Severe Exacerbation Reduction

DUPIXENT SIGNIFICANTLY REDUCED SEVERE EXACERBATIONS UP TO 81%
IN PATIENTS WITH EOS ≥300 CELLS/μL

EOS ≥300 CELLS/µL: Significant reductions when added to SOC (secondary endpoint)1,a

Severe exacerbations through Week 24
BASELINE BLOOD EOS ≥300 CELLS/μLTrial 1

  • aSevere exacerbations were defined as deterioration of asthma requiring the use of systemic corticosteroids for at least 3 days or hospitalization or emergency department visit due to asthma that required systemic corticosteroids.1

SIGNIFICANTLY REDUCED SEVERE EXACERBATIONS IN PATIENTS
WITH EOS ≥150 CELLS/μL

EOS ≥150 cells/µL: Significant reductions when added to SOC (secondary endpoint)1,2,a

Severe exacerbations through Week 52
BASELINE BLOOD EOS ≥150 CELLS/µLTrial 2
  • a Severe exacerbations were defined as deterioration of asthma requiring the use of systemic corticosteroids for at least 3 days or hospitalization or emergency department visit due to asthma that required systemic corticosteroids.1

DUPIXENT CONSISTENTLY PREVENTED SEVERE EXACERBATIONS IN PATIENTS
WITH NO MINIMUM BIOMARKER REQUIREMENT

No biomarker requirement (ITT population): Significant reductions when added to SOC, with no minimum blood eosinophil requirement (primary endpoint)1,a,b

Severe exacerbations through Week 52
No biomarker requirementTrial 2

No statistically significant differences were observed during the 52-week treatment period in patients with baseline blood eosinophils <150 cells/μL taking DUPIXENT 200 mg or 300 mg + SOC and in the ≥150 to <300 cells/μL eosinophil subgroup treated with DUPIXENT 200 mg + SOC vs matching placebo + SOC.1

  • a ITT population was unrestricted by minimum baseline eosinophils or other Type 2 biomarkers (eg, FeNO or IgE).3
  • b For inclusion in the study, all patients were required to have had ≥1 severe asthma exacerbation in the prior year. Placebo-treated patients with greater numbers of prior exacerbations had greater numbers of exacerbations during the treatment period. A severe asthma exacerbation was defined as deterioration of asthma requiring the use of systemic corticosteroids for ≥3 days or asthma-related hospitalization or emergency department visit requiring systemic corticosteroids between the first dose and last dose plus 14 days. Subjects with baseline eosinophil levels >1500 cells/μL (<1.3%) were excluded.1,4

  • ITT, intention-to-treat.

Greater exacerbation reduction in patients with a greater
need for control

No biomarker requirement (ITT population): Greater reductions in patients with a history of more frequent exacerbations4,a,b

Severe exacerbations through Week 52
No biomarker requirementTrial 2

The analysis of this endpoint was not multiplicity protected. Results are descriptive.3,5

  • aITT population was unrestricted by minimum baseline eosinophils or other Type 2 biomarkers (eg, FeNO or IgE).3
  • bFor inclusion in the study, all patients were required to have had ≥1 severe asthma exacerbation in the prior year. Placebo-treated patients with greater numbers of prior exacerbations had greater numbers of exacerbations during the treatment period. A severe asthma exacerbation was defined as deterioration of asthma requiring the use of systemic corticosteroids for ≥3 days or asthma-related hospitalization or emergency department visit requiring systemic corticosteroids between the first dose and last dose plus 14 days.4

Lung Function Improvement

UP TO 480 mL IMPROVEMENT IN LUNG FUNCTION IN PATIENTS WITH
EOS ≥300 CELLS/µL

EOS ≥300 cells/µL: Greater improvements vs placebo seen as early as Week 2, at Week 12, and maintained through Week 52 (secondary endpoints)1

Change in lung function over 1 year
BASELINE BLOOD EOS ≥300 CELLS/µLTrial 2

  • LSM, least squares mean.

