TABLE 1.
Baseline demographic and disease characteristics in phase 2b and phase 3 QUEST studies by baseline ICS dose
| Dupilumab phase 2b | Dupilumab phase 3 QUEST | ||||||
|---|---|---|---|---|---|---|---|
| Placebo a |
Dupilumab 200 mg q2w |
Dupilumab 300 mg q2w |
Matching placebo to dupilumab 200 mg q2w |
Dupilumab 200 mg q2w |
Matching placebo to dupilumab 300 mg q2w |
Dupilumab 300 mg q2w |
|
| High‐dose ICS at baseline, n | 77 | 75 | 79 | 172 | 317 | 167 | 323 |
| Age, mean (SD), years | 50.3 (10.9) | 54.0 (11.6) | 48.3 (12.4) | 48.9 (14.1) | 49.5 (13.8) | 49.5 (13.9) | 49.1 (14.9) |
| Age <18 y, n (%) | 0 | 0 | 0 | 6 (3.5) | 6 (1.9) | 3 (1.8) | 11 (3.4) |
| Female sex, n (%) | 54.0 (70.1) | 43 (57.3) | 52 (65.8) | 110 (64.0) | 199 (62.8) | 119 (71.3) | 203 (62.8) |
| Ongoing atopic medical condition, n (%) | 57 (75.0) | 52 (69.3) | 59 (74.7) | 147 (85.5) | 257 (81.1) | 136 (81.4) | 262 (81.1) |
| Prebronchodilator FEV1, mean (SD), L | 1.70 (0.50) | 1.73 (0.54) | 1.80 (0.53) | 1.74 (0.55) | 1.69 (0.56) | 1.65 (0.50) | 1.70 (0.60) |
| Percent predicted, mean (SD) | 58.97 (10.79) | 59.45 (11.45) | 60.14 (10.79) | 58.10 (12.77) | 56.38 (13.48) | 56.43 (13.33) | 56.37 (14.40) |
| Postbronchodilator FEV1, mean (SD), L | NA | NA | NA | 2.11 (0.62) | 2.06 (0.69) | 2.03 (0.61) | 2.11 (0.71) |
| FEV1 reversibility b , mean (SD), % | 25.79 (12.12) | 25.61 (19.02) | 27.59 (17.25) | 23.57 (15.65) | 28.23 (23.58) | 27.04 (16.43) | 28.20 (26.72) |
| Severe asthma exacerbations in past year, mean (SD), n | 2.57 (2.72) | 2.19 (1.75) | 2.77 (2.77) | 2.26 (1.77) | 2.24 (2.11) | 2.57 (2.33) | 2.22 (1.67) |
| ACQ‐5 score c , mean (SD) | 2.82 (0.82) | 2.88 (0.74) | 2.98 (0.86) | 2.82 (0.76) | 2.90 (0.87) | 2.89 (0.82) | 2.91 (0.79) |
| AQLQ(S) global score, mean (SD) | 3.84 (1.06) | 3.91 (1.16) | 3.70 (1.15) | 4.15 (1.05) | 4.18 (1.10) | 4.13 (1.04) | 4.04 (1.02) |
| Biomarker levels | |||||||
| Blood eosinophil count, median (IQR), cells/µL | 280.0 (190.0‐450.0) | 280.0 (150.0‐550.0) | 260.0 (160.0‐420.0) | 280.0 (130.0‐485.0) | 250.0 (130.0‐470.0) | 280.0 (150.0‐510.0) | 250.0 (130.0‐470.0) |
| Total IgE, median (IQR), IU/mL | 216.0 (94.0‐463.0) | 151.0 (47.0‐428.0) | 163.0 (78.0‐405.0) | 176.0 (52.0‐406.0) | 151.0 (51.0‐459.0) | 160.5 (62.0‐363.0) | 175.5 (59.5‐450.0) |
| FeNO, median (IQR), ppb | 30.0 (18.0‐41.0) | 27.0 (15.0‐41.0) | 29.0 (13.0‐62.0) | 23.0 (14.0‐38.0) | 23.0 (14.0‐39.0) | 27.0 (15.5‐43.5) | 24.0 (15.0‐42.0) |
| Medium‐dose ICS at baseline, n | 78 | 69 | 74 | 144 | 310 | 151 | 303 |
| Age, mean (SD), years | 47.4 (14.1) | 47.9 (14.6) | 46.7 (12.6) | 47.5 (17.3) | 46.2 (16.6) | 46.7 (15.5) | 46.4 (16.1) |
| Age <18 y, n (%) | 0 | 0 | 0 | 15 (10.4) | 28 (9.0) | 15 (9.9) | 23 (7.6) |
| Female sex, n (%) | 48 (61.5) | 47 (68.1) | 48 (64.9) | 87 (60.4) | 186 (60.0) | 96 (63.6) | 191 (61.6) |
