DUPIXENT trials enrolled a total population of 724 patients with uncontrolled CRSwNP despite prior surgery or SCS use1-3

Trial 1(N=276) 24 WEEKS Trial 2(N=448) 52 WEEKS
Randomized DUPIXENT + INCS 300 mg Q2W for 24 weeks (n=143)

Placebo + INCS for 24 weeks (n=133)

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 intranasal corticosteroidsc 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

Study
population

Adults (≥18 years) on background intranasal corticosteroidsc 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

Adults (≥18 years) on background intranasal corticosteroidsc 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 score averaged over 28 days (NC)
  • Bilateral endoscopic nasal polyp score (NPS)
Coprimary
endpoints

Change from baseline at Week 24 in:

  • Nasal congestion/obstruction score averaged over 28 days (NC)
  • Bilateral endoscopic nasal polyp score (NPS)

Change from baseline at Week 24 in:

  • Nasal congestion/obstruction score averaged over 28 days (NC)
  • 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

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
Prespecified
pooled analysis

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

Prespecified
pooled analysis

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

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

  • 1
  • 2

Patient Demographics

TRIAL 1 (N=276) 24 WEEKS TRIAL 2 (N=448) 52 WEEKS
Mean age (SD), years 50 (13) 52 (12)
Male, % 57 62
Mean CRSwNP duration
(SD), years
11 (9) 11 (10)
Patients with ≥1 prior
surgery, %
72 58
Patients with SCS use in
previous 2 years, %
65 80
Mean bilateral endoscopic NPSd (SD),
range 0-8
5.8 (1.3) 6.1 (1.2)
Mean nasal congestion (NC) scored (SD),
range 0-3
2.4 (0.6) 2.4 (0.6)
Mean LMK sinus CT total scored (SD),
range 0-24
19 (4.4) 18 (3.8)
Mean loss of smell scored
(AM) (SD), range 0-3
2.7 (0.5) 2.8 (0.5)
Mean SNOT-22 total scored
(SD), range 0-110
49.4 (20.2) 51.9 (20.9)
Mean blood eosinophil
count (SD), cells/μL
440 (330) 430 (350)
Mean total IgE (SD), IU/mL 212 (276) 240 (342)
Atopic medical
history, % overall
75 82
Asthma, % 58 60
NSAID-ERD, % 30 27
  • 1
  • 2

~79% of patients enrolled in both trials had atopic diseases


  • dHigher scores indicate greater disease severity.
  • AM, morning; NSAID-ERD, nonsteroidal anti-inflammatory drug-exacerbated respiratory disease.
    References:
  1. DUPIXENT Prescribing Information.
  2. Data on file, Sanofi US. CSR SAR231893/REGN668, 2018.
  3. Data on file, Sanofi US. 2019.
  4. Data on file, Sanofi US. QUEST CSR, 2017.

Nasal Congestion/Obstruction & NASAL POLYP SCOREs

DUPIXENT rapidly improved nasal congestion and obstruction as early as Week 4 and at Week 24

Significantly improved NC score and NPS vs placebo at Week 24 (primary endpoints)1-3

Change in NC score through Week 48 in Trial 1

NC score improved as early as Week 4 in Trial 1

(LSM difference vs placebo: -0.41 [95% CI: -0.52, -0.30])1

NPS at Week 24 (Trial 1: coprimary endpoint)1

  • 34% IMPROVEMENT with DUPIXENT Q2W + INCS (n=143) (-1.89 from a baseline score of 5.64)
    vs 3% worsening with placebo + INCS (n=133) (0.17 from a baseline score of 5.86)
    (LSM difference: -2.06 [95% CI: -2.43, -1.69])
  • NC score (range 0 to 3): reduced score indicates improvement; NPS (range 0 to 8): reduced score indicates improvement.
  • LSM, least squares mean.

