DI-015 Safety of dimethyl fumarate in the treatment of relapsing remitting multiple sclerosis: a retrospective study

BackgroundDimethyl fumarate (DMF) represents a new class of treatment for patients with relapsing remitting multiple sclerosis (RRMS). Scientific investigations are still in progress to clarify the ultimate mechanism of action responsible for the treatment effects of DMF. DMF does not have a single mechanism of action but rather has a multitude of biological effects. In vitro studies have revealed that DMF has anti-inflammatory properties linked to its ability to promote a Th2 immune response.PurposeTo evaluate the safety profile of RRMS patients treated with DMF.Material and methodsA retrospective observational study included all patients >18 years old with RRMS. Recruitment period was 12 months. Patients were treated with 240 mg every 12 hours. Safety variable considered all patients who had to discontinue treatment due to significant adverse events of DMF. The information was obtained from the outpatient dispense programme (Dominion) from where the following data were collected: age, sex, diagnosis, treatment, dosage, adverse events and duration of treatment. The data were added to a database.Results43 subjects were recruited (n=21), 73.4% women, mean age 44.3 years (27–63). 24.4% of patients discontinued treatment. Mean treatment time to DMF discontinuation in these patients was 6.2 months (0.5–24), producing early discontinuation at week 2 in 1 patient. 27.2% of cases were discontinued due to flushing events, 63.3% due to gastrointestinal events and 18% due to lymphopenia (normal values: 710–4530/mm3). No changes were observed in the normal values for leucocytes, alanine aminotransferase or aspartate aminotransferase during the study period.ConclusionTo date, two of the most relevant clinical trials on DMF in this pathology, ‘CONFIRMAR’ and ‘DEFINIR’, have proven that DMF is a safe treatment. Data collected in our study showed a high percentage of discontinuation, in disagreement with the clinical trials published. However more patients and a longer periods of treatment are needed to reach definitive conclusions.References and/or acknowledgementsTo my pharmacist colleagues.No conflict of interest