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Treatment satisfaction in patients with rrms treated with teriflunomide in routine clinical practice: aubpro study design
  1. Steve Vucic1,
  2. Michael H Barnett2,
  3. Stefan Blum3,
  4. Neil Shuey4,
  5. Richard Worrell5,
  6. Richard Macdonell6
  1. 1University of Sydney, Sydney, NSW, Australia
  2. 2Brain and Mind Centre, University of Sydney, Sydney, NSW, Australia
  3. 3Princess Alexandra Hospital, Wooloongabba, QLD, Australia
  4. 4St Vincent’s Hospital, Melbourne, VIC, Australia
  5. 5Sanofi Genzyme, Macquarie Park, NSW, Australia
  6. 6Austin Health, Heidelberg, VIC, Australia

Abstract

Objectives Teriflunomide is a once-daily immunomodulator approved for the treatment of patients with relapsing-remitting MS (RRMS). Here, we describe the design of AubPRO, a prospective observational study to evaluate treatment satisfaction using patient-reported outcomes (PROs) in patients with RRMS treated with teriflunomide (AUBAGIO) in routine clinical practice in Australia.

Methods The AubPRO study will include ~150 adult patients with RRMS initiating treatment with teriflunomide according to local clinical practice. Study duration for each patient will be ~13 months. The primary endpoint is treatment satisfaction with teriflunomide, measured using the Treatment Satisfaction Questionnaire for Medication (TSQM, v1.4), which includes 4 domains: Effectiveness, Side Effects, Convenience, and Global Satisfaction. Secondary endpoints include changes in other PROs, including: the Multiple Sclerosis Performance Scale (MSPS), measuring disability according to subscales for Mobility, Hand Function, Vision, Fatigue, Cognitive Symptoms, Bladder/Bowel, Sensory Symptoms, and Spasticity Symptoms; the 12-item Multiple Sclerosis Walking Scale (MSWS-12); the Multiple Sclerosis Impact Scale (MSIS-29, v2), measuring the physical and psychological impact of MS; and the Health-Related Productivity Questionnaire (HRPQ, v2), evaluating work capacity and daily life activity. Clinical observations (relapses and treatment adherence) and safety will also be recorded. Patients will be assessed at 3 clinic visits: Baseline, Week 24, and Week 48. All PROs and adherence questionnaires will be administered by ‘MOD-MS’ (Medical Safety Systems, Sydney, Australia), a novel digital tool that enables automated platform-independent data collection with smartphones, tablets, or computers.

Results TSQM, MSPS, MSWS-12, MSIS-29, and HRPQ assessments used in AubPRO will be discussed in detail in the presentation. Results from AubPRO will be reported after study completion.

Conclusions AubPRO will evaluate patient-reported satisfaction with teriflunomide treatment in a real-world setting. PROs will extend clinical knowledge of the benefits of teriflunomide as a therapy for treatment of RRMS from the patient perspective.

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