Table 1.
Baseline Demographics and Clinical Characteristics
| Demographic or Characteristic | Tezepelumab 210 mg Q4W (n = 665) |
Placebo (n = 669) |
|---|---|---|
| Age, yr, mean (SD) | 50.5 (15.6) | 49.7 (15.2) |
| Female, n (%) | 422 (63.5) | 431 (64.4) |
| BMI, kg/m2, mean (SD) | 28.7 (6.7) | 28.3 (6.6) |
| ICS dose subgroup,* n (%) | ||
| Medium | 201 (30.2) | 205 (30.6) |
| High | 464 (69.8) | 463 (69.2) |
| Maintenance OCS use, n (%)† | 58 (8.7) | 65 (9.7) |
| Prebronchodilator FEV1, L, mean (SD) | 1.8 (0.7) | 1.8 (0.7) |
| Prebronchodilator FEV1, % predicted, mean (SD) | 62.0 (17.1) | 62.2 (17.2) |
| Number of exacerbations in the past 12 mo,‡ n (%) | ||
| 1 | 3 (0.5) | 4 (0.6) |
| 2 | 412 (62) | 431 (64.4) |
| ≥3 | 250 (37.6) | 234 (35.0) |
| FeNO level, ppb | ||
| Mean (SD) | 39.4 (35.3) | 44.5 (43.8) |
| Median (min, max) | 28 (4, 235) | 28 (4, 276) |
| FeNO subgroup, ppb, n (%) | ||
| <25 | 291 (43.8) | 294 (43.9) |
| ≥25–<50 | 191 (28.7) | 181 (27.1) |
| ≥50 | 175 (26.3) | 189 (28.3) |
| Blood eosinophil count, cells/μl | ||
| Mean (SD) | 335 (306) | 359 (460) |
| Median (min, max) | 260 (0, 3,650) | 260 (0, 8,170) |
| Blood eosinophil count subgroup, cells/μl, n (%) | ||
| <300 | 379 (57.0) | 382 (57.1) |
| ≥300 | 286 (43.0) | 287 (42.9) |
| <150 | 166 (25.0) | 171 (25.6) |
| 150–<300 | 213 (32.0) | 211 (31.5) |
| 300–<450 | 127 (19.1) | 116 (17.3) |
| ≥450 | 159 (23.9) | 171 (25.6) |
| Serum total IgE, IU/ml | ||
| Mean (SD) | 509.1 (1,064.9) | 585.3 (1,183.8) |
| Median (min, max) | 177.1 (1.5, 12,823.2) | 182.8 (1.5, 11,859.6) |
| FEIA positive for any perennial aeroallergen,§ n (%) | 410 (61.7) | 405 (60.5) |
Definition of abbreviations: BMI = body mass index; FEIA = fluorescence enzyme immunoassay; FeNO = fractional exhaled nitric oxide; ICS = inhaled corticosteroid; max = maximum; min = minimum; NAVIGATOR = Study to Evaluate Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma; OCS = oral corticosteroid; PATHWAY = Study to Evaluate the Efficacy and Safety of MEDI9929 (AMG 157) in Adult Subjects With Inadequately Controlled, Severe Asthma; Q4W = every 4 weeks.
Medium-dose ICS: fluticasone propionate 500 μg/d (in NAVIGATOR) or 250 to <500 μg/d (in PATHWAY) or equivalent; high-dose ICS: fluticasone propionate >500 μg/d or equivalent. There was one patient in the placebo group who received fluticasone propionate <500 μg/d or equivalent.
Mean daily maintenance OCS dose of 11 mg (min, 2.5 mg; max, 40 mg).
Patients in PATHWAY were required to have a history of at least two asthma exacerbations that led to systemic corticosteroid treatment, or at least one severe exacerbation that was associated with hospitalization, in the 12 months before study entry.
Positive for at least one perennial aeroallergen (cat dander, dog dander, cockroach, dust mite [Dermatophagoides farinae or Dermatophagoides pteronyssinus], and mold mix).