Mepolizumab use has led to a significant and sustained reduction in oral corticosteroids (OCS) use in patients with severe eosinophilic asthma, Australian research indicates.
Observational data from 309 patients in the Australian Mepolizumab Registry shows that in the 48% of patients using maintenance OCS before starting the biologic, there was a gradual reduction in steroid use until about half were using OCS at 12 months.
Before mepolizumab initiation, 95.5% of patients used at least one short course burst of OCS in the previous year but that reduced to 50.2% at 12 months.
Overall OCS exposure (either maintenance or burst) dropped from 97.4% at baseline to 66.7%.
“Following mepolizumab commencement, the daily dose reduced from a median (IQR) of 10 (5.0, 12.5) mg/day at baseline to 2 (0, 7.0) mg/day at 12-month follow-up (p<0.001),” the study authors said.
The effect of biologic initiation on OCS use was observed as early as the first follow-up visit at three months.
The study, published in the Journal of Allergy and Clinical Immunology in Practice, also found that asthma symptoms were well controlled in patients who were OCS free after six months of mepolizumab therapy.
But it noted there was a conundrum in that patients first had to have high OCS use in order to be eligible for mepolizumab.
“Relaxing the criteria for access to mepolizumab in Australia with a lower total dose of OCS might help these patients,” the study authors wrote.
Reset oral steroid thresholds?
Senior investigator Professor Peter Gibson, from the Priority Research Centre for Healthy Lungs in Newcastle, said the real world registry data supported other evidence from RCTs that biologic use can achieve important steroid reductions.
“It agrees with the clinical trial data … [it] provides validation and allows people to be confident in the benefits of treatment for the people that they actually care for,” he told the limbic.
“What it highlights is this issue of oral steroid stewardship.”
“We know the benefit of acute courses of steroids – they are life saving for people with asthma. And what we are now learning about is the risk. And the risks are different in that they are cumulative and long term. The benefits are acute and short term.”
“Is it a false economy to be so restrictive in access to biologics? It is based on cost benefit analysis but when the biologics were registered we didn’t have good data on the costs of cumulative steroids toxicity.”
Professor Gibson said clinicians had to reset their threshold for what was acceptable oral steroid use.
“We need to lower our threshold for being comfortable with using oral steroids. If someone has one or two courses a year then that should be a flag to reevaluate what is going on with their asthma.”
First steps included optimising the patient’s self-management skills such as adherence and inhaler technique, and ruling out any inappropriate use of steroids for non-asthma conditions such as vocal cord dysfunction.
“If those issues are addressed and the person is still having problems then stepping up to a biologic is appropriate.”
Professor Gibson said a TSANZ position paper on OCS stewardship was in development.
Disclosures: The Australian Mepolizumab Registry is an investigator-initiated and managed study funded through the GlaxoSmithKline Investigator-Sponsored Studies program. Professor Gibson reported receiving grants and personal fees for lectures from GSK.