Table 1.
Baseline characteristics: weeks 0–24 (double-blind treatment period; intent-to-treat population)a
| Characteristics | PBO (N = 106) | ADA (N = 101) | IXEQ4W (N = 107) | IXEQ2W (N = 103) | Total (N = 417) |
|---|---|---|---|---|---|
| Age, years | 50.6 (12.3) | 48.6 (12.4) | 49.1 (10.1) | 49.8 (12.6) | 49.5 (11.9) |
| Male, n (%) | 48 (45.3) | 51 (50.5) | 45 (42.1) | 48 (46.6) | 192 (46.0) |
| Weight, kg | 83.8 (19.6) | 91.6 (21.9) | 85.5 (23.0) | 81.6 (17.5) | 85.6 (20.9) |
| Race, n (%) | |||||
| American Indian/Alaska Native | 2 (1.9) | 3 (3.0) | 2 (1.9) | 2 (1.9) | 9 (2.2) |
| Asian | 5 (4.7) | 3 (3.0) | 2 (1.9) | 5 (4.9) | 15 (3.6) |
| White | 99 (93.4) | 95 (94.1) | 102 (95.3) | 96 (93.2) | 392 (94.0) |
| Multiple | 0 | 0 | 1 (0.9) | 0 | 1 (0.2) |
| Conventional DMARD use, n (%) | |||||
| Naïve | 13 (12.3) | 14 (13.9) | 17 (15.9) | 17 (16.5) | 61 (14.6) |
| Past use | 24 (22.6) | 20 (19.8) | 22 (20.6) | 23 (22.3) | 89 (21.3) |
| Current use | 69 (65.1) | 67 (66.3) | 68 (63.6) | 63 (61.2) | 267 (64.0) |
| Current MTX use, n (%) | 59 (55.7) | 57 (56.4) | 57 (53.3) | 53 (51.5) | 226 (54.2) |
| Time since PsA diagnosis, years | 6.3 (6.9) | 6.9 (7.5) | 6.2 (6.4) | 7.2 (8.0) | 6.7 (7.2) |
| Tender joint count (68 joints) | 19.2 (13.0) | 19.3 (13.0) | 20.5 (13.7) | 21.5 (14.1) | 20.1 (13.4) |
| Swollen joint count (66 joints) | 10.6 (7.3) | 9.9 (6.5) | 11.4 (8.2) | 12.1 (7.2) | 11.0 (7.4) |
| Joint Pain Visual Analogue Scale | 58.5 (23.0) | 58.7 (19.7) | 60.1 (19.4) | 58.4 (21.7) | 58.9 (20.9) |
| HAQ-Disability Index | 1.2 (0.6) | 1.1 (0.6) | 1.2 (0.5) | 1.2 (0.6) | 1.2 (0.6) |
| Patients with current psoriasis, n (%) | 102 (96.2) | 97 (96.0) | 100 (93.5) | 95 (92.2) | 394 (94.5) |
| Body surface area ≥3%, n (%)b | 67 (67.7) | 68 (72.3) | 73 (73.0) | 59 (64.8) | 267 (69.5) |
| Psoriasis Area and Severity Indexc | 6.2 (7.5) | 5.5 (6.5) | 6.9 (6.6) | 6.0 (7.0) | 6.1 (6.9) |
| Dermatology Life Quality Indexb | 7.5 (5.6) | 6.7 (7.0) | 8.0 (6.0) | 8.8 (5.9) | 7.7 (6.2) |
| SF-36 Physical Component Summary | 34.0 (8.3) | 33.9 (8.8) | 32.4 (10.1) | 34.2 (8.7) | 33.6 (9.0) |
| SF-36 Mental Component Summary | 47.4 (12.5) | 46.6 (11.7) | 46.5 (13.4) | 48.0 (9.8) | 47.1 (11.9) |
| SF-36 domain scores | |||||
| Physical functioning | 46.9 (25.5) | 46.0 (25.5) | 41.5 (24.4) | 46.3 (25.7) | 45.1 (25.3) |
| Role physical | 47.3 (23.5) | 45.5 (24.9) | 43.3 (26.0) | 49.8 (25.1) | 46.5 (24.9) |
| Bodily pain | 40.2 (19.1) | 41.3 (18.1) | 37.9 (18.6) | 41.3 (17.8) | 40.2 (18.4) |
| General health | 45.3 (17.7) | 45.2 (18.7) | 44.3 (18.7) | 46.2 (17.6) | 45.2 (18.1) |
| Vitality | 46.2 (21.1) | 42.9 (21.9) | 40.0 (20.5) | 45.2 (19.9) | 43.6 (20.9) |
| Social functioning | 64.6 (27.3) | 65.2 (26.8) | 65.5 (27.4) | 68.4 (22.9) | 65.9 (26.1) |
| Mental health | 65.4 (21.7) | 64.9 (20.3) | 62.0 (22.2) | 66.6 (16.7) | 64.7 (20.4) |
| Role emotional | 74.6 (27.3) | 71.9 (26.6) | 73.3 (26.1) | 74.4 (23.2) | 73.6 (25.8) |
| EQ-5D VAS | 53.9 (22.3) | 56.5 (19.9) | 54.1 (20.6) | 57.1 (19.2) | 55.4 (20.5) |
| Itch Numeric Rating Scaled | 4.6 (2.4) | 4.3 (2.8) | 4.6 (2.5) | 5.1 (2.6) | 4.6 (2.6) |
| WPAI-SH | |||||
| Absenteeism | 8.9 (24.5) | 8.7 (21.4) | 9.2 (21.0) | 7.7 (23.0) | 8.6 (22.3) |
| Presenteeism | 32.4 (21.2) | 37.3 (24.5) | 40.0 (26.7) | 35.8 (21.6) | 36.6 (23.8) |
| Work productivity | 34.6 (23.4) | 40.6 (25.2) | 42.3 (28.5) | 37.4 (21.6) | 38.9 (24.9) |
| Activity impairment | 46.1 (24.7) | 46.9 (26.0) | 47.9 (26.3) | 47.1 (23.4) | 47.0 (25.1) |
Unless indicated, values are mean (s.d.).
a
Data from: Mease PJ et al. Ann Rheum Dis 2017;76:79–87.
b
Patients with psoriasis and body surface area measured at baseline.
c
Patients with psoriasis.
d
Patients with baseline psoriatic lesions ≥3% of body surface area. ADA: Adalimumab; IXEQ4W/Q2W: ixekizumab every 4 or 2 weeks; EQ-5D VAS: European Quality of Life 5 Dimensions Visual Analogue Scale; N: population size; n: number in group; PBO: placebo; SF-36: 36-Item Short Form Health Survey; WPAI-SH: Work Productivity and Activity Impairment-Specific Health Problem.