PMID- 30877216 OWN - NLM STAT- MEDLINE DCOM- 20201118 LR - 20201118 IS - 1499-2752 (Electronic) IS - 0315-162X (Linking) VI - 46 IP - 10 DP - 2019 Oct TI - Effects of Sarilumab on Rheumatoid Arthritis as Reported by Patients Using the Rheumatoid Arthritis Impact of Disease Scale. PG - 1259-1267 LID - 10.3899/jrheum.180904 [doi] AB - OBJECTIVE: We evaluated the effect of sarilumab on patient-perceived impact of rheumatoid arthritis (RA) using the 7-domain RA Impact of Disease (RAID) scale. METHODS: Two 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. RESULTS: Sarilumab 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. CONCLUSION: Based 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). FAU - Gossec, Laure AU - Gossec L AUID- ORCID: 0000-0002-4528-310X AD - From the Sorbonne Universite, Institut Pierre Louis d'Epidemiologie et de Sante Publique (UMRS 1136), GRC-UPMC 08 (EEMOIS); Rheumatology Department, Hopital Pitie Salpetriere, 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. AD - L. Gossec, MD, PhD, Sorbonne Universite and Rheumatology Department, Hopital Pitie Salpetriere, Institut Pierre Louis d'Epidemiologie et de Sante Publique (UMRS 1136), GRC-UPMC 08 (EEMOIS); V. Strand, MD, Stanford University; C. Proudfoot, PhD, Novartis; C.I. Chen, MPH, Regeneron Pharmaceuticals Inc.; S. Guillonneau, MSc, Sanofi; T. Kimura, MSc, Regeneron Pharmaceuticals Inc.; H. van Hoogstraten, MD/PhD, Sanofi; E. Mangan, PhD, Regeneron Pharmaceuticals Inc.; M. Reaney, MSc, formerly of Sanofi. FAU - Strand, Vibeke AU - Strand V AUID- ORCID: 0000-0003-4978-4072 AD - From the Sorbonne Universite, Institut Pierre Louis d'Epidemiologie et de Sante Publique (UMRS 1136), GRC-UPMC 08 (EEMOIS); Rheumatology Department, Hopital Pitie Salpetriere, 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. AD - L. Gossec, MD, PhD, Sorbonne Universite and Rheumatology Department, Hopital Pitie Salpetriere, Institut Pierre Louis d'Epidemiologie et de Sante Publique (UMRS 1136), GRC-UPMC 08 (EEMOIS); V. Strand, MD, Stanford University; C. Proudfoot, PhD, Novartis; C.I. Chen, MPH, Regeneron Pharmaceuticals Inc.; S. Guillonneau, MSc, Sanofi; T. Kimura, MSc, Regeneron Pharmaceuticals Inc.; H. van Hoogstraten, MD/PhD, Sanofi; E. Mangan, PhD, Regeneron Pharmaceuticals Inc.; M. Reaney, MSc, formerly of Sanofi. FAU - Proudfoot, Clare AU - Proudfoot C AD - From the Sorbonne Universite, Institut Pierre Louis d'Epidemiologie et de Sante Publique (UMRS 1136), GRC-UPMC 08 (EEMOIS); Rheumatology Department, Hopital Pitie Salpetriere, 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. AD - L. Gossec, MD, PhD, Sorbonne Universite and Rheumatology Department, Hopital Pitie Salpetriere, Institut Pierre Louis d'Epidemiologie et de Sante Publique (UMRS 1136), GRC-UPMC 08 (EEMOIS); V. Strand, MD, Stanford University; C. Proudfoot, PhD, Novartis; C.I. Chen, MPH, Regeneron Pharmaceuticals Inc.; S. Guillonneau, MSc, Sanofi; T. Kimura, MSc, Regeneron Pharmaceuticals Inc.; H. van Hoogstraten, MD/PhD, Sanofi; E. Mangan, PhD, Regeneron Pharmaceuticals