)
as early as day 31,a
Patient-reported outcome. Post hoc analysis. Results are
descriptive. Definitive conclusions cannot be made.1,2
- SINUS-52: significant improvement was observed as early as Week 43
THROUGH WEEK 523,4,b
- -1.10 (95% CI: -1.31, -0.89) LSM difference for DUPIXENT + INCS
(n=150) vs placebo + INCS (n=153)3
Analysis was not multiplicity controlled. Results are descriptive.4
aLSM difference between DUPIXENT 300 mg Q2W + INCS (n=438) and placebo + INCS (n=286): -0.07 (95% CI: -0.12, -0.02).1,5
bLoS score at Week 24 in SINUS-52 (key secondary endpoint). LSM difference between DUPIXENT 300 mg Q2W + INCS (n=295, pooled arms) and placebo + INCS (n=153): -0.98
(95% CI: -1.15, -0.81) (-1.21 from a baseline score of 2.77 vs -0.23 from a baseline score of 2.72, respectively) (P<0.0001).4
Loss of Smell (LoS) score (range 0-3): reduced score indicates improvement.3
Analysis was not multiplicity controlled. Results are descriptive. Definitive conclusions cannot be
made.4
UPSIT score classification: anosmia (complete loss of smell) (≤18), severe microsmia (19-25), moderate microsmia (26-30), mild microsmia (31-34), normosmia (normal smell appreciation) (35-40).4
c
UPSIT score at Week 24 in SINUS-52 (key secondary endpoint). LSM difference between DUPIXENT 300 mg Q2W + INCS (n=295, pooled arms) and placebo + INCS (n=153):
10.52 (95% CI: 8.98, 12.07)
(9.71 from a baseline score of 13.53 vs -0.81 from a baseline score of 13.78, respectively)
(P<0.0001).4
University of Pennsylvania Smell Identification Test (UPSIT) score (range 0-40): higher score indicates improvement.4
Phase 3 Clinical Trials in Adults: Coprimary Endpoints, LSM difference, DUPIXENT 300 mg Q2W + INCS vs placebo + INCS at Week 243,4
SINUS-24 (DUPIXENT n=143, placebo n=133): NC score: -0.89 (95% CI: -1.07, -0.71). NPS: -2.06 (95% CI: -2.43, -1.69).
SINUS-52 (DUPIXENT n=295, placebo n=153): NC score: -0.87 (95% CI: -1.03, -0.71). NPS: -1.80 (95% CI: -2.10, -1.51).
Nasal congestion/obstruction (NC) score (range 0-3): reduced score indicates improvement.3
Nasal polyp score (NPS) (range 0-4 for each nostril, range 0-8 in total): reduced score indicates improvement.3
CRSwNP, chronic rhinosinusitis with nasal polyps; INCS, intranasal corticosteroids; LSM, least squares mean; Q2W, once every 2 weeks.
Use of DUPIXENT for the CRSwNP indication in patients aged 12-17 years is supported by evidence from
studies of DUPIXENT as add-on maintenance
treatment in adults with inadequately controlled
CRSwNP.3