TERIFLUNOMIDE IN CLINICAL PRACTICE: TERI-PRO STUDY DESIGN

IntroductionTeriflunomide is a once-daily oral immunomodulator approved for relapsing-remitting multiple sclerosis (RRMS). Here we report the design of the Teri-PRO study (NCT01895335) that is evaluating the use, benefits and safety of teriflunomide in routine clinical practice using patient-reported outcomes (PROs).MethodsTeri-PRO is a global, prospective, non-randomised, non-comparative, open-label trial, in which similar to 1000 European and North American adult patients with relapsing forms of MS receive teriflunomide for 48 weeks, with doses given according to local labelling. Primary endpoints are changes in PROs over the study period, including global treatment satisfaction (TSQM-II), quality of life (Multiple Sclerosis International Quality of life [MusiQoL]), and disease progression (Patient-Determined Disease Steps [PDDS] scale and the MS Performance Scale [MSPS]), using descriptive statistics for analyses. Secondary endpoints include change in annualised relapse rate. Safety analyses include adverse event and laboratory evaluations.ResultsThe PRO measures used in Teri-PRO will be discussed in more detail in the poster. Results will be reported after completion of the study.ConclusionsTeri-PRO will improve knowledge of the benefits of teriflunomide on treatment satisfaction, disability progression, QoL and safety in routine clinical practice, and provide outcomes from a patient perspective.