Contributions
Abstract: P1213
Type: Poster Sessions
Abstract Category: Therapy - Immunomodulation/Immunosuppression
Background: In our experience in clinical practice, Alemtuzumab has demonstrated a high reduction on annualized relapse rate (ARR) in Multiple Sclerosis (MS) patients, no significant changes in EDSS and improves on MRI outcomes.
Objectives: To analyze efficacy and safety of Alemtuzumab in patients who switched from a second line therapy (fingolimod and natalizumab).
Methods: This is a prospective observational multicentre study from Northwest of Spain.
Results: 59 patients were treated with Alemtuzumab, n=43 switched from fingolimod and n=16 from Natalizumab. The main reason for switching to alemtuzumab was the loss of efficacy of fingolimod (88%) and the high risk of developing progressive multifocal leukoencephalopathy (PML) with Natalizumab (56%). 41 (69%) were females. The mean age of these patients was 39.8±7.94 and the mean disease duration was 15.3±6.38 years. After a mean follow up of 12 months with Alemtuzumab, the ARR showed an important reduction from 1.08±0.95 to 0.15±0.36 (p< 0.001; RRR 86%) and the mean EDSS did not change (from 3.59±1.63 to 3.54±1.81).
86% of patients (n=35) did not present new T2 lesions on MRI and there was a reduction from 64% to 9% (n=33) in the number of patients with gadolinium-enhancing lesions.
Infections were detected in 50% of patients (n=59); the most common were urinary tract infections (UTIs). Thyroid disease was the only secondary autoimmune disorder observed (7%). Serious adverse events occurred in 5% (3 UTIs and 1 Listeria infection).
Conclusions: Alemtuzumab demonstrated to be effective in controlling disease in patients who switched from fingolimod and natalizumab. It provides immunotherapeutic rescue for patients with an aggressive disease. Few severe adverse events occurred and they resolved without problems.
Disclosure: Pato Pato A.: has served as speaker for Biogen, Novartis, Genzyme, Almirall, Bayern.
Solar Sánchez D. M. has served as consultant for Almirall, Biogen, Bayer, Merck, Novartis, Sanofi-Genzyme, Teva
Costa Arpín E.: has served as speaker or consultant for Biogen Idec, Merck Serono, Bayer Health Care, Genzyme, TEVA and UCB Pharma.
López Real A.M., has served as speaker for Biogen Idec, Merck Serono, Sanofi-Genzyme, Novartis and TEVA.
Álvarez Rodriguez E.: has served as speaker and consultant for Sanofi, Biogen and Merck-Serono
González Quintanilla V.: has served as speaker for Biogen, Almirall, Merck, Teva, Sanofi-Genzyme, Allergan, MSD and Novartis; He has also participates in clinical trials for Lilly, Sanofi, Allergan and Novartis
Gonzalez Suarez I.: She has received grants for Biogen, Novartis, Genzyme.
Álvarez Leticia: has no disclosures
Lorenzo González J.R., has received grants for clinical research from Biogen, Novartis, Genzyme, Almirall, Bayern.
Arias Gomez, M., has served as advisor, for Merck, Biogen-Idec, Genzyme, Roche, Novartis, TEVA, Actelion and Jansen.
Lema Devesa C.: has served as speaker for Sanofi Genzyme and Teva
Amigo Jorrín, M. C.: has served as speaker for Sanofi, Novartis, Biogen and Teva
Peña Martínez J.: has served as speaker for Sanofi Genzyme, Merck, Bayer, Teva, Biogen Idec, Novartis, Almirall, Krka and Qualigen
Abstract: P1213
Type: Poster Sessions
Abstract Category: Therapy - Immunomodulation/Immunosuppression
Background: In our experience in clinical practice, Alemtuzumab has demonstrated a high reduction on annualized relapse rate (ARR) in Multiple Sclerosis (MS) patients, no significant changes in EDSS and improves on MRI outcomes.
Objectives: To analyze efficacy and safety of Alemtuzumab in patients who switched from a second line therapy (fingolimod and natalizumab).
Methods: This is a prospective observational multicentre study from Northwest of Spain.
Results: 59 patients were treated with Alemtuzumab, n=43 switched from fingolimod and n=16 from Natalizumab. The main reason for switching to alemtuzumab was the loss of efficacy of fingolimod (88%) and the high risk of developing progressive multifocal leukoencephalopathy (PML) with Natalizumab (56%). 41 (69%) were females. The mean age of these patients was 39.8±7.94 and the mean disease duration was 15.3±6.38 years. After a mean follow up of 12 months with Alemtuzumab, the ARR showed an important reduction from 1.08±0.95 to 0.15±0.36 (p< 0.001; RRR 86%) and the mean EDSS did not change (from 3.59±1.63 to 3.54±1.81).
86% of patients (n=35) did not present new T2 lesions on MRI and there was a reduction from 64% to 9% (n=33) in the number of patients with gadolinium-enhancing lesions.
Infections were detected in 50% of patients (n=59); the most common were urinary tract infections (UTIs). Thyroid disease was the only secondary autoimmune disorder observed (7%). Serious adverse events occurred in 5% (3 UTIs and 1 Listeria infection).
Conclusions: Alemtuzumab demonstrated to be effective in controlling disease in patients who switched from fingolimod and natalizumab. It provides immunotherapeutic rescue for patients with an aggressive disease. Few severe adverse events occurred and they resolved without problems.
Disclosure: Pato Pato A.: has served as speaker for Biogen, Novartis, Genzyme, Almirall, Bayern.
Solar Sánchez D. M. has served as consultant for Almirall, Biogen, Bayer, Merck, Novartis, Sanofi-Genzyme, Teva
Costa Arpín E.: has served as speaker or consultant for Biogen Idec, Merck Serono, Bayer Health Care, Genzyme, TEVA and UCB Pharma.
López Real A.M., has served as speaker for Biogen Idec, Merck Serono, Sanofi-Genzyme, Novartis and TEVA.
Álvarez Rodriguez E.: has served as speaker and consultant for Sanofi, Biogen and Merck-Serono
González Quintanilla V.: has served as speaker for Biogen, Almirall, Merck, Teva, Sanofi-Genzyme, Allergan, MSD and Novartis; He has also participates in clinical trials for Lilly, Sanofi, Allergan and Novartis
Gonzalez Suarez I.: She has received grants for Biogen, Novartis, Genzyme.
Álvarez Leticia: has no disclosures
Lorenzo González J.R., has received grants for clinical research from Biogen, Novartis, Genzyme, Almirall, Bayern.
Arias Gomez, M., has served as advisor, for Merck, Biogen-Idec, Genzyme, Roche, Novartis, TEVA, Actelion and Jansen.
Lema Devesa C.: has served as speaker for Sanofi Genzyme and Teva
Amigo Jorrín, M. C.: has served as speaker for Sanofi, Novartis, Biogen and Teva
Peña Martínez J.: has served as speaker for Sanofi Genzyme, Merck, Bayer, Teva, Biogen Idec, Novartis, Almirall, Krka and Qualigen