Indication DUPIXENT is indicated as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP).

CLINICAL TRIALS ENROLLED PATIENTS
DESPITE PRIOR SURGERY OR SCS USE1,2

Patients enrolled were continued on background INCS throughout the duration of both trials

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 INCSa 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 Trials 1 and 2 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

Additional endpoints

Change from baseline at Week 24 in FEV1 and ACQ-6 scores in patients with comorbid asthma

Prespecified pooled analysis

Change from baseline at Week 52 in proportion of patients requiring SCS or sino-nasal surgery

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 INCSa 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 Trials 1 and 2 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 Weeks 24 and 52 in:

  • NC score (at Week 52)
  • NPS (at Week 52)
  • 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 comorbid asthma

Prespecified pooled analysis

Change from baseline at Week 52 in proportion of patients requiring SCS or sino-nasal surgery

  • aAll patients in the placebo and DUPIXENT arms were on a background therapy of INCS, mometasone furoate nasal spray.
  • bIn Trial 2, data from baseline to Week 24 are pooled from DUPIXENT Q2W treatment arms (n=295).
  • cThe recommended dose of DUPIXENT for adult patients with CRSwNP is 300 mg given subcutaneously every other week.

ALL PRIMARY AND SECONDARY ENDPOINTS WERE MET WITH STATISTICAL SIGNIFICANCE1,2

Patient demographics1

TRIAL 1: 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%.

TRIAL 2: 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 Trials 1 and 2, 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; ACQ-6, Asthma Control Questionnaire, 6-item version; CRSwNP, chronic rhinosinusitis with nasal polyposis; FEV1, forced expiratory volume in 1 second; INCS, intranasal corticosteroids; 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.

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patients appropriate
for DUPIXENT

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References:

  1. DUPIXENT Prescribing Information.
  2. Data on file, Sanofi US. Clinical overview (chronic rhinosinusitis with nasal polyposis). 2018.