MedicalResearch.com Interview with:
Danny McBryan, MD
Vice president, Clinical Development & Medical Affairs, Respiratory
Boehringer Ingelheim Pharmaceuticals, Inc.
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. MvBryan: The new post-hoc analysis from the WISDOM study shows a routine blood test could help identify the small minority of patients with severe or very severe COPD who may benefit from the addition of inhaled corticosteroids (ICS). This post-hoc analysis was recently published online in The Lancet Respiratory Medicine.
For 80 percent of patients in the WISDOM study, the use of ICS on top of SPIRIVA HANDIHALER (a long-acting muscarinic antagonist – LAMA) and salmeterol (a long-acting beta-agonist – LABA) had no additional benefit in reducing the risk of exacerbations, compared to SPIRIVA HANDIHALER and the LABA without ICS.
The post-hoc analysis shows that these patients can be easily identified by measuring the level of white blood cells, called eosinophils. Patients with levels lower than 4 percent (300 cells/µL) were associated with a lack of response to ICS.
The WISDOM study evaluated stepwise withdrawal of inhaled corticosteroids (ICS) in severe to very severe COPD patients with a history of exacerbation. WISDOM was a 12-month, double-blind, parallel-group, active-controlled study in which all patients received triple therapy (tiotropium 18 μg once daily, salmeterol 50 μg twice daily and fluticasone 500 μg twice daily) for a six-week run-in period. Patients were randomized 1:1 to continue triple therapy or stepwise withdrawal of ICS over 12 weeks (dose reduction every six weeks).
The WISDOM data show that in patients with severe to very severe COPD, the risk of moderate/severe exacerbations during one year of follow-up was non-inferior between those patients who continued on inhaled corticosteroids and those where ICS therapy was withdrawn in a stepwise manner.
MedicalResearch.com: What should clinicians and patients take away from your report?
Dr. MvBryan: Historically, it has been difficult to determine what COPD patients should receive inhaled corticosteroids treatment. These findings suggest that it may be possible to more confidently identify those patients who might benefit from ICS treatment, helping to minimize exposure to the risk of long-term side effects of inhaled corticosteroids use.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Dr. MvBryan: These results further inform the current debate about the appropriate role of inhaled corticosteroids in the treatment of COPD.
Boehringer Ingelheim has an ongoing commitment to help healthcare providers and patients better understand how to optimally treat COPD. We look forward to additional studies on this topic to provide us with more information.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Blood eosinophil count and exacerbations in severe chronic obstructive pulmonary disease after withdrawal of inhaled corticosteroids: a post-hoc analysis of the WISDOM trial
Watz, Henrik et al.
The Lancet Respiratory Medicine , Volume 0 , Issue 0 ,
Published Online: 07 April 20
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