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New Research - April 2009Tumor necrosis factor-alpha, a player or not?Tumor necrosis factor-alpha has been thought to play a role in the production of asthma, especially in patients with severe steroid-dependent disease. Small trials of tumor necrosis alpha inhibition with infliximab and etanercept have reported mixed, but they overall are somewhat favorable effects in patients with a range of asthma severity. Recently two articles, one in an animal model (1), and the other in a human trial (2), looked to further investigate the role of TNF-alpha in asthma. In the animal model (1), it was found that TNF-alpha was required for the development of airway hyperreactivity after ozone exposure in mice. The experiment with human asthmatics (2) involved the use of golimumab, a fully human monoclonal antibody to TNF-alpha that is similar to infliximab. The object of the study was to assess the efficacy of golimumab in a population of patients with severe persistent asthma. Three hundred nine patients with uncontrolled asthma despite high dose inhaled corticosteroids and long-acting beta-agonists were evaluated. Golimumab in several doses was compared to placebo over a 52-week period. There were two co-primary endpoints. These were change from baseline through week 24 in pre-bronchodilator, percent-predicted FEV1 and the number of severe asthma exacerbations through week 24. There was no significant difference between golimumab and placebo treated patients for either co-primary endpoint. An unfavorable "risk-benefit profile" led to early discontinuation of study-agent administration after week 24 database lock. The authors concluded, "Overall, treatment with golimumab did not demonstrate a favorable risk-benefit profile in this study population of patients." Reference
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