Table 2.
Demographic and baseline characteristics of patients included in the placebo‐controlled period data set (SPIRIT‐P1 and SPIRIT‐P2), according to treatment groupa
Characteristic | Placebo (N = 224) | IXEQ4W (N = 229) | IXEQ2W (N = 225) | Total IXE (N = 454) |
---|---|---|---|---|
Age, mean ± SD years | 51.1 ± 11.33 | 50.9 ± 12.16 | 50.9 ± 12.22 | 50.9 ± 12.18 |
≥65 years, no. (%) | 25 (11.2) | 34 (14.8) | 35 (15.6) | 69 (15.2) |
Sex, no. (%) | ||||
Male | 104 (46.4) | 108 (47.2) | 97 (43.1) | 205 (45.2) |
Female | 120 (53.6) | 121 (52.8) | 128 (56.9) | 249 (54.8) |
White race, no. (%)b | 207 (92.4) | 213 (93.0) | 208 (92.9) | 421 (92.9) |
Weight, mean ± SD kg | 88.0 ± 21.58 | 87.8 ± 22.54 | 83.5 ± 19.25 | 85.7 ± 21.06 |
BMI, mean ± SD kg/m2 b | 30.6 ± 7.25 | 30.6 ± 7.73 | 29.4 ± 6.70 | 30.0 ± 7.26 |
Tobacco use, no. (%)c | 72 (32.3) | 89 (38.9) | 86 (38.1) | 175 (38.5) |
cDMARD‐experienced, no. (%)d | 121 (54.0) | 128 (55.9) | 136 (60.2) | 264 (58.0) |
MTX at baseline, no. (%)d | 99 (44.2) | 105 (45.9) | 114 (50.4) | 219 (48.1) |
Corticosteroids at baseline, no. (%) | 31 (13.8) | 29 (12.7) | 44 (19.6) | 73 (16.1) |
Time since PsA onset, mean ± SD yearsd | 10.4 ± 8.55 | 11.7 ± 10.21 | 10.9 ± 9.04 | 11.3 ± 9.65 |
Time since psoriasis onset, mean ± SD yearsd | 17.5 ± 12.71 | 18.3 ± 13.17 | 18.6 ± 13.68 | 18.5 ± 13.41 |
Active psoriasis with BSA ≥3%, no. (%)e | 134 (65.0) | 141 (67.1) | 127 (63.8) | 268 (65.5) |
No. of tender joints (68 assessed), mean ± SDc | 21.2 ± 14.88 | 21.3 ± 13.88 | 23.4 ± 15.97 | 22.4 ± 14.98 |
No. of swollen joints (66 assessed), mean ± SDc | 10.4 ± 7.29 | 12.3 ± 9.90 | 12.9 ± 9.79 | 12.6 ± 9.84 |
CRP >6 mg/liter, no. (%)c | 122 (55.0) | 129 (57.1) | 107 (47.3) | 236 (52.2) |
Unless indicated, data are from the safety population. BMI = body mass index; BSA = body surface area; MTX = methotrexate (see Table 1 for other definitions).
Data are missing for some patients; the actual denominator of a particular baseline measure is the number of patients with no missing data for baseline measures.
Baseline data are missing for some patients; the actual denominator of a particular baseline measure is the number of patients with no missing data for baseline measures. Data are from the intent‐to‐treat (ITT) population (226 for IXEQ2W and 455 for total IXE).
Data are from the ITT population (226 for IXEQ2W and 455 for total IXE).
Among patients with plaque psoriasis in the ITT population (206 for placebo, 210 for IXEQ4W, 199 for IXEQ2W, and 409 for total IXE).