)
ALL PRIMARY AND KEY SECONDARY ENDPOINTS WERE MET WITH STATISTICAL SIGNIFICANCE1,2
Patients enrolled received background INCS throughout the duration of both trials1,2
SINUS-24(N=276) 24 WEEKS
SINUS-24(N=276) 24 WEEKS
300 mg Q2W for 24 weeks (n=143)
Placebo + INCS for 24 weeks (n=133)
Study
population
Adults (≥18 years) on background INCSd with CRSwNP despite prior sinus surgery or prior treatment with (unless ineligible to receive or intolerant to) SCS in the past 2 years
Patients with chronic rhinosinusitis without nasal polyps were not included in these trials
Rescue with SCS or surgery was allowed at investigators’ discretion
The total population of patients in SINUS-24 and SINUS-52 was unrestricted by minimum baseline blood eosinophil count
Coprimary
endpoints
- NC score averaged over 28 days
- Bilateral endoscopic NPS
Key secondary
endpoints
Change from baseline at Week 24 in:
- Daily LoS score
- LMK-CT score
- SNOT-22 score
- UPSIT score
Other secondary endpoints
Change from baseline at Week 52 in:
- Daily LoS score
- LMK-CT score
- UPSIT score
- SNOT-22 score
Prespecified
pooled analysis
Change from baseline at Week 24 in proportion of patients requiring SCS or sinus surgery
SINUS-52(N=448) 52 WEEKS
SINUS-52(N=448) 52 WEEKS
DUPIXENT + INCS
300 mg Q2W for 52 weeks (n=150)b
DUPIXENT + INCS
300 mg Q2W for 24 weeks, followed by Q4Wc through Week 52 (n=145)b
Placebo + INCS for 52 weeks (n=153)
Study
population
Adults (≥18 years) on background INCSd with CRSwNP despite prior sino-nasal surgery or prior treatment with (unless ineligible to receive or intolerable to) SCS in the past 2 years
Patients with chronic rhinosinusitis without nasal polyposis were not included in these trials
Rescue with SCS or surgery was allowed at investigators’ discretion
The total population of patients in SINUS-24 and SINUS-52 was unrestricted by minimum baseline blood eosinophil count
Coprimary
endpoints
Change from baseline at Week 24 in:
- NC score averaged over 28 days
- Bilateral endoscopic NPS
Key secondary
endpoints
Change from baseline at Week 24 in:
- Daily LoS score
- LMK-CT score
- SNOT-22 score
- UPSIT score
Change from baseline at Week 52 in:
- NC score
- NPS
Additional
endpoints
Change from baseline at Week 52 in:
- Daily LoS score
- LMK-CT score
- UPSIT score
- SNOT-22 score
Other secondary
endpoints
Change from baseline at Week 52 in:
- Daily LoS score
- LMK-CT score
- UPSIT score
- SNOT-22 score
Additional
endpoints
Change from baseline at Week 24 in FEV1 and ACQ-6 scores in patients with co-existing asthma
Prespecified
pooled analysis
Change from baseline at Week 52 in proportion of patients requiring SCS or sinus surgery
PATIENT DEMOGRAPHICS1
SINUS-24: 24 WEEKS (N=276)—Mean age: 50 years; male: 57%; mean CRSwNP duration: 11 years; patients with ≥1 prior surgery: 72%; patients with SCS use in previous 2 years: 65%; mean bilateral endoscopic NPS,e range 0-8: 5.8; mean NC score,e range 0-3: 2.4; mean LMK sinus CT total score,e range 0-24: 19; mean LoS scoree (AM), range 0-3: 2.7; mean SNOT-22 total score,e range 0-110: 49.4; mean blood eosinophil count: 440 cells/μL; mean total IgE: 212 IU/mL; atopic medical history, overall: 75%; asthma: 58%; NSAID-ERD: 30%.
SINUS-52: 52 WEEKS (N=448)—Mean age: 52 years; male: 62%; mean CRSwNP duration: 11 years; patients with ≥1 prior surgery: 58%; patients with SCS use in previous 2 years: 80%; mean bilateral endoscopic NPS,e range 0-8: 6.1; mean NC score,e range 0-3: 2.4; mean LMK sinus CT total score,e range 0-24: 18; mean LoS scoree (AM), range 0-3: 2.8; mean SNOT-22 total score,e range 0-110: 51.9; mean blood eosinophil count: 430 cells/μL; mean total IgE: 240 IU/mL; atopic medical history, overall: 82%; asthma: 60%; NSAID-ERD: 27%.
~79% of patients enrolled in both trials had atopic diseases. In SINUS-24 and SINUS-52, all subjects had evidence of sinus opacification on the LMK sinus CT scan, and 73% to 90% of subjects had opacification of all sinuses. Patients with prior surgery had a mean of 2.0 prior surgeries, and patients with prior SCS use had a mean of 1.6 SCS courses in the previous 2 years.
aValid as of February 2024.
bIn SINUS-52, data from baseline to Week 24 are pooled from DUPIXENT 300 mg Q2W treatment arms (n=295).2
cThe recommended dose of DUPIXENT for CRSwNP is 300 mg given subcutaneously every other week.1
dAll patients in the placebo and DUPIXENT arms were on a background therapy of INCS, mometasone furoate nasal spray.2
eHigher scores indicate greater disease severity.1
AM, morning; INCS, intranasal corticosteroid; LMK-CT, Lund-Mackay computed tomography; LoS, Loss of Smell; NC, nasal congestion/obstruction; NPS, nasal polyp score; NSAID-ERD, nonsteroidal anti‑inflammatory drug–exacerbated respiratory disease; Q2W, once every 2 weeks; Q4W, once every 4 weeks; SCS, systemic corticosteroid; SNOT-22, 22-item Sino-Nasal Outcome Test; UPSIT, University of Pennsylvania Smell Identification Test.
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.1
Explore the Safety Data
Dosage and
Administration
See the recommended dosing and
administration options for patients
on DUPIXENT.