Patient-reported outcomes in relapsing forms of MS: Real-world, global treatment experience with teriflunomide from the Teri-PRO study

Mult Scler Relat Disord. 2017 Oct;17:107-115. doi: 10.1016/j.msard.2017.07.006. Epub 2017 Jul 6.

Abstract

Background: Patient-reported outcomes (PROs) provide clinicians with further understanding of the impact of treatment on patients' daily lives. In addition, real-world studies, which employ broader inclusion criteria than randomized trials, may help to inform prescribing decisions when selecting a disease-modifying therapy (DMT) to treat relapsing forms of MS (RMS). We sought to use PROs to determine patient treatment satisfaction and other treatment outcomes, and report safety and tolerability associated with teriflunomide, in the global, phase 4 Teri-PRO study (NCT01895335).

Methods: Patients with RMS (N = 1000) received teriflunomide for 48 weeks per local labeling. The primary endpoint was Global Satisfaction with teriflunomide treatment measured by the Treatment Satisfaction Questionnaire for Medication (TSQM, V1.4). Secondary endpoints included TSQM scores at Week (W)48 vs baseline in patients switching to teriflunomide from other DMTs ('switchers'), additional PROs, and safety.

Results: Mean TSQM Global Satisfaction score at W48 was high (68.2). Switchers reported significant improvements across all four TSQM domains at W48 vs baseline (all p < 0.0001). Adverse events were consistent with teriflunomide clinical trials.

Conclusion: Patients reported high treatment satisfaction with teriflunomide, with switchers also reporting improved treatment satisfaction vs baseline. High treatment satisfaction in patients with RMS may lead to improved adherence, and hence treatment outcomes.

Keywords: Disease-modifying therapy; Multiple sclerosis; Patient-reported outcomes; Quality of life; Teriflunomide; Treatment satisfaction.

Publication types

  • Multicenter Study

MeSH terms

  • Crotonates / adverse effects
  • Crotonates / therapeutic use*
  • Disability Evaluation
  • Drug Substitution
  • Female
  • Humans
  • Hydroxybutyrates
  • Immunologic Factors / adverse effects
  • Immunologic Factors / therapeutic use*
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Multiple Sclerosis, Relapsing-Remitting / drug therapy*
  • Multiple Sclerosis, Relapsing-Remitting / psychology
  • Nitriles
  • Patient Reported Outcome Measures*
  • Patient Satisfaction
  • Prospective Studies
  • Quality of Life
  • Surveys and Questionnaires
  • Toluidines / adverse effects
  • Toluidines / therapeutic use*
  • Treatment Outcome

Substances

  • Crotonates
  • Hydroxybutyrates
  • Immunologic Factors
  • Nitriles
  • Toluidines
  • teriflunomide

Associated data

  • ClinicalTrials.gov/NCT01895335