DUPIXENT rapidly improved nasal congestion and obstruction as early as Week 4, at Week 24, and sustained through 52 weeks

Significantly improved NC score and NPS vs placebo at Weeks 24 (primary endpoints)
and 52 (secondary endpoints) in Trial 21-3

At Week 24 51 % IMPROVEMENT IN NC SCORE

with DUPIXENT Q2W + INCS (n=295, pooled DUPIXENT arms) (-1.25 from a
baseline score of 2.46) vs 16% improvement with placebo + INCS (n=153)
(-0.38 from a baseline score of 2.38) (LSM difference: -0.87 [95% CI: -1.03, -0.71])

At Week 52 54 % IMPROVEMENT IN NC SCORE

with DUPIXENT Q2W + INCS (n=150) (-1.35 from a baseline score of 2.48) vs
16% improvement with placebo + INCS (n=153) (-0.37 from a baseline score of 2.38)
(LSM difference: -0.98 [95% CI: -1.17, -0.79])

NC score improved as early as Week 4 in Trial 21

-0.52 with DUPIXENT Q2W + INCS (n=295, pooled DUPIXENT arms) vs
-0.16 with placebo + INCS (n=153) (LSM difference: -0.37 [95% CI: -0.46, -0.27])


NPS at Week 24 (Trial 2: coprimary endpoint)1
  • 28% IMPROVEMENT with DUPIXENT Q2W + INCS (n=295, pooled DUPIXENT arms) (-1.71 from
    a baseline score of 6.18) vs 2% worsening with placebo + INCS (n=153) (0.10 from a baseline
    score of 5.96) (LSM difference: -1.80 [95% CI: -2.10, -1.51])
NPS at Week 52 (Trial 2: secondary endpoint)1-3
  • 37% IMPROVEMENT with DUPIXENT Q2W + INCS (n=150) (-2.24 from a baseline score of
    6.07) vs 3% worsening with placebo + INCS (n=153) (0.15 from a baseline score of 5.96)
    (LSM difference: -2.40 [95% CI: -2.77, -2.02])

Scs use & sino-nasal surgery

DUPIXENT reduced SCS use and need for sino-nasal surgery

Significantly reduced SCS use or the need for sino-nasal surgery vs placebo over 52 weeks in a pooled analysis of
Trials 1 and 2 (HR: 0.24 [95% CI: 0.17, 0.35])1

DUPIXENT 300 mg Q2W + INCS (Day 0: n=438; Week 24: n=376; Week 52: n=100);
placebo + INCS (Day 0: n=286; Week 24: n=187; Week 52: n=61)

74 % REDUCTION
IN THE PROPORTION OF PATIENTS WHO REQUIRED
SCS USE AT WEEK 52a

(HR: 0.26 [95% CI: 0.18, 0.38])

75% REDUCTION in SCS courses per year (RR: 0.25 [95% CI: 0.17, 0.37])a

83 % REDUCTION
IN THE PROPORTION OF PATIENTS WHO REQUIRED
SINO-NASAL SURGERY AT WEEK 52a

(HR: 0.17 [95% CI: 0.07, 0.46])

  • aIndividually, SCS reduction and need for sino-nasal surgery were not multiplicity-adjusted endpoints.
  • HR, hazard ratio; RR, risk ratio.

LOSS OF SMELL

DUPIXENT rapidly improved daily loss of smell score as early as Week 4, sustained through 52 weeks

Significantly improved daily loss of smell score vs placebo at Weeks 24 and 52 (secondary endpoints)1-3

46 % IMPROVEMENT

with DUPIXENT Q2W + INCS (n=150) (-1.29 from a baseline score of 2.81) vs
7% improvement with placebo + INCS (n=153) (-0.19 from a baseline score of 2.72)
(LSM difference: -1.10 [95% CI: -1.31, -0.89])

Daily loss of smell score improved as early as Week 4 in Trial 2

  • -0.38 with DUPIXENT Q2W + INCS (n=295, pooled DUPIXENT arms) vs -0.07 with placebo + INCS (n=153) (LSM difference vs placebo: -0.31 [95% CI: -0.41, -0.22])2

Daily loss of smell score at Week 24 (Trial 2: secondary endpoint)1,2

  • 44% IMPROVEMENT with DUPIXENT Q2W + INCS (n=295, pooled DUPIXENT arms) (-1.21 from a baseline score of 2.77) vs 8% improvement with placebo + INCS (n=153) (-0.23 from a baseline score of 2.72) (LSM difference: -0.98 [95% CI: -1.15, -0.81])

Daily loss of smell score at Week 24 (Trial 1: secondary endpoint)1,2

  • 52% IMPROVEMENT with DUPIXENT Q2W + INCS (n=143) (-1.41 from a baseline score of 2.70) vs 11% improvement with placebo + INCS (n=133) (-0.29 from a baseline score of 2.73) (LSM difference: -1.12 [95% CI: -1.31, -0.93])
  • Daily loss of smell score (range 0 to 3): reduced score indicates improvement.

