Study finds long-term etanercept tx for psoriasis to be safe, effective

Austin, Texas - A recently published study suggests that psoriasis patients who have had extended exposure to high-dose etanercept (Enbrel, Immunex) respond positively and experience no increased infections or other serious adverse effects, MedPage Today reports.

The study, conducted by a University of Texas research team and published in the June issue of Archives of Dermatology, involved 618 adults with moderate to severe plaque psoriasis at 39 medical centers in the United States and Canada from May 23, 2003, through June 22, 2005. Of that total, 307 patients were randomized to placebo treatment for the first 12 weeks, while 311 were given twice-weekly subcutaneous injections of 50 mg of etanercept.

At week 13, all the remaining 591 patients were given etanercept. During the study’s open-label phase, assessments were done every 12 weeks. Patients given etanercept from the start took the drug for up to 96 weeks.

The study says that patients responded within two weeks to etanercept, with statistically significant differences between the treated and placebo groups at week 12 in the Psoriasis Area and Severity Index. At week 24, after 12 weeks of open-label etanercept treatment, the patients in the original placebo group were experiencing comparable clinical benefits to the etanercept patients.

After 96 weeks, 51.1 percent of the original etanercept-treated patients and 51.6 percent of those given placebo for the first 12 weeks had improvements from baseline of at least 75 percent.

Serious events, such as gangrene, viral meningitis, diverticulitis, infectious enteritis, gastroenteritis and localized staphylococcal infection, were each reported in one patient. However, viral meningitis was the only serious infection considered to be possibly related to the drug, the study notes.

“This study represents, to our knowledge, the longest continuous exposure of patients with psoriasis to 50 mg of etanercept twice weekly and provides further insights into the safety and efficacy of high-dose etanercept therapy for the management of moderate to severe psoriasis,” the study’s authors write.

The study was supported by Immunex, a wholly owned subsidiary of Amgen and the maker of etanercept.