Inc.; M. Reaney, MSc, formerly of Sanofi. FAU - Chen, Chieh-I AU - Chen CI AD - From the Sorbonne Universite, Institut Pierre Louis d'Epidemiologie et de Sante Publique (UMRS 1136), GRC-UPMC 08 (EEMOIS); Rheumatology Department, Hopital Pitie Salpetriere, 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. AD - L. Gossec, MD, PhD, Sorbonne Universite and Rheumatology Department, Hopital Pitie Salpetriere, Institut Pierre Louis d'Epidemiologie et de Sante Publique (UMRS 1136), GRC-UPMC 08 (EEMOIS); V. Strand, MD, Stanford University; C. Proudfoot, PhD, Novartis; C.I. Chen, MPH, Regeneron Pharmaceuticals Inc.; S. Guillonneau, MSc, Sanofi; T. Kimura, MSc, Regeneron Pharmaceuticals Inc.; H. van Hoogstraten, MD/PhD, Sanofi; E. Mangan, PhD, Regeneron Pharmaceuticals Inc.; M. Reaney, MSc, formerly of Sanofi. FAU - Guillonneau, Sophie AU - Guillonneau S AUID- ORCID: 0000-0001-9455-9793 AD - From the Sorbonne Universite, Institut Pierre Louis d'Epidemiologie et de Sante Publique (UMRS 1136), GRC-UPMC 08 (EEMOIS); Rheumatology Department, Hopital Pitie Salpetriere, 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. AD - L. Gossec, MD, PhD, Sorbonne Universite and Rheumatology Department, Hopital Pitie Salpetriere, Institut Pierre Louis d'Epidemiologie et de Sante Publique (UMRS 1136), GRC-UPMC 08 (EEMOIS); V. Strand, MD, Stanford University; C. Proudfoot, PhD, Novartis; C.I. Chen, MPH, Regeneron Pharmaceuticals Inc.; S. Guillonneau, MSc, Sanofi; T. Kimura, MSc, Regeneron Pharmaceuticals Inc.; H. van Hoogstraten, MD/PhD, Sanofi; E. Mangan, PhD, Regeneron Pharmaceuticals Inc.; M. Reaney, MSc, formerly of Sanofi. FAU - Kimura, Toshio AU - Kimura T AD - From the Sorbonne Universite, Institut Pierre Louis d'Epidemiologie et de Sante Publique (UMRS 1136), GRC-UPMC 08 (EEMOIS); Rheumatology Department, Hopital Pitie Salpetriere, 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. AD - L. Gossec, MD, PhD, Sorbonne Universite and Rheumatology Department, Hopital Pitie Salpetriere, Institut Pierre Louis d'Epidemiologie et de Sante Publique (UMRS 1136), GRC-UPMC 08 (EEMOIS); V. Strand, MD, Stanford University; C. Proudfoot, PhD, Novartis; C.I. Chen, MPH, Regeneron Pharmaceuticals Inc.; S. Guillonneau, MSc, Sanofi; T. Kimura, MSc, Regeneron Pharmaceuticals Inc.; H. van Hoogstraten, MD/PhD, Sanofi; E. Mangan, PhD, Regeneron Pharmaceuticals Inc.; M. Reaney, MSc, formerly of Sanofi. FAU - van Hoogstraten, Hubert AU - van Hoogstraten H AD - From the Sorbonne Universite, Institut Pierre Louis d'Epidemiologie et de Sante Publique (UMRS 1136), GRC-UPMC 08 (EEMOIS); Rheumatology Department, Hopital Pitie Salpetriere, 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. AD - L. Gossec, MD, PhD, Sorbonne Universite and Rheumatology Department, Hopital Pitie Salpetriere, Institut Pierre Louis d'Epidemiologie et de Sante Publique (UMRS 1136), GRC-UPMC 08 (EEMOIS); V. Strand, MD, Stanford University; C. Proudfoot, PhD, Novartis; C.I. Chen, MPH, Regeneron Pharmaceuticals Inc.; S. Guillonneau, MSc, Sanofi; T. Kimura, MSc, Regeneron Pharmaceuticals