Rapid lung function improvement patients can feel as early as
Week 21-3
Lung function improvement through Week 52
Baseline blood EOS ≥300 cells/μL (QUEST, secondary endpoint)
- At Week 12 in patients with no biomaker requirement: 320 mL improvement
from
baseline in
pre-bronchodilator FEV1 with DUPIXENT
200 mg Q2W + SOC (n=631) vs 180 mL with placebo + SOC (n=317) (LSM difference: 140 mL [95% Cl: 80, 190 mL]) (QUEST, primary endpoint)1,4 -
480 mL improvement from baseline in
pre-bronchodilator FEV1 at Week 52 with DUPIXENT
300 mg Q2W + SOC (n=277) vs
230 mL with
placebo + SOC (n=142) (baseline blood EOS ≥300 cells/μL, QUEST, secondary endpoint)1 -
In QUEST, a significant difference from placebo + SOC was not
observed at 12 weeks in change in pre-bronchodilator FEV1
in patients
with baseline blood EOS ≥150 to <300 cells/μL taking DUPIXENT 300 mg Q2W + SOC and in patients with baseline blood EOS <150
cells/μL taking DUPIXENT 200 mg Q2W or 300 mg Q2W + SOC1
Sustained lung function
improvement
patients
can feel2,4,5,a,b
UP TO
~3YEARS OFBREATHING RELIEF
-
310 mL improvement in FEV1 at Week 96 in
the DUPIXENT/DUPIXENT group (n=447) from 1.78 L at baseline in the
parent study
for patients enrolled from QUEST (overall exposed population, TRAVERSE OLE study, secondary endpoint)4 - 330 mL improvement in FEV1 at Week 96 in the placebo/DUPIXENT
group (n=219) from 1.75 L at baseline in the parent
study for patients enrolled from QUEST4
Results are descriptive. Definitive conclusions cannot be made.
Data were not multiplicity controlled and there are limitations associated
with open-label study design, including lack of comparator
arm, decreasing
sample size, and potential continued
involvement of responders and
attrition of
nonresponders.
a1.78 L was the baseline FEV1
level from QUEST (n=633) compared with a
placebo value of 1.75 L
(n=321).4
bFEV1 was assessed in the exposed
population (observed cases) using
descriptive statistics.5
Lung function
improvement in patients
with elevated EOS (≥150
cells/μL) and elevated
EOS + allergic asthma3,4
PATIENTS WITH ELEVATED EOS (QUEST, post hoc analyses)
Results are descriptive. Definitive conclusions cannot be made as this was a post-hoc
analysis. There are limitations on sample size and data
were not
multiplicity controlled.
DUPIXENT trials enrolled patients
with eosinophil levels up to 1500 cells/μL.1
QUEST primary endpoint
results (ITT
population)
- 320 mL improvement from baseline in pre-bronchodilator FEV1 at Week 12 with DUPIXENT 200 mg Q2W + SOC (n=631) vs 180 mL with placebo + SOC (n=317) (LSM difference: 140 mL [95% CI: 80, 190 mL])1,4
- 340 mL improvement from baseline in pre-bronchodilator FEV1 at Week 12 with DUPIXENT 300 mg Q2W + SOC (n=633) vs 210 mL with placebo + SOC (n=321) (LSM difference: 130 mL [95% CI: 80, 180 mL])6
- In QUEST, a significant difference from placebo + SOC was not observed at 12 weeks in change in pre-bronchodilator FEV1 in patients with baseline blood EOS ≥150 to <300 cells/μL taking DUPIXENT 300 mg Q2W + SOC and in patients with baseline blood EOS <150 cells/μL taking DUPIXENT 200 mg Q2W or 300 mg Q2W + SOC1
PATIENTS WITH ELEVATED EOS AND
ALLERGIC ASTHMA (QUEST, post
hoc
analyses)
Results are descriptive. Definitive conclusions cannot be made as this was a post-hoc
analysis. There are limitations on sample size and data
were not
multiplicity controlled.
Allergic asthma was defined as total serum IgE ≥30 IU/mL + ≥1
positive perennial-aeroallergen–specific IgE ≥0.35 kU/L at
baseline.7
EOS, eosinophils; FEV1, forced expiratory
volume in 1
second; ICS, inhaled corticosteroid; ITT, intention-to-treat; LSM, least squares mean; OLE,
open-label extension;
Q2W, once every 2 weeks; SOC, standard
of care.
Rapid lung function improvement patients can feel as early as
Week 22,4,6,8
Lung function improvement through Week 52
Baseline blood EOS ≥300 cells/μL (QUEST, post hoc analysis)
-
500 mL improvement from baseline in
pre-bronchodilator FEV1 at Week 52 with DUPIXENT
300 mg Q2W + SOC (n=129) vs
250 mL with
placebo + SOC (n=61) (LSM difference: 250 mL [95% CI: 110, 390 mL])4,6,8
Results are descriptive. Definitive conclusions cannot be made as
this was a post-hoc analysis. There are limitations on sample
size and
data were not multiplicity controlled.
Sustained lung function improvement patients can feel2,4,5,a,b
UP TO
~3YEARS OFBREATHING RELIEF
-
450 mL improvement in FEV1 at Week 96 in the
DUPIXENT/DUPIXENT group (n=92) from 1.84 L at baseline
in the parent study for patients enrolled from QUEST (baseline blood EOS ≥300 cells/μL, TRAVERSE OLE
study, post hoc analysis)4-
440 mL improvement in FEV1 at Week 96 in the
placebo/DUPIXENT group (n=50)
from 1.89 L at baseline in the parent study for patients enrolled from QUEST4
-
440 mL improvement in FEV1 at Week 96 in the
placebo/DUPIXENT group (n=50)
Results are descriptive. Definitive conclusions cannot be made as this was
a post hoc analysis of open-label extension data.
Data were not multiplicity controlled and there are limitations associated
with open-label study design, including lack of comparator
arm, decreasing
sample size, and potential continued
involvement of responders and
attrition of
nonresponders.
a1.84 L was the baseline FEV1
level from QUEST (n=129) compared with a
placebo value of 1.89 L
(n=61).4
bFEV1 was assessed in the exposed
population (observed cases) using
descriptive statistics.5
EOS, eosinophils; FEV1,
forced expiratory volume in 1 second; ICS, inhaled
corticosteroid; ITT, intention-to-treat; LSM, least squares mean; OLE,
open-label extension; Q2W, once
every 2 weeks; SOC, standard of care.
