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High levels of interleukin-6 in patients with rheumatoid arthritis are associated with greater improvements in health-related quality of life for sarilumab compared with adalimumab
- Source :
- Arthritis Research & Therapy, Arthritis Research & Therapy, Vol 22, Iss 1, Pp 1-9 (2020)
- Publication Year :
- 2020
- Publisher :
- BioMed Central, 2020.
-
Abstract
- Background Increased levels of cytokines, including interleukin-6 (IL-6), reflect inflammation and have been shown to be predictive of therapeutic responses, fatigue, pain, and depression in patients with rheumatoid arthritis (RA), but limited data exist on associations between IL-6 levels and health-related quality of life (HRQoL). This post hoc analysis of MONARCH phase III randomized controlled trial data evaluated the potential of baseline IL-6 levels to differentially predict HRQoL improvements with sarilumab, a fully human monoclonal antibody directed against both soluble and membrane-bound IL-6 receptor α (anti-IL-6Rα) versus adalimumab, a tumor necrosis factor α inhibitor, both approved for treatment of active RA. Methods Baseline serum IL-6 levels in 300/369 randomized patients were categorized into low (1.6–7.1 pg/mL), medium (7.2–39.5 pg/mL), and high (39.6–692.3 pg/mL) tertiles. HRQoL was measured at baseline and week (W)24 and W52 by Short Form 36 (SF-36) physical/mental component summary (PCS/MCS) and domain scores, Functional Assessment of Chronic Illness Therapy -fatigue, and duration of morning stiffness visual analog scale (AM-stiffness VAS). Linear regression of changes from baseline in HRQoL (IL-6 tertile, treatment, region as a stratification factor, and IL-6 tertile-by-treatment interaction as fixed effects) assessed predictivity of baseline IL-6 levels, with low tertile as reference. Pairwise comparisons of improvements between treatment groups were performed by tertile; least squares mean differences and 95% CIs were calculated. Similar analyses evaluated W24 patient-level response on minimum clinically important differences (MCID). Results At baseline, patients with high versus medium or low IL-6 levels (n = 100, respectively) reported worse (nominal p p p Conclusions Patients with high baseline IL-6 levels reported better improvements in PCS, physical functioning domain, and AM-stiffness scores with sarilumab versus adalimumab and safety consistent with IL-6R blockade. Trial registration NCT02332590. Registered on 5 January 2015
- Subjects :
- medicine.medical_specialty
lcsh:Diseases of the musculoskeletal system
Visual analogue scale
Health-related quality of life
Pain
Antibodies, Monoclonal, Humanized
Arthritis, Rheumatoid
Internal medicine
Post-hoc analysis
medicine
Adalimumab
Humans
Rheumatoid arthritis
Fatigue
business.industry
Interleukin-6
Minimal clinically important difference
Sarilumab
Odds ratio
medicine.disease
Rheumatology
Treatment Outcome
Antirheumatic Agents
Quality of Life
Physical function
Morning stiffness
lcsh:RC925-935
business
Biomarkers
medicine.drug
Research Article
Subjects
Details
- Language :
- English
- ISSN :
- 14786362, 14786354, and 02332590
- Volume :
- 22
- Database :
- OpenAIRE
- Journal :
- Arthritis Research & Therapy
- Accession number :
- edsair.doi.dedup.....1a38105c537ecaccd39565b0c993c814