Contributions
Abstract: EP1697
Type: ePoster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: This study aimed to further characterise the safety profile of fingolimod, the first approved oral therapy for multiple sclerosis (MS), by generating real-world evidence on its long-term (2-year) safety.
Methods: A total of 506 patients (498 eligible) were enrolled in this non-interventional, observational study between 20-Feb-2012 and 13-Jan-2014 at 40 study sites across Greece. Patients were followed over a period of 24 months. Fingolimod (0.5 mg) had been initiated 0 to 15 days prior to enrolment (median: 0.0 days).
Results: Over a median of 23.6 months of fingolimod exposure, 20.5% (n=102) patients experienced 233 fingolimod-related adverse events (AECommon AEs (i.e. frequency ≥1%) included 'lymphopenia' [45 events by 8.8%; exposure-adjusted incidence rate (EAIR): 5.3 cases per 100 patient-years; 95%CI: 3.8-7.1]; 'leukopenia' (21 events by 4.2%; EAIR: 2.4; 95%CI: 1.5-3.7); 'hepatic enzyme increased' (31 events by 3.4%; EAIR: 2.0; 95%CI: 1.1-3.1), 'headache' (9 events by 1.8%; EAIR: 1.0; 95%CI: 0.5-2.0); 'dizziness' (7 events by 1.2%; EAIR: 0.7; 95%CI: 0.3-1.5), 'bradycardia' [6 events (five on the day of fingolimod onset) by 1.2%; EAIR: 0.7; 95%CI: 0.3-1.5]; and 'herpes viral infections' (5 events by 1.0%; EAIR: 0.6; 95%CI: 0.2-1.3). Overall, infections (19 AEs) were reported by 3.0% (EAIR: 1.7; 95%CI: 1.0-2.8) of the patients. Among other events of interest, malignant neoplasms (one event each of B-cell lymphoma and intestinal adenocarcinoma) were reported in 0.4%, while there was a single event of a first degree atrioventricular block. Serious AEs were reported by 9.6%; 'lymphopenia' (5.0%; EAIR: 2.9; 95%CI: 1.9-4.3), 'leukopenia' (1.6%; EAIR: 0.9; 95%CI: 0.4-1.8), and 'hepatic enzyme increased' (1.4%; EAIR: 0.8; 95%CI: 0.3-1.6) were the only common serious AEs. No cases of macular oedema were reported. Overall, 5.6% of the patients permanently discontinued fingolimod treatment due to AE occurrence. At the end of the study, 57.1% of the AEs had recovered, 32.6% were ongoing, 8.2% had fatal outcome, while the outcome was unknown in 2.1%.
Conclusions: The study yielded real-world data on the well-established safety profile of fingolimod in a representative MS population. No new safety signals were identified.
Disclosure: Novartis Hellas S.A.C.I is the sponsor of the study
D.D Mitsikostas has received grants and honoraria from: Allergan, Amgen, Biogen, Genesis Pharma, Electocore, Eli Lilly, Merck-Serono, Novartis, Roche, Sanofi-Genzyme, Teva
E. Zafeiropoulou is currently a Novartis (Hellas) S.A.C.I employee
E. Dardiotis has received personal compensation for consulting, speaking and scientific advisory boards from Novartis Hellas SA, Genesis Pharma, Bayer Hellas AG, Merck- Serono, Sanofi-Genzyme and Teva
A. Orologas received grants/research support from Merck-Serono, Sanofi-Aventis, Teva, Novartis, Genesis Pharma, honoraria or consultation fees from Merck-Serono, Bayer Schering, Sanofi-Aventis and/or Teva, Novartis, Genesis Pharma and participation in a company sponsored speaker's bureau from Merck-Serono, Bayer Schering, Sanofi-Aventis, Teva, Novartis, Genesis Pharma
V. Mastorodimos has received travel grants from Biogen Idec, Novartis, Merck-Serono, Teva and Bayer I. Markakis has nothing to disclose
K. Karageorgiou received travel support, consultancy and lecture fees from Biogen Idec, Novartis, Bayer, Merck Serono, Genesis Pharma, ELPEN and Sanofi - Aventis
N. Grigoriadis received honoraria, travel support, consultancy and lecture fees from Biogen Idec, Novartis, TEVA, Bayer, Merck Serono, Genesis Pharma, Sanofi - Aventis and Research grants from Biogen Idec, Novartis, TEVA, Merck Serono, Genesis Pharma
All authors, except of E.Z are Principal Investigators of the study.
