DUPIXENT was studied in two multipart, phase 3 clinical trials.
ADULTS & ADOLESCENTS AGED 12+ YEARS
All enrolled subjects (81 in Part A and 159 in Part Ba) were required to have uncontrolled EoE—as defined by ≥15 EOS/HPF despite an 8-week course of a high-dose PPI and a Dysphagia Symptom Questionnaire (DSQ) score of ≥10.1,3,4
The demographics and baseline characteristics were similar in Parts A and B. At baseline, 43% of subjects in Part A and 37% of subjects in Part B had a history of prior esophageal dilations. The mean age in years was 32 years (range, 13 to 62 years) in Part A and 28 years (range, 12 to 66 years) in Part B. The majority of subjects were male (60% in Part A and 68% in Part B) and White (96% in Part A and 90% in Part B). The mean baseline DSQ score (SD) was 33.6 (12.4) in Part A and 37.2 (10.7) in Part B.1
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.1,3
CHILDREN AGED 1-11 YEARS
All enrolled subjects were required to have uncontrolled EoE—as defined by ≥15 EOS/HPF despite an 8-week course of a high-dose PPI and a history of EoE signs and symptoms.1
The demographics and baseline characteristics were similar between treatment groups. At baseline, the mean age was 8 years (range, 1 to 11 years), the median weight was 28 kg, 75% of subjects were male, 85% identified as White, 12% as Black, 2% as Asian, and 2% identified as another racial subgroup.1
Unless used as rescue medications, systemic and/or swallowed topical corticosteroids were prohibited in both clinical trials during the treatment period. Patients using PPIs during screening were to continue throughout the treatment period or stop prior to baseline.3