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Once Weekly 50 mg Etanercept As Good As Twice Weekly 25 Mg In Rheumatoid Arthritis: Presented at EULAR

By Adrian Burton

LISBON, PORTUGAL -- June 20, 2003 -- Patients with rheumatoid arthritis (RA) who self-inject etanercept twice weekly need now do so once only - with double the dose, according to findings of an American study.

The results were presented at the Annual European Congress of Rheumatology here in Lisbon yesterday.

"The question was, can you give etanercept once a week at 50 mg and get the same effect as 25 mg twice a week?" explained Roy Fleischmann, Clinical Professor of Medicine, University of Texas Southwestern Medical School, Dallas, Texas. "What we found was that they are equivalent."

The news should help patients who find difficulty in administering themselves injections.

In this double-blind, placebo controlled trial, 420 patients with active RA were randomised into one of three groups: 53 received a placebo (for 8 weeks before receiving standard 25 mg etanercept treatment), 214 received etanercept 50 mg once a week, and 153 received the same drug in two weekly 25 mg injections. After 8 and 16 weeks, the severity of the patients' disease was measured using American College of Rheumatology (ARC) criteria, the non-inferiority of the drug regimens determined by comparing how many patients reached a target ARC 20 response.

Compared to 19% of the placebo group, 50% of the 50 mg group reached ACR 20 (P<0.001), while 49% of the standard 2x25 mg group achieved the same at 8 weeks. There was therefore no difference in the primary endpoint between the two dose regimens.

At 16 weeks, no statistical differences were seen between the continued improvement of patients (55% and 63% of the 50 mg and 2x25 mg reached ACR 20 by week 16). Neither were any differences seen in components of the ACR evaluation. "Of course, versus placebo they were significantly different," explained Dr. Fleischmann.

Adverse events were also comparable at both evaluation dates, with no statistical differences found between the two treatment groups for any of the normal side effects, including asthenia, diarrhoea, headache, injection site reaction, nausea, rash or upper respiratory tract infection.

"There are patients who would much rather inject once a week rather than twice a week," explained Dr. Fleischmann. "And now they can."

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