Contributions
Abstract: EP1623
Type: ePoster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: In pivotal studies alemtuzumab have demonstrated a marked reduction of relapse rates and improved on MRI outcomes. Different results were obtained about disability.
Objectives: To describe “real-world” experience of the use of alemtuzumab in a multicentre cohort of patients.
Methods: Patients from 11 centres from the Northwest of Spain who received first dose Alemtuzumab were included. Baseline and prospective data were obtained. Previous disease-modifying treatment (DMT) use and reason for changing to Alemtuzumab, relapse rate, EDSS change and magnetic resonance imaging (MRI) are described. EDSS were performed at baseline and every 6 months. The reported cranial MRI scans were performed at baseline and annually.
Results: Eighty three patients: 55 (66%) females and 28 (34%) males, were included. Mean of age was 39.4±8.27 years. Mean duration of follow up was 11.0±5.88 months; 30 patients received the second course. Mean MS duration was of 10.8±6.86 years. Annualized relapse rate (ARR) in the previous year was 1.3±1.13 and mean baseline EDSS was 3.5±1.66 (median 3.5). The mean number of previous DMT was 2.5±1.51. The main reason for switching to alemtuzumab was lack of efficacy (80%). The 28 patients who was followed for 12 months, showed an important reduction of ARR, from 1.82±1.36 to 0.07±0.26 (U=319.5; p< 0.001); and mean EDSS did not change. From baseline to 12 months, there was a reduction from 58% to 15% (n=26) in the number of patients with gadolinium-enhancing lesions on T1-wheighted MRI and there were 23% of patients with new T2-hyperintense lesions (n=26). Infusion-related reactions were registered in 67 (81%) patients (all were mild-moderate). Infections were detected in 33% of patients; the most common were urinary tract infections. Thyroid disease was the only observed secondary autoimmune disorder (6% of patients). No serious adverse events (AE) occurred.
Conclusions: This study confirms a positive effect on clinic (relapses, EDSS) and radiological measures. AE are predictable and treatable. Thyroid disease was the only autoinmune disorder observed.
Disclosure:
López Real A.M. has served as speaker for Biogen Idec, Merck Serono, Genzyme, Novartis and TEVA;
Peña Martínez J. has served as speaker for Sanofi Genzyme, Merck, Bayer, Teva, Biogen Idec, Novartis, Almirall, Krka and Qualigen;
Rodriguez Regal A has served as speaker for Genzyme, Biogen and TEVA.
Oterino Duran A., has served as speaker for Biogen, Almirall, Merck, Teva, Sanofi-Genzyme, Allergan, MSD and Novartis.
Solar Sanchez D.M. has served as consultant for Almirall, Biogen, Bayer, Merck, Novartis, Sanofi-Genzyme, TEVA;
Pato Pato A. has received grants for clinical research from Biogen, Novartis, Genzyme, Almirall, Bayern;
Gonzalez Suarez I. has received grants from Biogen, Novartis, Genzyme;
Garcia-Pelayo Rodriguez A.M. has served as speaker for Merck Serono and Genzyme.
Costa Arpín E.: has served as speaker or consultant for Biogen Idec, Merck Serono, Bayer Health Care, Genzyme, TEVA and UCB Pharma;
Llaneza Gonzalez M. has served as speaker for Sanofi-Genzyme, Biogen, Novartis, Teva, Merck, Almirall;
García Bargo M.D. has served as speaker for Sanofi Genzyme;
Rodriguez Rodriguez M has served as speaker for Sanofi, Biogen, Merck, Novartis and TEVA;
Prieto González J.M. has served as advisor, consultant and speaker for Bayer HealthCare Pharmaceuticals, Biogen Idec Inc, Genzyme Corporation, Novartis, Sanofi and Teva. He also has received grants for clinical research from Biogen Idec Inc and Novartis Pharmaceuticals Corporation.
Abstract: EP1623
Type: ePoster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: In pivotal studies alemtuzumab have demonstrated a marked reduction of relapse rates and improved on MRI outcomes. Different results were obtained about disability.
Objectives: To describe “real-world” experience of the use of alemtuzumab in a multicentre cohort of patients.
Methods: Patients from 11 centres from the Northwest of Spain who received first dose Alemtuzumab were included. Baseline and prospective data were obtained. Previous disease-modifying treatment (DMT) use and reason for changing to Alemtuzumab, relapse rate, EDSS change and magnetic resonance imaging (MRI) are described. EDSS were performed at baseline and every 6 months. The reported cranial MRI scans were performed at baseline and annually.
Results: Eighty three patients: 55 (66%) females and 28 (34%) males, were included. Mean of age was 39.4±8.27 years. Mean duration of follow up was 11.0±5.88 months; 30 patients received the second course. Mean MS duration was of 10.8±6.86 years. Annualized relapse rate (ARR) in the previous year was 1.3±1.13 and mean baseline EDSS was 3.5±1.66 (median 3.5). The mean number of previous DMT was 2.5±1.51. The main reason for switching to alemtuzumab was lack of efficacy (80%). The 28 patients who was followed for 12 months, showed an important reduction of ARR, from 1.82±1.36 to 0.07±0.26 (U=319.5; p< 0.001); and mean EDSS did not change. From baseline to 12 months, there was a reduction from 58% to 15% (n=26) in the number of patients with gadolinium-enhancing lesions on T1-wheighted MRI and there were 23% of patients with new T2-hyperintense lesions (n=26). Infusion-related reactions were registered in 67 (81%) patients (all were mild-moderate). Infections were detected in 33% of patients; the most common were urinary tract infections. Thyroid disease was the only observed secondary autoimmune disorder (6% of patients). No serious adverse events (AE) occurred.
Conclusions: This study confirms a positive effect on clinic (relapses, EDSS) and radiological measures. AE are predictable and treatable. Thyroid disease was the only autoinmune disorder observed.
Disclosure:
López Real A.M. has served as speaker for Biogen Idec, Merck Serono, Genzyme, Novartis and TEVA;
Peña Martínez J. has served as speaker for Sanofi Genzyme, Merck, Bayer, Teva, Biogen Idec, Novartis, Almirall, Krka and Qualigen;
Rodriguez Regal A has served as speaker for Genzyme, Biogen and TEVA.
Oterino Duran A., has served as speaker for Biogen, Almirall, Merck, Teva, Sanofi-Genzyme, Allergan, MSD and Novartis.
Solar Sanchez D.M. has served as consultant for Almirall, Biogen, Bayer, Merck, Novartis, Sanofi-Genzyme, TEVA;
Pato Pato A. has received grants for clinical research from Biogen, Novartis, Genzyme, Almirall, Bayern;
Gonzalez Suarez I. has received grants from Biogen, Novartis, Genzyme;
Garcia-Pelayo Rodriguez A.M. has served as speaker for Merck Serono and Genzyme.
Costa Arpín E.: has served as speaker or consultant for Biogen Idec, Merck Serono, Bayer Health Care, Genzyme, TEVA and UCB Pharma;
Llaneza Gonzalez M. has served as speaker for Sanofi-Genzyme, Biogen, Novartis, Teva, Merck, Almirall;
García Bargo M.D. has served as speaker for Sanofi Genzyme;
Rodriguez Rodriguez M has served as speaker for Sanofi, Biogen, Merck, Novartis and TEVA;
Prieto González J.M. has served as advisor, consultant and speaker for Bayer HealthCare Pharmaceuticals, Biogen Idec Inc, Genzyme Corporation, Novartis, Sanofi and Teva. He also has received grants for clinical research from Biogen Idec Inc and Novartis Pharmaceuticals Corporation.