in unadjusted annualized severe exacerbation rate in patients who enrolled in EXCURSION OLE (DUPIXENT/DUPIXENT group [rate: 0.118; n=209]) from PSBL through Year 2 in patients with moderate-to-severe asthma (EOS count ≥150 cells/μL or FeNO ≥20 ppb) (PSBL rate: 2.56) (secondary endpoint)2,b
EXCURSION OLE 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.
bSevere exacerbation was defined as an event requiring SCS for ≥3 days, hospitalization, or an ED visit.2
cMost children (286 [91%] of 315) remained exacerbation-free throughout the study.2
ED, emergency department; EOS, eosinophil; FeNO, fractional exhaled nitric oxide; OLE, open-label extension; PSBL parent study baseline; Q2W, once every 2 weeks; QoL, quality of life; SCS, systemic corticosteroid; SOC, standard of care.