Showing the study designs of DRI12544 and QUEST. DRI12544 was a 24-week, dose-ranging study. 776 patients were randomized in a one-to-one-to-one-to-one-to-one ratio. 150 patients received DUPIXENT 200 mg every two weeks, following a 400 mg loading dose. 157 patients received DUPIXENT 300 mg every two weeks, following a 600 mg loading dose. 158 patients received placebo. The primary endpoint was the mean change from baseline to Week 12 in FEV1. The primary analysis population was subjects with baseline eosinophils greater than or equal to 300 cells per microlitre. DRI12544 also included randomized comparator arms of DUPIXENT dosed every 4 weeks (data not shown). This dosing frequency is not recommended. See the Product Monograph for dosing information. QUEST was a 52-week study. 1,902 patients were randomized in a two-to-two-to-one-to-one ratio. 631 patients received DUPIXENT 200 mg every two weeks, following a 400 mg loading dose. 633 patients received DUPIXENT 300 mg every two weeks, following a 600 mg loading dose. 321 patients received placebo. The primary endpoints were the annualized rate of severe asthma exacerbation events over 52 weeks, and the change from baseline to Week 12 in pre-bronchodilator FEV.

Adapted from the Product Monograph.

Patients were enrolled without requiring a minimum baseline blood eosinophil or other type 2 inflammatory biomarkers. A severe exacerbation was defined as a deterioration of asthma requiring the use of systemic corticosteroids for at least 3 days, or hospitalization or ER visit due to asthma that required systemic corticosteroids.

Showing the study design of VENTURE, a 24-week study. 210 patients were randomized in a one-to-one ratio. 103 patients received DUPIXENT 300 mg every two weeks, following a 600 mg loading dose. 107 patients received placebo. The primary endpoint was the percent reduction of oral corticosteroid dose at Weeks 20 to 24 compared with the baseline dose, while maintaining asthma control.

Adapted from the Product Monograph.

Study population

In VENTURE, enrolled subjects were receiving high-dose inhaled corticosteroids plus additional controller(s). All subjects were receiving OCS. After optimizing OCS dose (screening period), subjects were randomized and continued to receive their existing asthma medicine during the study; however their OCS dose was reduced every 4 weeks during the OCS reduction phase (weeks 4-20), if asthma control was maintained. Asthma control was maintained if subjects did not experience i) an increase in ACQ-5 ≥0.5 units, ii) a severe asthma exacerbation, or iii) a clinically significant event that required OCS dose adjustment. Patients were enrolled without requiring a minimum baseline blood eosinophil or other type 2 inflammatory biomarkers.

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MAT-CA-2300228
Last updated: 06/2023


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