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Significant reductions in asthma exacerbations, improvements in lung function and improvements in quality of life vs placebo1–4

  • DUPIXENT was studied in three randomised, double-blind, placebo-controlled, parallel-group, multi-centre trials including 2,888 patients aged 12 years and older, for up to 52 weeks1
  • LIBERTY QUEST data is a post-hoc analysis within license: patients with eosinophils (EOS) ≥150 cells/µL or fractional exhaled nitric oxide (FeNO) ≥25 ppb and high-dose inhaled corticosteroid (ICS) at baseline2

Efficacy with DUPIXENT + standard of care (SOC) compared to placebo2,4

DUPIXENT significantly reduced asthma exacerbations vs placebo2


LIBERTY QUEST: Annualised rate of severe asthma exacerbations through Week 52*2

LIBERTY QUEST has met the endpoint of annualised rate of severe exacerbation by Week 52 in patients on high-dose ICS at baseline2

Presented above is the post-hoc analysis of patients with EOS ≥150 cells/µL or FeNO ≥25 ppb and high-dose ICS at baseline2

 

LIBERTY QUEST: A randomised (2:2:1:1), placebo-controlled, double-blind, parallel-group, multi-centre, Phase 3 trial including patients aged ≥12 years (N=1,902) with moderate-to-severe asthma, irrespective of baseline blood EOS counts or other Type 2 biomarkers, randomised to receive either a) 200 mg subcutaneous (SC) DUPIXENT + SOC every 2 weeks (Q2W) with 400 mg loading dose (n=631), b) 300 mg DUPIXENT + SOC Q2W with 600 mg loading dose (n=633) (licenced dose), c) placebo + SOC Q2W with placebo loading dose (n=317) (placebo 1.14 mL match with DUPIXENT 200 mg/1.14 mL) or d) placebo + SOC SC Q2W with placebo loading dose (n=321) (placebo 2 mL match with DUPIXENT 300 mg/2 mL) for 52 weeks.1,3


The primary endpoints were the annualised rate of severe exacerbation events over 52 weeks* and forced expiratory volume in 1 second (FEV1) change from baseline at Week 12.3


The key secondary endpoint was the percentage change from baseline in pre-bronchodilator (BD) FEV1 at Week 12.5


Other secondary endpoints were annualised rate of severe asthma exacerbations in patients with ≥150 EOS/µL over 52 weeks, annualised rate of severe asthma exacerbations in patients with ≥300 EOS/µL over 52 weeks, change from baseline in pre-BD FEV1 in patients with ≥150 EOS/µL at Week 12 and change from baseline in pre-BD FEV1 in patients with ≥300 EOS/µL at Week 12.5

DUPIXENT significantly improved lung function measured as FEV1 vs placebo2


LIBERTY QUEST: Change in FEV1 from baseline through Week 522,6

LIBERTY QUEST has met the endpoint of change in FEV1, at Week 52 in patients on high-dose ICS at baseline2

Presented above is the post-hoc analysis of patients with EOS ≥150 cells/µL or FeNO ≥25 ppb and high-dose ICS at baseline2

 

LIBERTY QUEST: A randomised (2:2:1:1), placebo-controlled, double-blind, parallel-group, multi-centre, Phase 3 trial including patients aged ≥12 years (N=1,902) with moderate-to-severe asthma, irrespective of baseline blood EOS counts or other Type 2 biomarkers, randomised to receive either a) 200 mg SC DUPIXENT + SOC Q2W with 400 mg loading dose (n=631), b) 300 mg DUPIXENT + SOC Q2W with 600 mg loading dose (n=633) (licenced dose), c) placebo + SOC Q2W with placebo loading dose (n=317) (placebo 1.14 mL match with DUPIXENT 200 mg/1.14 mL) or d) placebo + SOC SC Q2W with placebo loading dose (n=321) (placebo 2 mL match with DUPIXENT 300 mg/2 mL) for 52 weeks.1,3


The primary endpoints were the annualised rate of severe exacerbation events over 52 weeks* and FEV1 change from baseline at Week 12.3


The key secondary endpoint was the percentage change from baseline in pre-BD FEV1 at Week 12.5


Other secondary endpoints were annualised rate of severe asthma exacerbations in patients with ≥150 EOS/µL over 52 weeks, annualised rate of severe asthma exacerbations in patients with ≥300 EOS/µL over 52 weeks, change from baseline in pre-BD FEV1 in patients with ≥150 EOS/µL at Week 12 and change from baseline in pre-BD FEV1 in patients with ≥300 EOS/µL at Week 12.5

