Alemtuzumab Treatment In Multiple Sclerosis: Real Clinical Experience In The Northwest Of Spain

Objective: To characterize the effectivity and security of the use of Alemtuzumab in routine clinical practice. Background: In pivotal studies, Alemtuzumab has demonstrated a significant reduction of relapse rates and improved MRI outcomes. Different results were obtained about disability. Design/Methods: Patients from 11 centers from the Northwest of Spain who received a first dose of Alemtuzumab were included. Baseline and prospective data, previous disease-modifying treatment (DMT) use and reason for changing, relapse rate, EDSS change and magnetic resonance imaging (MRI) parameters were collected and described. Results: 108 patients were included; 74 (69%) females. Mean of age was 39.6±8.09 years. Annualized relapse rate (ARR) mean in the previous year was 1.3±1.09. Baseline EDSS mean was 3.5±1.70. Mean of number of previous DMT was 2.3±1.51. The main reason for switching to Alemtuzumab was inefficacy (79%). The 55 patients who were monitored for 12 months, showed an important reduction of ARR, from 1.51±1.25 to 0.09±0.29 (U=2667.5; p From baseline to 12 months, there was a reduction from 57% to 14% (n=44) in the number of patients with gadolinium-enhancing lesions and there were 75% of patients without new T2 lesions (n=44) on MRI. Infusion-related reactions were registered in 88 (81%) patients during first course and in 42 (76%) in the second course (all were mild-moderate). Infections were detected in 63% of patients; the most common were urinary tract infections. Thyroid disease was the only observed secondary autoimmune disorder (5% of patients). No serious adverse events occurred. Conclusions: The study confirms a positive effect of Alemtuzumab on clinic (ARR, EDSS) and radiological outcomes. Disclosure: Dr. Lopez Real has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen, Sanofi Genzyme, Merck Serono, Roche. Dr. Gonzalez has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen, Novartis and Sanofi Genzyme. Dr. Gonzalez has received research support from Biogen, Novartis and Sanofi Genzyme. Dr. Costa Arpin has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen Idec, Merck Serono, Bayer Health Care, Genzyme and TEVA. Dr. Pato has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen, Novartis, Genzyme, Almirall and Bayer. Dr. Alvarez Rodriguez has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Sanofi, Biogen and Merck Serono. Dr. Rodriguez Regal has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Genzyme, Biogen and TEVA. Dr. Garcia-Pelayo Rodriguez has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Merck Serono, Genzyme and Roche. Dr. Garcia Bargo has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Sanofi Genzyme. Dr. Llaneza Gonzalez has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Sanofi-Genzyme, Biogen, Novartis, TEVA, Merck Serono and Almirall. Dr. Rodriguez Rodriguez has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Sanofi, Biogen, Merck Serono, Novartis and TEVA. Dr. Solar Sanchez has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Almirall, Biogen, Bayer, Merck Serono, Novartis, Sanofi Genzyme and TEVA. Dr. Oterino Duran has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen, Almirall, Merck Serono, TEVA, Sanofi Genzyme, Allergan, MSD and Novartis. Dr. Pena Martinez has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Sanofi Genzyme, Merck Serono, Bayer, TEVA, Biogen Idec, Novartis, Almirall, Krka and Qualigen.