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Switch from Sulfasalazine to Etanercept Beneficial in Rheumatoid Arthritis Treatment: Presented at ACR

By Bruce Sylvester

NEW ORLEANS, LA -- October 30, 2002 -- Etanercept, used as monotherapy or in combination with sulfasalazine (SSZ), achieves significant improvement in the signs and symptoms of rheumatoid arthritis, report French researchers.

This research was presented here at the annual meeting of the American College of Rheumatology.

"Etanercept treatment produced a much better outcome for our patients in general than their use of sulfasalazine," said lead investigator Bernard Combe, M.D., Ph.D., researcher at the Lapeyronie Hospital in Montpelier, France. " Alone or with sulfasalazine, etanercept brought about rapid and significant improvements in all measure of disease activity and physical functioning. And we did not see increases in adverse events above that level reported with sulfasalazine."

The researchers enrolled 254 adult RA patients in the double-blind, randomized, 24-week study. All subjects who had used SSZ (2-3 g/day) and still met active disease criteria were randomized in a 2:2:1 ratio: Etanercept 25 mg twice weekly subcutaneously, (with SSZ discontinued at trial baseline, n=103), etanercept 25 mg twice weekly subcutaneously plus SSZ tablets (etanercept-plus-SSZ, n=101), or SSZ tablets only (unchanged regimen, n=50).

The primary endpoint was an ACR 20 response at 24 weeks.

Mean demographic data and disease activity were similar in the three groups at baseline. The mean number of tender and swollen joints ranged from 29 to 31 (tender) and 18 to 19 (swollen).

Thirty-three subjects left the study before endpoint, 9 patients taking etanercept, 7 taking etanercept+SSZ and 17 taking SSZ.

A significantly higher percentage of subjects using etanercept as monotherapy (74 percent) or in combination (74 percent) achieved an ACR 20 response at 24 weeks, compared to the SSZ group (28 percent).

ACR 50 and ACR 70 indices were significantly higher for etanercept subjects.

The investigators saw significant differences in all ACR components and did so generally by Week 2.

The investigators reported that adverse events (headache, nausea, asthenia, pruritus) were lower among etanercept subjects than with etanercept plus SSZ subjects.

The most frequent infections were upper respiratory, bronchitis, and flu syndrome, with no significant difference among the treatment groups. Two subjects in the etanercept group were briefly hospitalized for infections (foot infection in a diabetic patient and URI). The safety profile, including serious adverse events, was comparable to prior etanercept trial data.

"Etanercept therapy, either when substituted for SSZ or when added to SSZ, resulted in a comparable significant improvement in RA disease activity and was significantly better than SSZ alone. Etanercept alone was better tolerated than etanercept-plus-SSZ in terms of common non-infectious events. The safety of etanercept monotherapy was consistent with that observed in other RA studies of etanercept," the authors concluded.

"In selecting drug therapy for rheumatoid arthritis it is easy to lean toward sulfasalazine because of its lower cost," added Dr. Combe. "But this study shows us that the 'cost' of doing so may be higher than we want to think. We might miss the chance to help a patient make their choice based upon the knowledge of what a new biological agent can do in terms of effectively reducing the signs and symptoms of their disease, and improving their whole quality of life. They deserve the information and the choice."

This study was supported by a grant from Wyeth Research.

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