Lung Function

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Lung Function

EFFICACY DATA

Change from baseline in pre-bronchodilator FEV₁^1,5

In the overall population in QUEST, the FEV₁ mean change from baseline was 0.32 L (21%) and 0.34 L (23%) for DUPIXENT® 200 mg Q2W and DUPIXENT® 300 mg Q2W, respectively, vs. matched placebo means of 0.18 L (12%) and 0.21 L (14%). LS mean treatment differences vs. placebo were 0.14 L (95% CI 0.08, 0.19) and 0.13 L (0.08, 0.18), respectively.

Mean change from baseline in pre-bronchodilator FEV₁ over time in QUEST (ITT population)^1,2

Adapted from the Product Monograph and Castro M, et al.

Mean change in pre-bronchodilator FEV1 over time in QUEST (line graph) full text

Mean change from baseline in pre-bronchodilator FEV₁ at Week 12 in QUEST
(baseline blood EOS ≥300 cells/mcL)

Adapted from the Product Monograph

Mean change in pre-bronchodilator FEV1 at Week 12 in QUEST (table) full text

Change in pre-bronchodilator FEV₁ at Week 12 across baseline blood EOS counts in QUEST

Adapted from the Product Monograph

Change in pre-bronchodilator FEV1 at Week 12 across baseline blood EOS counts in QUEST full text

Change in pre-bronchodilator FEV₁ at Week 12 across baseline FeNO (ppb) in QUEST

Adapted from the Product Monograph

Change in pre-bronchodilator FEV1 at Week 12 across baseline FeNO in QUEST full text

FEV₁=forced expiratory volume in 1 second; CI=confidence interval; LS=least squares.

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MAT-CA-2300228
Last updated: 06/2023

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Baseline characteristics

Adapted from the Product Monograph.

ACQ-5=Asthma Control Questionnaire-5; AD=atopic dermatitis; AQLQs=Asthma Quality of Life Questionnaire, Standardized Version;
AR=allergic rhinitis; EOS=blood eosinophil; FeNO=fraction of exhaled nitric oxide; FEV₁=forced expiratory volume in 1 second; ICS=inhaled corticosteroid; LABA=long-acting β2-agonist; NP=nasal polyposis; SD=standard deviation.

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Bar chart showing the rate of severe exacerbations in QUEST in patients with a baseline blood EOS of greater than or equal to 300 cells per microlitre. The chart shows the data for DUPIXENT 200 mg (n=264) versus placebo (n=148) and DUPIXENT 300 mg (n=277) versus placebo (n=142) at Week 52. The y-axis is the adjusted rate of severe exacerbations per year. The x-axis label is Week 52. The adjusted rate of severe exacerbations per year for DUPIXENT 200 mg and placebo was 0.37 versus 1.08, respectively. The rate ratio was 0.34 with a 95% CI of 0.24 to 0.48. The adjusted rate of severe exacerbations per year for DUPIXENT 300 mg and placebo was 0.40 versus 1.24, respectively. The rate ratio was 0.33 with a 95% CI of 0.23 to 0.45. The data was significant with a p-value of less than 0.0001.

Bar chart showing the rate of severe exacerbations, a secondary endpoint, in DRI12544. The y-axis is the adjusted rate of severe exacerbations per year. The x-axis label is Week 24. The chart shows the data for DUPIXENT 200 mg (n=65), DUPIXENT 300 mg (n=64) and placebo (n=68). The adjusted rate of severe exacerbations per year for DUPIXENT 200 mg, 300 mg and placebo were 0.30, 0.20 and 1.04, respectively. The rate ratio for DUPIXENT 200 mg versus placebo was 0.29 with a 95% CI of 0.11 to 0.76. The rate ratio of DUPIXENT 300 mg versus placebo was 0.19 with a 95% CI of 0.07 to 0.56.

