Humira plus MTX improves quality of life

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Rheumawire

June 4, 2004

Adalimumab plus MTX improves quality of life

Burlington, ON - Adalimumab (HumiraTM, Abbot Laboratories) plus

methotrexate (MTX) substantially improves health-related quality of life

(QOL) in rheumatoid arthritis (RA) patients, according to new research

published in the June 2004 issue of Rheumatology [1].

Researchers compared health-related QOL data from 2 randomized,

controlled trials in the US and Canada of RA patients treated with

adalimumab plus MTX or placebo plus MTX. The Health Utilities Index Mark

3 (HUI3) was administered in both studies at baseline, at the end of the

study, and twice during the course of the study. The health utility data

collected were secondary end points from ARMADA, a 4-arm, 24-week study

of 271 RA patients with active disease taking MTX, and DE019, a 3-arm,

52-week trial of 619 RA patients. Only data from patients randomized to

placebo or adalimumab were analyzed.

First and foremost, these trials evaluated the efficacy and safety of

adalimumab. The HUI is only 1 measure of overall health-related QOL. It

comprises a health classification system, questionnaires, and a scoring

formula that produces the utility score. The score is based on the

conventional interval score where 0.0 is death and 1.0 is the equivalent

of perfect health.

In the new study, patients' HUI3 scores were compared with population

norm scores and change was defined as end-of-study score minus the

baseline score. Specifically, utility gained throughout the study was

measured by the area under the utility curve and expressed as

quality-adjusted life years (QALYs). In addition, statistical testing

adjusted for confounders; the Dunnett test accounted for multiple

comparisons.

At baseline, RA patients' HUI3 scores ranged between 0.38 and 0.44,

compared with population norms of 0.88. HUI3 mean changes from baseline

scores for adalimumab-treated patients were 0.22 and 0.21 in both ARMADA

and DE019, whereas placebo patients' changes were 0.04 and 0.07, the

study showed.

The rates of QALYs gained per year in the treatment group compared with

the placebo group were 0.145 in the ARMADA trial and 0.104 in the DE019

trial.

" The quality-of-life gain that we saw in this study was really quite

large and larger then we typically see in studies that use utility

measures, " lead researcher Dr W Torrance (McMaster University,

Hamilton, ON) tells rheumawire.

" The take-home message is that, in terms of the health utility index as

a measure of quality of life, this is quite a substantial improvement, "

he says.

" In chronic diseases that are non-life-threatening such as RA, quality

of life is the important outcome to measure, and improving quality of

life is what you are trying to achieve, " he says.

HUI measure is a big consideration for funders, he says. " The bottom

line to payers is that this is quite a substantial improvement in QALYs,

so it is much more suitable for funding vs a small improvement, " he

says.

Mann

Source

1. Torrance GW, Tugwell P, Amorosi S, Chartash E, Sengupta N.

Improvement in health utility among patients with rheumatoid arthritis

treated with adalimumab (a human anti-TNF monoclonal antibody) plus

methotrexate. Rheumatology (Oxford) 2004 Jun; 43(6):712-8.

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org