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Effects of Sarilumab on Patient-Reported Impact of Rheumatoid Arthritis Using the Rheumatoid Arthritis Impact of Disease Scale

Author

Gossec L1, Strand V1, Proudfoot C1, Chen CI1, Guillonneau S1, Kimura T1, van Hoogstraten H1, Mangan E1, Reaney M1. J Rheumatol. 2019 Mar 15. pii: jrheum.180904. doi: 10.3899/jrheum.180904. [Epub ahead of print]

Author Information

1 From the Sorbonne Université and Rheumatology Department, Hôpital; Stanford University; Novartis; Regeneron Pharmaceuticals, Inc and Sanofi. L. Gossec has acted as a consultant for Abbvie, BMS, Celgene, Janssen, Lilly, Novartis, MSD, Pfizer, Roche, Sanofi and UCB. V. Strand has acted as a consultant for AbbVie, Amgen, AstraZeneca, Biogen, BMS, Celgene, Celltrion, Consortium of Rheumatology Researchers of North America (CORRONA), Crescendo/Myriad Genetics, Genentech/Roche, GSK, Janssen, Eli Lilly, Novartis, Pfizer Inc., Regeneron Pharmaceuticals, Inc., Sandoz, Sanofi, and UCB. C. Proudfoot is a former employee of and current shareholder in Sanofi and current employee and shareholder of ViiV Healthcare/GlaxoSmithKline. C. Chen, T. Kimura, and E. Mangan are employees of and shareholders in Regeneron Pharmaceuticals, Inc. E. Mangan is also a shareholder in Pfizer. S. Guillonneau, H. van Hoogstraten, and M. Reaney are employees of and hold shares or options in Sanofi. Address correspondence to Matthew Reaney, Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK. E-mail: matthew.reaney@sanofi.com.

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.