Dupilumab in Adults and Adolescents with Eosinophilic Esophagitis
| Autor: | Evan S. Dellon, Marc E. Rothenberg, Margaret H. Collins, Ikuo Hirano, Mirna Chehade, Albert J. Bredenoord, Alfredo J. Lucendo, Jonathan M. Spergel, Seema Aceves, Xian Sun, Matthew P. Kosloski, Mohamed A. Kamal, Jennifer D. Hamilton, Bethany Beazley, Eilish McCann, Kiran Patel, Leda P. Mannent, Elizabeth Laws, Bolanle Akinlade, Nikhil Amin, Wei Keat Lim, Matthew F. Wipperman, Marcella Ruddy, Naimish Patel, David R. Weinreich, George D. Yancopoulos, Brad Shumel, Jennifer Maloney, Angeliki Giannelou, Arsalan Shabbir |
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| Přispěvatelé: | Gastroenterology and Hepatology, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism |
| Rok vydání: | 2022 |
| Předmět: |
Adult
Allergy Adolescent Gastroenterology General Injections Subcutaneous Gastroenterology Infant Newborn Inflammatory Disease General Medicine Eosinophilic Esophagitis Antibodies Monoclonal Humanized Pediatrics Allergy/Immunology General Allergy/Immunology Young Adult Treatment Outcome Adolescent Medicine Double-Blind Method Humans Pediatrics General Child Deglutition Disorders |
| Zdroj: | The New England journal of medicine, 387(25), 2317-2330. Massachussetts Medical Society |
| ISSN: | 1533-4406 0028-4793 |
| Popis: | Background Dupilumab, a fully human monoclonal antibody, blocks interleukin-4 and interleukin-13 signaling, which have key roles in eosinophilic esophagitis. Methods We conducted a three-part, phase 3 trial in which patients 12 years of age or older underwent randomization in a 1:1 ratio to receive subcutaneous dupilumab at a weekly dose of 300 mg or placebo (Part A) or in a 1:1:1 ratio to receive 300 mg of dupilumab either weekly or every 2 weeks or weekly placebo (Part B) up to week 24. Eligible patients who completed Part A or Part B continued the trial in Part C, in which those who completed Part A received dupilumab at a weekly dose of 300 mg up to week 52 (the Part A-C group); Part C that included the eligible patients from Part B is ongoing. The two primary end points at week 24 were histologic remission (≤6 eosinophils per high-power field) and the change from baseline in the Dysphagia Symptom Questionnaire (DSQ) score (range, 0 to 84, with higher values indicating more frequent or more severe dysphagia). Results In Part A, histologic remission occurred in 25 of 42 patients (60%) who received weekly dupilumab and in 2 of 39 patients (5%) who received placebo (difference, 55 percentage points; 95% confidence interval [CI], 40 to 71; P |
| Databáze: | OpenAIRE |
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