Improvements in Patient-Reported Outcomes (PROs) with Teriflunomide: Results from the US Cohort of the Teri-PRO Phase 4 Study

Thursday, June 2, 2016
Exhibit Hall
Patricia K Coyle, MD , Stony Brook University, Stony Brook, NY
Chris LaGanke, MD , North Central Neurology Associates, Cullman, AL
Bhupendra Khatri, MD , The Regional MS Center, Center for Neurological Disorders, Wheaton Franciscan Health Care, Milwaukee, WI
Keith R Edwards, MD , Multiple Sclerosis Center of Northeastern New York, Latham, NY
Steve Cavalier, MD , Genzyme, a Sanofi company, Cambridge, MA
Pascal Rufi, MD , Genzyme, a Sanofi company, Chilly-Mazarin, France
Sandrine Brette, MSc , Lincoln, Boulogne-Billancourt, France
Miqun Robinson, MD, PhD , Sanofi, Bridgewater, NJ
Matt Mandel, MD , Genzyme, a Sanofi company, Cambridge, MA
Ralf Gold, MD , St. Josef-Hospital, Ruhr University Bochum, Bochum, Germany


Teriflunomide is a once-daily oral immunomodulator that has shown consistent efficacy in 2 phase 3 studies in patients with relapsing forms of MS (RMS) and has a well-characterized safety profile. The phase 4 Teri-PRO study (NCT01895335) examined efficacy, safety, and tolerability, and satisfaction with teriflunomide treatment using PROs, in patients with RMS.


To report treatment satisfaction, measured by the Treatment Satisfaction Questionnaire for Medication (TSQM; version 1.4), and safety outcomes up to Week 48 for US patients enrolled in Teri-PRO.


Teri-PRO is a prospective, single-arm, open-label study in patients with RMS receiving once-daily teriflunomide 7 mg or 14 mg for 48 weeks, administered according to local labeling, with a primary outcome measure of TSQM Global Satisfaction at Week 48 or end of treatment.


The US cohort included 545 patients with mean (SD) age 50.6 (10.5) years and mean (SD) time since first MS symptom of 14.7 (9.75) years.

At Week 48, teriflunomide was associated with comparable mean (SD) TSQM scores across all 4 domains vs Week 4. Mean (SD) scores for Week 4/Week 48 were: Global Satisfaction 72.1 (20.7), n=485/67.6 (29.6), n=446; Side Effects 88.4 (19.9), n=486/82.8 (25.9), n=445; Convenience 92.9 (11.4), n=487/90.7 (13.8), n=447; Effectiveness 65.7 (20.0), n=487/65.8 (24.7), n=447.

In patients who switched to teriflunomide from another disease-modifying therapy (DMT) within the prior 6 months (n=316), mean (SD) scores at baseline/Week 48 were: Global Satisfaction 52.2 (25.9), n=275/69.0 (29.3), n=263; Side Effects 68.4 (31.8), n=274/83.7 (25.9), n=264; Convenience 61.6 (23.5), n=276/90.9 (14.4), n=264; Effectiveness 56.4 (22.3), n=274/67.7 (24.1), n=264.

Adverse events (AEs) were reported in 79.4% of patients, with 11.2% discontinuing treatment due to AEs. AEs reported in ≥5% of patients were alopecia, diarrhea, nausea, urinary tract infection, headache, paresthesia, and fatigue.

Of deaths reported during treatment (n=3; MS relapse, pneumonia, arrhythmia) or after end of treatment (n=1; non-small cell lung cancer stage IV) none were treatment-related.


Teriflunomide is associated with high treatment satisfaction and should be considered as a first-line treatment. Patients switching to teriflunomide from other DMTs reported substantial increases in treatment satisfaction across all 4 TSQM domains. The safety and tolerability of teriflunomide for US patients in Teri-PRO was consistent with that seen in phase 2 and 3 studies.