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PS-002 New oral therapies in relapsing-remitting multiple sclerosis: Safety profile evaluation
  1. V García,
  2. M Camps,
  3. Q Moreno,
  4. M Miarons,
  5. L Campins,
  6. A Sánchez,
  7. S Marín,
  8. T Gurrera,
  9. X Fábregas,
  10. C Agustí
  1. Hopital de Mataró, Pharmacy, Mataró, Spain


Background Teriflunomide and dimethyl-fumarate (DMF) are two new oral drugs for relapsing-remitting multiple sclerosis (RRMS).

Due to the lack of experience in the management of these drugs, we performed a study to provide some knowledge.

Purpose To evaluate the safety profile and adherence to a new oral treatment for RRMS in actual practice.

Material and methods Observational, descriptive, cross sectional study in a community hospital.

All patients with RRMS who started treatment with teriflunomide or DMF from January to May 2015.

Data were obtained from blood tests and information from pharmaceutical care visits.

We recorded demographic variables, line of treatment and adverse effects. Adherence was measured using the Morisky-Green and Haynes-Sackett tests.

Results 24 patients (13 teriflunomide, 11 DMF) were included, representing 30.4% of patients receiving multiple sclerosis treatment. In the teriflunomide group (38.5% women, mean age 50.5 years, SD 7.8), 76.9% of patients were pretreated, half were prescribed secondline treatment and the other half thirdline. 84.6% were adherent.

The most common adverse events recorded in pharmaceutical care visits were: abnormal liver enzymes in 46.1% of patients, gastrointestinal discomfort in 15.4% and hypertension, diarrhoea, hair weakness, headache, dizziness and loss of appetite in 7.7% each.

  1. patient discontinued treatment because of diarrhoea and another one because of abnormal liver enzymes three times the upper limit of normal.

Of all the patients treated with DMF (54.5% women, mean age 41 years, SD 9.4) 10 were pretreated and 80% were receiving secondline treatment. Adherence was correct in 81.8%.

The most common side effects were hot flashes in 54.5% of patients, gastrointestinal discomfort in 36.4%, abnormal liver enzymes in 18.2%, and headache and diarrhoea in 9.1% each. No data were available for 3 patients because they were in the first month of treatment.

No patient discontinued treatment due to adverse effects.

Conclusion The withdrawal rate due to adverse effects with teriflunomide was not negligible.

In the DMF group this was not evaluable because of the short follow-up time.

Adherence was lower in the group treated with DMF. This effect may be associated with worst dosage (BID) than teriflumomide (QD).

Monthly pharmaceutical care visits allowed us to assess the safety profile of new oral drugs for RRMS in actual clinical practice and intervene in enhancing adherence.

No conflict of interest.

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