Etanercept does not impact maintenance of remission in patients with Wegener's granulomatosis, according to results from a multicenter, randomized, placebo-controlled trial.
“Our results underscore three points,” according to John H. Stone, M.D., of the Johns Hopkins Vasculitis Center, Baltimore. “Standard therapy fails to induce durable remissions in the majority of patients, etanercept does not enhance the effects of standard therapy, and even with the shorter courses of cyclophosphamide, now regarded as the standard of care, adverse events are common and frequently severe, with or without the addition of a specific tumor necrosis factor-? blockade.”
Dr. Stone and other members of the Wegener's Granulomatosis Etanercept Trial Research Group evaluated etanercept for maintenance of remission in 180 patients with Wegener's granulomatosis (N. Engl. J. Med. 2005;352:351-61). Of the total, 89 received 25 mg etanercept twice a week via subcutaneous injection, and 91 received placebo. Each patient received standard therapy that consisted of glucocorticoids plus cyclophosphamide or methotrexate.
During the mean 27-month follow-up period, there were no differences between the etanercept group and the controls in terms of sustained remission (70% vs. 75%, respectively), sustained periods of low-level disease activity (87% vs. 91%, respectively), or the time required to achieve those measures.
In addition, 118 flares occurred in the etanercept group, compared with 134 in the control group, a difference that was not statistically significant.