Dupixent late-breaking pivotal data showing significant improvement in eosinophilic esophagitis signs and symptoms presented at ACG and UEG meetings- Sanofi.
Additional positive results were announced from Part A of a pivotal Phase III trial evaluating the investigational use of Dupixent (dupilumab) in patients 12 years and older with eosinophilic esophagitis (EoE). As previously reported, the trial met both of its co-primary and all key secondary endpoints. New late-breaking data showing additional improvements in disease severity and extent at the microscopic level, as well as normalization of gene expression pattern associated with type 2 inflammation, were presented at the virtual American College of Gastroenterology (ACG) Annual Scientific Meeting and the United European Gastroenterology (UEG) Week Virtual 2020. Previously announced results showed Dupixent improved symptomatic, structural and histologic measures of EoE. The use of Dupixent to treat EoE is investigational and has not been fully evaluated by any regulatory authority. Part A of the randomized, double-blind, placebo-controlled trial enrolled 81 patients aged 12 years and older with EoE, who were treated with Dupixent 300 mg weekly over a 24-week treatment period or placebo. New results presented at virtual ACG 2020 and UEG Week 2020 showed patients treated with Dupixent experienced : 1.Rapid improvement in ability and comfort of swallowing: patients reported significant improvement on the Dysphagia Symptom Questionnaire (DSQ) as early as 4 weeks and continued to improve through 24 weeks (p<0.05 and p><0.001, respectively). 2. reduced esophageal eosinophil count below the diagnostic disease threshold: 64% of patients treated with dupixent achieved><15 eosinophils high-power field (eos hpf) compared to 8% for placebo at 24 weeks (p><0.001). peak esophageal eosinophil count was reduced by 71% with dupixent compared to 3% with placebo from baseline (p><0.001). 3.reduced severity and extent of the disease at the microscopic level: the grade and stage scores that measure esophageal tissue changes associated with the disease were reduced by 0.761 and 0.753 with dupixent compared to a 0.001 and 0.012 reduction for placebo at 24 weeks; the eoe histology scoring system (eoe-hss) grade and stage scores measure changes in eight cellular and tissue features on four-point scales, respectively (p><0.001 for all values). 4. normalized gene expression in esophageal tissue: gene expression patterns associated with type 2 inflammation and eoe were reduced by 1.97-fold and 2.66-fold, compared to a 0.32-fold and 0.16-fold reduction with placebo, respectively, as measured by the normalized enrichment score (nes) at 24 weeks from baseline. the nes evaluated a panel of genes associated with type 2 inflammation or eoe (p><0.001 for all values). the changes observed with dupixent demonstrate a shift in gene expression pattern from one that resembles eoe disease to a pattern that resembles healthy controls. the trial demonstrated similar safety results to the well-established safety profile of dupixent in its approved indications. for the 24-week treatment period, overall rates of adverse events were 86% for dupixent and 82% for placebo. adverse events that were more commonly observed with dupixent included injection site reactions (n="15" for dupixent, n="12" for placebo) and upper respiratory tract infections (n="11" for dupixent, n="6" for placebo). there was one treatment discontinuation in the dupixent group due to joint pain. about the dupixent eosinophilic esophagitis trial : the phase iii, randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of dupixent in adolescents and adults with eosinophilic esophagitis. part a of the trial enrolled 81 patients (42 treated with dupixent and 39 with placebo) aged 12 years and older with eoe, as determined by histological and patient-reported measures. the co-primary endpoints assessed the change from baseline in the dsq, a patient-reported measure of difficulty swallowing, and the proportion of patients achieving peak esophageal intraepithelial eosinophil count of ?6 eos hpf, a measure of esophageal inflammation, at 24 weeks. key secondary endpoints of the trial assessed histopathologic measures of the severity and extent of tissue scarring in the esophagus, as measured by the eoe-hss grade and stage scores, and the proportion of patients achieving peak esophageal intraepithelial eosinophil count of><15 eos hpf at 24 weeks. other secondary endpoints of the trial assessed nes for the relative change from baseline to week 24 in the eoe diagnostic panel and type 2 inflammation transcriptome signatures. in total, 85% of these patients suffered from at least one concurrent atopic condition such as allergic rhinitis, food allergy and asthma. patients received weekly subcutaneous injections of dupixent 300 mg or placebo for the 24-week treatment period. the eoe trial is ongoing, with additional patients enrolling in part b as well as patients continuing in a 28-week extended active treatment period (part c) after completing either part a or part b. part b of the trial is evaluating an additional dupixent dosing regimen.></15></0.001></0.001></0.001).></0.001).></15></0.001,></0.05>