Contributions
Abstract: EP1799
Type: ePoster
Abstract Category: Therapy - disease modifying - 32 Others
Background: Fingolimod is a sphingosine 1-phospahte receptor (S1PR) modulator, approved for the treatment of RRMS in over 80 countries, including Portugal since March 2012. The increasing experience with fingolimod allows the collection of local real-world evidence (RWE) data to evaluate fingolimod's clinical impact in the local setting.
Objective: To collect retrospective RWE from the clinical records of RRMS patients concerning the efficacy of fingolimod treatment.
Methods: 275 patients with RRMS from 9 centers across Portugal. The neurologists from the participant sites have reviewed all the clinical histories from patients being treated with fingolimod for at least 12 months.
Results: The median (IQR) age of the patients was 41.0 (12.0 years), ranging from 18 to 78 years. When analyzed as percentage, relapse-free patients increased steadily and significantly up to the 3rd year after switching to fingolimod. The percentage of patients free from relapses increased significantly over the years after fingolimod treatment when compared to the previous year, reaching 91% after 3 years compared to 45%, one year prior to starting fingolimod treatment. Regarding EDSS, these patients remain stable over the 3 years.
Conclusions: The results from the REALMS study support the clinical efficacy of fingolimod that is demonstrated in phase III clinical trials and with real-world evidence data.
Disclosure: This study was funded by Novartis Farma, Portugal
Dra. Sónia Batista received compensation from Biogen, Genzyme, Merck Serono, Novartis Roche, Teva; Dr. Carla C. Nunes received compensation from Novartis, Biogen and Sanofi Genzyme; Prof. João de Sá received compensation for consultant and research support from Bayer, Biogen, Genzyme, Merck Serono, Novartis, Roche Teva; Dr. Vasco Salgado received compensation from Biogen, Boehringer Ingelheim, Genzyme Merck Serono, Novartis, Roche, Servier, Teva; Dra.Ana Sofia Correia received an educational sponsorship from Merck Serono, consultant and speaking fees from Novartis, Biogen Idec and Merck, as well as research support from Biogen Idec; Dr. J. Sequeira has received personal compensation for activities with Bayer, Biogen, Genzyme, Merck, Novartis and Teva; Prof. Ana Martins da Silva received compensation from Bayer, Biogen, Genzyme, Merck Serono, Novartis, Roche, Teva; Prof. João Cerqueira received compensation from Bayer, Biogen, Genzyme, Merck Serono, Novartis, Roche, Teva; Dr. Joaquim Pinheiro received compensation from Bayer, Biogen, Genzyme, Merck Serono, Novartis, Teva; Dra. Teresa Mendonça received compensation from Bayer, Biogen, Genzyme, Merck Serono, Novartis, Teva; Dra. Lívia Sousa received compensation as consultant, research support and advisory Board from Bayer, Biogen, Genzyme, Merck Serono, Novartis, Roche, Teva. Andreia Costa is employee of Novartis Farma,Portugal
Abstract: EP1799
Type: ePoster
Abstract Category: Therapy - disease modifying - 32 Others
Background: Fingolimod is a sphingosine 1-phospahte receptor (S1PR) modulator, approved for the treatment of RRMS in over 80 countries, including Portugal since March 2012. The increasing experience with fingolimod allows the collection of local real-world evidence (RWE) data to evaluate fingolimod's clinical impact in the local setting.
Objective: To collect retrospective RWE from the clinical records of RRMS patients concerning the efficacy of fingolimod treatment.
Methods: 275 patients with RRMS from 9 centers across Portugal. The neurologists from the participant sites have reviewed all the clinical histories from patients being treated with fingolimod for at least 12 months.
Results: The median (IQR) age of the patients was 41.0 (12.0 years), ranging from 18 to 78 years. When analyzed as percentage, relapse-free patients increased steadily and significantly up to the 3rd year after switching to fingolimod. The percentage of patients free from relapses increased significantly over the years after fingolimod treatment when compared to the previous year, reaching 91% after 3 years compared to 45%, one year prior to starting fingolimod treatment. Regarding EDSS, these patients remain stable over the 3 years.
Conclusions: The results from the REALMS study support the clinical efficacy of fingolimod that is demonstrated in phase III clinical trials and with real-world evidence data.
Disclosure: This study was funded by Novartis Farma, Portugal
Dra. Sónia Batista received compensation from Biogen, Genzyme, Merck Serono, Novartis Roche, Teva; Dr. Carla C. Nunes received compensation from Novartis, Biogen and Sanofi Genzyme; Prof. João de Sá received compensation for consultant and research support from Bayer, Biogen, Genzyme, Merck Serono, Novartis, Roche Teva; Dr. Vasco Salgado received compensation from Biogen, Boehringer Ingelheim, Genzyme Merck Serono, Novartis, Roche, Servier, Teva; Dra.Ana Sofia Correia received an educational sponsorship from Merck Serono, consultant and speaking fees from Novartis, Biogen Idec and Merck, as well as research support from Biogen Idec; Dr. J. Sequeira has received personal compensation for activities with Bayer, Biogen, Genzyme, Merck, Novartis and Teva; Prof. Ana Martins da Silva received compensation from Bayer, Biogen, Genzyme, Merck Serono, Novartis, Roche, Teva; Prof. João Cerqueira received compensation from Bayer, Biogen, Genzyme, Merck Serono, Novartis, Roche, Teva; Dr. Joaquim Pinheiro received compensation from Bayer, Biogen, Genzyme, Merck Serono, Novartis, Teva; Dra. Teresa Mendonça received compensation from Bayer, Biogen, Genzyme, Merck Serono, Novartis, Teva; Dra. Lívia Sousa received compensation as consultant, research support and advisory Board from Bayer, Biogen, Genzyme, Merck Serono, Novartis, Roche, Teva. Andreia Costa is employee of Novartis Farma,Portugal