with DUPIXENT 300 mg Q2W + SOC (n=64) vs placebo + SOC (n=68) (0.20 vs 1.04; rate ratio: 0.19 [95% CI: 0.07, 0.56]) (baseline blood EOS ≥300 cells/µL, DRI12544, secondary endpoint)1
QUEST primary endpoint results (ITT population)
aSevere exacerbations were defined as deterioration of asthma requiring the use of systemic corticosteroids for at least 3 days or hospitalization or ED visit due to asthma that required systemic corticosteroids.1
(Weeks 48-96) when treated with DUPIXENT 200 mg/300 mg Q2W + SOC (n=816) for 52 weeks in QUEST and continued with DUPIXENT 300 mg Q2W + SOC in the OLE period (TRAVERSE OLE study, other endpoint)2
Results are descriptive. Definitive conclusions cannot be made.
Data were not multiplicity controlled and there are limitations associated with open-label study design, including lack of comparator arm, decreasing sample size, and potential continued involvement of responders and attrition of nonresponders.
bAnalysis includes DRI12544 and QUEST patients enrolled in TRAVERSE.2
cOf the 542 patients who experienced at least 1 severe asthma exacerbation, 66 (3.2% of the overall study population) had an exacerbation that required hospitalization or ED visit during the TRAVERSE study period (unadjusted annualized event rate of 0.027).2
Reductions in severe exacerbations when added to SOC. No statistically
significant differences were observed during the 52-week treatment period in patients with
baseline blood EOS <150 cells/μL taking DUPIXENT 200 mg Q2W or 300 mg Q2W + SOC and in the
≥150 to <300 cells/μL eosinophil subgroup treated with DUPIXENT 200 mg Q2W + SOC vs
matching placebo + SOC.1,2
DUPIXENT trials enrolled patients with eosinophil levels up to 1500
cells/μL.1
dSecondary endpoint.2
Results are descriptive. Definitive conclusions cannot be made as this was
a post-hoc analysis. There are limitations on sample size and data
were
not multiplicity controlled.
Allergic asthma was defined as total serum IgE ≥30 IU/mL + ≥1 positive perennial-aeroallergen–specific IgE ≥0.35 kU/L at baseline.3