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DUPIXENT was studied in adult and adolescent patients (aged ≥12 years) with uncontrolled moderate-to-severe and severe asthma vs placebo1,2,4–7

Recruited patients had a high rate of severe asthma exacerbations and decreased
lung function1–3 or high oral corticosteroid (OCS) dose5

Asthma exacerbations:3

2

(2.15)

mean annualised
exacerbations
(standard deviation (SD))

Lung function:3

58

(13.52)

mean % predicted
pre-bronchodilator
(BD) forced expiratory
volume in 1 second (FEV1) (SD)

Asthma control:3

3

(0.77)

mean 5-item Asthma
Control Questionnaire
(ACQ-5) score* (SD)

Quality of life:3

4

(1.05)

mean Asthma Quality
of Life Questionnaire
(AQLQ) score (SD)

DRI125441,7

24-week, randomised, placebo-controlled, double-blind, parallel-group, multi-centre, pivotal Phase 2b trial including patients aged ≥18 years with moderate-to-severe asthma, irrespective of baseline blood eosinophils (EOS) counts or other Type 2 biomarkers1,7

STUDY STUDY DURATION (WEEKS) NUMBER OF PATIENTS TREATMENT ARMS PRIMARY ENDPOINTS
DRI12544 24 776* Patients were randomised (1:1:1:1:1) for 24 weeks of treatment with a) 200 mg DUPIXENT + SOC every 4 weeks (Q4W) (n=154),
b) 300 mg DUPIXENT + SOC Q4W (n=157),
c) 200 mg DUPIXENT + SOC every 2 weeks (Q2W) (n=150) or d) 300 mg DUPIXENT + SOC Q2W (n=157) (licenced dose),
e) placebo + SOC (n=158)
FEV1 change from baseline at Week 12

*Inclusion criteria was defined by patients aged ≥18 years with physician-diagnosed moderate-to-severe asthma for ≥12 months based on the Global Initiative for Asthma (GINA) guidelines, pre-BD FEV1 40–80% predicted at screening and at baseline, FEV1 reversibility of ≥12% and 200 mL, ACQ-5 score ≥1.5 and ≥1 systemic (oral or parenteral) corticosteroid burst therapy, or a hospital admission, emergency or urgent medical care visit that required treatment with systemic steroids for worsening asthma.7


SOC involved treatment with medium-to-high-dose inhaled corticosteroid (ICS) plus long-acting ß2-agonist (LABA) (fluticasone propionate ≥250 μg, or equivalent ICS, twice daily) with a stable dose of ICS, plus a LABA for ≥1 month before screening.7

LIBERTY QUEST1,2

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 biomarkers1,2

STUDY STUDY DURATION (WEEKS) NUMBER OF PATIENTS TREATMENT ARMS PRIMARY ENDPOINTS
LIBERTY QUEST 52*
1,902
Patients were randomised (2:2:1:1), to 52 weeks of treatment with a) 200 mg subcutaneous (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)
Annualised rate of severe exacerbation events over 52 weeks§

FEV1 change from baseline at Week 12
LIBERTY QUEST - POST-HOC ANALYSIS 52*
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) Annualised rate of severe exacerbation events over 52 weeks§

FEV1 change from baseline at Week 12

*LIBERTY QUEST consisted of a 52-week treatment phase, and a 12-week follow-up period.2


Inclusion criteria was defined by patients aged ≥12 years with physician-diagnosed moderate-to-severe asthma for ≥12 months based on the GINA guidelines, pre-BD FEV1 ≤80% of the predicted normal value or ≤90% of the predicted value for those aged ≤17 years, FEV1 reversibility of ≥12% and 200 mL, ACQ-5 score ≥1.5 and ≥1 exacerbation defined as worsening of asthma in the previous year leading to hospitalisation, emergency medical care, or treatment with systemic corticosteroids for ≥3 days.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 LABA or leukotriene receptor antagonist [LTRA]).2


§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.2


LIBERTY VENTURE1,5

24-week, randomised, placebo-controlled, double-blind, parallel-group, multi-centre, Phase 3 trial including patients aged ≥12 years with severe asthma, irrespective of baseline blood EOS counts or other Type 2 biomarkers1,5

STUDY STUDY DURATION (WEEKS) NUMBER OF PATIENTS TREATMENT ARMS PRIMARY ENDPOINTS
LIBERTY VENTURE
24* 210 Patients were randomised (1:1), to 24 weeks of treatment with a) 300 mg SC DUPIXENT + SOC Q2W with 600 mg loading dose (n=103) (licenced dose) or b) placebo + SOC SC Q2W with placebo loading dose (n=107) (placebo 2 mL match with DUPIXENT 300 mg/2 mL) Percentage reduction of OCS dose from baseline while maintaining asthma control at Week 24

*LIBERTY VENTURE consisted of a 24-week treatment phase, followed by a 12-week evaluation phase.5


Inclusion criteria was defined by patients aged ≥12 years with physician-diagnosed severe asthma for ≥12 months based on the GINA guidelines with ≥6 months of documented OCS treatment (5–35 mg/day prednisone/prednisolone or equivalent), pre-BD FEV1 ≤80% of the predicted normal value or ≤90% of the predicted value for those aged ≤17 years, FEV1 reversibility of ≥12% and 200 mL or airway hyperresponsiveness documented the prior year.6


SOC involved treatment with a medium-to-high-dose inhaled glucocorticoid (fluticasone propionate at a total daily dose of ≥500 μg or equipotent equivalent) in combination with up to two additional controllers (e.g. a LABA or LTRA) and daily oral glucocorticoids (i.e. 5–35 mg per day of prednisone or prednisolone or equivalent).5

INTRODUCING THE DUPIXENT PRE-FILLED PEN

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

*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 0.5.2,9
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 0.57.2,10


ACQ-5, 5-item Asthma Control Questionnaire; BD, bronchodilator; EOS, eosinophil; FeNO, fractional exhaled nitric oxide; FEV1, forced expiratory volume in 1 second; GINA, Global Initiative for Asthma; ICS, inhaled corticosteroids; LABA, long-acting ß2-agonist; LTRA, leukotriene receptor antagonist; MCID, minimal clinically important difference; OCS, oral corticosteroids; ppb, parts per billion; Q2W, every 2 weeks; Q4W, every 4 weeks; SC, subcutaneous; SD, standard deviation; SOC, standard of care; TCS, topical corticosteroids.

References

  1. Sanofi Genzyme. Dupixent Summary of Product Characteristics, September 2021.
  2. Castro M, et al. N Engl J Med. 2018;378(26):2486–2496.
  3. Castro M, et al. N Engl J Med. 2018;378(26):2486–2496. Supplementary Appendix.
  4. Bourdin A, et al. Allergy. 2021;76(1):269–280.
  5. Rabe KF, et al. N Engl J Med. 2018;378(26):2475–2485.
  6. Rabe KF, et al. N Engl J Med. 2018;378(26):2475–2485. Supplementary Appendix.
  7. Wenzel S, et al. Lancet. 2016;388(10039):31–44.
  8. Sanofi Data on file. REF-145318. September 2021.
  9. Meltzer EO, et al. J Allergy Clin Immunol. 2011;127:167–172.
  10. Khusial R J, et al. ERJ Open Res. 2020;6:00289–2019.