| Ongoing atopic medical condition, n (%) | 55 (73.3) | 55 (80.9) | 49 (69.0) | 118 (81.9) | 249 (80.3) | 127 (84.1) | 255 (84.2) |
| Prebronchodilator FEV1, mean (SD), L | 1.95 (0.58) | 1.87 (0.52) | 1.91 (0.54) | 1.80 (0.67) | 1.88 (0.66) | 1.86 (0.62) | 1.87 (0.59) |
| Percent predicted, mean (SD) | 62.9 (10.5) | 62.9 (10.3) | 61.3 (10.2) | 58.9 (13.7) | 60.4 (13.2) | 60.4 (14.3) | 60.6 (12.2) |
| Postbronchodilator FEV1, mean (SD), L | NA | NA | NA | 2.23 (0.79) | 2.27 (0.79) | 2.25 (0.77) | 2.24 (0.73) |
| FEV1 reversibility b , mean (SD), % | 29.84 (16.08) | 27.89 (16.40) | 26.89 (15.92) | 27.17 (21.48) | 26.39 (21.95) | 25.99 (19.05) | 23.31 (20.14) |
| Severe asthma exacerbations in past year, mean (SD), n | 1.95 (1.67) | 1.45 (0.83) | 1.96 (1.59) | 1.85 (1.30) | 1.91 (3.14) | 2.03 (1.71) | 1.82 (2.03) |
| ACQ‐5 score c , mean (SD) | 2.57 (0.76) | 2.55 (0.86) | 2.64 (0.68) | 2.59 (0.68) | 2.62 (0.70) | 2.61 (0.69) | 2.62 (0.70) |
| AQLQ(S) global score d , mean (SD) | 4.35 (1.10) | 4.19 (1.15) | 4.14 (1.07) | 4.39 (0.97) | 4.43 (1.05) | 4.52 (0.98) | 4.53 (1.03) |
| Biomarker levels | |||||||
| Blood eosinophil count, median (IQR), cells/µL | 245.0 (150.0‐420.0) | 240.0 (180.0‐400.0) | 270.0 (160.0‐380.0) | 260.0 (140.0‐490.0) | 250.0 (120.0‐450.0) | 245.0 (130.0‐420.0) | 250.0 (130.0‐450.0) |
| Total IgE, median (IQR), IU/mL | 182.0 (84.0‐430.0) | 237.0 (51.0‐647.0) | 168.5 (73.0‐409.0) | 173.5 (75.0‐493.0) | 158.0 (65.0‐441.0) | 188.0 (52.5‐482.0) | 172.5 (66.0‐454.0) |
| FeNO, median (IQR), ppb | 28.0 (16.0‐53.0) | 32.0 (18.0‐52.0) | 28.0 (16.0‐48.0) | 27.0 (16.0‐51.5) | 24.0 (16.0‐47.0) | 27.0 (16.0‐51.0) | 24.0 (13.0‐43.0) |
Abbreviations: ACQ‐5, 5‐Item Asthma Control Questionnaire; AQLQ[S], Asthma Quality of Life Questionnaire [Standardized]; FeNO, fractional exhaled nitric oxide; FEV1, forced expiratory volume in 1 s; HRQoL, health‐related quality of life; ICS, inhaled corticosteroids; IgE, immunoglobulin E; IQR, interquartile range; NA, not applicable; ppb, parts per billion; q2w, every 2 wk; SD, standard deviation.
In the phase 2b study, the same amount of placebo was given regardless of dupilumab dose (not volume‐matched).
Forced expiratory volume in 1 s (L) reversibility indicates the change in FEV1 between prebronchodilator and postbronchodilator measurements.
5‐item asthma control questionnaire is a patient‐reported measure of the adequacy of asthma control and change in asthma control that occurs either spontaneously or as a result of treatment. Scores range between 0 (totally controlled) and 6 (severely uncontrolled).
Asthma quality of life questionnaire (standardized) is a patient‐reported measure of asthma‐specific HRQoL. Higher scores indicate better HRQoL; a global score is rated on a 7‐point Likert‐like scale (7 = “not impaired at all” to 1 = “severely impaired”).