Treatment of rheumatoid arthritis patients with abatacept and methotrexate significantly improved health-related quality of life
Department of Quantitative Health Sciences
Adolescent; Adult; Aged; Aged, 80 and over; Antirheumatic Agents; Arthritis, Rheumatoid; Double-Blind Method; Female; Humans; Immunoconjugates; International Cooperation; Male; Methotrexate; Middle Aged; *Quality of Life; Severity of Illness Index; Sickness Impact Profile; Treatment Outcome
Biostatistics | Epidemiology | Health Services Research
OBJECTIVE: This study examined the effect of abatacept, a costimulation modulator, on the health-related quality of life (HRQOL) of patients with rheumatoid arthritis (RA).
METHODS: Three hundred thirty-nine patients with RA on a background of methotrexate (MTX), who participated in a multicenter, double-blind, placebo-controlled trial, were randomized to abatacept 2 mg/kg, abatacept 10 mg/kg, or placebo. HRQOL was assessed at pretreatment, and at 3, 6, and 12 months posttreatment using the SF-36 Health Survey (SF-36). Changes in SF-36 scores from baseline to 12 months were compared across treatment and placebo groups to examine HRQOL benefits of abatacept. A link between American College of Rheumatology improvement and changes in SF-36 scores was established to demonstrate the association between HRQOL outcomes and clinical response.
RESULTS: After 12 months of treatment, patients randomized to abatacept 10 mg/kg showed significantly better HRQOL outcomes overall versus patients randomized to placebo (MANOVA F = 4.71, p < 0.001) or to abatacept 2 mg/kg (MANOVA F = 1.97, p = 0.05). Differences in SF-36 change scores between abatacept 10 mg/kg and placebo groups reached statistical significance on all 8 domain scales, the 2 summary measures, and the SF-36 utility index (SF-6D). Differences in SF-36 change scores between abatacept 10 mg/kg and abatacept 2 mg/kg reached statistical significance on 5 of the 8 domain scales, the physical summary measure, and the SF-6D. Improvement in HRQOL was highly related to clinical response.
CONCLUSION: Abatacept 10 mg/kg plus MTX demonstrated a stronger HRQOL response than placebo plus MTX. The abatacept 2 mg/kg arm showed a very weak and transient response.
J Rheumatol. 2006 Apr;33(4):681-9. Epub 2006 Mar 1. Link to article on publisher's site
The Journal of rheumatology
Emery, Paul; Kosinski, Mark; Li, Tracy; Martin, Marie; Williams, G. Rhys; Becker, Jean-Claude; Blaisdell, Bonnie; Ware, John E. Jr.; Birbara, Charles; and Russell, Anthony S., "Treatment of rheumatoid arthritis patients with abatacept and methotrexate significantly improved health-related quality of life" (2006). Quantitative Health Sciences Publications and Presentations. 600.