DUPIXENT was studied in the largest CRSwNP Biologics Trial Program to date1,2,e
OF PRIOR systemic
corticosteroid USE IN
PREVIOUS TWO YEARS1,f
HISTORY OF ≥1
PRIOR SURGERY1,f
All primary and key secondary endpoints were met with statistical
significance1,2
PATIENTS ENROLLED
WERE CONTINUED ON
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 INCSc with CRSwNP despite prior sinus surgery or prior treatment with, or who were ineligible to receive or were intolerant to, systemic corticosteroids in the past 2 years
Patients with chronic rhinosinusitis without nasal polyposis were not included in these trials
Rescue with systemic corticosteroids 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
- Nasal congestion/obstruction (NC) score averaged over 28 days
- Bilateral endoscopic nasal polyp score (NPS)
Key secondary
endpoints
Change from baseline at Week 24 in:
- Daily Loss of Smell score
- LMK-CT score
- SNOT-22 score
- UPSIT score
Other secondary endpoints
Change from baseline at Week 52 in:
- Daily Loss of Smell score
- LMK-CT score
- UPSIT score
Prespecified
pooled analysis
Change from baseline at Week 52 in proportion of patients requiring systemic corticosteroids 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)a
DUPIXENT + INCS
300 mg Q2W for 24 weeks, followed by Q4Wb through week 52 (n=145)a
Placebo + INCS for 52 weeks (n=153)
Study
Population
Adults (≥18 years) on background INCSc with CRSwNP despite prior sino-nasal surgery or prior treatment with, or who were ineligible to receive or were intolerant to, systemic corticosteroids in the past 2 years
Patients with chronic rhinosinusitis without nasal polyposis were not included in these trials
Rescue with systemic corticosteroids 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:
- Nasal congestion/obstruction (NC) score averaged over 28 days
- Bilateral endoscopic nasal polyps score (NPS)
Key secondary
endpoints
Change from baseline at Week 24 in:
- Daily Loss of Smell score
- LMK-CT score
- SNOT-22 score
- UPSIT score
Change from baseline at Week 52 in:
- NC score
- NPS
- SNOT-22 score
Additional
endpoints
Change from baseline at Week 52 in:
- Daily Loss of Smell score
- LMK-CT score
- UPSIT score
Other secondary
endpoints
Change from baseline at Week 52 in:
- Daily Loss of Smell score
- LMK-CT score
- UPSIT 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 systemic corticosteroids or sino-nasal 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,d range 0-8: 5.8; mean NC score,d range 0-3: 2.4; mean LMK sinus CT total score,d range 0-24: 19; mean Loss of Smell scored (AM), range 0-3: 2.7; mean SNOT-22 total score,d 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,d range 0-8: 6.1; mean NC score,d range 0-3: 2.4; mean LMK sinus CT total score,d range 0-24: 18; mean Loss of Smell scored (AM), range 0-3: 2.8; mean SNOT-22 total score,d 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%.
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. Prior surgery patients had a mean number of 2.0 prior surgeries, and SCS use patients had 1.6 SCS courses in the previous 2 years.
aIn SINUS-52, data from baseline to Week 24 are pooled from DUPIXENT 300 mg Q2W treatment arms (n=295).2
bThe recommended dose of DUPIXENT for adult patients with CRSwNP is 300 mg given subcutaneously every other week.1
cAll patients in the placebo and DUPIXENT arms were on a background therapy of INCS, mometasone furoate nasal spray.2
dHigher scores indicate greater disease severity.1
eValid as of April 2023.
fIn SINUS-24.
AM, morning; INCS, intranasal corticosteroid; LMK-CT, Lund-Mackay computed tomography; 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.
Explore the Safety Data
Dosage and
Administration
See the recommended dosing and
administration options for patients
on DUPIXENT.