Effects of Sarilumab on Rheumatoid Arthritis as Reported by Patients Using the Rheumatoid Arthritis Impact of Disease Scale

Autor: Toshio Kimura, Hubert van Hoogstraten, Sophie Guillonneau, Laure Gossec, Chieh-I Chen, E.K. Mangan, Clare Proudfoot, M. Reaney, Vibeke Strand
Přispěvatelé: Service de rhumatologie [CHU Pitié Salpêtrière] (GRC-08 EEMOIS), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Stanford School of Medicine [Stanford], Stanford Medicine, Stanford University-Stanford University
Rok vydání: 2019
Předmět:
Adult
Male
medicine.medical_specialty
Immunology
Disease
Antibodies
Monoclonal
Humanized
Placebo
Severity of Illness Index
Gastroenterology
Arthritis
Rheumatoid
03 medical and health sciences
0302 clinical medicine
Rheumatology
Internal medicine
Adalimumab
medicine
Humans
Immunology and Allergy
In patient
030212 general & internal medicine
RHEUMATOID ARTHRITIS
Aged
030203 arthritis & rheumatology
business.industry
Minimal clinically important difference
[SDV.IMM.IMM]Life Sciences [q-bio]/Immunology/Immunotherapy
Middle Aged
medicine.disease
DISEASE-MODIFYING ANTIRHEUMATIC DRUGS
RHEUMATOID ARTHRITIS IMPACT OF DISEASE SCALE
3. Good health
Sarilumab
Treatment Outcome
[SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system
Antirheumatic Agents
Rheumatoid arthritis
Drug Therapy
Combination
Female
[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie
business
Antirheumatic drugs
medicine.drug
Zdroj: Journal of Rheumatology
Journal of Rheumatology, Journal of Rheumatology Publishing Company Limited, 2019, 46 (10), pp.1259-1267. ⟨10.3899/jrheum.180904⟩
ISSN: 1499-2752
0315-162X
Popis: 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)
Databáze: OpenAIRE
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