The efficacy and safety of DUPIXENT were evaluated for up to 24 weeks
- Two randomized, double-blind, parallel-group, placebo-controlled, 24-week treatment periods
- Enrolled adult and pediatric (12-17 yrs) subjects, weighing at least 40 kg, with EoE
Eligible subjects had ≥15 intraepithelial EOS/HPF following a treatment course of a PPI either prior to or during the screening period and symptoms of dysphagia as measured by the Dysphagia Symptom Questionnaire (DSQ).
Study design
Part A
24-Week Placebo-Controlled Treatment Period
24-Week Placebo-Controlled Treatment Period
Part B
24-Week Placebo-Controlled Treatment Period
24-Week Placebo-Controlled Treatment Period
Demographics and baseline characteristics were similar across parts A and B1-3
| Part A | Part B | |||
|---|---|---|---|---|
| DUPIXENT (n=42) |
Placebo (n=39) |
DUPIXENT (n=80) |
Placebo (n=79) |
|
| Mean age (range), years | 34 (13-61) | 29 (13-62) | 29 (12-66) | 28 (12-57) |
| Male, % | 67 | 54 | 63 | 73 |
| White, % | 98 | 95 | 89 | 91 |
| Prior esophageal dilation(s), % | 43 | 44 | 33 | 42 |
| PPI use at randomization, n(%) | 28 (67%) | 27 (69%) | 58 (73%) | 59 (75%) |
| Prior swallowed TCS use at randomization, n(%) | 29 (69%) | 31 (80%) | 55 (69%) | 56 (71%) |
| DSQ scorea (0-84), mean (SD) | 32.2 (12.7) | 35.1 (12.1) | 38.4 (10.7) | 36.1 (10.6) |
| Peak esophageal EOS count of 3 regions, mean (SD) | 82.6 (41.0) | 96.5 (54.7) | 89.2 (46.7) | 84.3 (41.2) |
| Mean esophageal EOS count of 3 regions, mean (SD) | 58.7 (33.8) | 70.3 (40.9) | – | – |
| EREFS total scorea (0-18), mean (SD) | 6.5 (3.2) | 6.0 (2.4) | 6.8 (3.0) | 7.2 (3.3) |
| Part A | - |
|---|---|
| DUPIXENT (n=42) |
34 (13-61) |
| Placebo (n=39) |
29 (13-62) |
| DUPIXENT (n=42) |
67 |
| Placebo (n=39) |
54 |
| DUPIXENT (n=42) |
98 |
| Placebo (n=39) |
95 |
| DUPIXENT (n=42) |
43 |
| Placebo (n=39) |
44 |
| DUPIXENT (n=42) |
28 (67%) |
| Placebo (n=39) |
27 (69%) |
| DUPIXENT (n=42) |
29 (69%) |
| Placebo (n=39) |
31 (80%) |
| DUPIXENT (n=42) |
32.2 (12.7) |
| Placebo (n=39) |
35.1 (12.1) |
| DUPIXENT (n=42) |
82.6 (41.0) |
| Placebo (n=39) |
96.5 (54.7) |
| DUPIXENT (n=42) |
58.7 (33.8) |
| Placebo (n=39) |
70.3 (40.9) |
| DUPIXENT (n=42) |
6.5 (3.2) |
| Placebo (n=39) |
6.0 (2.4) |
| Part B | - |
|---|---|
| DUPIXENT (n=80) |
29 (12-66) |
| Placebo (n=79) |
28 (12-57) |
| DUPIXENT (n=80) |
63 |
| Placebo (n=79) |
73 |
| DUPIXENT (n=80) |
89 |
| Placebo (n=79) |
91 |
| DUPIXENT (n=80) |
33 |
| Placebo (n=79) |
42 |
| DUPIXENT (n=80) |
58 (73%) |
| Placebo (n=79) |
59 (75%) |
| DUPIXENT (n=80) |
55 (69%) |
| Placebo (n=79) |
56 (71%) |
| DUPIXENT (n=80) |
38.4 (10.7) |
| Placebo (n=79) |
36.1 (10.6) |
| DUPIXENT (n=80) |
89.2 (46.7) |
| Placebo (n=79) |
84.3 (41.2) |
| DUPIXENT (n=80) |
– |
| Placebo (n=79) |
– |
| DUPIXENT (n=80) |
6.8 (3.0) |
| Placebo (n=79) |
7.2 (3.3) |
a Higher scores indicate greater disease severity.
EOS/HPF, eosinophils per high-power field; EREFS, endoscopic reference score; PPI, proton pump inhibitor; QW, once weekly; TCS, topical corticosteroids.
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