Half-Dose Etanercept Effective at 1 Year in RA

Alice Goodman

November 11, 2011

November 11, 2011 (Chicago, Illinois) — In patients with moderately active rheumatoid arthritis (RA) who had achieved low disease activity, half-dose etanercept was as effective as full-dose etanercept in maintaining clinical and functional benefits at 52 weeks, according to the results of PRESERVE, a randomized double-blind study presented here at the American College of Rheumatology (ACR) 2011 Annual Meeting as a late-breaking poster.

Lead author Josef Smolen, MD, from the Medical University of Vienna, Austria, said: "This is the first trial of adults with moderately active RA despite methotrexate treatment to evaluate both the induction of...low disease activity and clinical, functional, and radiographic outcomes with etanercept full-dose continuation, reduction, or elimination on a background of methotrexate."

Subjects who received full-dose or half-dose etanercept were significantly more likely to maintain clinical benefits for 52 weeks, after a 36-week induction of low disease activity, than those who recieved placebo. "We need more research on the longer-term implications of these observations at 52 weeks," Dr. Smolen explained.

The study involved 604 patients with moderately active RA (Disease Activity Score measured in 28 joints [DAS28], 3.2 to 5.1) who achieved low disease activity (DAS28 ≤ 3.2) or remission (DAS28 < 2.6) after receiving full-dose etanercept (50 mg) plus methotrexate for 36 weeks. Patients were then randomized to etanercept 50 mg once a week, etanercept 25 mg once a week, or placebo for 52 weeks. All patients were maintained on a stable dose of methotrexate during the 52-week period.

Overall, 497 patients completed the study. Both etanercept groups were superior to the placebo group. Low disease activity was maintained in 82.6% of the full-dose group and in 79.1% of the half-dose group, compared with 42.6% of the placebo group (P < .0001 vs either etanercept group). Significantly more patients had a DAS28 score below 2.6 at week 88 in the etanercept groups (66.7% for the full-dose and 60.2% for the half-dose group) than in the placebo group (29.4%) (P < .0001 vs either etanercept group).

A similar pattern was observed for other measures of disease activity and health, favoring both doses of etanercept over placebo.

There were no significant differences in safety in the 3 treatment groups. Serious adverse events were reported in 35 patients (5.8%), including 2 deaths (0.3%) in the full-dose group related to pulmonary embolism and septicemia.

"This fascinating study found that the 2 groups of patients with moderately active RA who took etanercept did better than those who had etanercept withdrawn, but patients on half-dose etanercept did as well as those on full-doses etanercept," stated Eric Ruderman, MD, from Northwestern University Feinberg School of Medicine in Chicago, Illinois.

"The company cannot use that finding because it is off-label, but doctors can tell their patients with moderately active RA that they can be maintained on half a dose of etanercept once they achieve low disease activity. This is one of the first studies to look at this, and it has huge cost implications. A course of full-dose etanercept costs about $26,000 per year," Dr. Ruderman pointed out.

Dr. Smolen reports receiving financial support from Pfizer. Dr. Ruderman reports receiving financial support from Abbott, Amgen, Bristol-Myers Squibb, Pfizer, Genentech, UCB, and CVS CareMark.

American College of Rheumatology (ACR) 2011 Annual Meeting: Abstract L1. Presented November 8, 2011.

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