Clinical trialThe management and outcomes of fingolimod first dose cardiac monitoring in UK patients with relapsing-remitting multiple sclerosis

•Clinical observations during fingolimod initiation were analysed for 850 episodes.•In real world UK practice fingolimod initiation was largely uneventful.•Clinical observations were similar to those reported previously in clinical trials.•The results provide reassurance to neurologists prescribing fingolimod in the UK.

BackgroundPatients initiated on Gilenya (fingolimod) require cardiovascular monitoring for 6 h after the first dose. Novartis has engaged an independent provider (Regent's Park Heart Clinics [RPHC]) to provide a first dose observation (FDO) service to UK neurologists.ObjectivesTo describe routinely-documented clinical observations (heart rate [HR], blood pressure [BP], cardiac rhythm [CR]) and outcomes from the RPHC fingolimod FDO service.MethodsPseudonymised data (clinical observations pre-dose and for 6 h after the first dose and any requirement for extended monitoring) were collected retrospectively from RPHC records for the first 850 RPHC FDO episodes (undertaken Jul-2012 to Jan-2015). All episodes involved patients with relapsing-remitting MS who were initiated on fingolimod in routine National Health Service (NHS) clinical practice.ResultsIn 78% of FDO episodes the patient was female. Mean age at date of episode was 40.1 years. Mean HR was 72.7 bpm (beats per minute) pre-dose, 64.3 bpm at 5 h (the lowest recorded HR) and 66.1 bpm at 6 h post-dose. New-onset heart block was observed in 2% of episodes (1.5% first-degree; 0.5% second-degree). The patient was discharged at 6 hours post-dose in 97% of episodes and required extended monitoring in 3%. In 5 episodes overnight monitoring was required. There were no episodes in which the patient required pharmacological intervention or temporary cardiac pacing.ConclusionsIn this real-world UK population fingolimod initiation was predominantly uneventful; clinical observations were similar to previous clinical trials.