Background Multiple sclerosis (MS) is a chronic and inflammatory neurological disease in which focal demyelination occurs in the CNS. Dimethyl fumarate (DMF) is indicated for the treatment of adult patients with relapsing-remitting multiple sclerosis. It is administered orally. The dose is 240 mg twice daily; 120 mg twice daily for the first 7 days.

Purpose Our goal was to analyse the profile of patients and tolerability of DMF.

Material and methods A retrospective observational study was constructed from October 2014 to May 2015.

SAP software was used for medical history, nursing and recording dispensations of patients treated with DMF. Data recorded were: age, sex, EDSS, pretreatment, analytical performed and adverse reactions.

Results 16 patients, 11 women and 5 men, with a mean age of 39.31 years (16–63) were analysed. Mean EDSS was 2.4 (1–4.5).

DMF was prescribed as the firstline treatment in 5 patients (31.25%), as secondline in 7 (43.75%), as the third treatment in 3 (18.75%) and as the fourth treatment in 1 (6.25%).

DMF was given immediately before treatment with interferon beta-1b 250 µg in 4 patients, interferon beta-1a 30 µg and 44 µg interferon beta-1a in 3 and glatiramer acetate 1. In all cases, the reason for the change was pain and skin reactions, flu-like syndrome uncontrolled in two cases and radiographic progression in one.

All patient analyses were performed to assess renal function, liver function and blood count 1 month after starting treatment, and at 3 and 6 months.

5 (31.25%) patients had mild to moderate disease at baseline, 1 (6.25%) patient experienced flushing and elevated liver transaminases more than three times the normal value and 3 (18.75%) patients had major digestive problems, with 2 (12.5%) suspending treatment despite starting treatment using a gradual protocol: doses of 120 mg-0–120 mg for the first week, 120 mg-0–240 mg for the second and third weeks, and full dose 240 mg-0–240 mg from the fourth week, trying to reduce subsequent doses.

Mean duration of treatment with DMF was 4.56 months  (2–8).

Conclusion DMF was accepted well by patients after oral administration despite its side effects (mainly flushing and gastrointestinal effects) that appeared at the start of drug treatment.

The adverse reaction profile observed was similar to that described in the product information.

References and/or Acknowledgements

1. http://www.aemps.gob.es/medicamentosUsoHumano/informesPublicos/docs/IPT-dimetilfumarato-tecfidera.pdf

References and/or AcknowledgementsNo conflict of interest.