Printed From:

QUESTIONS ABOUT NOVEL CORONAVIRUS?
CLICK HERE.

Significant reduction in oral corticosteroids (OCS) dose 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

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

DUPIXENT significantly reduced OCS dose in steroid-dependent patients vs placebo2


LIBERTY VENTURE: Percentage reduction in OCS dose from baseline through Week 24*2

OCS dose was reduced every 4 weeks during the OCS reduction phase from weeks 4–20, as long as asthma control was maintained2

Percentage reduction of OCS dose was calculated as (optimised OCS dose [mg/day] at baseline–final OCS dose at Week 24)/optimised OCS dose at baseline x 100. Result is presented as LS mean (standard error) percentage reduction from baseline derived from the Analysis of Covariance (ANCOVA) model with missing data multiply imputed.3


LIBERTY VENTURE: A randomised (1:1), placebo-controlled, double-blind, parallel-group, multi-centre, Phase 3 trial including patients aged ≥12 years (N=210) with severe asthma, irrespective of baseline blood EOS counts or other Type 2 biomarkers, randomised to receive either 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) for 24 weeks.1,2


The primary endpoint was the percentage reduction of OCS dose from baseline while maintaining asthma control at Week 24.2


The key secondary endpoints were the proportion of patients achieving a reduction of ≥50% or greater in their OCS dose compared with baseline while maintaining asthma control at Week 24 and the proportion of patients achieving a reduction of OCS dose to <5 mg/day while maintaining asthma control at Week 24.3


Other secondary endpoints were the proportion of patients achieving their maximum possible reduction of OCS dose per protocol while maintaining asthma control at Week 24 and the proportion of patients no longer requiring OCS while maintaining asthma control at Week 24.3


DUPIXENT reduced OCS dose in steroid-dependent patients vs placebo3


LIBERTY VENTURE: Percentage reduction in OCS dose from baseline through Week 24*3

OCS dose was reduced every 4 weeks during the OCS reduction phase from weeks 4–20, as long as asthma control was maintained2

Percentage reduction of OCS dose was calculated as (optimised OCS dose [mg/day] at baseline–final OCS dose at Week 24)/optimised OCS dose at baseline x 100. Result is presented as LS mean (standard error) percentage reduction from baseline derived from the ANCOVA model with missing data multiply imputed.3


LIBERTY VENTURE: A randomised (1:1), placebo-controlled, double-blind, parallel-group, multi-centre, Phase 3 trial including patients aged ≥12 years (N=210) with severe asthma, irrespective of baseline blood EOS counts or other Type 2 biomarkers, randomised to receive either 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) for 24 weeks.1,2


The primary endpoint was the percentage reduction of OCS dose from baseline while maintaining asthma control at Week 24.2


The key secondary endpoints were the proportion of patients achieving a reduction of ≥50% or greater in their OCS dose compared with baseline while maintaining asthma control at Week 24 and the proportion of patients achieving a reduction of OCS dose to <5 mg/day while maintaining asthma control at Week 24.3


Other secondary endpoints were the proportion of patients achieving their maximum possible reduction of OCS dose per protocol while maintaining asthma control at Week 24 and the proportion of patients no longer requiring OCS while maintaining asthma control at Week 24.3

DUPIXENT reduced OCS dose in steroid-dependent patients vs placebo3


LIBERTY VENTURE: Percentage reduction in OCS dose from baseline through Week 24*3


OCS dose was reduced every 4 weeks during the OCS reduction phase from weeks 4–20, as long as asthma control was maintained2

Percentage reduction of OCS dose was calculated as (optimised OCS dose [mg/day] at baseline–final OCS dose at Week 24)/optimised OCS dose at baseline x 100. Result is presented as LS mean (standard error) percentage reduction from baseline derived from the ANCOVA model with missing data multiply imputed.3


LIBERTY VENTURE: A randomised (1:1), placebo-controlled, double-blind, parallel-group, multi-centre, Phase 3 trial including patients aged ≥12 years (N=210) with severe asthma, irrespective of baseline blood EOS counts or other Type 2 biomarkers, randomised to receive either 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) for 24 weeks.1,2


The primary endpoint was the percentage reduction of OCS dose from baseline while maintaining asthma control at Week 24.2


