Contributions
Abstract: EP1494
Type: ePoster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Objectives: Describe the tolerability of fingolimod within the first months of treatment initiation according to the clinical practice in Spain in relapsing-remitting multiple sclerosis (RRMS) patients.
Material and methods: Observational, retrospective, multicentre and national study. Patients of both sexes, ≥18 years, diagnosed with RRMS (McDonald criteria 2010) who started treatment with fingolimod at least 6 months before starting the study were included. The study was approved by the Ethic Committee of the Hospital Universitario Virgen de las Nieves (Granada), Spain.
Results: 30 centers participated in the study. A total of 271 patients were recruited and 237 were included in the analysis of the study, meting all the required criteria: 168 female and 69 males, mean age of 40.4 years (SD=8.9), mean EDSS 2.9 (SD=1.7). The recruitment period was 15 months (September 2014-December 2015).
After the first dose 8 patients (3.4%) presented adverse events (AE): 5 cardiac (2.1%) and 3 gastrointestinal disorders (1.2%), all of them were mild and continued with the study. Only 5 patients (2.1 %) required monitoring of the second dose and were discharged after this second administration.
Two patients (0.8%) presented macular edema, 1 required fingolimod discontinuation to solve the event.
During the study 92 AEs were reported in 68 patients, 1 was reported as severe (behavior disorder), it was reported as not related to the study medication. About half of the AEs reported during the study were classified as infections (42) none of them was considered as severe. No correlation between lower lymphocytes level and infection rates was observed.
During the first 6 months of treatment 12 patients discontinued the study drug, 4 (1.7%) being permanent (3 AEs and 1 due to loss of efficacy). After the first 6 months 20 patients (8.4%) discontinued the treatment permanently for different reasons: 11 loss of efficacy (4.6%), 5 due to AEs (2.1%), 3 wish for pregnancy (1.3%) and 1 patient´s decision (0.4%).
Conclusions: The results from this study show the safety and tolerability of fingolimod in clinical practice. Our RRMS patients treated with fingolimod have a safety and tolerability profile consistent with previous findings from clinical trial and RWE results. The percentage of patients permanently discontinuing treatment was low, showing a high treatment persistency. All this data will allow us to improve the management of these patients in the future in clinical practice.
Disclosure: 1- Dr. C ARNAL GARCIA has received honoraria as speaker in scientific meetings with BIOGEN, NOVARTIS, TEVA, MERCK y GENZYME
2- Yolanda Rodríguez has received consulting/speaker fees from Biogen and Novartis, and been involved with clinical trials for Novartis.
3- Dr. García-Merino has received compensation for travel expenses, speaking honoraria and consultation fees from Bayer, Merck, Teva, Biogen Idec, Novartis, Roche, Almirall, Sanofi-Aventis and Genzyme.
4- Dr. V. Meca Lallana, has received honoraria and travel expenses for scientific meetings and has participated in advisory boards in the past years with: Almirall, Biogen Idec, Genzyme, Merck Serono, Novartis, Roche, TEVA and Terumo
5- Dra. Y. Aladro received research support by Novartis, Teva, Biogen Idec and Genzime, served on the scientific advisory board for Biogen Idec, Merck-Serono, and Novartis and received speaker honoraria from Biogen Idec, Merck-Serono, Teva, Almirall and Novartis.
6- Ll. Ramió-Torrentà has received speaking honoraria and travel expenses for scientific meetings and has participated in advisory boards in the past years with Bayer Schering Pharma, Biogen, EMD Merck Serono, Sanofi Genzyme, Novartis, Sanofi-Aventis, Teva Phramaceuticals, Almirall and Roche.
7- Dr. J. Peña has received honoraria as speaker in meetings with: Biogen Idec, Merck, Novartis, Sanofi Genzyme, Bayer Shering Pharmay Teva.
8- El Dr. J.M. Prieto es consultor de Bayer HealthCare Pharmaceuticals, Biogen Idec Inc., Genzyme Corporation, Novartis Pharmaceuticals Corporation, Sanofi-Aventis. Teva Pharmaceuticals, Roche Pharma y Almirall Prodesfarma S.A. Ha intervenido como conferenciante en reuniones y/o simposios organizados por Almirall Prodesfarma S.A., Bayer HealthCare Pharmaceuticals, Biogen Idec Inc, Genzyme Corporation, Merck Serono, Novartis Pharmaceuticals Corporation, Sanofi-Aventis y Teva Pharmaceuticals. Ha recibido financiación de Almirall Prodesfarma S.A., Biogen Idec, Novartis Pharmaceuticals Corporation y Sanofi Genzyme S.A. para la realización de proyectos de investigación.