DUPIXENT significantly improved quality of life vs placebo4


LIBERTY QUEST: LS mean change from baseline in 5-item Asthma Control Questionnaire (ACQ-5) scores at Week 52§4

LIBERTY QUEST has met the endpoint of change in ACQ-5 at Week 52 in patients on high-dose ICS at baseline2,4

Presented above is the post-hoc analysis of patients with EOS ≥150 cells/µL or FeNO ≥25 ppb and high-dose ICS at baseline4

 

LIBERTY QUEST: A randomised (2:2:1:1), placebo-controlled, double-blind, parallel-group, multi-centre, Phase 3 trial including patients aged ≥12 years (N=1,902) with moderate-to-severe asthma, irrespective of baseline blood EOS counts or other Type 2 biomarkers, randomised to receive either a) 200 mg SC DUPIXENT + SOC Q2W with 400 mg loading dose (n=631), b) 300 mg DUPIXENT + SOC Q2W with 600 mg loading dose (n=633) (licenced dose), c) placebo + SOC Q2W with placebo loading dose (n=317) (placebo 1.14 mL match with DUPIXENT 200 mg/1.14 mL) or d) placebo + SOC SC Q2W with placebo loading dose (n=321) (placebo 2 mL match with DUPIXENT 300 mg/2 mL) for 52 weeks.1,3


The primary endpoints were the annualised rate of severe exacerbation events over 52 weeks* and FEV1 change from baseline at Week 12.3


The key secondary endpoint was the percentage change from baseline in pre-BD FEV1 at Week 12.5


Other secondary endpoints were annualised rate of severe asthma exacerbations in patients with ≥150 EOS/µL over 52 weeks, annualised rate of severe asthma exacerbations in patients with ≥300 EOS/µL over 52 weeks, change from baseline in pre-BD FEV1 in patients with ≥150 EOS/µL at Week 12 and change from baseline in pre-BD FEV1 in patients with ≥300 EOS/µL at Week 12.5

INTRODUCING THE DUPIXENT PRE-FILLED PEN

A convenient option to ensure patients
administer DUPIXENT as directed1

*A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for ≥3 days; or hospitalisation or emergency room visit because of asthma, requiring systemic corticosteroids. Annualised event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.3
SOC involved treatment with a medium-to-high-dose inhaled glucocorticoid (fluticasone propionate at a total daily dose of ≥500 µg or equipotent equivalent) plus up to two additional controllers (e.g. a long-acting ß2-agonist (LABA) or leukotriene receptor antagonist (LTRA)).3
ACQ-5 is a patient-reported measure of the adequacy of asthma control and change in asthma control that occurs either spontaneously or as a result of treatment. Scores range from 0 to 6, with higher scores indicating less control and tracks measures of sleep, activity limitations and breathing. The minimal clinically important difference (MCID) is 0.5.3,7
§Results were derived from MMRM model with change from baseline in ACQ-5 score up to Week 52 as the response variable and treatment, age, region (pooled country), baseline eosinophil strata, visit, treatment by-visit interaction, baseline ACQ-5 score and baseline-by-visit interaction as covariates.5


ACQ-5, 5-item Asthma Control Questionnaire; BD, bronchodilator; EOS, eosinophil; FeNO, fractional exhaled nitric oxide; FEV1, forced expiratory volume in 1 second; ICS, inhaled corticosteroids; LABA, long-acting ß2-agonist; LS, least squares; LTRA, leukotriene receptor antagonist; MCID, minimal clinically important difference; MMRM, Mixed-effects Model with Repeated Measures; ppb, parts per billion; Q2W, every 2 weeks; SC, subcutaneous; SOC, standard of care.

References

  1. Sanofi Genzyme. Dupixent Summary of Product Characteristics, May 2021.
  2. Bourdin A, et al. Allergy. 2021;76(1):269–280.
  3. Castro M, et al. N Engl J Med. 2018;378(26):2486–2496.
  4. Sanofi Data on file. REF-98937. October 2020.
  5. Castro M, et al. N Engl J Med. 2018;378(26):2486–2496. Supplementary Appendix.
  6. Bourdin A, et al. Allergy. 2021;76(1):269–280. Supplementary Appendix S1.
  7. Meltzer EO, et al. J Allergy Clin Immunol. 2011;127:167–172.