Effects of Sarilumab on Patient-Reported Impact of Rheumatoid Arthritis Using the Rheumatoid Arthritis Impact of Disease Scale
Abstract
Objective The impact of rheumatoid arthritis (RA) symptoms on patients’ lives is significant. This study evaluated the effect of sarilumab on patient-perceived impact of RA using the 7-domain RA Impact of Disease (RAID) scale.
Methods Two phase III, randomized, controlled trials of sarilumab in patients with active, long-standing RA were analyzed: sarilumab 150 mg and 200 mg twice-weekly plus conventional synthetic disease-modifying antirheumatic drugs (+csDMARDs) versus placebo+csDMARDs [TARGET (NCT01709578)]; sarilumab 200 mg versus adalimumab 40 mg monotherapy (MONARCH [NCT02332590]). Least squares mean (LSM) differences in RAID total score (range 0–10), and 7 key RA symptoms, including pain and fatigue (baseline to weeks 12 and 24), were compared. ‘Responders’ by RAID total score were defined by improvements from baseline ≥Minimal Clinically Important Difference (MCID), and ≥Patient Acceptable Symptom State (PASS) at end point.
Results Sarilumab 150 mg and 200 mg+csDMARDs were nominally superior (p<0.05) versus placebo+csDMARDs and 200 mg versus adalimumab 40 mg in LSM differences for RAID total score at weeks 12 (–0.93 and –1.13; –0.49, respectively) and 24 (–0.75 and –1.01; –0.78), and all impacts of RA (except functional impairment in MONARCH week 12). Effects were greater in physical domains (e.g., pain) than mental domains (e.g., emotional well-being). More patients receiving sarilumab versus placebo or adalimumab reported improvements ≥MCID and PASS in total RAID scores at both assessments.
Conclusion Based on the RAID, sarilumab+csDMARDs or as monotherapy reduced the impact of RA on patients’ lives to a greater extent than placebo+csDMARDs or adalimumab monotherapy.