By Mark Cowen, Senior medwireNews Reporter
Results from a randomized, double-blind, controlled trial suggest that the tumor necrosis factor α antagonist etanercept is no more effective than standard therapy with prednisone for the treatment of acute exacerbations in patients with chronic obstructive pulmonary disease (COPD).
The team also found that patients with serum eosinophil concentrations of more than 2% at the time of exacerbation had fewer treatment failures if treated with prednisone versus etanercept.
"Based on the results of this study, a second large clinical trial of etanercept in unselected patients with COPD exacerbation is probably not warranted although further trials in patients who do not have serum eosinophilia could be of benefit," the authors comment in Thorax.
Shawn Aaron (University of Ottawa, Ontario, Canada) and team studied 81 patients with acute COPD exacerbations who were randomly assigned to receive daily oral prednisone 40 mg for 10 days or subcutaneous etanercept 50 mg given at randomization and 1 week later.
Patients in both groups also received levofloxacin for 10 days plus inhaled bronchodilators.
The researchers found that there was no significant difference between the etanercept and prednisone groups regarding the primary endpoint of mean change from baseline in forced expiratory volume in 1 second (FEV1) after 14 days, at 15.2% and 20.1%, respectively.
There were also no significant differences between the etanercept and prednisone groups regarding the secondary endpoints of change from baseline in FEV1 at 7, 30 or 90 days, or the proportion of patients who experienced a treatment failure by 90 days, at 40% and 32%, respectively. Time to treatment failure was also not significantly different between the two groups.
In addition, both groups showed similar improvements in dyspnea and disease-specific quality of life at 14 and 90 days.
However, in a subgroup of 36 patients with serum eosinophil concentrations above 2%, only 22% (n=4) of patients treated with prednisone experienced treatment failure compared with 50% (n=9) of those treated with etanercept.
Aaron et al conclude: "Etanercept failed to demonstrate evidence of improved clinical efficacy compared with standard treatment with prednisone for any of the lung function or clinical endpoints evaluated during this trial."
They add: "Improvements, while not statistically different between the two treatment groups, tended to favour the prednisone-treated patients."
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