Is Eosinophil-Guided Therapy Safe for Patients With COPD?
Though its safety profile is not yet fully understood, eosinophil-guided therapy can reduce the duration of systemic corticosteroid exposure in patients admitted to the hospital with acute exacerbations of chronic obstructive pulmonary disease (COPD), according to a new trial.
The results of the randomized, open-label trial also showed that eosinophil-guided therapy was non-inferior compared with standard care for the number of days alive and out of hospital.
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To analyze the association between an algorithm based on blood eosinophil counts and systemic corticosteroid exposure in patients with COPD, the researchers studied data from the respiratory departments of 3 university-affiliated hospitals in Denmark.
The researchers enrolled participants within 24 hours of their hospital admission. To be eligible for enrollment, the participants had to have been aged 40 years or older, had to have known airflow limitation (defined as a post-bronchodilator FEV1/forced vital capacity [FVC] ratio of 0.70 or less), had to have had their COPD diagnosis verified by a specialist, and had to have been directed to begin systemic corticosteroids by the respiratory medicine physician on duty.
The participants received either eosinophil-guided therapy or standard therapy with systemic corticosteroids. On the first day, all participants received intravenous methylprednisolone, 80 mg.
Beginning on the second day, participants receiving eosinophil-guided therapy took an oral tablet of prednisolone, 37.5 mg, daily. This tablet was taken for a maximum of up to 4 days and only on days when the participants’ blood eosinophil count was at least 0.3 × 109 cells per L.
“If a patient was discharged during the treatment period, a treatment based on the last measured eosinophil count was prescribed for the remaining days within the 5-day period (last observation carried forward),” the study authors explained.
Among the standard care group, beginning on the second day, participants received daily tablets of prednisolone, 37.5 mg, for 4 days.
The researchers determined that participants in the eosinophil-guided group had a lower median duration of systemic corticosteroid therapy (2 days) compared with those in the control group (5 days).
There was also no difference in days alive and out of hospital within 14 days after recruitment between the eosinophil-guided group (mean 8.9 days) and the control group (mean 9.3 days).
The number of participants who experienced treatment failure at 30 days was also similar between the eosinophil-guided group (42) and control group (41).
While the researchers could not entirely exclude harm on some secondary outcome measures, they did determine that eosinophil-guided therapy was non-inferior (non-inferiority margin of 1 to 2 days) compared with standard care for the number of days alive and out of hospital.
“Larger studies will help to determine the full safety profile of this strategy and its role in the management of COPD exacerbations,” the researchers concluded.
Sivapalan P, Lapperre TS, Janner J, et al. Eosinophil-guided corticosteroid therapy in patients admitted to hospital with COPD exacerbation (CORTICO-COP): a multicentre, randomised, controlled, open-label, non-inferiority trial. Lancet Respir Med. 2019;7(8):699-709. doi:10.1016/S2213-2600(19)30176-6.