Line graph showing the mean change from baseline in pre-bronchodilator FEV1 over time in QUEST for the intent-to-treat population. The y-axis is the LS mean change from baseline in pre-bronchodilator FEV1 in litres. The y-axis ranges from 0 to 0.6 in increments of 0.1. The x-axis ranges from Week 0 to Week 52 in increments of 4. The chart shows the data for DUPIXENT 300 mg (n=633) and the corresponding placebo arm (n=321) as well as DUPIXENT 200 mg (n=631) and the corresponding placebo arm (n=317).

At Week 12, the LS mean change from baseline in pre-bronchodilator FEV1 in litres for DUPIXENT 300 mg and the corresponding placebo arm was 0.34 and 0.21, respectively. The LS mean change from baseline in pre-bronchodilator FEV1 in litres for DUPIXENT 200 mg and the corresponding placebo arm was 0.32 and 0.18, respectively.

At Week 52, the LS mean change from baseline in pre-bronchodilator FEV1 in litres for DUPIXENT 300 mg and the corresponding placebo arm was 0.35 and 0.22, respectively. The LS mean change from baseline in pre-bronchodilator FEV1 in litres for DUPIXENT 200 mg and the corresponding placebo arm was 0.36 and 0.16, respectively.

Table showing the mean change from baseline in pre-bronchodilator FEV1 at Week 12 in QUEST in patients with baseline blood EOS greater than or equal to 300 cells per microlitre. The table shows the data for DUPIXENT 200 mg (n=264) and placebo (n=148), as well as DUPIXENT 300 mg (n=277) and placebo (n=142). The LS mean change from baseline in pre-bronchodilator FEV1 at Week 12 in litres for DUPIXENT 200 mg and placebo is 0.43 and 0.21, respectively. The LS mean difference versus placebo (95% CI) is 0.21 (0.13 to 0.29). The LS mean change from baseline in pre-bronchodilator FEV1 at Week 12 in litres for DUPIXENT 300 mg and placebo is 0.47 and 0.22, respectively. The LS mean difference versus placebo (95% CI) is 0.24 (0.16 to 0.32). This data was statistically significant with a p value of less than 0.0001.

Forest plot showing the change in pre-bronchodilator FEV1 at Week 12 across baseline blood EOS counts in QUEST. The y-axis title is “Baseline blood EOS group (cells per microlitre)”. The y-axis sub-titles are: “Overall”, “greater than or equal to 500”, “greater than or equal to 300 to less than 500”, “greater than or equal to 150 to less than 300”, and “less than 150”. The x-axis is the LS mean difference. The x-axis ranges from negative 0.25 to plus 0.5. There is a vertical dotted line at the 0 mark. Results to the left of this mark are favourable for placebo. Results to the right of this mark are favourable for DUPIXENT. The chart shows the data for DUPIXENT 300 mg versus placebo and DUPIXENT 200 mg versus placebo.

The LS mean difference in litres (95% CI) for DUPIXENT 300 mg and DUPIXENT 200 mg versus placebo in the “Overall” group is 0.13 (0.08 to 0.18) and 0.14 (0.08 to 0.19), respectively. The LS mean change from baseline is: 0.34 for DUPIXENT 300 mg (n=633) and 0.21 for placebo (n=321); 0.32 for DUPIXENT 200 mg (n=631) and 0.18 for placebo (n=317).

The LS mean difference in litres (95% CI) for DUPIXENT 300 mg and DUPIXENT 200 mg versus placebo in the “greater than or equal to 500” group is 0.30 (0.19 to 0.42) and 0.28 (0.17 to 0.39), respectively. The LS mean change from baseline is: 0.24 for DUPIXENT 300 mg (n=141) and 0.54 for placebo (n=74); 0.47 for DUPIXENT 200 mg (n=145) and 0.19 for placebo (n=76).

