TABLE 1.
Demographics and baseline disease characteristics
| Demographics | OMA 300 N = 168 | OMA 150 N = 167 | Placebo N = 83 | Total N = 418 |
|---|---|---|---|---|
| Age (years) | ||||
| Median (range) | 38.0 (20–67) | 36.0 (18–67) | 42.0 (22–72) | 38.0 (18–72) |
| Age group in years, n (%) | ||||
| <65 | 164 (97.6) | 163 (97.6) | 79 (95.2) | 406 (97.1) |
| ≥65 | 4 (2.4) | 4 (2.4) | 4 (4.8) | 12 (2.9) |
| Sex female, n (%) | 115 (68.5) | 108 (64.7) | 53 (63.9) | 276 (66.0) |
| BMI (kg/m2), mean (SD) | 23.35 (3.26) | 23.53 (3.10) | 23.72 (2.81) | 23.49 (3.11) |
| Baseline disease characteristics | ||||
| Duration of CSU (years), mean (SD) | 4.18 (6.16) | 4.11 (5.26) | 4.79 (6.46) | 4.27 (5.87) |
| Prior medication for CSU, n (%) | ||||
| ≤3 | 49 (29.2) | 52 (31.1) | 25 (30.1) | 126 (30.1) |
| >3 | 119 (70.8) | 115 (68.9) | 58 (69.9) | 292 (69.9) |
| Prior systemic treatment for CSU yes, n (%) | 101 (60.1) | 103 (61.7) | 52 (62.7) | 256 (61.2) |
| Total IgE (ng/ml), median (range) |
230 (6.6–3170) |
272 (0–3770) |
232 (12.1–2810) |
256 (0–3770) |
| In‐clinic UAS, mean (SD) | 4.4 (1.25) | 4.6 (1.21) | 4.7 (1.13) | 4.6 (1.21) |
| ISS7, mean (SD) | 14.38 (3.87) | 14.92 (3.90) | 16.11 (3.76) | 14.94 (3.90) |
| UAS7, mean (SD) | 30.52 (7.38) | 31.94 (7.10) | 33.96 (6.81) | 31.77 (7.25) |
| NHS7, mean (SD) | 16.14 (4.33) | 17.02 (4.04) | 17.84 (3.91) | 16.83 (4.17) |
| Angioedema yes, n (%) | 29 (17.3) | 43 (25.7) | 23 (27.7) | 95 (22.7) |
Note: Duration of CSU is calculated from the date of diagnosis of CSU recorded on the visit 1. Previous numbers of CSU medication and systemic treatment for CSU are collected at visit 1. Baseline related to eDiary data is defined over the 7 days prior to the first treatment date (or prior the randomization date when a patient did not take any study medication). Other baseline disease characteristics are defined as the last non‐missing assessment collected before or on the first treatment date (or before or on the randomization date when a patient did not take any study medication). Total IgE values below the lower limit of quantification (4.80 ng/ml) were set to 0.
Abbreviations: BMI, body mass index; CSU, chronic spontaneous urticaria; IgE, immunoglobulin E; ISS7, weekly Itch Severity Score; NHS7, weekly Number of Hives Score; OMA, omalizumab; UAS7, weekly Urticaria Activity Score.