Background Teriflunomide (TRF) and dimethyl fumarate (DMF) are oral drugs authorised in Spain to treat relapsing remitting multiple sclerosis (RRMS).

Purpose To compare the safety profile of both drugs in the treatment of RRMS in adults in a tertiary hospital.

Material and methods An observational retrospective study was conducted in patients who began treatment with TRF and DMF from January 2015 to March 2016. Collected variables: age, sex, previous treatment, safety profile (adverse reactions (AR), suspension, reduction of dose) and subsequent treatment in case of withdrawal. The information was obtained from the clinical history and RA record in the Farmatools programme when they came to collect their medication.

Results 53 patients were included, 12 men/41 women (mean age 40.59 years). 38 received DMF and 15 TRF. 15 were treated with firstline DMF and 4 with TRF. The main reasons for the change were: poor tolerance, AR at the site of injection and convenience of oral administration. 25 patients showed no AR (35% of patients with DMF and 73% of TRF), or were not mentioned. 26 patients treated with DMF presented AR: skin (redness/eczema), gastrointestinal (nausea/vomiting/burning), fatigue and others. 69.23% of patients (18) reported skin changes which appeared after taking medication and disappeared after 3–4 hours. 69.23% (18) had gastrointestinal disorders, and was the main reason for suspension/dose reduction. 19.23% (5) had fatigue/malaise, especially at the beginning of treatment.

5 patients had other AR, including changes in blood glucose (2), lymphopenia (1), palpitations (1) and possible urinary tract infection (1). 8 patients required dose reduction temporarily. Only 1 patient is continuing with reduced doses. Only 4 patients treated with TRF reported any AR: headache (1), gastrointestinal disorders (2) and alopecia (1). 3 of the 15 patients experienced moderate elevation of liver enzymes. 5 patients discontinued treatment, 3 due to intolerance (DMF) and 2 ineffectiveness (DMF+TRF). They are currently receiving treatment with natalizumab (1), teriflunomide (2) and PegIFN-B1a (2).

Conclusion The AR that patients manifested were mild and the majority disappeared with withdrawal of the drugs. However, analysing the percentage of patients who presented AR, we consider that TRF has a better profile for frequency and severity of AR compared with DMF. AR were in line with those described in the data sheet and other studies, although increased monitoring is necessary to assess effectiveness and long term safety.

References and/or acknowledgements Thanks to all colleagues who participated in the study.

No conflict of interest