Table 1.
Demographics and disease characteristics
| SPIRIT-P1 | SPIRIT-P2 | ||||||||
| PBO (N=106) |
IXE Q4W (N=107) |
IXE Q2W (N=103) |
ADA Q2W* (N=101) |
Total (N=417) |
PBO (N=118) |
IXE Q4W (N=122) |
IXE Q2W (N=123) |
Total (N=363) |
|
| Age, years | 50.6 (12.3) | 49.1 (10.1) | 49.8 (12.6) | 48.6 (12.4) | 49.5 (11.9) | 51.5 (10.4) | 52.6 (13.6) | 51.7 (11.9) | 51.9 (12.0) |
| Male, n (%) | 48 (45.3) | 45 (42.1) | 48 (46.6) | 51 (50.5) | 192 (46.0) | 56 (47.5) | 63 (51.6) | 50 (40.7) | 169 (46.6) |
| White, n (%) | 99 (93.4) | 102 (95.3) | 96 (93.2) | 95 (94.1) | 392 (94.0) | 108 (91.5) | 111 (91.0) | 113 (92.6) | 332 (91.7) |
| CRP, mg/L | 15.1 (23.6) | 12.8 (16.4) | 15.1 (25.9) | 13.2 (19.1) | 14.1 (21.5) | 12.1 (19.6) | 17.0 (27.5) | 13.5 (26.1) | 14.2 (24.7) |
| TJC 68 | 19.2 (13.0) | 20.5 (13.7) | 21.5 (14.1) | 19.3 (13.0) | 20.1 (13.4) | 23.0 (16.2) | 22.0 (14.1) | 25.0 (17.3) | 23.4 (15.9) |
| SJC 66 | 10.6 (7.3) | 11.4 (8.2) | 12.1 (7.2) | 9.9 (6.5) | 11.0 (7.4) | 10.3 (7.4) | 13.1 (11.2) | 13.5 (11.5) | 12.3 (10.3) |
| Time since PsO diagnosis, years | 16.0 (13.8) | 16.5 (13.8) | 17.0 (14.0) | 15.7 (12.7) | 16.3 (13.5) | 15.3 (12.6) | 15.7 (12.3) | 16.5 (13.0) | 15.8 (12.6) |
| Time since PsA diagnosis, years | 6.3 (6.9) | 6.2 (6.4) | 7.2 (8.0) | 6.9 (7.5) | 6.7 (7.2) | 9.2 (7.3) | 11.0 (9.6) | 9.9 (7.4) | 10.0 (8.2) |
| Fatigue NRS score | 5.4 (2.2) | 5.4 (2.3) | 5.8 (2.3) | 5.5 (2.4) | 5.5 (2.3) | 5.9 (2.3) | 5.9 (2.5) | 6.0 (2.5) | 6.0 (2.4) |
Data are mean (SD) unless otherwise stated.
*ADA Q2W was an active reference arm for comparison with PBO in the SPIRIT-P1 trial; the trial was not powered to test equivalence or non-inferiority of ixekizumab versus adalimumab.
ADA Q2W, adalimumab 40 mg every 2 weeks; CRP, C reactive protein; IXE Q2W, ixekizumab 80 mg every 2 weeks; IXE Q4W, ixekizumab 80 mg every 4 weeks; n, number of patients in the specified category; N, number of patients in the analysis population; NRS, numeric rating scale; PBO, placebo; PsA, psoriatic arthritis; PsO, psoriasis; SJC 66, swollen joint count out of 66 joints; SPIRIT, Standard Protocol Items: Recommendations for Interventional Trials; TJC 68, tender joint count out of 68 joints.