Inc.; H. van Hoogstraten, MD/PhD, Sanofi; E. Mangan, PhD, Regeneron Pharmaceuticals Inc.; M. Reaney, MSc, formerly of Sanofi. FAU - Mangan, Erin AU - Mangan E AD - From the Sorbonne Universite, Institut Pierre Louis d'Epidemiologie et de Sante Publique (UMRS 1136), GRC-UPMC 08 (EEMOIS); Rheumatology Department, Hopital Pitie Salpetriere, 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. AD - L. Gossec, MD, PhD, Sorbonne Universite and Rheumatology Department, Hopital Pitie Salpetriere, Institut Pierre Louis d'Epidemiologie et de Sante Publique (UMRS 1136), GRC-UPMC 08 (EEMOIS); V. Strand, MD, Stanford University; C. Proudfoot, PhD, Novartis; C.I. Chen, MPH, Regeneron Pharmaceuticals Inc.; S. Guillonneau, MSc, Sanofi; T. Kimura, MSc, Regeneron Pharmaceuticals Inc.; H. van Hoogstraten, MD/PhD, Sanofi; E. Mangan, PhD, Regeneron Pharmaceuticals Inc.; M. Reaney, MSc, formerly of Sanofi. FAU - Reaney, Matthew AU - Reaney M AD - From the Sorbonne Universite, Institut Pierre Louis d'Epidemiologie et de Sante Publique (UMRS 1136), GRC-UPMC 08 (EEMOIS); Rheumatology Department, Hopital Pitie Salpetriere, 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. matthew.reaney@iqvia.com. AD - L. Gossec, MD, PhD, Sorbonne Universite and Rheumatology Department, Hopital Pitie Salpetriere, Institut Pierre Louis d'Epidemiologie et de Sante Publique (UMRS 1136), GRC-UPMC 08 (EEMOIS); V. Strand, MD, Stanford University; C. Proudfoot, PhD, Novartis; C.I. Chen, MPH, Regeneron Pharmaceuticals Inc.; S. Guillonneau, MSc, Sanofi; T. Kimura, MSc, Regeneron Pharmaceuticals Inc.; H. van Hoogstraten, MD/PhD, Sanofi; E. Mangan, PhD, Regeneron Pharmaceuticals Inc.; M. Reaney, MSc, formerly of Sanofi. matthew.reaney@iqvia.com. LA - eng SI - ClinicalTrials.gov/NCT01709578 SI - ClinicalTrials.gov/NCT02332590 PT - Clinical Trial, Phase III PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20190315 PL - Canada TA - J Rheumatol JT - The Journal of rheumatology JID - 7501984 RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (Antirheumatic Agents) RN - FYS6T7F842 (Adalimumab) RN - NU90V55F8I (sarilumab) SB - IM MH - Adalimumab/administration & dosage/adverse effects/*therapeutic use MH - Adult MH - Aged MH - Antibodies, Monoclonal, Humanized/administration & dosage/adverse effects/*therapeutic use MH - Antirheumatic Agents/administration & dosage/adverse effects/*therapeutic use MH - Arthritis, Rheumatoid/*drug therapy MH - Drug Therapy, Combination MH - Female MH - Humans MH - Male MH - Middle Aged MH - Severity of Illness Index MH - Treatment Outcome OTO - NOTNLM OT - DISEASE-MODIFYING ANTIRHEUMATIC DRUGS OT - RHEUMATOID ARTHRITIS OT - RHEUMATOID ARTHRITIS IMPACT OF DISEASE SCALE EDAT- 2019/03/17 06:00 MHDA- 2020/11/20 06:00 CRDT- 2019/03/17 06:00 PHST- 2019/02/06 00:00 [accepted] PHST- 2019/03/17 06:00 [pubmed] PHST- 2020/11/20 06:00 [medline] PHST- 2019/03/17 06:00 [entrez] AID - jrheum.180904 [pii] AID - 10.3899/jrheum.180904 [doi] PST - ppublish SO - J Rheumatol. 2019 Oct;46(10):1259-1267. doi: 10.3899/jrheum.180904. Epub 2019 Mar 15.