Patients were treated with ALZ for a mean of 29.7 (13.8) months. ALZ reduced the annualized relapse rate (ARR) (1.5 before vs 0.05 after; p<0.001) and improved the median EDSS (4.63 before vs 4.00 after; p<0.001). Most (90.2%) patients were relapse-free while receiving alemtuzumab. The mean number of gadolinium-enhancing [Gd+] T1 lesions were reduced (1.7 before vs 0.1 after; p<0.001) and the mean number of T2 hyperintense lesions was maintained (35.7 before vs 35.4 after; p=0.392). Twenty-seven (21.9%) patients reported a total of 29 autoimmune diseases: hyperthyroidism (12), hypothyroidism (11), idiopathic thrombocytopenic purpura (ITP) (3), alopecia areata (1), chronic urticaria (1), and vitiligo (1). The mean number of health resources (outpatient visits, emergency room visits, hospital admissions, and tests performed in the hospital) used while patients were treated with alemtuzumab progressively decreased from year 1 to year 4, except for a slight increase at year 2 of outpatient visits. 
Conclusion: The ReaLMS study provides real-world evidence that ALZ can promote clinical and magnetic resonance imaging (MRI) disease remission, as well as disability improvement in patients with MS despite several prior DMT failure. ALZ safety profile was consistent with data available from clinical trials and other real-world studies. Healthcare resource use was reduced throughout the treatment period.