Sarilumab plus Methotrexate Improves Patient-reported Outcomes in Patients with Active Rheumatoid Arthritis and Inadequate Responses to Methotrexate: Results of a Phase III Trial
Evidence is presented that treatment with sarilumab improves patient-reported outcomes (PROs). These improvements complement the clinical efficacy previously reported for sarilumab.
Data were analysed from the 52-week Phase 3 MOBILITY randomised controlled trial in adult patients with active RA and previous inadequate response to MTX. Patients received subcutaneous placebo or sarilumab 150 mg or 200 mg every 2 weeks in combination with MTX, for 52 weeks.
PROs assessed were: Patient Global Assessment of Arthritis (PtGA), Pain, HAQ-DI, HRQOL (by assessing the individual Short-Form [SF]-36 domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health) and fatigue.
Improvements in PtGA, Pain, HAQ-DI and fatigue were greater with both doses of sarilumab than placebo. These were reported as early as Week 2 and were maintained to Week 52. Improvements greater than normative values for SF-36 scores and fatigue were also significant with sarilumab versus placebo indicating that treatment improved health status and fatigue to levels similar to individuals without RA.