Contributions
Abstract: EP1640
Type: ePoster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Fingolimod is a sphingosine 1-phosphate receptor modulator approved for relapsing-remitting multiple sclerosis (RRMS). Continuous collection and analysis of real world data is key to make accurate treatment decisions.
Objective: Fingoview study aimed to describe the effectiveness of fingolimod in Spanish RRMS patients in clinical practice. Here we present the results of the subpopulation previously treated with first line injectable disease-modifying treatment (iDMT).
Methods: Fingoview is a pooled analysis of two observational, retrospective and multicentric studies (MS-SECOND LINE GATE + MS-NEXT) including patients ≥18 years, treated with fingolimod and followed up for ≥12 months (Nov2014-Dec2015).
Results: Fingoview study included 988 patients (MS-Next: 804, MS-2nd-Line GATE: 184). 666 patients were post-iDMT (1 iDMT=382, >1 iDMT=284): 71% female, mean age=40 years, and mean time from first diagnosis to fingolimod treatment initiation=8 years. The mean annual relapse rate (ARR) of the whole post-iDMT subpopulation decreased by 82%, 88% and 91% at year 1, 2 and 3 after treatment initiation respectively (p< 0.0001 all), with decrease in both 1 iDMT and >1 iDMT subgroups (p< 0.0001 all). The ARR decrease was higher in 1 iDMT than >1 iDMT cohorts (85% vs 78%, 90% vs 84% and 93% vs 87%, years 1, 2 and 3 respectively) with statistically significant difference at year 1 (p< 0.05). At year 1, 90% (1 iDMT=91%, >1 iDMT=90%) of patients had stable or improved EDSS that was maintained in 85% (1 iDMT=84%, >1 iDMT=87%) of patients at year 2. There was no significant difference between cohorts. At year 1 and 2, 73% (1 iDMT=69%, >1 iDMT=78%; p=0.0696) and 55% (1 iDMT=50%, >1 iDMT=63%; p=0.2370) of iDMT patients did not show new/increased T2 lesions respectively, and the mean number of T1 Gd+ lesions decreased by 72% (1 iDMT=74%, >1 iDMT=70%) and 80% (1 iDMT=76%, >1 iDMT=89%) respectively (p< 0.0001). At year 1, 83% of 1 iDMT patients and 76% of >1 iDMT were relapse-free (p< 0.05). This difference was maintained at year 2 (75% and 67% respectively).
Conclusions: Fingolimod is an effective treatment for RRMS patients previously treated with iDMT in clinical practice. For the first 3 years, there was a decrease in the ARR in both 1 iDMT and >1 iDMT cohorts, with a higher reduce in 1 iDMT cohort at year 1. After fingolimod treatment initiation, most than 80% of post-iDMT patients improved or had stable EDSS without differences between 1 iDMT and >1 iDMT cohorts.
Disclosure: J. Mallada:has received honoraria from Merck, Bayer, Teva, Sanofi, Novartis, Biogen y Roche
J. Meca-Lallana:Nothing to disclosure
M. Martínez:Nothing to disclosure
E. Marzo:Eugenia 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: T. Ayuso has received compensation for travel expenses, speaking honoraria and consultation fees from Almirall, Biogen, Genzyme, Merck Serono, Novartis and Teva
F. Barrero: Francisco 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.
V. Meca-Lallana: 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
S. Martinez Yélamos. Sergio Martínez-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
M.J. Moreno:Novartis employee
I. Salutregui:Novartis employee
J.Ricart:Novartis employee
E. Garcia:Novartis employee
Abstract: EP1640
Type: ePoster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Fingolimod is a sphingosine 1-phosphate receptor modulator approved for relapsing-remitting multiple sclerosis (RRMS). Continuous collection and analysis of real world data is key to make accurate treatment decisions.
Objective: Fingoview study aimed to describe the effectiveness of fingolimod in Spanish RRMS patients in clinical practice. Here we present the results of the subpopulation previously treated with first line injectable disease-modifying treatment (iDMT).
Methods: Fingoview is a pooled analysis of two observational, retrospective and multicentric studies (MS-SECOND LINE GATE + MS-NEXT) including patients ≥18 years, treated with fingolimod and followed up for ≥12 months (Nov2014-Dec2015).
Results: Fingoview study included 988 patients (MS-Next: 804, MS-2nd-Line GATE: 184). 666 patients were post-iDMT (1 iDMT=382, >1 iDMT=284): 71% female, mean age=40 years, and mean time from first diagnosis to fingolimod treatment initiation=8 years. The mean annual relapse rate (ARR) of the whole post-iDMT subpopulation decreased by 82%, 88% and 91% at year 1, 2 and 3 after treatment initiation respectively (p< 0.0001 all), with decrease in both 1 iDMT and >1 iDMT subgroups (p< 0.0001 all). The ARR decrease was higher in 1 iDMT than >1 iDMT cohorts (85% vs 78%, 90% vs 84% and 93% vs 87%, years 1, 2 and 3 respectively) with statistically significant difference at year 1 (p< 0.05). At year 1, 90% (1 iDMT=91%, >1 iDMT=90%) of patients had stable or improved EDSS that was maintained in 85% (1 iDMT=84%, >1 iDMT=87%) of patients at year 2. There was no significant difference between cohorts. At year 1 and 2, 73% (1 iDMT=69%, >1 iDMT=78%; p=0.0696) and 55% (1 iDMT=50%, >1 iDMT=63%; p=0.2370) of iDMT patients did not show new/increased T2 lesions respectively, and the mean number of T1 Gd+ lesions decreased by 72% (1 iDMT=74%, >1 iDMT=70%) and 80% (1 iDMT=76%, >1 iDMT=89%) respectively (p< 0.0001). At year 1, 83% of 1 iDMT patients and 76% of >1 iDMT were relapse-free (p< 0.05). This difference was maintained at year 2 (75% and 67% respectively).
Conclusions: Fingolimod is an effective treatment for RRMS patients previously treated with iDMT in clinical practice. For the first 3 years, there was a decrease in the ARR in both 1 iDMT and >1 iDMT cohorts, with a higher reduce in 1 iDMT cohort at year 1. After fingolimod treatment initiation, most than 80% of post-iDMT patients improved or had stable EDSS without differences between 1 iDMT and >1 iDMT cohorts.
Disclosure: J. Mallada:has received honoraria from Merck, Bayer, Teva, Sanofi, Novartis, Biogen y Roche
J. Meca-Lallana:Nothing to disclosure
M. Martínez:Nothing to disclosure
E. Marzo:Eugenia 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: T. Ayuso has received compensation for travel expenses, speaking honoraria and consultation fees from Almirall, Biogen, Genzyme, Merck Serono, Novartis and Teva
F. Barrero: Francisco 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.
V. Meca-Lallana: 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
S. Martinez Yélamos. Sergio Martínez-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
M.J. Moreno:Novartis employee
I. Salutregui:Novartis employee
J.Ricart:Novartis employee
E. Garcia:Novartis employee