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.