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Dupilumab is currently the only treatment for eosinophilic esophagitis approved by the US Food and Drug Administration.
While dupilumab has been approved by the US Food and Drug Administration (FDA) since May for the treatment of eosinophilic esophagitis (EoE), there remain questions and understudied aspects of the treatment mainly centered on dosing.
A major reason there are questions regarding dosing is that although it is the only FDA approved treatment for EoE, the treatment is also prominently used to treat a number of other diseases, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, and prurigo nodularis.
That makes dosing more complicated as a patient could be prescribed dupilumab for more than 1 disease with different dosing schedules.
In an interview with HCPLive®, Evan S. Dellon, MD, MPH, FACG, Professor of Medicine and Adjunct Professor of Epidemiology, Center for Esophageal Diseases and Swallowing, University of North Carolina School of Medicine, said while the data on dupilumab has been positive, there remains a need to study the drug more in the future to address some of these questions.
“It’s really going to be based on the comorbidities,” Dellon said. “Since the approved dose for EoE is weekly, if EoE is 1 of the things you are going to be treating, you are probably going to need to do the weekly dosing, at least up front. I think that’s 1 of the areas where we need more data. We don't know if you can dose reduce this to every other week with EoE."
Dellon said there are also unanswered questions within the EoE population, mainly in the segment of patients that have long-standing EoE.
“I think that’s where doctors in the field are really trying to understand which patients to use it in,” Dellon said. “We have to balance the indication with what our clinical algorithms really are.”
Dellon was part of a recent study published in the New England Journal of Medicine showing 60% (n = 25) of patients met the primary endpoint of histologic remission who were treated with dupilumab in part A of the three-part, phase 3 trial, compared to 5% (n = 2) of the placebo group (difference, 55 percentage points; 95% CI, 40-71; P <0.001).
The results from part B show histologic remission occurred in 59% (n = 47) of the weekly dupilumab group, 60% (n = 49) of the biweekly dupilumab group, and 6% (n = 5) of the placebo group (difference between weekly dupilumab and placebo, 54 percentage points; 95% CI, 41-66; P <0.001; difference between dupilumab every 2 weeks and placebo, 56 percentage points; 95% CI, 43-69). At baseline, the mean DSQ scores were 33.6±12.41 in part A and 36.7±11.22 in part B.