Study Design of Transition: An Observational Study to Evaluate the Safety Profile of Fingolimod in Patients Switched from Natalizumab

Background: The safety and efficacy of fingolimod in relapsing multiple sclerosis (MS) has been successfully demonstrated in the phase III clinical program and various post-marketing studies. However, very limited longer-term data are available on the safety and disease activity in MS patients switched from natalizumab to fingolimod in routine medical practice.

Objectives: The TRANSITION study evaluates, over 2 years, the overall safety profile of fingolimod and the incidence of selected safety outcomes in patients switched from natalizumab to fingolimod in routine medical practice.

Methods: This is a two-year, prospective, observational, multi-center, single-cohort, global study in up to 1500 patients with relapsing MS, previously treated with natalizumab and switched to fingolimod within 12 months prior to study entry or currently transitioning to fingolimod. Specific safety events will be monitored during the study, including opportunistic infections such as progressive multifocal leukoencephalopathy (PML), cardiac and vascular events, macular edema, liver events, malignancies and atypical MS relapses.  MS disease activity using EDSS score and number of recorded relapses will be documented. The effect of switch from natalizumab to fingolimod on health-related quality of life will be explored as part of an optional sub-study using the Multiple Sclerosis Impact Scale (MSIS-29), Treatment Satisfaction Questionnaire for Medication (TSQM-9) and a questionnaire to assess medication preference. Adherence of patients to fingolimod treatment will be assessed based on treatment discontinuation, overall study retention and compliance data.

Results: Study design will be presented at the congress. First descriptive summary of the study data will be compiled when approximately 500 patients complete 6 months follow-up and thereafter on a yearly basis.

Conclusions: TRANSITION is the first large prospective observational study that aims to describe safety and disease activity in MS patients treated with fingolimod after natalizumab discontinuation in routine medical practice, over 2 years.