Contributions
Abstract: EP1716
Type: ePoster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: Fingolimod 0.5 mg daily has an established efficacy, safety and tolerability profile in patients with relapsing-remitting multiple sclerosis (RRMS), with data from a large clinical development programme demonstrating its benefits on relapse rates, disability progression and imaging activity compared to placebo and/or IFNB-1a IM. However, limited data are available in real-world settings, which include patients with a wide range of co-morbidities and concomitant treatments.The French Health Authorities (HAS, CEPS) requested a pharmacoepidemiological study to assess the use and impact of fingolimod in the treatment of highly active forms of RRMS in France. VIRGILE is the largest study in France to date evaluating the long-term efficacy, safety, and tolerability profiles of fingolimod in real-world settings. A natalizumab arm was included in the study.
Objective: To assess the effect of fingolimod 0.5 mg on relapse activity, disability progression and quality of life in real-life practice. The study will also describe baseline characteristics of patients treated with fingolimod and natalizumab, and assess the impact of fingolimod treatment on health resource use in both groups.
Methods: This is a non-interventional, multicentre, post-authorisation, observational study with prospective follow up of patients treated with fingolimod or natalizumab for 3 years, and potentially an additional 2 years for patients in the fingolimod group. The primary endpoint is the change in annualised relapse rate (ARR) at 2 years compared to baseline (relapse rate in the year prior to treatment). Other endpoints include Expanded Disability Status Scale (EDSS) and tolerability.
Results: Enrollment was completed last year, with the inclusion of 1114 patients in the fingolimod arm and 335 patients in the natalizumab arm. Primary outcome results will be presented along with other efficacy and safety results for patients who reached the two-year time point.
Conclusion: The results support the long-term efficacy and safety profile of fingolimod in daily clinical practice.
Disclosure: This work has been done in collaboration with the Observatoire Français de la Sclérose en Plaques (OFSEP), a national cohort supported by a public grant from the French Agence Nationale de la Recherche within the context of the Investments for the Future programme, referenced ANR-10 COHO-002; www.ofsep.org.
Funding statement: This study is supported by Novartis Pharma S.A.S.
CLF has received consultancy fees from Merck, Novartis, Biogen, MEDDAY, Roche, Teva.
CP: has received compensation as a consultant, advisory board member or speaker for Roche, Novartis, Biogen idec, Teva Aventis, Genzyme-Sanofi, Merck.
GK has received consultancy fees from Biogen, Merck Serono, Novartis, Genzyme, Roche, Teva
MV has received compensation from Novartis for educational activity and consulting
MC disclosures: Biogen, Merck, Novartis, Genzyme
MD has done consulting research and/or workshops for Biogen-Idec, Bayer-Schering, Genzyme, Merck-Serono, Novartis, Sanofi-Aventis and Teva Pharma.
FL and IC are employees of Novartis Pharma S.A.S
Abstract: EP1716
Type: ePoster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: Fingolimod 0.5 mg daily has an established efficacy, safety and tolerability profile in patients with relapsing-remitting multiple sclerosis (RRMS), with data from a large clinical development programme demonstrating its benefits on relapse rates, disability progression and imaging activity compared to placebo and/or IFNB-1a IM. However, limited data are available in real-world settings, which include patients with a wide range of co-morbidities and concomitant treatments.The French Health Authorities (HAS, CEPS) requested a pharmacoepidemiological study to assess the use and impact of fingolimod in the treatment of highly active forms of RRMS in France. VIRGILE is the largest study in France to date evaluating the long-term efficacy, safety, and tolerability profiles of fingolimod in real-world settings. A natalizumab arm was included in the study.
Objective: To assess the effect of fingolimod 0.5 mg on relapse activity, disability progression and quality of life in real-life practice. The study will also describe baseline characteristics of patients treated with fingolimod and natalizumab, and assess the impact of fingolimod treatment on health resource use in both groups.
Methods: This is a non-interventional, multicentre, post-authorisation, observational study with prospective follow up of patients treated with fingolimod or natalizumab for 3 years, and potentially an additional 2 years for patients in the fingolimod group. The primary endpoint is the change in annualised relapse rate (ARR) at 2 years compared to baseline (relapse rate in the year prior to treatment). Other endpoints include Expanded Disability Status Scale (EDSS) and tolerability.
Results: Enrollment was completed last year, with the inclusion of 1114 patients in the fingolimod arm and 335 patients in the natalizumab arm. Primary outcome results will be presented along with other efficacy and safety results for patients who reached the two-year time point.
Conclusion: The results support the long-term efficacy and safety profile of fingolimod in daily clinical practice.
Disclosure: This work has been done in collaboration with the Observatoire Français de la Sclérose en Plaques (OFSEP), a national cohort supported by a public grant from the French Agence Nationale de la Recherche within the context of the Investments for the Future programme, referenced ANR-10 COHO-002; www.ofsep.org.
Funding statement: This study is supported by Novartis Pharma S.A.S.
CLF has received consultancy fees from Merck, Novartis, Biogen, MEDDAY, Roche, Teva.
CP: has received compensation as a consultant, advisory board member or speaker for Roche, Novartis, Biogen idec, Teva Aventis, Genzyme-Sanofi, Merck.
GK has received consultancy fees from Biogen, Merck Serono, Novartis, Genzyme, Roche, Teva
MV has received compensation from Novartis for educational activity and consulting
MC disclosures: Biogen, Merck, Novartis, Genzyme
MD has done consulting research and/or workshops for Biogen-Idec, Bayer-Schering, Genzyme, Merck-Serono, Novartis, Sanofi-Aventis and Teva Pharma.
FL and IC are employees of Novartis Pharma S.A.S