PRE-BRONCHODILATOR FEV1 RESULTS IN CRSwNP TRIALS

In CRSwNP patients with comorbid asthma

Improvements in pre-bronchodilator FEV1 were similar to patients in the DUPIXENT asthma program1

PRESPECIFIED POOLED ANALYSIS OF CSNP TRIALS 1 AND 2: Week 24

140 mL
IMPROVEMENT
FROM BASELINE IN PRE-BRONCHODILATOR FEV1

with DUPIXENT 300 mg Q2W + INCS (n=258) vs -70 mL with placebo + INCS (n=170) (LSM difference: 210 mL [95% CI: 130, 290 mL])2

Selected baseline demographics for cohort of patients with CRSwNP and comorbid asthma2,3

  • 59% of the total enrolled population (n=724) had asthma (self-reported)
    • - The majority of these patients (66%) reported using ICS/LABA
  • Mean FEV1: Trial 1, 2.69 L; Trial 2, 2.57 L
  • Mean FEV1 percent predicted: Trial 1, 85.30%; Trial 2, 83.39%
  • FEV1, forced expiratory volume in 1 second; ICS, inhaled corticosteroid; LABA, long-acting beta agonist.

PRE-BRONCHODILATOR FEV1 RESULTS IN ASTHMA TRIALS

DUPIXENT is indicated as an add-on maintenance treatment in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with OCS-dependent asthma

Limitation of Use: DUPIXENT is not indicated for the relief of acute bronchospasm or status asthmaticus.

In the asthma clinical trial program

EOS ≥300 cells/μL: Significantly improved lung function vs placebo at Week 12, sustained through Week 52 (secondary endpoints)1

Change in lung function through Week 52 in Asthma Trial 2

Change in lung function at Week 12 in the ITT population (Asthma Trial 2, primary endpoint)1,4,a:

  • 340 mL improvement from baseline in pre-bronchodilator FEV1 with DUPIXENT 300 mg Q2W + SOC (n=633) vs 210 mL improvement with placebo + SOC (n=321) (LSM difference: 130 mL [95% CI: 80, 180 mL])

In Trial 2, a significant difference from placebo + SOC was not observed at 12 weeks in change in pre-bronchodilator FEV1 in patients with baseline blood eosinophil levels ≥150 to <300 cells/µL taking DUPIXENT 300 mg Q2W + SOC and in patients with baseline blood eosinophil levels <150 cells/µL taking DUPIXENT 200 mg or 300 mg Q2W + SOC.1

Change in lung function at Week 12 in patients with eosinophil counts ≥300 cells/µL (Asthma Trial 1, primary endpoint)1:

  • 390 mL improvement from baseline in pre-bronchodilator FEV1 with DUPIXENT 300 mg Q2W + SOC (n=64) vs 180 mL improvement with placebo + SOC (n=68) (LSM difference: 210 mL [95% CI: 60, 360 mL])
DUPIXENT ASTHMA CLINICAL TRIAL PROGRAM STUDY DESIGNS

AS TRIAL 1: 24-WEEK STUDY–776 adults (≥18 years) with moderate-to-severe asthma on a standard of care of medium- or high-dose ICS and a LABA were randomized to either DUPIXENT 200 mg Q2Wb + SOC (n=150), DUPIXENT 300 mg Q2Wc + SOC (n=157), or placebo + SOC (n=158). Subjects enrolled in Trial 1 were required to have a history of 1 or more asthma exacerbations that required treatment with systemic corticosteroids or emergency department visit or hospitalization for the treatment of asthma in the year prior to trial entry. DUPIXENT was administered as an add-on to background asthma treatment. Primary endpoint: Mean change from baseline to Week 12 in FEV1 in patients with baseline eosinophils ≥300 cells/μL. Selected baseline demographics: Mean age: 49 years; female: 63%; white: 78%; mean duration of asthma: 22 years; mean exacerbations in previous year: 2.2; high-dose ICS use: 50%; pre-dose FEV1 at baseline: 1.84 L; mean FeNO: 39 ppb; mean total IgE: 435 IU/mL; and mean baseline blood eosinophil count: 350 cells/µL.