The LS mean difference in litres (95% CI) for DUPIXENT 300 mg and DUPIXENT 200 mg versus placebo in the “greater than or equal to 300 to less than 500” group is 0.18 (0.07 to 0.30) and 0.15 (0.03 to 0.26), respectively. The LS mean change from baseline is: 0.39 for DUPIXENT 300 mg (n=136) and 0.20 for placebo (n=68); 0.38 for DUPIXENT 200 mg (n=119) and 0.23 for placebo (n=72).

The LS mean difference in litres (95% CI) for DUPIXENT 300 mg and DUPIXENT 200 mg versus placebo in the “greater than or equal to 150 to less than 300” group is 0.00 (-0.10 to 0.10) and 0.11 (0.01 to 0.21), respectively. The LS mean change from baseline is: 0.25 for DUPIXENT 300 mg (n=175) and 0.25 for placebo (n=95); 0.28 for DUPIXENT 200 mg (n=173) and 0.17 for placebo (n=84).

The LS mean difference in litres (95% CI) for DUPIXENT 300 mg and DUPIXENT 200 mg versus placebo in the “less than 150” group is 0.09 (-0.01 to 0.18) and 0.06 (-0.04 to 0.15), respectively. The LS mean change from baseline is: 0.20 for DUPIXENT 300 mg (n=181) and 0.11 for placebo (n=83); 0.19 for DUPIXENT 200 mg (n=193) and 0.13 for placebo (n=85).

Forest plot showing the change in pre-bronchodilator FEV1 at Week 12 across baseline FeNO (parts per billion) in QUEST. The y-axis title is “Baseline FeNO group (parts per billion)”. The y-axis sub-titles are: “Overall”, “greater than or equal to 50”, “greater than or equal to 25 to less than 50”, and “less than 25”. The x-axis is the LS mean difference. The x-axis ranges from negative 0.25 to plus 0.5. There is a vertical dotted line at the 0 mark. Results to the left of this mark are favourable for placebo. Results to the right of this mark are favourable for DUPIXENT. The chart shows the data for DUPIXENT 300 mg versus placebo and DUPIXENT 200 mg versus placebo.

The LS mean difference in litres (95% CI) for DUPIXENT 300 mg and DUPIXENT 200 mg versus placebo in the “Overall” group is 0.13 (0.08 to 0.18) and 0.14 (0.08 to 0.19), respectively. The LS mean change from baseline is: 0.34 for DUPIXENT 300 mg (n=633) and 0.21 for placebo (n=321); 0.32 for DUPIXENT 200 mg (n=631) and 0.18 for placebo (n=317).

The LS mean difference in litres (95% CI) for DUPIXENT 300 mg and DUPIXENT 200 mg versus placebo in the “greater than or equal to 50” group is 0.39 (0.26 to 0.52) and 0.30 (0.17 to 0.44), respectively. The LS mean change from baseline is: 0.59 for DUPIXENT 300 mg (n=124) and 0.19 for placebo (n=75); 0.53 for DUPIXENT 200 mg (n=119) and 0.23 for placebo (n=71).

The LS mean difference in litres (95% CI) for DUPIXENT 300 mg and DUPIXENT 200 mg versus placebo in the “greater than or equal to 25 to less than 50” group is 0.12 (0.03 to 0.21) and 0.19 (0.09 to 0.28), respectively. The LS mean change from baseline is: 0.35 for DUPIXENT 300 mg (n=186) and 0.23 for placebo (n=97); 0.21 for DUPIXENT 200 mg (n=180) and 0.39 for placebo (n=91).

The LS mean difference in litres (95% CI) for DUPIXENT 300 mg and DUPIXENT 200 mg versus placebo in the “less than 25” group is 0.03 (-0.04 to 0.10) and 0.05 (-0.02 to 0.12), respectively. The LS mean change from baseline is: 0.23 for DUPIXENT 300 mg (n=317) and 0.20 for placebo (n=144); 0.20 for DUPIXENT 200 mg (n=325) and 0.15 for placebo (n=149).

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