Contributions
Abstract: EP1523
Type: ePoster
Abstract Category: Therapy - disease modifying - Risk management for disease modifying treatments
Background: Fingolimod was the first oral therapy approved for the treatment of RRMS. Due to its action on cardiac sphingosine 1-phosphate (S1P) receptors, Fingolimod is leading to a transient decrease in heart rate (HR) and the occurrence of rare and asymptomatic self-limited atrioventricular blocks.
Objectives: This German non interventional clinical study aimed to assess the cardiac safety profile in RRMS patients during at least 6 hours after the first dose of fingolimod or restart after a treatment interruption in real world settings.
Methods: The GoCARD study (CFTY720DDE18) was a prospective, multi-center non-interventional study which was conducted in neurological and other medical practices or hospitals, qualified to routinely assess ECG findings. Data were collected through interviews, clinical evaluations (notably ECGs) and laboratory tests. Medical history (Laboratory values, MS history including EDSS, cardiologic parameters, Body mass index), vital signs and a pre-dose 12-lead ECG were assessed before fingolimod administration. After first dose, a 6-hour ECG was performed and vital signs (blood pressure and heart rate) were measured and documented hourly. The occurrence of bradycardia (HR≤45BPM), atrioventricular blocks (2nd degree Mobitz type I or higher and QTc intervals were also documented.
Results: More than 95% of physician adhered to full extent to the cardiac monitoring recommendations. The observation of 217 patients in 42 study centers showed that while 35,9% of patients had a cardiac risk profile (tobacco use, overweight, hypertension or elevated blodd lipids), none of them experienced a bradycardia during the 6 hours post dose observation. Overall, only 1,8% of all patients displayed bradycardia (HR ≤ 45 BPM) during 6 hours after treatment initiation. Moreover, in this cohort, none of the patients showed a new onset AV-block (2nd degree Mobitz type I or higher) or corrected QT interval (QTc) ≥500 ms.
Conclusion: These data suggest that the first dose observation after fingolimod initiation in most cases is uneventful and that the rare observed events often remain asymptomatic and self-limited.
Disclosure:
Ralf A. Linker received travel grants or speaker honoraria from Bayer HealthCare Pharmaceuticals, Biogen Idec, Merck Serono, Novartis Pharma GmbH, Roche, and TEVA Pharmaceutical Industries LTD, as well as research support from Novartis Pharma GmbH, Biogen Idec, and Merck Serono.
Guillaume Wendt is employee of Novartis.
Abstract: EP1523
Type: ePoster
Abstract Category: Therapy - disease modifying - Risk management for disease modifying treatments
Background: Fingolimod was the first oral therapy approved for the treatment of RRMS. Due to its action on cardiac sphingosine 1-phosphate (S1P) receptors, Fingolimod is leading to a transient decrease in heart rate (HR) and the occurrence of rare and asymptomatic self-limited atrioventricular blocks.
Objectives: This German non interventional clinical study aimed to assess the cardiac safety profile in RRMS patients during at least 6 hours after the first dose of fingolimod or restart after a treatment interruption in real world settings.
Methods: The GoCARD study (CFTY720DDE18) was a prospective, multi-center non-interventional study which was conducted in neurological and other medical practices or hospitals, qualified to routinely assess ECG findings. Data were collected through interviews, clinical evaluations (notably ECGs) and laboratory tests. Medical history (Laboratory values, MS history including EDSS, cardiologic parameters, Body mass index), vital signs and a pre-dose 12-lead ECG were assessed before fingolimod administration. After first dose, a 6-hour ECG was performed and vital signs (blood pressure and heart rate) were measured and documented hourly. The occurrence of bradycardia (HR≤45BPM), atrioventricular blocks (2nd degree Mobitz type I or higher and QTc intervals were also documented.
Results: More than 95% of physician adhered to full extent to the cardiac monitoring recommendations. The observation of 217 patients in 42 study centers showed that while 35,9% of patients had a cardiac risk profile (tobacco use, overweight, hypertension or elevated blodd lipids), none of them experienced a bradycardia during the 6 hours post dose observation. Overall, only 1,8% of all patients displayed bradycardia (HR ≤ 45 BPM) during 6 hours after treatment initiation. Moreover, in this cohort, none of the patients showed a new onset AV-block (2nd degree Mobitz type I or higher) or corrected QT interval (QTc) ≥500 ms.
Conclusion: These data suggest that the first dose observation after fingolimod initiation in most cases is uneventful and that the rare observed events often remain asymptomatic and self-limited.
Disclosure:
Ralf A. Linker received travel grants or speaker honoraria from Bayer HealthCare Pharmaceuticals, Biogen Idec, Merck Serono, Novartis Pharma GmbH, Roche, and TEVA Pharmaceutical Industries LTD, as well as research support from Novartis Pharma GmbH, Biogen Idec, and Merck Serono.
Guillaume Wendt is employee of Novartis.