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Significant asthma control and quality of life improvements vs placebo1,2

  • 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 was a 52-week, randomised, placebo-controlled, double-blind, parallel-group, multi-centre, Phase 3 trial including patients aged ≥12 years with moderate-to-severe asthma, irrespective of baseline blood EOS counts or other Type 2 biomarkers1,3
  • LIBERTY QUEST data included in this section is a post-hoc analysis within license: patients with eosinophils (EOS) ≥150 cells/µL and fractional exhaled nitric oxide (FeNO) ≥25 ppb and high-dose inhaled corticosteroid (ICS) at baseline2

Quality of life and asthma control with DUPIXENT + standard of care (SOC) compared to placebo2

DUPIXENT significantly improves asthma control vs placebo4


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

Presented above is the post-hoc analysis of patients with EOS ≥150 cells/µL and 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 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 1.3


The key secondary endpoint was the percentage change from baseline in pre-bronchodilator (BD) FEV1 at Week 1.5


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 1.5


The LIBERTY QUEST post-hoc analysis was also done during the 52-week treatment period (n=390). Patients with ≥150 eosinophils/μL and FeNO ≥25 ppb and high-dose ICS at baseline by study arm, patients were randomised to: DUPIXENT 200mg Q2W (n=121) with matching placebo (n=64) and to DUPIXENT 300mg Q2W (n=130) with matching placebo (n=75). The primary endpoints were the annualised rate of severe exacerbation events over 52 weeks and FEV1 change from baseline at Week 12.4


DUPIXENT significantly improves quality of life vs placebo4


LIBERTY QUEST: Least square (LS) mean change from baseline in the Asthma Quality of Life Questionnaire (AQLQ) global scores at Week 52II4

Presented above is the post-hoc analysis of patients with EOS ≥150 cells/µL and 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


The LIBERTY QUEST post-hoc analysis was also done during the 52-week treatment period (n=390). Patients with ≥150 eosinophils/μL and FeNO ≥25 ppb and high-dose ICS at baseline by study arm, patients were randomised to: DUPIXENT 200mg Q2W (n=121) with matching placebo (n=64) and to DUPIXENT 300mg Q2W (n=130) with matching placebo (n=75). The primary endpoints were the annualised rate of severe exacerbation events over 52 weeks and FEV1 change from baseline at Week 12.4

INTRODUCING THE DUPIXENT PRE-FILLED PEN

DUPIXENT can be administered via
a pre-filled pen or a syringe1

*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.3

AQLQ is a patient-reported measure that assesses the extent to which asthma limits and impacts day-to-day life for adults aged between 17–70. Scores range from 0 to 7, with higher scores indicating better quality of life. The MCID is 0.57.8

IIResults were derived from MMRM model with change from baseline in AQLQ global score values up to Week 52 as the response variable, and treatment, age, region (pooled country), baseline eosinophil strata, baseline ICS dose level, visit, treatment by-visit interaction, baseline AQLQ global score value and baseline-by-visit interaction as covariates.4


ACQ-5, 5-item Asthma Control Questionnaire; AQLQ, Asthma Quality of life 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, September 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. Supplementary Appendix.
  4. Sanofi Data on file. REF-145318. September 2021.
  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.
  8. Khusial R J, et al. ERJ Open Res. 2020;6:00289–2019.