AS TRIAL 2: 52-WEEK STUDY–1902 adolescents (12-17 years) and adults (≥18 years) with moderate-to-severe asthma on a standard of care of medium- or high-dose ICS and a minimum of 1 and up to 2 additional controller medications were randomized into 2 groups: DUPIXENT 200 mg Q2Wb + SOC (n=631) or placebo + SOC (n=317); or DUPIXENT 300 mg Q2Wc + SOC (n=633) or placebo + SOC (n=321). Subjects enrolled in Trial 2 were required to have a history of 1 or more asthma exacerbations that required treatment with systemic corticosteroids or emergency department visit or hospitalization for the treatment of asthma in the year prior to trial entry. Subjects with baseline blood eosinophil levels >1500 cells/µL (<1.3%) were excluded. DUPIXENT was administered as an add-on to background asthma treatment. Two primary endpoints: Mean change from baseline to Week 12 in FEV1 in the overall population and annualized rate of severe exacerbation events during the 52-week treatment period in the overall population. Secondary endpoint: Mean change from baseline to Week 52 in FEV1 in patients with baseline eosinophils ≥300 cells/μL. Selected baseline demographics: Mean age: 48 years; female: 63%; white: 83%; mean duration of asthma: 21 years; mean exacerbations in previous year: 2.1; high-dose ICS use: 52%; pre-dose FEV1 at baseline: 1.78 L; mean FeNO: 35 ppb; mean total IgE: 432 IU/mL; and mean baseline blood eosinophil count: 360 cells/µL.

  • a ITT population was unrestricted by minimum baseline blood eosinophil count.
  • b With 400 mg loading dose.
  • c With 600 mg loading dose.
  • EOS, eosinophils; FeNO, fractional exhaled nitric oxide; ITT, intention-to-treat; OCS, oral corticosteroid; SOC, standard of care.

LMK-CT & SNOT-22

DUPIXENT decreased sinus opacification and improved sino-nasal symptoms as measured by SNOT-22a

Significantly decreased LMK-CT score vs placebo at Week 24, with greater improvement
at Week 52 (secondary endpoints) in Trial 21-3

At Week 24 29 %
IMPROVEMENT
IN LMK-CT SCORE

with DUPIXENT 300 mg Q2W + INCS (n=295, pooled DUPIXENT arms) (-5.21 from a baseline score of
18.12) vs 0.5% improvement with placebo + INCS (n=153) (-0.09 from a baseline score of 17.65)
(LSM difference: -5.13 [95% CI: -5.80, -4.46])

At Week 52 37 %
IMPROVEMENT
IN LMK-CT SCORE

with DUPIXENT Q2W + INCS (n=150) (-6.83 from a baseline score of 18.42) vs 0.6% worsening
with placebo + INCS (n=153) (0.11 from a baseline score of 17.65)
(LSM difference: -6.94 [95% CI: -7.87, -6.01])

SNOT-22 score at Weeks 24 and 52 (Trial 2: secondary endpoints)1-3
  • 54% IMPROVEMENT at Week 24 with DUPIXENT Q2W + INCS (n=295, pooled DUPIXENT arms) (-27.77 from a baseline score of 51.02) vs 19% improvement with placebo + INCS (n=153) (-10.40 from a baseline score of 53.48) (LSM difference: -17.36 [95% CI: -20.87, -13.85])

  • 59% IMPROVEMENT at Week 52 with DUPIXENT Q2W + INCS (n=150) (-29.84 from a baseline score of 50.16) vs 17% improvement with placebo + INCS (n=153) (-8.88 from a baseline score of 53.48) (LSM difference: -20.96 [95% CI: -25.03, -16.89])

  • Lund-Mackay computed tomography (LMK-CT) (range 0 to 24): reduced score indicates improvement; SNOT-22 score (range 0 to 110): reduced score indicates improvement.
  • a SNOT-22 includes 22 items assessing symptoms and symptom impact associated with CRSwNP. SNOT-22 had a 2-week recall period. The meaningful clinically important difference is 8.9.

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