Dupilumab, nuova possibilità terapeutica dell'esofagite eosinofila resistente al trattamento farmacologico: un trial di fase 3

Abstract

Dupilumab, a new therapeutic possibility for drug-resistant eosinophilic esophagitis: a phase 3 trial To date, therapy for eosinophilic esophagitis is based on proton pump inhibitors (PPIs), topical corticosteroids, elimination diets, and esophageal dilation in cases of stenosis. Only for topical corticosteroids are there high-grade evidence, and treatment choices are not codified, but tailored based on patient characteristics and clinical practice. Dupilumab, a human monoclonal antibody already approved for therapy in selected cases of diseases with type 2 inflammation (severe asthma, moderate-to-severe atopic dermatitis, chronic rhinosinusitis with nasal polyposis), was tested in this phase 3 study in patients aged ≥12 years with a diagnosis of eosinophilic esophagitis documented by endoscopic biopsy, at a dose of 300 mg 1 time per week or every 2 weeks, compared with placebo. The two coprimary outcomes (histologic remission and change in symptom score) at 24 weeks were achieved only for dupilumab administered 1 time per week, however, histologic remission was similar for both schemes: 59 and 60 percent of cases. On the basis of these data, although there was no comparison with currently used therapies, dupilumab was also approved in Europe for the treatment of eosinophilic esophagitis in adolescents and adults.