Phase 3 Dupilumab Data Shows Improved Symptoms of Eosinophilic Esophagitis

New data from the second phase 3 trial on dupilumab for eosinophilic esophagitis (EoE) found that biologic significantly improved signs and symptoms of the disease at 24 weeks compared to placebo in patients 12 years and older.

The data was presented this weekend at the American Academy of Allergy, Asthma & Immunology Annual Meeting (AAAAI) 2022.

To date, dupilumab is the only biologic medicine to show positive, clinically meaningful phase 3 results in adults and adolescents with EoE. Currently, there are no approved treatments for the underlying drivers of the disease.

Over the past 2 decades, estimates have shown an increasing prevalence of EoE. Of the roughly 160,000 patients in the US who are currently being treated, however, approximately 48,000 have failed multiple treatments.

Typical treatments include proton pump inhibitors, topical steroids, and diet elimination, many of which are not sufficient for up to 30-40% of EoE patients.

In an interview with HCPLive, Evan Dellon, MD, MPH, University of Northern Carolina School of Medicine, spoke of how the newest data on dupilumab could aid in EoE management.

“When people aren't able to respond to the current options that we have for treatment, that's where a biologic very naturally fits,” he said. “And I think it fits the paradigm for dupilumab and other treatments, quite honestly, may fit in other allergic diseases too.”

In the recent phase 3 trial, which featured an independent cohort and was twice the size of the previous phase 3 trial, patients on dupilumab saw a 64% reduction in disease symptoms from baseline compared to 41% for placebo (p=0.0008) and experienced a 23.78 point improvement on the patient-reported Dysphagia Symptom Questionnaire compared to a 13.86 point improvement for placebo (p<0.0001).

Additionally, Nearly 10 times as many patients receiving Dupixent achieved histological disease remission (p<0.0001).

“In terms of the results, it was quite striking; the dupilumab group had a very high histologic treatment response, approximately 59% compared to placebo, which was about 6%,” Dellon said. “And these Part B data were almost identical to Part A . In Part A, it was about 60%, dupilumab response compared to 5% placebo. So, I think very nice to see that same consistent and very strong response.”

Additionally, a significant decrease in symptoms of dysphagia was observed in the dupilumab group.

Regarding the future of the biologic for EoE care, US and global regulatory filings are expected to take place in 2022, though Dellon added that investigators are waiting on more data including endoscopic severity.

“The safety was good in these trials, it's well tolerated; there were really no new types of safety signals that were seen in the program that hadn't been previously reported in the phase 2 data or in the other clinical experience with the medications,” Dellon said. “So I think we’re waiting to see how it looks longer term, and then starting to think about where it's may be able to be used.”

To hear more from Dr. Dellon on eosinophilic esophagitis and dupilumab, watch the video above.