Dupilumab Efficacy in Patients with Type 2 Asthma with and without Elevated Blood Neutrophils
Table 1
Baseline characteristics for patients with elevated type 2 biomarkers with or without elevated neutrophil counts at baseline.
Patients with blood eosinophils ≥150 cells/µL or FeNO ≥ 20 ppb at baseline
Patients with blood eosinophils ≥300 cells/µL or FeNO ≥ 50 ppb at baseline
Neutrophils < 4,000 cells/µL
Neutrophils ≥ 4,000 cells/µL
Neutrophils < 4,000 cells/µL
Neutrophils ≥ 4,000 cells/µL
Combined PBO (n = 259)
Combined DPL (n = 508)
Combined PBO (n = 284)
Combined DPL (n = 531)
Combined PBO (n = 176)
Combined DPL (n = 296)
Combined PBO (n = 161)
Combined DPL (n = 322)
Age, mean (SD) (years)
48.1 (15.9)
46.7 (16.3)
47.7 (14.3)
48.1 (14.4)
47.9 (16.0)
46.3 (16.1)
46.6 (14.9)
47.0 (14.2)
Age 12–18 years, n (%)
23 (8.9)
37 (7.3)
10 (3.5)
16 (3.0)
16 (9.1)
24 (8.1)
7 (4.3)
11 (3.4)
Female sex, n (%)
165 (63.7)
302 (59.4)
179 (63.0)
323 (60.8)
111 (63.1)
173 (58.4)
96 (59.6)
201 (62.4)
Prebronchodilator FEV1, mean (SD) (L)
1.79 (0.62)
1.86 (0.65)
1.74 (0.56)
1.75 (0.58)
1.74 (0.63)
1.87 (0.65)
1.80 (0.59)
1.70 (0.56)
Percent predicted FEV1, mean (SD) (L)
59.4 (13.1)
60.0 (12.9)
57.2 (13.8)
57.0 (13.9)
58.1 (13.9)
60.2 (12.6)
57.9 (13.8)
55.4 (14.4)
Postbronchodilator FEV1, mean (SD) (L)
2.17 (0.73)
2.26 (0.77)
2.16 (0.69)
2.12 (0.70)
2.14 (0.73)
2.31 (0.77)
2.22 (0.71)
2.06 (0.67)
FEV1 reversibility, mean (SD) (%)
25.1 (17.4)
27.2 (23.4)
27.2 (19.0)
26.1 (20.6)
26.2 (18.0)
27.4 (23.5)
26.3 (20.0)
26.0 (19.5)
Severe asthma exacerbations† in past year, mean (SD)
2.22 (1.98)
1.91 (1.61)
2.23 (1.84)
2.18 (2.86)
2.32 (2.08)
2.07 (1.79)
2.20 (1.67)
2.28 (2.21)
High-dose ICS at baseline, n (%)
134 (51.7)
229 (45.1)
152 (53.5)
297 (55.9)
87 (49.4)
130 (43.9)
89 (55.3)
179 (55.6)
With ongoing atopic medical condition,‡n (%)
215 (83.0)
427 (84.1)
241 (84.9)
438 (82.5)
145 (82.4)
258 (87.2)
141 (87.6)
260 (80.7)
ACQ-5 score, mean (SD)
2.75 (0.74)
2.66 (0.73)
2.75 (0.77)
2.88 (0.83)
2.80 (0.75)
2.62 (0.73)
2.80 (0.74)
2.90 (0.86)
AQLQ(S) global score, mean (SD)
4.33 (1.04)
4.42 (1.03)
4.20 (1.00)
4.20 (1.10)
4.26 (1.03)
4.45 (1.03)
4.16 (0.94)
4.20 (1.10)
Blood eosinophil count, median (IQR) (cells/µL)
340.0 (200.0–540.0)
300.0 (180.0–495.0)
280.0 (190.0–525.0)
320.0 (180.0–560.0)
440.0 (340.0–685.0)
440.0 (340.0–650.0)
480.0 (370.0–780.0)
490.0 (340.0–710.0)
Total IgE, median (IQR) (IU/mL)
207.5 (75.0–456.0)
192.0 (69.0–522.0)
212.0 (73.0–503.5)
167.5 (77.0–499.0)
244.0 (82.0–507.0)
214.0 (94.0–574.0)
298.0 (102.5–636.0)
214.0 (88.0–587.0)
FeNO, median (IQR) (ppb)
32.0 (20.0–54.0)
29.0 (19.0–53.0)
29.00 (18.0–49.0)
27.00 (18.0–43.0)
42.0 (24.0–65.0)
43.5 (25.0–68.0)
40.0 (22.0–67.0)
33.0 (21.0–60.0)
Note: ACQ-5 = 5-item Asthma Control Questionnaire; AQLQ(S) = standardized Asthma Quality of Life Questionnaire; DPL = dupilumab; FeNO = fractional exhaled nitric oxide; FEV1 = forced expiratory volume in 1 s; ICS = inhaled corticosteroids; IgE = immunoglobulin E; IQR = interquartile range; PBO = placebo; ppb = parts per billion; SD = standard deviation. †Severe asthma exacerbation prior to the study is defined as any treatment with one or more systemic (oral or parenteral) steroid bursts for worsening asthma, or hospitalization, or an emergency/urgent medical care visit for worsening asthma. ‡A patient is considered to have an ongoing atopic medical condition if they have any of the following ongoing conditions: atopic dermatitis, allergic conjunctivitis or rhinitis, eosinophilic esophagitis, food allergy, hives, or has baseline total IgE ≥ 100 IU/mL and at least one aero-antigen–specific IgE is positive (≥0.35 IU/mL) at baseline.
