Baseline characteristics of the patients according to treatment group
| Placebo | IXEQ4W | IXEQ2W | Adalimumab 40 mg Q2W* | Total | |
|---|---|---|---|---|---|
| N=106 | N=107 | N=103 | N=101 | N=417 | |
| Age (years), mean (SD) | 50.6 (12.3) | 49.1 (10.1) | 49.8 (12.6) | 48.6 (12.4) | 49.5 (11.9) |
| Male, n (%) | 48 (45.3) | 45 (42.1) | 48 (46.6) | 51 (50.5) | 192 (46.0) |
| Weight (kg), mean (SD) | 83.8 (19.6) | 85.5 (23.0) | 81.6 (17.5) | 91.6 (21.9)† | 85.6 (20.9) |
| BMI (kg/m2), mean (SD) | 29.2 (6.3) | 30.2 (8.4) | 28.6 (6.6) | 32.1 (11.4)‡ | 30 (8.5) |
| Race, n (%) | |||||
| White | 99 (93.4) | 102 (95.3) | 96 (93.2) | 95 (94.1) | 392 (94.0) |
| Asian | 5 (4.7) | 2 (1.9) | 5 (4.9) | 3 (3.0) | 15 (3.6) |
| American Indian or Alaska native | 2 (1.9) | 2 (1.9) | 2 (1.9) | 3 (3.0) | 9 (2.2) |
| Other | 0 | 1 (0.9) | 0 | 0 | 1 (0.2) |
| Time since psoriatic arthritis diagnosis (years), mean (SD) | 6.3 (6.9) | 6.2 (6.4) | 7.2 (8.0) | 6.9 (7.5) | 6.7 (7.2) |
| Time since psoriasis diagnosis (years), mean (SD) | 16.0 (13.8) | 16.5 (13.8) | 17.0 (14.0) | 15.7 (12.7) | 16.3 (13.5) |
| Background cDMARD therapy, n (%) | |||||
| Naïve | 13 (12.3) | 17 (15.9) | 17 (16.5) | 14 (13.9) | 61 (14.6) |
| Past use | 24 (22.6) | 22 (20.6) | 23 (22.3) | 20 (19.8) | 89 (21.3) |
| Current use | 69 (65.1) | 68 (63.6) | 63 (61.2) | 67 (66.3) | 267 (64.0) |
| Methotrexate current use, n (%) | 59 (55.7) | 57 (53.3) | 53 (51.5) | 57 (56.4) | 226 (54.2) |
| Patients with specific disease characteristics, n (%) | |||||
| Current psoriasis§ | 102 (96.2) | 100 (93.5) | 95 (92.2) | 97 (96.0) | 394 (94.5) |
| Psoriasis BSA ≥3%¶ | 67 (67.7) | 73 (73.0) | 59 (64.8) | 68 (72.3) | 267 (69.5) |
| Fingernail psoriasis§ | 74 (69.8) | 70 (65.4) | 74 (71.8) | 71 (70.3) | 289 (69.3) |
| Dactylitis§ | 39 (36.8) | 54 (50.5) | 41 (39.8) | 23 (22.8)‡ | 157 (37.6) |
| Enthesitis§ | 57 (53.8) | 70 (65.4) | 59 (57.3) | 56 (55.4) | 242 (58.0) |
| Baseline disease and quality of life scores, mean (SD) | |||||
| Tender joint count (68 joints) | 19.2 (13.0) | 20.5 (13.7) | 21.5 (14.1) | 19.3 (13.0) | 20.1 (13.4) |
| Swollen joint count (66 joints) | 10.6 (7.3) | 11.4 (8.2) | 12.1 (7.2) | 9.9 (6.5) | 11.0 (7.4) |
| HAQ-DI | 1.2 (0.60) | 1.2 (0.54) | 1.2 (0.57) | 1.1 (0.59) | 1.2 (0.58) |
| Patient-reported pain VAS 0–100 | 58.5 (23.0) | 60.1 (19.4) | 58.4 (21.7) | 58.7 (19.7) | 58.9 (20.9) |
| Patient-assessed global disease activity VAS 0–100 | 61.1 (22.7) | 62.7 (19.1) | 62.5 (19.9) | 59.1 (19.1) | 61.4 (20.2) |
| Physician-assessed global disease activity VAS 0–100 | 55.9 (19.3) | 57.6 (18.7) | 58.5 (19.0) | 55.4 (18.7) | 56.9 (18.9) |
| CRP (mg/L) | 15.1 (23.6) | 12.8 (16.4) | 15.1 (25.9) | 13.2 (19.1) | 14.1 (21.5) |
| mTSS | 17.6 (28.6) | 19.2 (32.7) | 15.2 (28.9) | 15.9 (27.4) | 17.0 (29.4) |
| DAS28-CRP | 4.9 (1.0) | 5.0 (1.0) | 5.0 (1.1) | 4.9 (1.0) | 4.9 (1.0) |
| LEI** | 2.9 (1.7) | 2.7 (1.6) | 3.1 (1.8) | 3.0 (1.6) | 2.9 (1.7) |
| LDI-B†† | 46.2 (65.5) | 58.1 (96.7) | 40.6 (54.6) | 93.9 (111.9)‡ | 55.8 (83.6) |
| LDI-B‡‡ | 62.7 (69.3) | 73.0 (103.4) | 64.0 (56.6) | 119.9 (113.5)‡ | 75.9 (89.4) |
| % Psoriasis BSA involved¶ | 14.4 (20.2) | 15.1 (16.3) | 12.0 (15.6) | 14.8 (19.2) | 14.1 (17.9) |
| PASI total score¶ | 6.2 (7.5) | 6.9 (6.6) | 6.0 (7.0) | 5.5 (6.5) | 6.1 (6.9) |
| NAPSI§§ | 19.8 (17.2) | 21.3 (18.9) | 25.0 (21.2) | 20.9 (17.5) | 21.8 (18.8) |
| SF-36 PCS | 34.0 (8.3) | 32.4 (10.1) | 34.2 (8.7) | 33.9 (8.8) | 33.6 (9.0) |
*The adalimumab 40 mg Q2W treatment arm served as active reference for comparison with placebo. The study was not powered to test equivalence or non-inferiority of ixekizumab versus adalimumab.
†p≤0.01 vs placebo.
‡p<0.05 vs placebo.
§Presence or absence, as qualitatively assessed by the investigator.
¶Evaluated in patients with psoriasis, as qualitatively assessed by the investigator, at baseline.
**Evaluated in patients with enthesitis, as qualitatively assessed by the investigator, at baseline.
††Evaluated in patients with dactylitis, as qualitatively assessed by the investigator, at baseline.
‡‡Evaluated in patients with baseline LDI-B score >0; post hoc analysis.
§§Evaluated in patients with fingernail psoriasis, as qualitatively assessed by the investigator, at baseline.
BMI, body mass index; BSA, body surface area; cDMARD, conventional disease-modifying antirheumatic drug; CRP, C reactive protein; DAS28-CRP, 28-joint Disease Activity Score using C reactive protein; HAQ-DI, Health Assessment Questionnaire-Disability Index; IXEQ2W, 80 mg ixekizumab once every 2 weeks; IXEQ4W, 80 mg ixekizumab once every 4 weeks; LDI-B, Leeds Dactylitis Index-Basic; LEI, Leeds Enthesitis Index; mTSS, van der Heijde modified total Sharp score; NAPSI, Nail Psoriasis Severity Index; PASI, Psoriasis Area and Severity Index; Q2W, every 2 weeks; SF-36 PCS, Short Form (36 Items) Health Survey Physical Component Score; VAS, visual analogue scale.