The key secondary endpoints were the proportion of patients achieving a reduction of ≥50% or greater in their OCS dose compared with baseline while maintaining asthma control at Week 24 and the proportion of patients achieving a reduction of OCS dose to <5 mg/day while maintaining asthma control at Week 24.3


Other secondary endpoints were the proportion of patients achieving their maximum possible reduction of OCS dose per protocol while maintaining asthma control at Week 24 and the proportion of patients no longer requiring OCS while maintaining asthma control at Week 24.3

DUPIXENT reduced OCS dose in steroid-dependent patients vs placebo3


LIBERTY VENTURE: Percentage reduction in OCS dose from baseline through Week 24*3

OCS dose was reduced every 4 weeks during the OCS reduction phase from weeks 4–20, as long as asthma control was maintained2

Percentage reduction of OCS dose was calculated as (optimised OCS dose [mg/day] at baseline–final OCS dose at Week 24)/optimised OCS dose at baseline x 100. Result is presented as LS mean (standard error) percentage reduction from baseline derived from the ANCOVA model with missing data multiply imputed.3


LIBERTY VENTURE: A randomised (1:1), placebo-controlled, double-blind, parallel-group, multi-centre, Phase 3 trial including patients aged ≥12 years (N=210) with severe asthma, irrespective of baseline blood EOS counts or other Type 2 biomarkers, randomised to receive either 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) for 24 weeks.1,2


The primary endpoint was the percentage reduction of OCS dose from baseline while maintaining asthma control at Week 24.2


The key secondary endpoints were the proportion of patients achieving a reduction of ≥50% or greater in their OCS dose compared with baseline while maintaining asthma control at Week 24 and the proportion of patients achieving a reduction of OCS dose to <5 mg/day while maintaining asthma control at Week 24.3


Other secondary endpoints were the proportion of patients achieving their maximum possible reduction of OCS dose per protocol while maintaining asthma control at Week 24 and the proportion of patients no longer requiring OCS while maintaining asthma control at Week 24.3

DUPIXENT reduced OCS dose in steroid-dependent patients vs placebo3


LIBERTY VENTURE: Percentage reduction in OCS dose from baseline through Week 24*3


OCS dose was reduced every 4 weeks during the OCS reduction phase from weeks 4–20, as long as asthma control was maintained2

Percentage reduction of OCS dose was calculated as (optimised OCS dose [mg/day] at baseline–final OCS dose at Week 24)/optimised OCS dose at baseline x 100. Result is presented as LS mean (standard error) percentage reduction from baseline derived from the ANCOVA model with missing data multiply imputed.3


LIBERTY VENTURE: A randomised (1:1), placebo-controlled, double-blind, parallel-group, multi-centre, Phase 3 trial including patients aged ≥12 years (N=210) with severe asthma, irrespective of baseline blood EOS counts or other Type 2 biomarkers, randomised to receive either 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) for 24 weeks.1,2


The primary endpoint was the percentage reduction of OCS dose from baseline while maintaining asthma control at Week 24.2


The key secondary endpoints were the proportion of patients achieving a reduction of ≥50% or greater in their OCS dose compared with baseline while maintaining asthma control at Week 24 and the proportion of patients achieving a reduction of OCS dose to <5 mg/day while maintaining asthma control at Week 24.3


Other secondary endpoints were the proportion of patients achieving their maximum possible reduction of OCS dose per protocol while maintaining asthma control at Week 24 and the proportion of patients no longer requiring OCS while maintaining asthma control at Week 24.3

INTRODUCING THE DUPIXENT PRE-FILLED PEN

A convenient option to ensure patients
administer DUPIXENT as directed1

*Values are LS means, and error bars represent the standard error. Values are slightly offset from each other at each time point for clarity. The dashed line indicates baseline.2


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 long-acting ß2-agonist (LABA) or leukotriene receptor antagonist (LTRA)) and daily oral glucocorticoids (i.e. 5–35 mg per day of prednisone or prednisolone or equivalent).2


ANCOVA, Analysis of Covariance; EOS, eosinophil; FeNO, fractional exhaled nitric oxide; LABA, long-acting ß2-agonist; LS, least squares; LTRA, leukotriene receptor antagonist; OCS, oral corticosteroids; 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. Rabe KF, et al. N Engl J Med. 2018;378(26):2475–2485.
  3. Rabe KF, et al. N Engl J Med. 2018;378(26):2475–2485. Supplementary Appendix.