麻豆传媒

PHOENIX -- Treatment with the interleukin-5 (IL-5) antagonist mepolizumab (Nucala) reduced the need to take oral corticosteroids by 75% in patients who had depended on the steroids to control symptoms of severe asthma, a researcher reported here.

Patients on a median 10 mg maintenance dose of oral corticosteroids at baseline reduced their intake to 2.5 mg by the end of the year-long study, reported Mark Liu, MD, of Johns Hopkins Medicine in Baltimore.

And those on a median 5 mg maintenance dose at the start of the trial reduced their use to 0.4 mg by study end, Liu said in a video presentation at the annual meeting of the .

In the group taking high doses of steroids, 36% were able to be weaned off the drugs by the end of the study, he reported. In the patients who started with lower doses, 49% were able to discontinue steroid use, and among the entire group, 43% were able to get off steroids.

Overall, Liu said, treatment with mepolizumab reduced clinically significant annual exacerbations from a mean of 4.3 in the 12 months prior to the trial to 1.5 with mepolizumab use, and the reduction from baseline was seen across all patient groups, including those with high and low steroid use and those who were not taking steroids at baseline to control symptoms.

Liu suggested that despite the limitation of being a single-arm study, the "clinically important real-world findings indicate that patients with severe asthma treated with mepolizumab can reduce their oral corticosteroid use, potentially reducing the risk of side effects associated with their use, while improving their asthma control."

The co-moderator of the session at which the study was presented, William Anderson, MD, of Children's Hospital Colorado in Aurora, called the study important -- "especially for our adult patients who are on chronic steroids, because the side effects of chronic steroids are so profound and oftentimes can lead to equal if not worse effects than the underlying asthma itself."

"The ability to use a biologic agent to decrease the dose of an oral steroid for our patients is certainly extraordinarily promising," Anderson told 麻豆传媒. "Our ultimate goal is to get patients off oral steroids."

For the real-world, observational, prospective, international study, called REALITI-A, Liu and colleagues enrolled adults diagnosed with asthma who had been given a new prescription for mepolizumab and had available relevant medical records for at least 12 months prior to entering the trial. The decision to use mepolizumab was made at the discretion of the patient's physician and was given at the standard 100 mg subcutaneous dose.

"Patients with severe asthma often rely on oral corticosteroids to control their symptoms despite a well-recognized risk of complications even at low daily doses," Liu explained. The goal of the study, he said, was to determine what happened when these patients were treated with mepolizumab -- when stratified by steroid use -- in a real-world setting. The researchers enrolled patients from December 2016 through October 2019.

The researchers recruited 822 patients into the study. The average age was 54 years, and about 63% were women. Participants had been diagnosed with asthma for a mean of 19.7 years.

About 39% of the patients in the study were using oral steroids to control their asthma symptoms, with 139 patients taking less than 10 mg a day and 159 taking 10 mg or more.

Adverse events occurred in about 10% of the patients in the study, but serious adverse events occurred in less than 1%, Liu noted.

Comment