A promising anti-inflammatory drug failed to improve symptoms of moderate to severe chronic obstructive pulmonary disease, or COPD, in a large, multi-center trial.
The results of the randomized, double-blind, placebo-controlled trial of infliximab were published in the first issue of the May American Journal of Respiratory and Critical Care Medicine, published by the American Thoracic Society.
According to an editorial commenting on the research, the failure of the infliximab to provide any therapeutic benefit in COPD patients was unexpected because the drug has proven effective in treating other inflammatory diseases, particularly rheumatoid arthritis and Crohn's disease.
COPD is the fourth-leading cause of death of men and women in the United States and the world. It is projected to become the third-leading cause of death, after heart disease and cancer, by 2015.
Stephen I. Rennard, M.D., of the University of Nebraska Medical Center in Omaha, led a team of researchers at 41 U.S. medical centers that enrolled 234 subjects in the study. Patients receiving infliximab were randomly selected to receive the drug in doses of 3 mg/kg or 5 mg/kg six times during a six-month period of time.
At the end of six months, there was no meaningful difference in the quality of life among those taking the drug and those taking the placebo as measured by the Chronic Respiratory Questionnaire (CRQ). The questionnaire, which was the primary endpoint, assesses health-related quality of life in patients with functionally limiting chronic lung disease.
There were also no differences among the three groups in secondary efficacy endpoints as measured by FEV1, 6-minute walk distance, the transition dyspnea index and the number of exacerbations requiring a doctor or hospital visit.
According to the authors, the results of the study were surprising for a number of reasons. Infliximab is an anti-tumor necrosis factor TNF-, and a number of studies have reported increased production of TNF in COPD patients. This increased production has been linked to weight loss, muscle weakness and muscle loss.