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Etanercept provides sustained efficacy, improved patient-reported outcomes in AS

Wednesday, December 12 2007 | Comments
Evidence Grade 0 What's This?
Treatment of ankylosing spondylitis with etanercept provides sustained clinical efficacy and improvements in patient-reported outcomes throughout a 4-year period, with no new safety concerns, study data indicate.

Researchers conducted a double-blind trial in which 84 patients with active AS were randomized to receive subcutaneous etanercept 25 mg twice weekly or placebo for 12 weeks, followed by a 96-week, open-label extension study. Subsequently, 59 of the 81 patients who participated in the extension study (32 originally randomized to etanercept and 27 to placebo) continued to receive etanercept 25 mg twice weekly for an additional 104 weeks, for a total of 200 weeks of exposure for the patients who were initially randomized to receive placebo and 212 weeks of exposure for those who were initially randomized to receive etanercept.

A total of 48 patients completed the second phase of the open-label extension study. By the end of the study period, 44 of these patients (75%) had achieved a 20% improvement based on Assessment in AS criteria (ASAS 20), 38 (64%) had achieved an ASAS 40 response, 18 (31%) had achieved an ASAS 5/6 response, and 38 (64%) had achieved a 50% improvement in Bath AS Disease Activity Index scores.

During the study period, 2 patients experienced myocardial infarction; no other serious adverse events or serious infections occurred in more than 1 patient. No serious adverse events were related to hepatic function, and no cases of opportunistic infection, tuberculosis, or demyelinating disease were reported, according to the authors.

Eleven of 18 patients with a history of inflammatory eye disease had no flares of their ocular disease during the study period, and no withdrawals were attributed to inflammatory eye disease.

"In this population of [patients with AS], etanercept maintained improvements in clinical efficacy and patient-reported outcomes for up to 212 weeks of continuous treatment," the authors concluded. "No new safety signals were reported during weeks 108 to 212 of etanercept therapy in this ongoing open-label extension study. Etanercept was well-tolerated ...." (Dijkmans BAC, et al. Poster 1161.)

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