Contributions
Abstract: P1176
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Objectives: to describe efficacy and safety of Fingolimod in a cohort of patients treated for at least one year in the department of neurology of the Timone university hospital of Marseille.The primary objective was to evaluate the proportion of patients presented with disease free activity (relapse, disability and MRI) at year1 and year2. The secondary objectives were to describe clinical and MRI data before before starting Fingolimod, efficacy and safety profiles of the patients included in this retrospective observational study.
Methods: Patients were identified in the EDMUS database. Patients included had to start Fingolimod between January 1st 2012 and December 31 2013. Clinical, biological and MRI data had to be effective. 204 patients were included in the study with a treatment duration more than one year (130 were treated more than 2 years). 73.5% were female and 26.5% male. Mean age was 40y and mean disease duration was 10ys.
Results: RRMS represents 92% of patients, progressive MS (SP or PP) 8%. 23.5% of patients were treatment naïve (first line treatment) and 66.5% were treated in second line therapy (50.5% after a first line treatment, 26% after a second line). Mean EDSS before treatment was 2.9 and 66% presented one or more relapse one year before treatment (36% 2ys before). 78% of patients presented with new T2MRI lesion(s) and 54% with T1GadMRI lesion(s) at baseline. Mean treatment duration was 22.2months. Mean EDSS at Y1 was 2.7 and at Y2 5.6. Respectively, 86.5% and 92% had no new T2MRI and T1Gad MRI lesion at Y1 (91.5% and 95% at Y2). 80% of patients had no relapse at Y1 and 92% at Y2. At Y1 and Y2 73.7% and 85.8% respectively were NEDA3 (no clinical and MRI activity). 22% of patients stopped definitively Fingolimod (6% in the absence of efficacy: relapse and/or EDSS increase; 1.5% related with serious adverse events; (6% related with no serious AE; 8% related with personal reasons; 0.5% related with pregnancy). Safety profile was good: one death (pancreas cancer), one patient presented with pancreas cancer, 8 patients with liver abnormalities, 2 patients with lymphopenia (below 200), 2 patients with high blood pressure and 2 patients with infection.
Conclusions: This monocentric retrospective study confirm consistent efficacy benefit at Y1 and Y2 of Fingolimod both on clinical and MRI activity. This study also supports the positive safety profile of Fingolimod in real life.
Disclosure: Pelletier: unconditional grant from Novartis France
Gualtieri: nothing to disclose
DiLelio: nothing to disclose
Fontaine: nothing to disclose
Yaker: nothing to disclose
Ranjeva: nothing to disclose
Crespy: nothing to disclose
Rico: nothing to disclose
Audoin: nothing to disclose
Abstract: P1176
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Objectives: to describe efficacy and safety of Fingolimod in a cohort of patients treated for at least one year in the department of neurology of the Timone university hospital of Marseille.The primary objective was to evaluate the proportion of patients presented with disease free activity (relapse, disability and MRI) at year1 and year2. The secondary objectives were to describe clinical and MRI data before before starting Fingolimod, efficacy and safety profiles of the patients included in this retrospective observational study.
Methods: Patients were identified in the EDMUS database. Patients included had to start Fingolimod between January 1st 2012 and December 31 2013. Clinical, biological and MRI data had to be effective. 204 patients were included in the study with a treatment duration more than one year (130 were treated more than 2 years). 73.5% were female and 26.5% male. Mean age was 40y and mean disease duration was 10ys.
Results: RRMS represents 92% of patients, progressive MS (SP or PP) 8%. 23.5% of patients were treatment naïve (first line treatment) and 66.5% were treated in second line therapy (50.5% after a first line treatment, 26% after a second line). Mean EDSS before treatment was 2.9 and 66% presented one or more relapse one year before treatment (36% 2ys before). 78% of patients presented with new T2MRI lesion(s) and 54% with T1GadMRI lesion(s) at baseline. Mean treatment duration was 22.2months. Mean EDSS at Y1 was 2.7 and at Y2 5.6. Respectively, 86.5% and 92% had no new T2MRI and T1Gad MRI lesion at Y1 (91.5% and 95% at Y2). 80% of patients had no relapse at Y1 and 92% at Y2. At Y1 and Y2 73.7% and 85.8% respectively were NEDA3 (no clinical and MRI activity). 22% of patients stopped definitively Fingolimod (6% in the absence of efficacy: relapse and/or EDSS increase; 1.5% related with serious adverse events; (6% related with no serious AE; 8% related with personal reasons; 0.5% related with pregnancy). Safety profile was good: one death (pancreas cancer), one patient presented with pancreas cancer, 8 patients with liver abnormalities, 2 patients with lymphopenia (below 200), 2 patients with high blood pressure and 2 patients with infection.
Conclusions: This monocentric retrospective study confirm consistent efficacy benefit at Y1 and Y2 of Fingolimod both on clinical and MRI activity. This study also supports the positive safety profile of Fingolimod in real life.
Disclosure: Pelletier: unconditional grant from Novartis France
Gualtieri: nothing to disclose
DiLelio: nothing to disclose
Fontaine: nothing to disclose
Yaker: nothing to disclose
Ranjeva: nothing to disclose
Crespy: nothing to disclose
Rico: nothing to disclose
Audoin: nothing to disclose