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Clinicians
could use dupilumab in future to treat eosinophilic esophagitis in patients
older than 12 years as it has received a breakthrough therapy designation by
the FDA.
On September 14, 2020, the USFDA has designated dupilumab, an interleukin-4 receptor alpha antagonist, the breakthrough therapy for the treatment of eosinophilic esophagitis in patients older than 12 years.
The results from Part A of a double-blind, phase III, placebo-controlled clinical trial were taken into consideration that investigated the impact of dupilumab in 81 participants aged ≥12 years with eosinophilic esophagitis. Participants were randomized to either dupilumab 300 mg weekly group or placebo group for 24 weeks.
Following were the co-primary outcome measures: (a) The percentage of individuals attaining peak oesophagal intraepithelial eosinophil count of less than or equal to six eosinophils per high-power field, and (b) the alteration in Dysphagia Questionnaire (DSQ) score, at 24 weeks.
Patients managed with dupilumab fulfilled both co-primary outcome parameters. Compared with placebo, an improvement in DSQ score and a considerable decline in their oesophagal eosinophilic count was noted.
Furthermore, dupilumab was linked with a substantial decline in abnormal endoscopic findings (secondary outcome parameter). Dupilumab's safety profile demonstrated similarity to that observed in prior studies for approved indications.
Currently, the researchers are recruiting more subjects in part B of the study to investigate the dosing regimens, as well as part C of the study, a 28-week extended management period.
MPR
Dupilumab Gets Breakthrough Therapy Status for Eosinophilic Esophagitis
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