VIDEO: Mepolizumab for EoE does not yield ‘prominent symptom improvement’ after 6 months
Click Here to Manage Email Alerts
CHICAGO — In this Healio video, Evan S. Dellon, MD, MPH, explains that while mepolizumab outperformed placebo at 3 months, there were no additional symptom or endoscopic improvements at 6 months in patients with eosinophilic esophagitis.
“This study came about because of the need for additional treatments for EoE,” Dellon, professor of medicine and director of the Center for Esophageal Diseases and Swallowing at the University of North Carolina School of Medicine, said. “Second, the mechanism of this medication, which is blocking [interleukin 5], is one of the key factors that was thought to be involved in EoE pathogenesis. The medicine was studied a decade or so ago in a small trial in adults and in a larger trial in children.”
He added: “While there was a modest to moderate effect on results from biopsies and histologic response, the symptom data were not clear, but there were some clinical trial design elements that may have precluded this. We wanted to study this in more detail in an adult and adolescent population.”
In the first phase of the study, Dellon and colleagues enrolled 64 adolescent and adult patients with severe EoE to receive monthly mepolizumab 300 mg subcutaneous injections or placebo for 3 months, at which time researchers assessed for the primary outcome of change in dysphasia symptoms, measured by EoE Symptom Activity Index. Researchers also measured secondary histologic and endoscopic outcomes.
During the second phase, patients originally assigned to mepolizumab 300 mg continued the monthly dosing for an additional 3 months, and those on placebo received monthly mepolizumab 100 mg for 3 months.
According to Dellon, who presented results at Digestive Disease Week, there was a “mild” decrease in the symptom scores at 3 months in patients who received mepolizumab; however, scores were not significantly different in the placebo group. Additionally, there was a nearly 80% decrease in eosinophil counts with mepolizumab compared with an increase in eosinophil counts with placebo, and an approximately 40% histologic response rate compared with 3%, respectively.
Dellon noted 6-month outcomes showed patients who continued on mepolizumab “generally” preserved their responses, with similar results reported in placebo patients who began the lower dose of mepolizumab after the first 3 months. Mepolizumab was well-tolerated with no new safety signals.
“It remains to be seen if this medication will go on to be used in EoE more, where it should sit in the treatment algorithm or if it should be looked at for less severe patients,” Dellon said. “Of course, we need to do a little bit more work to understand why there was not a more prominent symptom improvement in this population.”
Reference:
- Dellon ES, et al. Abstract 463: Mepolizumab for treatment of adolescents and adults with eosinophilic esophagitis: A multicenter, randomized, double-blind, placebo-controlled clinical trial. Presented at: Digestive Disease Week; May 5-9, 2023; Chicago (hybrid meeting).
Collapse
Dellon ES, et al. Abstract 464: Impact of up to 6 months of mepolizumab treatment for adolescents and adults with eosinophilic esophagitis in the second phase of a multicenter, randomized, double-blind, placebo-controlled clinical trial. Presented at: Digestive Disease Week; May 5-9, 2023; Chicago (hybrid meeting).
Read more about
Click Here to Manage Email Alerts