Exacerbations by EOS Subgroup

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Exacerbations by EOS Subgroup

EFFICACY DATA

Annualized rates of severe exacerbation events by baseline EOS count in QUEST¹

Relative risk in annualized event rate of severe exacerbations across baseline blood EOS count (cells/mcL) in QUEST¹

Adapted from the Product Monograph.

Relative risk in annualized event rate of severe exacerbations across baseline blood EOS count in QUEST (bar chart) full text

Relative risk in annualized event rate of severe exacerbations across baseline blood EOS count (cells/mcL) in QUEST¹

Adapted from the Product Monograph.

Relative risk in annualized event rate of severe exacerbations across baseline blood EOS count in QUEST (Forest plot) full text

Severe exacerbations were defined as deterioration of asthma requiring the use of systemic corticosteroids for ≥3 days or hospitalization or emergency room visit due to asthma that required systemic corticosteroids.¹

EOS=eosinophil; CI=confidence interval.

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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.

Bar chart showing the relative risk in annualized event rate of severe exacerbations across baseline blood EOS count (cells per microlitre) in QUEST. The y-axis is the rate ratio (95% CI) versus placebo. The x-axis title is “Baseline blood EOS group (cells per microlitre)”. The x-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 chart shows the data for DUPIXENT 300 mg versus placebo and DUPIXENT 200 mg versus placebo.

The rate ratio (95% CI) for DUPIXENT 300 mg and DUPIXENT 200 mg versus placebo in the “Overall” group is 0.54 (0.43 to 0.68) and 0.52 (0.41 to 0.66), respectively. The event rates are: 0.52 for DUPIXENT 300 mg (n=633) and 0.97 for placebo (n=321); 0.46 for DUPIXENT 200 mg (n=631) and 0.87 for placebo (n=317).

The rate ratio (95% CI) for DUPIXENT 300 mg and DUPIXENT 200 mg versus placebo in the “greater than or equal to 500” group is 0.29 (0.18 to 0.45) and 0.26 (0.16 to 0.40), respectively. The event rates are: 0.36 for DUPIXENT 300 mg (n=141) and 1.25 for placebo (n=74); 0.34 for DUPIXENT 200 mg (n=145) and 1.33 for placebo (n=76).

The rate ratio (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 0.37 (0.22 to 0.60) and 0.50 (0.29 to 0.84), respectively. The event rates are: 0.45 for DUPIXENT 300 mg (n=136) and 1.22 for placebo (n=68); 0.40 for DUPIXENT 200 mg (n=119) and 0.80 for placebo (n=72).

The rate ratio (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 0.56 (0.35 to 0.89) and 0.64 (0.41 to 1.02), respectively. The event rates are: 0.47 for DUPIXENT 300 mg (n=175) and 0.84 for placebo (n=95); 0.56 for DUPIXENT 200 mg (n=173) and 0.87 for placebo (n=84).

The rate ratio (95% CI) for DUPIXENT 300 mg and DUPIXENT 200 mg versus placebo in the “less than 150” group is 1.15 (0.75 to 1.77) and 0.92 (0.58 to 1.47), respectively. The event rates are: 0.74 for DUPIXENT 300 mg (n=181) and 0.64 for placebo (n=83); 0.47 for DUPIXENT 200 mg (n=193) and 0.51 for placebo (n=85).

Forest plot showing the relative risk in annualized event rate of severe exacerbations across baseline blood EOS count (cells per microlitre) 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 rate ratio versus placebo. The x-axis ranges from 0.25 to 2.0. There is a vertical dotted line at the 1.0 mark. Results to the left of this mark are favourable for DUPIXENT. Results to the right of this mark are favourable for placebo. The chart shows the data for DUPIXENT 300 mg versus placebo and DUPIXENT 200 mg versus placebo.

The rate ratio (95% CI) for DUPIXENT 300 mg and DUPIXENT 200 mg versus placebo in the “Overall” group is 0.54 (0.43 to 0.68) and 0.52 (0.41 to 0.66), respectively. The event rates are: 0.52 for DUPIXENT 300 mg (n=633) and 0.97 for placebo (n=321); 0.46 for DUPIXENT 200 mg (n=631) and 0.87 for placebo (n=317).

The rate ratio (95% CI) for DUPIXENT 300 mg and DUPIXENT 200 mg versus placebo in the “greater than or equal to 500” group is 0.29 (0.18 to 0.45) and 0.26 (0.16 to 0.40), respectively. The event rates are: 0.36 for DUPIXENT 300 mg (n=141) and 1.25 for placebo (n=74); 0.34 for DUPIXENT 200 mg (n=145) and 1.33 for placebo (n=76).

The rate ratio (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 0.37 (0.22 to 0.60) and 0.50 (0.29 to 0.84), respectively. The event rates are: 0.45 for DUPIXENT 300 mg (n=136) and 1.22 for placebo (n=68); 0.40 for DUPIXENT 200 mg (n=119) and 0.80 for placebo (n=72).

The rate ratio (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 0.56 (0.35 to 0.89) and 0.64 (0.41 to 1.02), respectively. The event rates are: 0.47 for DUPIXENT 300 mg (n=175) and 0.84 for placebo (n=95); 0.56 for DUPIXENT 200 mg (n=173) and 0.87 for placebo (n=84).

The rate ratio (95% CI) for DUPIXENT 300 mg and DUPIXENT 200 mg versus placebo in the “less than 150” group is 1.15 (0.75 to 1.77) and 0.92 (0.58 to 1.47), respectively. The event rates are: 0.74 for DUPIXENT 300 mg (n=181) and 0.64 for placebo (n=83); 0.47 for DUPIXENT 200 mg (n=193) and 0.51 for placebo (n=85).

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