RAPID AND SUSTAINED IMPROVEMENT IN LUNG FUNCTION THROUGH
52 WEEKS

No biomarker requirement (ITT population): Greater improvements vs placebo seen as early as Week 2, at Week 12, and maintained through Week 52 (secondary endpoint)1,3,5,a

Change in lung function over 1 year
NO BIOMARKER REQUIREMENTTrial 2

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 + SOC and in patients with baseline blood eosinophil levels <150 cells/µL taking DUPIXENT 200 mg or 300 mg + SOC.1

  • aITT population was unrestricted by minimum baseline eosinophils or other Type 2 biomarkers (eg, FeNO or IgE).3

OCS Reduction

more asthma patients stopped using ocs with dupixent,
regardless of baseline eos levels

No biomarker requirement (ITT population): Significantly reduced use of maintenance OCS at Week 24 while maintaining asthma control (primary endpoint)1,6,a,b

OCS dose reduction at Week 24
NO BIOMARKER REQUIREMENTTrial 3



  • Effects on oral steroid reduction were similar irrespective of baseline blood eosinophil levels

  • aITT population was unrestricted by minimum baseline eosinophils or other Type 2 biomarkers (eg, FeNO or IgE).6
  • bThe baseline mean OCS dose was 12 mg in the placebo group and 11 mg in the group receiving DUPIXENT.1

dupixent is the only biologic indicated for an ocs-dependent asthma population, regardless of phenotype

No biomarker requirement (ITT population): Reduced severe exacerbation rates and improved lung function at Week 24 (secondary endpoints)1,6,a-c




  • Effects on lung function and exacerbation reduction were similar irrespective of baseline blood eosinophil levels



  • aITT population was unrestricted by minimum baseline eosinophils or other Type 2 biomarkers (eg, FeNO or IgE).6
  • bThe baseline mean OCS dose was 12 mg in the placebo group and 11 mg in the group receiving DUPIXENT.1
  • cAsthma exacerbation was defined as a temporary increase in OCS dose for at least 3 days.1

Quality of Life Improvement

DUPIXENT IMPROVED ASTHMA CONTROL (ACQ-5) AND QUALITY OF LIFE (AQLQ[S])

EOS ≥300 cells/µL: Responder rates at Week 52 in Trial 2 (secondary endpoints)1,a-c

ACQ-5 (Asthma control)

AQLQ(S) (quality of life)


  • aResponder rates were defined as an improvement in score of 0.5 or more (scale ranged from 0 to 6 for ACQ-5 and 1 to 7 for AQLQ[S]).1
  • bACQ-5: Asthma Control Questionnaire, 5-item version, a patient-reported measure of asthma control. Higher scores indicate less asthma control; a global score is calculated ranging from 0 to 6. The meaningful clinically important difference is 0.5.1
  • cAQLQ(S): Asthma Quality of Life Questionnaire, Standardized Version, a patient-reported measure of asthma-related quality of life. Higher scores indicate better quality of life; a global score is calculated ranging from 1 to 7. The meaningful clinically important difference is 0.5.1

Study Design

dupixent enrolled a diverse moderate-to-severe asthma patient
population across 3 clinical trials1

Trial 1(N=776) 24 Weeks Trial 2(N=1902) 52 Weeks Trial 3(N=210) 24 Weeks
Randomized DUPIXENT + SOC 200 mg Q2Wa (n=150)

Placebo + SOC (n=158)


DUPIXENT + SOC 300 mg Q2Wb (n=157)

Placebo + SOC (n=158)

 DUPIXENT + SOC 200 mg Q2Wa (n=631)

Placebo + SOC (n=317)


DUPIXENT + SOC 300 mg Q2Wb (n=633)

Placebo + SOC (n=321)

 DUPIXENT + SOC + OCS 300 mg Q2Wb (n=103)

Placebo + SOC (n=107)
Study
population

Adults (≥18 years) with moderate-to-severe asthma on a standard of care of medium- or high-dose ICS and a long-acting beta agonist

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; subjects with baseline blood eosinophil levels >1500 cells/μL (<1.3%) were excluded

Subjects (≥12 years) with asthma who required daily OCS in addition to regular use of standard of care of high-dose ICS plus an additional controller medication; subjects with baseline blood eosinophil levels >1500 cells/μL (<1.3%) were excluded

The total population of patients in Trials 1, 2, and 3 was unrestricted by minimum baseline blood eosinophil count

The total population of patients in Trials 1, 2, and 3 was unrestricted by minimum baseline blood eosinophil count

The total population of patients in Trials 1, 2, and 3 was unrestricted by minimum baseline blood eosinophil count

The total population of patients in Trials 1, 2, and 3 was unrestricted by minimum baseline blood eosinophil count

Subjects continued background asthma therapy throughout the duration of the studies, except in Trial 3 in which OCS dose was reduced every 4 weeks during the OCS reduction phase (Weeks 4-20), as long as asthma control was maintained

