Cytokine Signalling Forum


Sarilumab plus Methotrexate Improves Patient-reported Outcomes in Patients with Active Rheumatoid Arthritis and Inadequate Responses to Methotrexate: Results of a Phase III Trial

Strand V, Kosinski M, Chen C-I, Joseph G, Rendas-Baum R, Graham NMH, van Hoogstraten H, Bayliss M, Fan C, Huizinga T, Genovese MC. - Arthritis Res Ther 2016; 18:198. DOI.10.1186/s13075-016-9

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.

Access original article via Pubmed

Upload date: October 2016

Article image