• Laure Gossec, Vibeke Strand, Clare Proudfoot, Chieh-I Chen, Sophie Guillonneau, Toshio Kimura, Hubert van Hoogstraten, Erin Mangan, and Matthew Reaney.
• From the Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique (UMRS 1136), GRC-UPMC 08 (EEMOIS); Rheumatology Department, Hôpital Pitié Salpêtrière, AP-HP, Paris, France; Stanford University, Palo Alto, California, USA; Sanofi, Guildford, UK; Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA; Sanofi, Paris, France; Sanofi, Bridgewater, New Jersey, USA.
• J Rheumatol. 2019 Oct 1; 46 (10): 1259-1267.

ObjectiveWe evaluated the effect of sarilumab on patient-perceived impact of rheumatoid arthritis (RA) using the 7-domain RA Impact of Disease (RAID) scale.MethodsTwo phase III, randomized, controlled trials of sarilumab in patients with active, longstanding RA were analyzed: (1) sarilumab 150 mg and 200 mg every 2 weeks plus conventional synthetic disease-modifying antirheumatic drugs (+csDMARD) versus placebo + csDMARD [TARGET (NCT01709578)]; and (2) sarilumab 200 mg versus adalimumab (ADA) 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 endpoint.ResultsSarilumab 150 mg and 200 mg + csDMARD were nominally superior (p < 0.05) versus placebo + csDMARD and 200 mg sarilumab versus ADA 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 effects 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 ADA reported improvements ≥ MCID and PASS in total RAID scores at both assessments.ConclusionBased on the RAID, sarilumab + csDMARD or as monotherapy reduced the effect of RA on patients' lives to a greater extent than placebo + csDMARD or ADA monotherapy. (ClinicalTrials.gov: NCT01709578 and NCT02332590).

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