Subjects continued background asthma therapy throughout the duration of the studies, except in Trial 3 in which OCS dose was reduced every 4 weeks during the OCS reduction phase (Weeks 4-20), as long as asthma control was maintained

Subjects continued background asthma therapy throughout the duration of the studies, except in Trial 3 in which OCS dose was reduced every 4 weeks during the OCS reduction phase (Weeks 4-20), as long as asthma control was maintained

Subjects continued background asthma therapy throughout the duration of the studies, except in Trial 3 in which OCS dose was reduced every 4 weeks during the OCS reduction phase (Weeks 4-20), as long as asthma control was maintained
Primary
endpoint(s)

Mean change from baseline to Week 12 in FEV1 in patients with baseline eosinophils ≥300 cells/μL

Annualized rate of severe exacerbation events during the 52-week treatment period in the overall population


Mean change from baseline to Week 12 in FEV1 in the overall population

Percent reduction from baseline in OCS dose at Week 24, while maintaining asthma control, in the overall population
Other
endpoint(s)

Annualized rate of severe exacerbation events during the 24-week treatment periodc

Annualized rate of severe exacerbation events during the 52-week treatment period in patients with different baseline levels of eosinophils


Annualized rate of severe exacerbation events during the 52-week treatment period in subgroups of patients with ≥1, ≥2, ≥3, or ≥4 exacerbations in the prior year


Mean change from baseline to Week 52 in FEV1 in patients with different baseline levels of eosinophils


Responder rates in patient-reported ACQ-5 and AQLQ(S) scores

Annualized rate of severe exacerbation events during the 24-week treatment period


Mean change from baseline to Week 24 in FEV1
  • 1
  • 2
  • 3
  • aWith 400 mg loading dose.
  • b With 600 mg loading dose.
  • c Results were evaluated in the overall population and subgroups based on baseline blood eosinophil count.

  • ICS, inhaled corticosteroid; Q2W, once every 2 weeks.
TRIAL 1 (N=776) 24 WEEKS TRIAL 2 (N=1902) 52 WEEKS TRIAL 3 (N=210) 24 WEEKS
Mean age (SD), years 49 (13) 48 (15) 51 (13)
Female, %
White, %		 63
78		 63
83		 61
94
Mean duration of
asthma (±SD), years		 22 (15) 21 (15) 20 (14)
Never smoked, % 77 81 81
Mean exacerbations in previous year (±SD) 2.2 (2.1) 2.1 (2.2) 2.1 (2.2)
High-dose ICS use, % 50 52 89
Pre-dose FEV1 at
baseline (±SD), L		 1.84 (0.54) 1.78 (0.60) 1.58 (0.57)
Mean percent predicted FEV1 at baseline (±SD), % 61 (11) 58 (14) 52 (15)
Percent reversibility (±SD) 27 (15) 26 (22) 19 (23)
Atopic medical history, % overall
(atopic dermatitis, %)
(nasal polyposis, %)
(allergic rhinitis, %)		 73
(8)
(11)
(62)		 78
(10)
(13)
(69)		 72
(8)
(21)
(56)
Mean FeNO (±SD), ppb 39 (35) 35 (33) 38 (31)
Mean total IgE (±SD), IU/mL 435 (754) 432 (747) 431 (776)
Mean baseline eosinophil count (±SD), cells/µL 350 (430) 360 (370) 350 (310)
  • 1
  • 2
  • 3

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    References:
  1. DUPIXENT Prescribing Information.
  2. Data on file, Sanofi US. QUEST CSR, 2017.
  3. Castro M, Corren J, Pavord ID, et al. Dupilumab efficacy and safety in moderate-to-severe uncontrolled asthma. N Engl J Med. 2018;378(26):2486-2496.
  4. Ford L, Corren J, Kuna P, et al. Dupilumab reduces exacerbations and improves lung function in uncontrolled, moderate-to-severe asthma patients across prior historical exacerbation subgroups in the phase 3 LIBERTY ASTHMA QUEST study [EAACI abstract 0854]. Allergy. 2018;73(S105):464-465.
  5. Data on file, Sanofi US. QUEST CSR efficacy response data, 2017.
  6. Rabe KF, Nair P, Brusselle G, et al. Efficacy and safety of dupilumab in glucocorticoid-dependent severe asthma. N Engl J Med. 2018;378(26):2475-2485.