Contributions
Abstract: EP1648
Type: ePoster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Fingolimod, a sphingosine 1-phosphate receptor modulator, was the first approved oral disease-modifying therapy (DMT) in patients with multiple sclerosis (MS). In France, it is indicated in patients with high disease activity despite previous treatment with at least one DMT or patients with rapidly evolving severe relapsing remitting MS (RRMS). Retrospective database studies of patients with MS disease have demonstrated the superiority of switching to more efficacious therapy such as fingolimod compared to cycling between first-line DMTs. However, factors supporting the switch decision to fingolimod are not yet understood.
Objective: The objective of this study is to describe the factors leading to the switch to fingolimod after initial DMT in patients in clinical practice and to follow up with clinicians and patients on their treatment satisfaction after 1 year.
Methods: ESGILE is an observational, non-interventional, multicentric, 12-month, prospective study conducted in France in patients with RRMS. Included patients should have started fingolimod no longer than 4 weeks before baseline visit in line with its approved indication. Visits were scheduled at 6 and 12 months. This interim analysis describes the baseline characteristics of the patient population and the reasons for switching to fingolimod as a second-line treatment. Other outcomes will include clinical and patient global impression changes, and quality-of-life questionnaire (ACCEPT).
Results: Between November 2015 and March 2016, 35 centers included 87 patients with mean age of 40.3 years, 79.3% females, MS diagnosis of 5.8 ±6.2 years, Expanded Disability Status Scale (EDSS) average score of 2.1±1.3. The main reason for therapeutic change was the disease progression (74.7%), followed by administration modalities (34.5%), patient choice (14.9%), and tolerability (6.9%).
Conclusion: The change in treatment is mainly motivated by the progression of disease activity. This study also revealed a high occurrence for therapeutic change from other DMT to fingolimod that is linked to the administration modalities.
Disclosure:
Ayman Tourbah: Has received consulting and lecturing fees, travel grants and research support from Biogen, MedDay, Merck Serono, Novartis, Roche, Sanofi-Genzyme, and Teva
Caroline Papeix: Has received consulting and lecturing fees, advisory board: Sanofi-Aventis, Biogen, Merck Serono, Novartis, Roche, Sanofi-Genzyme, and Teva
Claude Mekies: Has received consulting and lecturing fees, advisory boards: Allergan, Almirall, Bayer, Biogen, Coloplast, EISAI, Lundbeck, Merck Serono, Novartis, Pfizer, Sanofi-Genzyme, and Teva
Patricia Tourniaire: Has received consulting fees, advisory boards: Biogen, Novartis, Sanofi-Genzyme, and Teva
Karin Rerat, Mohamed Meite, Isabelle Chouette: Are Novartis employees
Abstract: EP1648
Type: ePoster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Fingolimod, a sphingosine 1-phosphate receptor modulator, was the first approved oral disease-modifying therapy (DMT) in patients with multiple sclerosis (MS). In France, it is indicated in patients with high disease activity despite previous treatment with at least one DMT or patients with rapidly evolving severe relapsing remitting MS (RRMS). Retrospective database studies of patients with MS disease have demonstrated the superiority of switching to more efficacious therapy such as fingolimod compared to cycling between first-line DMTs. However, factors supporting the switch decision to fingolimod are not yet understood.
Objective: The objective of this study is to describe the factors leading to the switch to fingolimod after initial DMT in patients in clinical practice and to follow up with clinicians and patients on their treatment satisfaction after 1 year.
Methods: ESGILE is an observational, non-interventional, multicentric, 12-month, prospective study conducted in France in patients with RRMS. Included patients should have started fingolimod no longer than 4 weeks before baseline visit in line with its approved indication. Visits were scheduled at 6 and 12 months. This interim analysis describes the baseline characteristics of the patient population and the reasons for switching to fingolimod as a second-line treatment. Other outcomes will include clinical and patient global impression changes, and quality-of-life questionnaire (ACCEPT).
Results: Between November 2015 and March 2016, 35 centers included 87 patients with mean age of 40.3 years, 79.3% females, MS diagnosis of 5.8 ±6.2 years, Expanded Disability Status Scale (EDSS) average score of 2.1±1.3. The main reason for therapeutic change was the disease progression (74.7%), followed by administration modalities (34.5%), patient choice (14.9%), and tolerability (6.9%).
Conclusion: The change in treatment is mainly motivated by the progression of disease activity. This study also revealed a high occurrence for therapeutic change from other DMT to fingolimod that is linked to the administration modalities.
Disclosure:
Ayman Tourbah: Has received consulting and lecturing fees, travel grants and research support from Biogen, MedDay, Merck Serono, Novartis, Roche, Sanofi-Genzyme, and Teva
Caroline Papeix: Has received consulting and lecturing fees, advisory board: Sanofi-Aventis, Biogen, Merck Serono, Novartis, Roche, Sanofi-Genzyme, and Teva
Claude Mekies: Has received consulting and lecturing fees, advisory boards: Allergan, Almirall, Bayer, Biogen, Coloplast, EISAI, Lundbeck, Merck Serono, Novartis, Pfizer, Sanofi-Genzyme, and Teva
Patricia Tourniaire: Has received consulting fees, advisory boards: Biogen, Novartis, Sanofi-Genzyme, and Teva
Karin Rerat, Mohamed Meite, Isabelle Chouette: Are Novartis employees