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Adalimumab Plus Methotrexate May Improve the Health-Related Quality of Life for Patients with Rheumatoid Arthritis

Treatment with adalimumab, a human monoclonal antibody against tumour necrosis factor, plus methotrexate appears to improve the health-related quality of life for patients with rheumatoid arthritis (RA), new research suggests.

The autoimmune disease RA has a negative impact upon patients' health-related quality of life (HRQoL) because of the hallmark joint inflammation and erosive damage of articular cartilage and bone. Clinical trials have shown that a combination therapy of adalimumab plus methotrexate (MTX) is safe and significantly improves clinical disease response. However, the effect of adalimumab plus methotrexate on HRQoL had not been studied.

George Torrance, PhD, with Innovus Research, Burlington, Ontario, Canada, and colleagues analysed the data from 2 randomised, double-blind, placebo-controlled clinical trials of adalimumab plus MTX to extract information about this treatment's effect on HRQoL.

The first study, ARMADA, is a 24-week trial of 271 patients with RA who had active disease while on MTX. The second study, DE019, is a 52-week trial of 619 patients with RA. Only data from the placebo or adalimumab 40 mg every other week (eow) groups were analysed. At various time points during each study, patients were asked to fill out the most recent version of the well-established Health Utilities Index (HUI13), which measures vision, hearing, speech, ambulation, dexterity, emotion, cognition and pain.

HUI13 attribute scores over the time points were converted into a health utility curve. Area under the curve analysis was used to determine HRQoL changes for each patient, with the units of measure being quality-adjusted life years (QALYs).

Mean overall HUI3 scores at baseline were 0.38 for ARMADA and 0.44 for DE019 (trial-adjusted population norm HUI3 scores = 0.88). Patients treated with adalimumab 40 mg eow had improved HU13 scores as compared with the placebo group (0.22 vs. 0.04 in ARMADA and 0.21 vs. 0.07 in DE019). When HRQoL changes were calculated, the adalimumab treatment produced 0.145 QALYs gained per year in ARMADA and 0.104 QALYs gained per year in DE019 trials (P < .0001 for both).

"These results provide strong evidence that adalimumab, at the approved dose of 40 mg eow, plus methotrexate, achieves clinically important and statistically significant improvements in health utility," conclude Dr. Torrance and colleagues.

Rheumatology 2004 March 23;[epub ahead of print]. "Improvement in health utility among patients with rheumatoid arthritis treated with adalimumab (a human anti-TNF monoclonal antibody) plus methotrexate"

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