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DI-014 Efficacy and safety of fingolimod in patients with relapsing remitting multiple sclerosis
  1. FD Fernández-Ginés1,
  2. P Nieto-Guindo1,
  3. TB Rodríguez-Cuadros2,
  4. I Alférez-García1
  1. 1Hospital Torrecárdenas, Pharmacy, Almería, Spain
  2. 2Almería District, Family and Community Specialist, Almeria, Spain

Abstract

Background Fingolimod represents a new class of treatment for patients with relapsing remitting multiple sclerosis (RRMS) because it allows oral administration and it also has a mechanism of action that targets not only the immune system but also neural cells.

Purpose To evaluate the efficacy and adverse effect profile of RRMS patients treated with fingolimod.

Material and methods Retrospective observational study which included all patients aged >18 years with RRMS. Recruitment period: 12 months. Effectiveness was described based on the number of outbreaks during the year prior to treatment and 12 months after receiving the treatment, and also by a subjective score where the patient evaluated his/her current health condition in comparison with the previous year before starting fingolimod (5 item health condition: 1 (much better) to 5 (very much worse)). Safety was assessed in terms of significant adverse effects to fingolimod. Information was obtained across the dispense programme outpatient (Dominion) from where we collected data on: age, sex, diagnosis, treatment, dosage and duration of treatment. Subjects received a questionnaire to be completed at the pharmaceutical consultation at 12 months.

Results 21 subjects were recruited (n = 21), 71.4% women, mean age 47.3 (23–75) years. 19% of patients had >10 outbreaks during the year prior to the start of fingolimod, 9.5% had between 5 and 10 outbreaks and 42.9% had <5 outbreaks. 28.6% of patients had only one outbreak after a year of treatment with fingolimod, and none in the remaining number of patients. 19.1% of patients described feeling much better, 23.8% felt better, 38% felt the same, 14.3% felt worse and 4.8% felt much worse. From the beginning of therapy with fingolimod, we did not see any outbreaks in 16/21 patients (2 patients required hospitalisation), 52.4% had flu-like symptoms, 57% had headache and 33% had back pain. Bradycardia (9,5%) and increases in hepatic enzymes (4.7%) were the serious symptoms observed.

Conclusion To date, fingolimod has proved to be an effective treatment option (76.2% of patients without outbreaks) and safe (14.3% of patients had no significant adverse reactions). We need to highlight the fact that the subjective health of the patient in comparison with the previous year before starting fingolimod did not change.

References and/or Acknowledgements To my colleagues pharmacists and patients.

No conflict of interest.

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