Abstract: EP1697
Type: ePoster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: This study aimed to further characterise the safety profile of fingolimod, the first approved oral therapy for multiple sclerosis (MS), by generating real-world evidence on its long-term (2-year) safety.
Methods: A total of 506 patients (498 eligible) were enrolled in this non-interventional, observational study between 20-Feb-2012 and 13-Jan-2014 at 40 study sites across Greece. Patients were followed over a period of 24 months. Fingolimod (0.5 mg) had been initiated 0 to 15 days prior to enrolment (median: 0.0 days).
Results: Over a median of 23.6 months of fingolimod exposure, 20.5% (n=102) patients experienced 233 fingolimod-related adverse events (AECommon AEs (i.e. frequency ≥1%) included 'lymphopenia' [45 events by 8.8%; exposure-adjusted incidence rate (EAIR): 5.3 cases per 100 patient-years; 95%CI: 3.8-7.1]; 'leukopenia' (21 events by 4.2%; EAIR: 2.4; 95%CI: 1.5-3.7); 'hepatic enzyme increased' (31 events by 3.4%; EAIR: 2.0; 95%CI: 1.1-3.1), 'headache' (9 events by 1.8%; EAIR: 1.0; 95%CI: 0.5-2.0); 'dizziness' (7 events by 1.2%; EAIR: 0.7; 95%CI: 0.3-1.5), 'bradycardia' [6 events (five on the day of fingolimod onset) by 1.2%; EAIR: 0.7; 95%CI: 0.3-1.5]; and 'herpes viral infections' (5 events by 1.0%; EAIR: 0.6; 95%CI: 0.2-1.3). Overall, infections (19 AEs) were reported by 3.0% (EAIR: 1.7; 95%CI: 1.0-2.8) of the patients. Among other events of interest, malignant neoplasms (one event each of B-cell lymphoma and intestinal adenocarcinoma) were reported in 0.4%, while there was a single event of a first degree atrioventricular block. Serious AEs were reported by 9.6%; 'lymphopenia' (5.0%; EAIR: 2.9; 95%CI: 1.9-4.3), 'leukopenia' (1.6%; EAIR: 0.9; 95%CI: 0.4-1.8), and 'hepatic enzyme increased' (1.4%; EAIR: 0.8; 95%CI: 0.3-1.6) were the only common serious AEs. No cases of macular oedema were reported. Overall, 5.6% of the patients permanently discontinued fingolimod treatment due to AE occurrence. At the end of the study, 57.1% of the AEs had recovered, 32.6% were ongoing, 8.2% had fatal outcome, while the outcome was unknown in 2.1%.
Conclusions: The study yielded real-world data on the well-established safety profile of fingolimod in a representative MS population. No new safety signals were identified.
Disclosure: Novartis Hellas S.A.C.I is the sponsor of the study
D.D Mitsikostas has received grants and honoraria from: Allergan, Amgen, Biogen, Genesis Pharma, Electocore, Eli Lilly, Merck-Serono, Novartis, Roche, Sanofi-Genzyme, Teva
E. Zafeiropoulou is currently a Novartis (Hellas) S.A.C.I employee
E. Dardiotis has received personal compensation for consulting, speaking and scientific advisory boards from Novartis Hellas SA, Genesis Pharma, Bayer Hellas AG, Merck- Serono, Sanofi-Genzyme and Teva
A. Orologas received grants/research support from Merck-Serono, Sanofi-Aventis, Teva, Novartis, Genesis Pharma, honoraria or consultation fees from Merck-Serono, Bayer Schering, Sanofi-Aventis and/or Teva, Novartis, Genesis Pharma and participation in a company sponsored speaker's bureau from Merck-Serono, Bayer Schering, Sanofi-Aventis, Teva, Novartis, Genesis Pharma
V. Mastorodimos has received travel grants from Biogen Idec, Novartis, Merck-Serono, Teva and Bayer I. Markakis has nothing to disclose
K. Karageorgiou received travel support, consultancy and lecture fees from Biogen Idec, Novartis, Bayer, Merck Serono, Genesis Pharma, ELPEN and Sanofi - Aventis
N. Grigoriadis received honoraria, travel support, consultancy and lecture fees from Biogen Idec, Novartis, TEVA, Bayer, Merck Serono, Genesis Pharma, Sanofi - Aventis and Research grants from Biogen Idec, Novartis, TEVA, Merck Serono, Genesis Pharma
All authors, except of E.Z are Principal Investigators of the study.