Contributions
Abstract: P1170
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: The aim of the Spanish Gilenya Registry is to study the evolution of patients being treated with fingolimod in Spain.
Objectives: The aim of this preliminary analysis is to assess the safety and effectiveness of fingolimod after 4 years of registry.
Methods: Observational, retrospective/prospective and multicenter registry of cases, including all patients with relapsing remitting MS starting treatment with fingolimod in Spain.
Results: Data of 613 evaluable patients included in the registry until February 2016 was analyzed out of the 654 patients included on the registry, data were available for 428 patients after 1 year of treatment, 206 after 2 years and 65 after 3 years. Mean age at baseline was 39.0 years (± 8.7), 70.5% women. Mean time since onset of symptoms of MS was 11.0 years (± 6.8) and mean time since diagnosis of MS was 8.9 years (± 6.1). The test for JC virus antibodies was performed in 400 patients (65.6%), being 339 seropositive (84.8%). Patients switched from natalizumab (28.7%), glatiramer acetate (22.8%), interferon beta-1a (Rebif®) (16.3%), interferon beta-1b (10.0%), interferon beta-1a (Avonex®) (10.0%), mitoxantrone (0.5%), and other (2.4%), respectively, to fingolimod. Main reason for switching to fingolimod was efficacy (57.0%), followed by safety (35.1%) and other (15.3%). Mean time under treatment with fingolimod was 26.1 months (± 12.6). 9.8% of patients were monitored more than 6 hours after the first dose of fingolimod and mean monitoring time was 7.2 hours (± 6.7). 36 patients (5.9%) withdraw from the study. 13.5% of patients had adverse reactions, a total of 102 events were observed, being 7 of them serious. After 3 years in treatment with fingolimod and compared to the previous year, 88.3% of patients reported no relapses, 75.0% was free of disability progression [improvement or non-change of Expanded Disability Status Scale (EDSS) scores] and 66.7% was free of clinical activity (no relapses and free of disability progression).
Conclusions: The results obtained in this preliminary analysis support the safety and effectiveness of fingolimod after 4 years of registry.
Disclosure:
Study funded by ACADEM (Spanish Academy of MS and other autoimmune diseases) J. Meca-Lallana has received consulting or speaking fees from Almirall, Biogen, Genzyme, Merck Serono, Novartis, Roche and Teva.
C. Oreja-Guevara has received honoraria as moderator and speaker at meetings and participated in clinical trials sponsored by Biogen-Idec, Novartis, Merck-Serono, Almirall, Teva and Genzyme.
D. Muñoz has worked in consulting work, clinical trials and speaker at congresses held by Merck, Biogen, Teva, Novartis and Genzyme.
Javier Olascoaga serves on scientific advisory boards for Biogen Idec, Genzyme and Novartis; has received speaker honoraria from Biogen Idec, Bayer-Schering, Genzyme, Merck-Serono, Novartis and Teva and receives research grants from Biogen Idec, Merck Serono, Novartis and Teva
A. Pato has participated as a speaker and consultant for Novartis , Biogen and Genzyme Almirall .
Ll. Ramió serves on scientific advisory boards for Biogen Idec and Merck-Serono and has received speaker honoraria from Biogen Idec, Novartis, Bayer, Merck-Serono, Genzyme, Teva Pharmaceutical Industries Ltd.
V. Meca has received honoraria as a consultant, lecturer or moderator by Almirall, Biogen Idec, Genzyme, Merck Serono, Novartis, Roche, Teva and Terumo.
M.E. Hernandez: nothing to disclose
M.E. Marzo: nothing to disclose
J.C. Álvarez-Cermeño has received compensation for consulting services and speaking honoraria from Bayer Schering Pharma, Merk Serono, Biogen-Idec, Teva Pharmaceuticals, Sanofi-Aventis, Genzyme, and Novartis
A. Rodriguez-Antigüedad has received honoraria as moderator and speaker at meetings and participated in clinical trials sponsored by Biogen-Idec, Novartis, Merck-Serono, Teva and Genzyme.
X. Montalban has received honoraria as a consultant, advisor, moderator and speaker at meetings and participated in clinical trials and other research projects promoted by Biogen-Idec, Bayer-Schering, Merck-Serono, Teva, Novartis, and Sanofi-Genzyme Almirall.
O. Fernandez has received honoraria as a consultant, advisor, moderator and speaker at meetings and participated in clinical trials and other research projects promoted by Biogen-Idec, Bayer-Schering, Genzyme, Merck-Serono, Teva, Novartis, Actelion, Almirall, Allergan and Roche.
