The Largest Clinical Trial Program Conducted for Chronic Rhinosinusitis with Nasal Polyps

All primary and key secondary endpoints were met with statistical significance1-3

PATIENTS ENROLLED
WERE CONTINUED ON
BACKGROUND INCS
THROUGHOUT THE
DURATION OF BOTH
TRIALS

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 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 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

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

SINUS-52(N=448) 52 WEEKS

SINUS-52(N=448) 52 WEEKS

Randomized

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

aIn SINUS-52, data from baseline to Week 24 are pooled from DUPIXENT Q2W treatment arms (n=295).

bThe recommended dose of DUPIXENT for adult patients with CRSwNP is 300 mg given subcutaneously every other week.

cAll patients in the placebo and DUPIXENT arms were on a background therapy of INCS, mometasone furoate nasal spray.

All primary and key secondary endpoints were met with statistical significance1-3

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%.

~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. 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.

dHigher scores indicate greater disease severity.
 

AM, morning; Q4W, once every 4 weeks.

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