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STUDY DESIGNS IN ADULTS

DUPIXENT WAS STUDIED IN THE LARGEST CRSwNP
BIOLOGICS TRIAL PROGRAM TO DATE1,2,a

DUPIXENT WAS STUDIED IN THE LARGEST CRSwNP
BIOLOGICS TRIAL PROGRAM TO DATE1,2,a

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

Randomized
DUPIXENT + INCS
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

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

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

Randomized

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 sinus surgery or prior treatment with (unless ineligible to receive or intolerable 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

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

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

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