First Therapeutic Approval for Eosinophilic Esophagitis
Abstract
:1. Introduction
1.1. Definition and Symptoms
1.2. Pathogenesis
1.3. Prevalence
1.4. Complications
1.5. Current Treatment Strategies
2. Dupilumab (Dupixent®, Regeneron)
3. Discussion of the Study
4. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Part A | Part B | |||||
---|---|---|---|---|---|---|
Dupilumab 300 mg QW c n = 42 | Placebo c n = 39 | Difference vs. Placebo (95% CI) c | Dupilumab 300 mg QW c n = 80 | Placebo c n = 79 | Difference vs. Placebo (95% CI) c | |
Primary Endpoints | ||||||
Proportion of subjects achieving histological remission (peak esophageal intraepithelial eosinophil count ≤6 eos/hpf a), n (%) | 25 (59.5) | 2 (5.1) | 57.0 (40.9, 73.1) | 47 (58.8) | 5 (6.3) | 53.5 (41.2, 65.8) |
Absolute change from baseline in DSQ score (0–84 b), LS mean (SE) | −21.9 (2.5) | −9.6 (2.8) | −12.3 (−19.1, −5.5) | −23.8 (1.9) | −13.9 (1.9) | −9.9 (−14.8, −5.0) |
Parts A and B | ||
---|---|---|
Adverse Reaction | Dupilumab 300 mg QW n = 122 n (%) | Placebo n = 117 n (%) |
Injection site reaction a | 46 (38%) | 39 (33%) |
Upper respiratory tract infection b | 22 (18%) | 12 (10%) |
Arthralgia | 3 (2%) | 1 (1%) |
Herpes viral infections c | 3 (2%) | 1 (1%) |
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Al-Horani, R.A.; Chiles, R. First Therapeutic Approval for Eosinophilic Esophagitis. Gastroenterol. Insights 2022, 13, 238-244. https://doi.org/10.3390/gastroent13030024
Al-Horani RA, Chiles R. First Therapeutic Approval for Eosinophilic Esophagitis. Gastroenterology Insights. 2022; 13(3):238-244. https://doi.org/10.3390/gastroent13030024
Chicago/Turabian StyleAl-Horani, Rami A., and Raquel Chiles. 2022. "First Therapeutic Approval for Eosinophilic Esophagitis" Gastroenterology Insights 13, no. 3: 238-244. https://doi.org/10.3390/gastroent13030024