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Significant reductions in asthma exacerbations and improvements in lung function 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
  • 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 EOScounts 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 baseline received subcutaneous DUPIXENT 200 or 300mg or matched placebo, every 2 weeks (Q2W) for 52 weeks (n=390)2,4

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

DUPIXENT significantly reduces asthma exacerbations vs placebo4


LIBERTY QUEST: Annualised rate of severe asthma exacerbations through Week 52*4

LIBERTY QUEST has met the endpoint of annualised rate of severe exacerbation by Week 522,4

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 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


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 improved lung function measured as FEV1 vs placebo4


LIBERTY QUEST: Change in FEV1 from baseline through to Week 52 in treatment groups receiving 200 mg or 300 mg DUPIXENT and associated placebo groups4

LIBERTY QUEST has met the endpoint of the absolute change from baseline in the FEV1 at Week 122,4

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


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


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; 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.
  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