Randomized clinical trial (RCT) of monoclonal antibodies for the treatment of EoE
| Monoclonal antibody | Target | Author | Design | Study population | Dose | Primary outcome |
|---|---|---|---|---|---|---|
| Dupilumab | IL-4Rα | Dellon et al. [18] | Placebo-controlled, phase 3 RCT | n 240 (adolescents and adults) | 300 mg s.c. every week or every 2 weeks or placebo | At week 24 histologic remission (≤ 6 eosinophils per HPF) and the change from baseline in the DSQ score |
| Dupilumab | IL-4Rα | Hirano et al. [19] | Placebo-controlled, phase 2 RCT | n 47 (adults) | 300 mg or placebo weekly | At week 10 change from baseline in SDI, PRO score; histologic features of EoE (peak esophageal intraepithelial eosinophil count and EoE histologic scores) |
| Dectrekumab (QAX576) | IL-13 | Rothenberg et al. [20] | Placebo-controlled, phase 2 RCT | n 23 (adults) | 6 mg/kg monthly or placebo | At week 12 responder rate for a greater than 75% decrease in peak eosinophil counts |
| Cendakimab (RPC4046) | IL-13 | Hirano et al. [21] | Placebo-controlled, phase 2 RCT | n 99 (adults) | 180 mg, 360 mg, or placebo weekly | At week 16 change in mean esophageal eosinophil count in the 5 HPFs |
| Mepolizumab | IL-5 | Strauman et al. [24] | Placebo-controlled, phase 2 RCT | n 11 (adults) | 750 mg × 2 or placebo weekly, followed by 2 more infusions of 1,500 mg of drug or placebo in lack of histological response | Reduce peak esophageal eosinophilia to < 5 eos/HPF as assessed by histology in adults with active EoE |
| Mepolizumab | IL-5 | Assa’ad et al. [25] | Phase 2 RCT | n 59 (children) | 3 infusions of 0.55, 2.5, or 10 mg/kg monthly | At week 12 proportion of patients with a peak esophageal intraepithelial eosinophil count of < 5 per HPF; safety, tolerability, pharmacokinetics |
| Reslizumab | IL-5 | Spergel et al. [26] | Placebo-controlled, phase 2 RCT | n 227 (children and adolescents) | 4 infusions of 1, 2, or 3 mg/kg monthly or placebo | At week 15 changes in peak esophageal eosinophil count and in the physician’s global assessment score |
| Omalizumab | IgE | Clayton et al. [29] | Placebo-controlled, phase 2 RCT | n 30 (adolescents and adults) | 0.016 mg/kg per IgE every 2–4 weeks | At week 12 decrease in esophageal eosinophil content |
| Benralizumab | IL5Rα | NCT04543409 | Placebo-controlled, phase 3 RCT | EoE | APFS s.c., 1 mL fill volume or placebo | Esophageal eosinophil count ≤ 6 eos/HPF; change from baseline on the DSQ |
s.c.: subcutaneous; SDI: straumann dysphagia instrument; PRO: patient-reported outcome; APFS: single accessorized prefilled syringe
