Mitigation of Adverse Effects On Hispanics While Using Titration On Fingolimod

Background: Based on my clinical experience with Fingolimod, probability of developing adverse effects is variable from patient to patient. Fingolimod is a first oral medication approved for relapsing MS. Despite the good efficacy and safety, well documented in the clinical and post marketing  trials, still many  patients  refuse Fingolimod therapy due to the probability of developing adverse effects or because they already developed the adverse effects while using Fingolimod (drug discontinuation).

Objectives: Demonstrate that on the Hispanic population in a clinical practice setting, using titration of Fingolimod during the first month will mitigate the potential adverse effects without affecting drug efficacy.

Methods: Ongoing study has been conducted for the last six months. Data for the first three months of treatment will be collected and evaluated from two populations of relapsing MS patients. On the first month of treatment, Group 1 (control group) includes patients treated with the usual dose of 0.5mg per day, while Group 2 includes patients treated with 0.5mg every other day. Data will be collected by one or more of these methods, medical evaluation, questionnaire or telephone interview and evaluated for mild, moderate and severe adverse effects, on a monthly basis for a three months period. Additional data collected will include relapse rate and EDSS. Groups will be matched based on demographics, comorbid diseases (vitamin D deficiency, thyroid disease), MS duration, EDSS and treatment history.

Results:  Approximately 11% of patients discontinued medication due to side effects, adverse events and abnormal laboratories on Group 1. Current observations from ongoing study suggest that Group 2 presented much less adverse effect than Group 1 and has been able to keep the treatment.

Conclusions: This study will help us understand if titration during the first month of Fingolimod treatment will help to mitigate its adverse effects on the Hispanic population while maintaining drug efficacy.