Patients with symptomatic moderate asthma who were treated with antitumor necrosis factor alpha, an anti-inflammatory monoclonal antibody, experienced significantly fewer disease exacerbations than did individuals taking a placebo.
This research appears in the first issue for October 2006 of the American Journal of Respiratory and Critical Care Medicine.
Trevor T. Hansel, MD, PhD, of the National Heart and Lung Institute at Royal Brompton Hospital in London, and 11 associates infused 14 patients with infliximab, a monoclonal antibody that binds and neutralizes tumor necrosis factor alpha (TNF?). Eighteen patients received placebo during the eight-week double-blind study.
During the study, 13 of the 18 patients on placebo (72%) experienced exacerbations, as compared to only four out of 14 patients (29%) on infliximab therapy.
All patients in the study cohort continued to use inhaled corticosteroids for their asthma. Study protocol required them to be symptomatic during a 2- to 4-week run-in period.
After the run-in phase, infusions of either infliximab or placebo were administered at weeks 0, 2 and 6.
“Treatment with infliximab reduced the number of moderate exacerbations in patients with asthma, as monitored by morning and evening use of an electronic spirometer incorporating a clinical diary,” said Hansel. “Although infliximab therapy did not show significant efficacy for the primary endpoint of monitoring peak expiratory flow (PEF), it did produce a significant decrease in the diurnal (during the day) variation in the PEF rate.”
With PEF monitoring, patients take as deep as a breath as possible and then exhale as forcefully as possible into the mouthpiece of the PEF meter for three tests. As a gauge for pulmonary function, it is especially useful in patients older than age 5 who have persistent moderate to severe asthma.
“None of the exacerbations we saw in our study warranted treatment with oral corticosteroids or hospitalization, so they cannot be considered to have been severe,” said Hansel.
The researchers also noted that there were no adverse events associated with using the monoclonal antibody for treatment.