The efficacy and safety of DUPIXENT were evaluated at 24 weeks and up to 52 weeks2
Part A
24-Week Placebo-Controlled Treatment Period
24-Week Placebo-Controlled Treatment Period
Part Ba
24-Week Placebo-Controlled Treatment Period
24-Week Placebo-Controlled Treatment Period
- Parts A and B: Two 24-week, double-blind, placebo-controlled trials. Subjects were randomized to receive either DUPIXENT 300 mg QW, DUPIXENT 300 mg Q2W (Parts B and B-C only), or placebo QW1,2,a
- Part C: An optional 28-week active treatment extension study, for a total of 52 weeks of treatment in subjects who were treated with 300 mg DUPIXENT or placebo, completing Parts A or B1,2
- All enrolled subjects (81 in Part A and 159 in Part B) were required to have1,2:
- Uncontrolled EoE as defined by ≥15 intraepithelial EOS/HPF despite 8-week course of a high-dose PPI
- Dysphagia Symptom Questionnaire (DSQ) score ≥10
aDUPIXENT 300 mg Q2W was studied in Part B (n=81) and Part B-C
(n=116).
Patients from placebo arm in Part B were randomized to receive either DUPIXENT
300 mg Q2W
(n=37) or DUPIXENT 300 mg
QW (n=37) in Part B-C of the study. DUPIXENT 300 mg Q2W is not approved for the treatment of EoE.1,2
Patients who enrolled were uncontrolled despite PPI use1-3
| Part A | Part B | |||
|---|---|---|---|---|
| DUPIXENT QW (n=42) |
Placebo QW (n=39) |
DUPIXENT QW (n=80) |
Placebo QW (n=79) |
|
| Mean age, years (SD) | 34 (15.5) | 29 (12.5) | 29 (13.7) | 28 (12.6) |
| Male, % | 67 | 54 | 63 | 73 |
| White, % | 98 | 95 | 89 | 91 |
| PPI use at randomization, n (%) | 26 (62%) | 25 (64%) | 57 (71%) | 57 (72%) |
| Prior swallowed topical steroid use, n (%) | 29 (69%) | 31 (80%) | 55 (69%) | 56 (71%) |
| Topical steroid for EoE ineffective, n (%) | 23 (55%) | 21 (54%) | 32 (40%) | 34 (43%) |
| Prior esophageal dilation(s), n (%) | 18 (43%) | 17 (44%) | 26 (33%) | 33 (42%) |
| DSQ scoreb (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 (/HPF), mean (SD) | 82.6 (41.0) | 96.5 (54.7) | 89.2 (46.7) | 84.3 (41.2) |
| Esophageal EOS count of 3 regions (/HPF), mean (SD) | 58.7 (33.8) | 70.3 (40.9) | 61.8 (31.6) | 57.6 (30.3) |
| EREFS total scoreb (0-18), mean (SD) | 6.5 (3.2) | 6.0 (2.4) | 6.8 (3.0) | 7.2 (3.3) |
|
Part A |
- |
|---|
| DUPIXENT QW (n=42) |
34 (15.5) |
| Placebo QW (n=39) |
29 (12.5) |
| DUPIXENT QW (n=42) |
67 |
| Placebo QW (n=39) |
54 |
| DUPIXENT QW (n=42) |
95 |
| Placebo QW (n=39) |
95 |
| DUPIXENT QW (n=42) |
26 (62%) |
| Placebo QW (n=39) |
25 (64%) |
| DUPIXENT QW (n=42) |
29 (69%) |
| Placebo QW (n=39) |
31 (80%) |
| DUPIXENT QW (n=42) |
23 (55%) |
| Placebo QW (n=39) |
21 (54%) |
| DUPIXENT QW (n=42) |
18 (43%) |
| Placebo QW (n=39) |
17 (44%) |
| DUPIXENT QW (n=42) |
32.2 (12.7) |
| Placebo QW (n=39) |
35.1 (12.1) |
| DUPIXENT QW (n=42) |
82.6 (41.0) |
| Placebo QW (n=39) |
96.5 (54.7) |
| DUPIXENT QW (n=42) |
58.7 (33.8) |
| Placebo QW (n=39) |
70.3 (40.9) |
| DUPIXENT QW (n=42) |
6.5 (3.2) |
| Placebo QW (n=39) |
6.0 (2.4) |
|
Part B |
- |
|---|
| DUPIXENT QW (n=80) |
29 (13.7) |
| Placebo QW (n=79) |
28 (12.6) |
| DUPIXENT QW (n=80) |
63 |
| Placebo QW (n=79) |
73 |
| DUPIXENT QW (n=80) |
89 |
| Placebo QW (n=79) |
91 |
| DUPIXENT QW (n=80) |
57 (71%) |
| Placebo QW (n=79) |
57 (72%) |
| DUPIXENT QW (n=80) |
55 (69%) |
| Placebo QW (n=79) |
56 (71%) |
| DUPIXENT QW (n=80) |
32 (40%) |
| Placebo QW (n=79) |
34 (43%) |
| DUPIXENT QW (n=80) |
26 (33%) |
| Placebo QW (n=79) |
33 (42%) |
| DUPIXENT QW (n=80) |
38.4 (10.7) |
| Placebo QW (n=79) |
36.1 (10.6) |
| DUPIXENT QW (n=80) |
89.2 (46.7) |
| Placebo QW (n=79) |
84.3 (41.2) |
| DUPIXENT QW (n=80) |
61.8 (31.6) |
| Placebo QW (n=79) |
57.6 (30.3) |
| DUPIXENT QW (n=80) |
6.8 (3.0) |
| Placebo QW (n=79) |
7.2 (3.3) |
bHigher scores indicate greater disease severity.
- Patients using PPI during screening were to continue throughout the treatment period2
- Unless used as rescue medications, systemic and/or swallowed topical corticosteroids were prohibited during the treatment period2
EOS, eosinophil; HPF, high-power field; PPI, proton pump inhibitor; QW, once weekly; Q2W, once every 2 weeks.
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