Background and Importance Fingolimod is used when the disease remains active despite treatment with at least one other disease-modifying therapy, or is severe and getting worse rapidly. It had the benefit of being taken by mouth while most other drugs are given by injection.
Aim and Objectives To analyse the use of fingolimod treatment and analyse the causes of fingolimod´s treatment discontinuation.
Material and Methods Retrospective descriptive study was performed in an area reference hospital. All patients treated with fingolimod from its inclusion in the hospital's pharmacotherapeutic guide in August 2012 to the present were included. Data collected: age, sex, previous treatment received, reason for prescription, date of start and end of treatment, the reason for suspension and clinical data (basal, final or current EDSS). We used Excel to analyse the data.
Results A total of 61 patients were included, one person was excluded for receiving only one dose, 39(65%) were women, with a media age of 42 ± 11years. All patients were their heart activity closely monitored after the first dose. 7(10%) of patients used fingolimod as first line, whose prescription reason was: four for rapid and aggressive evolution and three due to positive JC antibody. 53(90%) of patients had used other disease-modifying therapies before, 23(43.4%) glatiramer acetate, 14(26.4) interferon beta-1a, 4(6.5%) dimethyl fumarate, 4(6.5%) teriflunomide, 1(1.8%) interferón beta-1b and 7(13.2%) started fingolimod after failure to natalizumab. Median EDSS was 1 in naïve patients and 1.5 in pretreated patients.
Median time to discontinuation was 42.3[49.8] months. 32 patients (53.3%) discontinued treatment for different reasons. Side effects was the main cause 17(53.1%), followed by inefficacy 10(31.2%), for both reasons 2(6.2%) and 2(6.2%) unknow. Lymphopenia represented the most prevalent of the adverse events (47.3%), followed by cefalea(21%), liver enzyme levels(21%) and other like arterial hypertension, atrioventricular block and infections. Median EDSS increased one point both in those who discontinued treatment due to inefficacy and adverse effects.
Conclusion and Relevance Therapeutic success is not assured, as it is a drug with a high prevalence of adverse effects, which makes it necessary to withdraw treatment. Is essential detecting the symptoms and signs of toxicity for avoid unwanted effects, it is possible by frequent visits to the hospital pharmacy.
Conflict of Interest No conflict of interest
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