Background Multiple sclerosis is a chronic demyelinating CNS disease. Oral drugs have recently been approved for relapsing-remitting multiple sclerosis (RRMS).
Purpose To analyse the use and safety profile of dimethylfumarate (DMF) and teriflunomide (TRF) in RRMS.
Material and methods A descriptive retrospective observational study of patients treated with DMF or TRF from January to 15 October 2015.
Variables: average age, sex, previous treatment, reason for changing treatment to oral treatment and average duration of treatment with DMF/TRF. In patients with previous therapies, the reason for switching was stratified as: (a) safety, caused by adverse effects (AE) to interferon beta (IFNβ)/glatiramer acetate (GA); and (b) efficacy, relapse within 6 months prior to the beginning of DMF/TRF. Analysis of the safety profile: percentage of patients with one or more AE associated with DMF/TRF.
Results 27 (18.1%) patients of 149 treated for MS in our outpatients pharmaceutical care unit initiated oral medication. 9 were excluded for lack of safety data. Overall, 4 patients had no prior treatment, and the rest had received the following: 41.1% IFNβ-1a, 21% IFNβ-1b and GA 15.8%. The switch to TRF/DMF occurred in 63% for safety reasons.
61.1% (11/18) started treatment with TRF, 40.7 ± 8.9 years, 85.7% women. 3 patients had no previous treatment, and in the remaining 38.5% had received IFNβ-1a, 27.3% IFNβ-1b and 18.2% GA. Switching to TRF for safety reasons occurred in 90.9%. Duration of treatment was 23.5 ± 9.2 weeks with TRF. 36.4% (4/11) of patients had an AE, the most frequent being diarrhoea (27.3%).
7 patients began with DMF, 34.3 ± 9.8 years, 75% women. 2 patients had not been treated previously and the rest had been treated with: 42.9% IFNβ-1a, 14.3% IFNβ-1b and 14.3% GA. 66.7% of the changes in DMF were for safety reasons. Average duration of treatment was 23.8 ± 2.7 weeks. 57.1% (4/7) had an AE, the most common being gastrointestinal disorders (57.1%); 2 patients required dose reduction.
Conclusion A high percentage of patients had received prior parenteral treatment. In fact, adverse reactions were the most frequent reason for changing to TRF/DMF.
According to our study, patients who began treatment with oral TRF had a slightly better safety profile compared with patients who started with DMF.
References and/or Acknowledgements Thanks to Julia Becerra Ramirez for the translation of the abstract.
No conflict of interest.
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