1 results match your criteria: "Clinical Pharmacology and Safety Sciences (W.I.W.)[Affiliation]"
Eosinophil Depletion with Benralizumab for Eosinophilic Esophagitis.
N Engl J Med
June 2024
From the Divisions of Allergy and Immunology (M.E.R., J.M.C.) and Pathology and Laboratory Medicine (M.H.C.), Department of Pediatrics, and the Department of Pathology and Laboratory Medicine (M.H.C.), University of Cincinnati College of Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati; the Center for Esophageal Diseases and Swallowing, Division of Gastroenterology and Hepatology, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill (E.S.D.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, Amsterdam (A.J.B.); the Kenneth C. Griffin Esophageal Center, Division of Gastroenterology and Hepatology, Northwestern University Feinberg School of Medicine, Chicago (I.H.); the Division of Gastroenterology, Department of Internal Medicine, University of Utah, Salt Lake City (K.A.P.); Late-Stage Respiratory and Immunology, BioPharmaceuticals Research and Development, AstraZeneca, Cambridge, United Kingdom (L.B.); Late-Stage Respiratory and Immunology, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (H.F., H.G.); and Patient Centered Science, BioPharmaceuticals Medical Evidence (C.N.H.), Late-stage Respiratory and Immunology (M.K., C.J.D.) and Translational Science and Experimental Medicine, Early Respiratory and Immunology (C.M.), BioPharmaceuticals Research and Development, and Data Sciences and AI (D.S.) and Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences (W.I.W.), Research and Development, AstraZeneca, Gaithersburg, MD.
Background: Benralizumab is an eosinophil-depleting anti-interleukin-5 receptor α monoclonal antibody. The efficacy and safety of benralizumab in patients with eosinophilic esophagitis are unclear.
Methods: In a phase 3, multicenter, double-blind, randomized, placebo-controlled trial, we assigned patients 12 to 65 years of age with symptomatic and histologically active eosinophilic esophagitis in a 1:1 ratio to receive subcutaneous benralizumab (30 mg) or placebo every 4 weeks.