Abstract: P1170
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: The aim of the Spanish Gilenya Registry is to study the evolution of patients being treated with fingolimod in Spain.
Objectives: The aim of this preliminary analysis is to assess the safety and effectiveness of fingolimod after 4 years of registry.
Methods: Observational, retrospective/prospective and multicenter registry of cases, including all patients with relapsing remitting MS starting treatment with fingolimod in Spain.
Results: Data of 613 evaluable patients included in the registry until February 2016 was analyzed out of the 654 patients included on the registry, data were available for 428 patients after 1 year of treatment, 206 after 2 years and 65 after 3 years. Mean age at baseline was 39.0 years (± 8.7), 70.5% women. Mean time since onset of symptoms of MS was 11.0 years (± 6.8) and mean time since diagnosis of MS was 8.9 years (± 6.1). The test for JC virus antibodies was performed in 400 patients (65.6%), being 339 seropositive (84.8%). Patients switched from natalizumab (28.7%), glatiramer acetate (22.8%), interferon beta-1a (Rebif®) (16.3%), interferon beta-1b (10.0%), interferon beta-1a (Avonex®) (10.0%), mitoxantrone (0.5%), and other (2.4%), respectively, to fingolimod. Main reason for switching to fingolimod was efficacy (57.0%), followed by safety (35.1%) and other (15.3%). Mean time under treatment with fingolimod was 26.1 months (± 12.6). 9.8% of patients were monitored more than 6 hours after the first dose of fingolimod and mean monitoring time was 7.2 hours (± 6.7). 36 patients (5.9%) withdraw from the study. 13.5% of patients had adverse reactions, a total of 102 events were observed, being 7 of them serious. After 3 years in treatment with fingolimod and compared to the previous year, 88.3% of patients reported no relapses, 75.0% was free of disability progression [improvement or non-change of Expanded Disability Status Scale (EDSS) scores] and 66.7% was free of clinical activity (no relapses and free of disability progression).
Conclusions: The results obtained in this preliminary analysis support the safety and effectiveness of fingolimod after 4 years of registry.
Disclosure:
Study funded by ACADEM (Spanish Academy of MS and other autoimmune diseases) J. Meca-Lallana has received consulting or speaking fees from Almirall, Biogen, Genzyme, Merck Serono, Novartis, Roche and Teva.
C. Oreja-Guevara has received honoraria as moderator and speaker at meetings and participated in clinical trials sponsored by Biogen-Idec, Novartis, Merck-Serono, Almirall, Teva and Genzyme.
D. Muñoz has worked in consulting work, clinical trials and speaker at congresses held by Merck, Biogen, Teva, Novartis and Genzyme.
Javier Olascoaga serves on scientific advisory boards for Biogen Idec, Genzyme and Novartis; has received speaker honoraria from Biogen Idec, Bayer-Schering, Genzyme, Merck-Serono, Novartis and Teva and receives research grants from Biogen Idec, Merck Serono, Novartis and Teva
A. Pato has participated as a speaker and consultant for Novartis , Biogen and Genzyme Almirall .
Ll. Ramió serves on scientific advisory boards for Biogen Idec and Merck-Serono and has received speaker honoraria from Biogen Idec, Novartis, Bayer, Merck-Serono, Genzyme, Teva Pharmaceutical Industries Ltd.
V. Meca has received honoraria as a consultant, lecturer or moderator by Almirall, Biogen Idec, Genzyme, Merck Serono, Novartis, Roche, Teva and Terumo.
M.E. Hernandez: nothing to disclose
M.E. Marzo: nothing to disclose
J.C. Álvarez-Cermeño has received compensation for consulting services and speaking honoraria from Bayer Schering Pharma, Merk Serono, Biogen-Idec, Teva Pharmaceuticals, Sanofi-Aventis, Genzyme, and Novartis
A. Rodriguez-Antigüedad has received honoraria as moderator and speaker at meetings and participated in clinical trials sponsored by Biogen-Idec, Novartis, Merck-Serono, Teva and Genzyme.
X. Montalban has received honoraria as a consultant, advisor, moderator and speaker at meetings and participated in clinical trials and other research projects promoted by Biogen-Idec, Bayer-Schering, Merck-Serono, Teva, Novartis, and Sanofi-Genzyme Almirall.
O. Fernandez has received honoraria as a consultant, advisor, moderator and speaker at meetings and participated in clinical trials and other research projects promoted by Biogen-Idec, Bayer-Schering, Genzyme, Merck-Serono, Teva, Novartis, Actelion, Almirall, Allergan and Roche.