Teriflunomide in Routine Clinical Practice: Design of the Teri-PRO Study

Background:

Teriflunomide is a once-daily, oral, disease-modifying drug recently approved in the USA and Australia for relapsing multiple sclerosis (RMS) treatment. Teriflunomide 14mg showed consistent significant positive outcomes on annualized relapse rate (ARR) and disability progression in two placebo-controlled phase 3 trials: TEMSO (NCT00134563) and TOWER (NCT00751881). Patient-reported outcomes (PROs) provide clinical information to support the evaluation of MS therapies. In clinical trials, a significant positive effect on global treatment satisfaction (TSQM-II) and a trend toward improvement in quality of life (QoL) outcomes (EuroQoL, EQ-5D, SF-36) and fatigue (FIS) were observed with teriflunomide.

Objectives:

To report the design of the Teri-PRO study evaluating the use, benefits, and safety of teriflunomide in routine clinical practice using PROs.

Methods:

Teri-PRO is a prospective, non-randomized, non-comparative, open-label trial, in which ~1000 patients with RMS will receive teriflunomide 7 or 14mg once daily for 48 weeks. Patients must be ≥18 years, diagnosed with RMS, not previously exposed to natalizumab or leflunomide, and using reliable contraception. Primary endpoints are PRO changes over the course of study, including TSQM-II, QoL (MusiQoL), disease progression, and fatigue (MFIS), using descriptive statistics for analyses. Patients will self-report disease progression with the Patient-Determined Disease Steps (PDDS) and the MS Performance Scale (MSPS). PDDS is scored from 0 (normal) to 6 (confined to wheelchair); MSPS uses single questions to assess mobility, hand function, vision, fatigue, cognitive, bladder/bowel, sensory and spasticity symptoms. Each MSPS subscale is scored from 0 (normal) to 5 (total disability), except mobility (scored 0–6). Secondary endpoints include PRO changes after 4 and 24 weeks of teriflunomide treatment and change in ARR (at end of treatment vs 48 weeks prior to enrollment). Primary and secondary endpoints will be assessed at baseline and Weeks 4, 8, 12, 16, 20, 24, and 48. Safety analyses will include adverse events and laboratory evaluations.  

Results:

Results will be reported after completion of the study.

Conclusions:

Teri-PRO will provide valuable information on PROs for disability progression, treatment satisfaction, QoL, and safety in  patients with RMS receiving teriflunomide in routine clinical practice. Teri-PRO will improve clinical knowledge of the benefits of teriflunomide from a patient perspective.