9- J. Ricart and E. Garcia are employees of Novartis Farmacéutica Spain
Abstract: EP1494
Type: ePoster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Objectives: Describe the tolerability of fingolimod within the first months of treatment initiation according to the clinical practice in Spain in relapsing-remitting multiple sclerosis (RRMS) patients.
Material and methods: Observational, retrospective, multicentre and national study. Patients of both sexes, ≥18 years, diagnosed with RRMS (McDonald criteria 2010) who started treatment with fingolimod at least 6 months before starting the study were included. The study was approved by the Ethic Committee of the Hospital Universitario Virgen de las Nieves (Granada), Spain.
Results: 30 centers participated in the study. A total of 271 patients were recruited and 237 were included in the analysis of the study, meting all the required criteria: 168 female and 69 males, mean age of 40.4 years (SD=8.9), mean EDSS 2.9 (SD=1.7). The recruitment period was 15 months (September 2014-December 2015).
After the first dose 8 patients (3.4%) presented adverse events (AE): 5 cardiac (2.1%) and 3 gastrointestinal disorders (1.2%), all of them were mild and continued with the study. Only 5 patients (2.1 %) required monitoring of the second dose and were discharged after this second administration.
Two patients (0.8%) presented macular edema, 1 required fingolimod discontinuation to solve the event.
During the study 92 AEs were reported in 68 patients, 1 was reported as severe (behavior disorder), it was reported as not related to the study medication. About half of the AEs reported during the study were classified as infections (42) none of them was considered as severe. No correlation between lower lymphocytes level and infection rates was observed.
During the first 6 months of treatment 12 patients discontinued the study drug, 4 (1.7%) being permanent (3 AEs and 1 due to loss of efficacy). After the first 6 months 20 patients (8.4%) discontinued the treatment permanently for different reasons: 11 loss of efficacy (4.6%), 5 due to AEs (2.1%), 3 wish for pregnancy (1.3%) and 1 patient´s decision (0.4%).
Conclusions: The results from this study show the safety and tolerability of fingolimod in clinical practice. Our RRMS patients treated with fingolimod have a safety and tolerability profile consistent with previous findings from clinical trial and RWE results. The percentage of patients permanently discontinuing treatment was low, showing a high treatment persistency. All this data will allow us to improve the management of these patients in the future in clinical practice.
Disclosure: 1- Dr. C ARNAL GARCIA has received honoraria as speaker in scientific meetings with BIOGEN, NOVARTIS, TEVA, MERCK y GENZYME
2- Yolanda Rodríguez has received consulting/speaker fees from Biogen and Novartis, and been involved with clinical trials for Novartis.
3- Dr. García-Merino has received compensation for travel expenses, speaking honoraria and consultation fees from Bayer, Merck, Teva, Biogen Idec, Novartis, Roche, Almirall, Sanofi-Aventis and Genzyme.
4- Dr. V. Meca Lallana, has received honoraria and travel expenses for scientific meetings and has participated in advisory boards in the past years with: Almirall, Biogen Idec, Genzyme, Merck Serono, Novartis, Roche, TEVA and Terumo
5- Dra. Y. Aladro received research support by Novartis, Teva, Biogen Idec and Genzime, served on the scientific advisory board for Biogen Idec, Merck-Serono, and Novartis and received speaker honoraria from Biogen Idec, Merck-Serono, Teva, Almirall and Novartis.
6- Ll. Ramió-Torrentà has received speaking honoraria and travel expenses for scientific meetings and has participated in advisory boards in the past years with Bayer Schering Pharma, Biogen, EMD Merck Serono, Sanofi Genzyme, Novartis, Sanofi-Aventis, Teva Phramaceuticals, Almirall and Roche.
7- Dr. J. Peña has received honoraria as speaker in meetings with: Biogen Idec, Merck, Novartis, Sanofi Genzyme, Bayer Shering Pharmay Teva.
8- El Dr. J.M. Prieto es consultor de Bayer HealthCare Pharmaceuticals, Biogen Idec Inc., Genzyme Corporation, Novartis Pharmaceuticals Corporation, Sanofi-Aventis. Teva Pharmaceuticals, Roche Pharma y Almirall Prodesfarma S.A. Ha intervenido como conferenciante en reuniones y/o simposios organizados por Almirall Prodesfarma S.A., Bayer HealthCare Pharmaceuticals, Biogen Idec Inc, Genzyme Corporation, Merck Serono, Novartis Pharmaceuticals Corporation, Sanofi-Aventis y Teva Pharmaceuticals. Ha recibido financiación de Almirall Prodesfarma S.A., Biogen Idec, Novartis Pharmaceuticals Corporation y Sanofi Genzyme S.A. para la realización de proyectos de investigación.
9- J. Ricart and E. Garcia are employees of Novartis Farmacéutica Spain