Dupilumab safe, efficacious in EoE
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Compared with placebo, dupilumab was safe and improved eosinophilic esophagitis at 24 and 52 weeks, according to a presentation at UEG Week Virtual.
“Current treatment options [for EoE] lack specificity, present adherence challenges and may offer suboptimal long-term disease control,” Evan S. Dellon, MD, MPH, of the University of North Carolina School of Medicine at Chapel Hill, said. “Efforts to elucidate EoE pathophysiology have generated evidence that identifies type 2 inflammation as a central driver of disease progression. Dupilumab, a fully human monoclonal antibody, blocks the shared receptor unit for interleukin-4 and interleukin-13, key drivers of type 2 inflammation in EoE.”
In Part A of the phase 3 LIBERTY EoE TREET study, patients who were aged at least 12 years received either placebo or 300 mg of dupilumab weekly for 24 weeks. At the time of follow-up, researchers found dupilumab was safe and effective, with patients achieving peak esophageal intraepithelial eosinophil count no greater than 6 eosinophils per high-power field (eos/hpf) and absolute change in Dysphagia Symptom Questionnaire (DSQ) score from baseline, according to the poster.
For the study extension (part C), Dellon and colleagues prescribed dupilumab to all 77 participants — 40 from the treatment group (DPL/DPL) and 37 from the placebo group (PBO/DPL) — who completed part A. Participants took 300 mg of dupilumab weekly for an additional 28 weeks, making for 52 weeks overall.
According to research findings, 55.9% of DPL/DPL participants achieved a peak eosinophil count of less than 6 eos/hpf and 82.4% of participants achieved a peak of no more than 15 eos/hpf at the end of 52 weeks; 60% of PBO/DPL participants reached a peak eosinophil count of less than 6 eos/hpf and 70% of participants achieved a peak of no more than 15 eos/hpf. The average percent change in eosinophil count from baseline to 52 weeks was –88.6% in DPL/DPL and –83.7% in PBO/DPL.
Mean absolute and percent change in DSQ score was –23.4 and –75.9% in DPL/DPL participants and –21.7 and –65.9% in PBO/DPL patients from baseline to 52 weeks.
“Dupilumab also reduced and improved endoscopic findings, as indicated by significant reductions in [EoE] from baseline compared to placebo at week 24, indicating a significant improvement in endoscopic abnormalities,” Dellon said. “This was sustained at week 52.”
The most common adverse events with dupilumab in DPL/DPL and PBO/DPL patients were injection site reactions (10% and 21.6%, respectively) and injection site erythema (10% and 13.5%). Only one patient had a severe adverse event in part C, which was hospitalization due to shortness of breath and diaphoresis due to asthma and seasonal allergies.
“This phase 3 study met both co-primary endpoints and all key secondary endpoints,” Dellon said. “Dupilumab demonstrated clinically meaningful improvements in histologic, symptomatic and endoscopic aspects of EoE at week 24, which were sustained through week 52 in Part C. For patients who received placebo in Part A and switched to dupilumab in Part C, dupilumab demonstrated a similar efficacy to dupilumab-treated patients in Part A.”
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Dellon ES, et al. Abstract LB10. Presented at: UEG Week; Oct. 3-5, 2021 (virtual meeting).
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