Grosshansdorf, Germany—For patients with severe to very severe chronic obstructive pulmonary disease (COPD) and a history of exacerbations, blood eosinophil counts at screening were related to the risk of worsening symptoms after complete withdrawal of inhaled corticosteroids (ICS), according to a new study.
The industry-sponsored study, published recently in The Lancet Respiratory Medicine, set out to determine if blood eosinophil counts might predict response to ICS in patients with chronic COPD with a history of exacerbations.
To determine that, a study team led by researchers from the German Center for Lung Research, used data from the WISDOM (Withdrawal of Inhaled Steroids During Optimized bronchodilator Management) trial to determine whether patients with COPD with higher blood eosinophil counts would be more likely to have exacerbations if ICS treatment was withdrawn.
In WISDOM, a 12-month, randomized, parallel-group trial, patients received 18 μg tiotropium, 100 μg salmeterol, and 1,000 μg fluticasone propionate daily for 6 weeks and were then randomly assigned electronically to receive either continued or reduced ICS over 12 weeks.
The post-hoc analysis, performed after complete ICS withdrawal from 3 to 12 months, compared rate of exacerbations and time to exacerbation outcomes based on differing levels of blood eosinophil at cutoff.
Results indicate that, of the 2,296 patients receiving treatment after ICS withdrawal, the moderate or severe exacerbation rate was higher in the ICS-withdrawal group versus the ICS-continuation group in patients with eosinophil counts—out of total white blood cell count—of 2% or greater, with a rate ratio of 1·22; 4% or greater, with a rate ratio of 1·63; and 5% or greater, with a rate ratio of 1·82.
“The increase in exacerbation rate became more pronounced as the eosinophil cutoff level rose, with significant treatment-by-subgroup interaction reached for 4% and 5% only,” study authors write. “Similar results were seen with eosinophil cutoffs of 300 cells per μL and 400 cells per μL, and mutually exclusive subgroups.”
Guidelines generally recommend the use of ICS-containing therapy only in COPD patients with severe-to-very severe lung-function impairment and/or at high risk of exacerbations, such as those studied in WISDOM. Long-term use of ICS treatments has been associated with serious side effects, such as pneumonia, osteoporosis, and diabetes onset and disease progression.
“Long acting bronchodilators are a mainstay therapy in COPD management, however in clinical practice, ICS is widely used across all COPD stages,” study investigator Peter Calverley, MD, professor of Pulmonary and Rehabilitation Medicine at the University of Liverpool, UK, said in a press release issued by Boehringer Ingelheim Pharmaceuticals, Inc., the study’s sponsor. “Previously, it has been difficult to determine the subset of patients who respond to ICS. These findings will help physicians more confidently identify which patients may benefit from ICS therapy, helping minimize exposure to the risk of long-term side effects of ICS use.”
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