Contributions
Abstract: EP1629
Type: ePoster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Fingolimod is a sphingosine 1-phosphate receptor modulator for relapsing-remitting multiple sclerosis RRMS treatment. Continuous collection and analysis of real world effectiveness and safety data is key to making accurate treatment decisions.
Objective: To describe baseline characteristics at fingolimod treatment initiation and effectiveness of fingolimod in RRMS patients in clinical practice.
Methods: Pooled analysis of 2 observational, retrospective, multicentre studies conducted in Spain: MS SECOND LINE GATE and MS NEXT. Both studies were carried out in RRMS patients, ≥18 years, treated with 0.5mg/day of fingolimod and followed for ≥1 year after treatment initiation.
Results: 988 patients were included (post first-line injectable disease-modifying treatment [iDMT]: 666 patients, post-natalizumab [NTZ]: 252, treatment-naïve: 70; 69% female, mean [SD] age: 40 [9] years). At year 1, 2 and 3 after treatment initiation, mean annual relapse rate (ARR) decreased by 77%, 82% and 86% compared to the year prior to treatment initiation (p< 0.0001 all). At year 3, mean ARR significantly decreased in iDMT and treatment-naïve subgroups by 91% and 96%, respectively, and remained stable in NTZ patients. At year 1, 90% of patients had stable or improved EDSS that was maintained in 84% of patients at year 2. Mean number of T1 Gd+ lesions decreased significantly in the overall population: 69% (year 1) and 80% (year 2) (p< 0.0001). At year 1 and year 2, 72% and 58% of patients did not show new/increased T2 lesions respectively, and 78% and 69% were relapse-free.
Conclusions: Fingolimod is an effective treatment for RRMS in the clinical practice. At year 3, there was a decrease in the mean ARR of treatment-naïve and iDMT patients, and stabilization in NTZ patients. After fingolimod treatment initiation, RRMS patients significantly improved clinical disease activity and most of the patients had a stable EDSS after one year of treatment.
Disclosure: 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
S. Martinez Yélamos: received honoraria compensation to participate in advisory boards, collaborations as a consultant and scientific communications and received research support, funding for travel and congress expenses from Biogen Idec, Novartis, TEVA, MerckSerono, Genyme and Almirall
J. Mallada: recived honoraria from Merck, Bayer, Teva, Sanofi, Novartis, Biogen andRoche
J. Meca-Lallana: Nothing to disclose
M. Martínez: Nothing to disclose
E. Marzo: has received compensation for travel expenses and speaking honoraria from Biogen Idec, Novartis and Genzyme.
C. Duran: I've received honoraria from Abbvie, Biogen, Novartis, Merck y Sanofi Genzyne
T. Ayuso: has received compensation for travel expenses, speaking honoraria and consultation fees from Almirall, Biogen, Genzyme, Merck Serono, Novartis and Teva
F. Barrero: has received consulting/speaker fees from and advisory board for Bayer HealthCare, Biogen, Genzyme, Merck Serono, Novartis, Roche, Sanofi-Aventis, and Teva, and been involved with clinical trials for Novartis.
R. Romero: Novartis employee
R. Guillen: Novartis employee
J.Ricart: Novartis employee
E. Garcia: Novartis employee
Abstract: EP1629
Type: ePoster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Fingolimod is a sphingosine 1-phosphate receptor modulator for relapsing-remitting multiple sclerosis RRMS treatment. Continuous collection and analysis of real world effectiveness and safety data is key to making accurate treatment decisions.
Objective: To describe baseline characteristics at fingolimod treatment initiation and effectiveness of fingolimod in RRMS patients in clinical practice.
Methods: Pooled analysis of 2 observational, retrospective, multicentre studies conducted in Spain: MS SECOND LINE GATE and MS NEXT. Both studies were carried out in RRMS patients, ≥18 years, treated with 0.5mg/day of fingolimod and followed for ≥1 year after treatment initiation.
Results: 988 patients were included (post first-line injectable disease-modifying treatment [iDMT]: 666 patients, post-natalizumab [NTZ]: 252, treatment-naïve: 70; 69% female, mean [SD] age: 40 [9] years). At year 1, 2 and 3 after treatment initiation, mean annual relapse rate (ARR) decreased by 77%, 82% and 86% compared to the year prior to treatment initiation (p< 0.0001 all). At year 3, mean ARR significantly decreased in iDMT and treatment-naïve subgroups by 91% and 96%, respectively, and remained stable in NTZ patients. At year 1, 90% of patients had stable or improved EDSS that was maintained in 84% of patients at year 2. Mean number of T1 Gd+ lesions decreased significantly in the overall population: 69% (year 1) and 80% (year 2) (p< 0.0001). At year 1 and year 2, 72% and 58% of patients did not show new/increased T2 lesions respectively, and 78% and 69% were relapse-free.
Conclusions: Fingolimod is an effective treatment for RRMS in the clinical practice. At year 3, there was a decrease in the mean ARR of treatment-naïve and iDMT patients, and stabilization in NTZ patients. After fingolimod treatment initiation, RRMS patients significantly improved clinical disease activity and most of the patients had a stable EDSS after one year of treatment.
Disclosure: 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
S. Martinez Yélamos: received honoraria compensation to participate in advisory boards, collaborations as a consultant and scientific communications and received research support, funding for travel and congress expenses from Biogen Idec, Novartis, TEVA, MerckSerono, Genyme and Almirall
J. Mallada: recived honoraria from Merck, Bayer, Teva, Sanofi, Novartis, Biogen andRoche
J. Meca-Lallana: Nothing to disclose
M. Martínez: Nothing to disclose
E. Marzo: has received compensation for travel expenses and speaking honoraria from Biogen Idec, Novartis and Genzyme.
C. Duran: I've received honoraria from Abbvie, Biogen, Novartis, Merck y Sanofi Genzyne
T. Ayuso: has received compensation for travel expenses, speaking honoraria and consultation fees from Almirall, Biogen, Genzyme, Merck Serono, Novartis and Teva
F. Barrero: has received consulting/speaker fees from and advisory board for Bayer HealthCare, Biogen, Genzyme, Merck Serono, Novartis, Roche, Sanofi-Aventis, and Teva, and been involved with clinical trials for Novartis.
R. Romero: Novartis employee
R. Guillen: Novartis employee
J.Ricart: Novartis employee
E. Garcia: Novartis employee