Patient demographics and baseline disease characteristics (all randomised patients)
| Parameter | AMVISION-1 | AMVISION-2 | Pooled | ||||||
| PBO (N=161) | BRO 140 mg Q2W (N=158) | BRO 210 mg Q2W (N=159) | PBO (N=161) | BRO 140 mg Q2W (N=160) | BRO 210 mg Q2W (N=163) | PBO (N=322) | BRO 140 mg Q2W (N=318) | BRO 210 mg Q2W (N=322) | |
| Age, years | 48.1 (11.8) | 49.9 (12.8) | 49.1 (12.2) | 48.3 (13.0) | 47.4 (12.8) | 47.0 (12.6) | 48.2 (12.4) | 48.6 (12.8) | 48.1 (12.4) |
| Female, n (%) | 80 (49.7) | 80 (50.6) | 70 (44.0) | 85 (52.8) | 80 (50.0) | 84 (51.5) | 165 (51.2) | 160 (50.3) | 154 (47.8) |
| Race, n (%) | |||||||||
| White | 152 (94.4) | 152 (96.2) | 155 (97.5) | 154 (95.7) | 150 (93.8) | 159 (97.5) | 306 (95.0) | 302 (95.0) | 314 (97.5) |
| Black or African American | 0 | 0 | 0 | 0 | 1 (0.6) | 0 | 0 | 1 (0.3) | 0 |
| Asian | 4 (2.5) | 0 | 0 | 1 (0.6) | 0 | 0 | 5 (1.6) | 0 | 0 |
| Other | 5 (3.1) | 5 (3.2) | 2 (1.3) | 2 (1.2) | 4 (2.5) | 2 (1.2) | 7 (2.2) | 9 (2.8) | 4 (1.2) |
| Duration of PsA, years | 9.4 (9.3) | 8.1 (8.1) | 8.2 (8.2) | 6.4 (7.7) | 6.5 (7.4) | 7.1 (7.5) | 7.9 (8.6) | 7.3 (7.8) | 7.7 (7.9) |
| Psoriasis affecting ≥3% of BSA, n (%) | 103 (64.0) | 113 (71.5) | 102 (64.2) | 118 (73.3) | 107 (66.9) | 117 (71.8) | 221 (68.6) | 220 (69.2) | 219 (68.0) |
| PASI score | 6.4 (8.0) | 8.2 (8.6) | 7.7 (9.2) | 8.9 (9.9) | 9.0 (11.2) | 7.9 (9.4) | 7.7 (9.0) | 8.6 (10.0) | 7.8 (9.3) |
| Dactylitis score | 2.3 (3.6) | 2.6 (4.2) | 2.2 (3.9) | 2.4 (4.0) | 1.7 (3.4) | 1.9 (3.5) | 2.4 (3.8) | 2.1 (3.8) | 2.0 (3.7) |
| Dactylitis score >0, n (%) | 84 (52.2) | 79 (50.0) | 78 (49.1) | 77 (47.8) | 60 (37.5) | 71 (43.6) | 161 (50.0) | 139 (43.7) | 149 (46.3) |
| Enthesitis score | 1.9 (1.9) | 1.8 (2.0) | 1.6 (1.9) | 1.7 (1.8) | 1.7 (2.0) | 1.6 (1.8) | 1.8 (1.9) | 1.8 (2.0) | 1.6 (1.8) |
| Enthesitis score >0, n (%) | 107 (66.5) | 93 (58.9) | 93 (58.5) | 101 (62.7) | 92 (57.5) | 100 (61.3) | 208 (64.6) | 185 (58.2) | 193 (59.9) |
| Swollen joint count | 12.3 (8.3) | 13.3 (10.1) | 12.4 (10.2) | 11.0 (8.6) | 11.4 (9.2) | 11.1 (8.5) | 11.7 (8.5) | 12.4 (9.7) | 11.7 (9.4) |
| Tender joint count | 21.4 (14.8) | 23.4 (15.5) | 20.7 (14.4) | 20.9 (14.3) | 20.5 (15.7) | 17.2 (12.5) | 21.1 (14.5) | 21.9 (15.6) | 18.9 (13.6) |
| CRP, mg/dL | 1.5 (2.2) | 1.9 (3.0) | 1.7 (2.7) | 0.8 (1.4) | 1.0 (1.8) | 0.9 (1.3) | 1.2 (1.9) | 1.5 (2.5) | 1.3 (2.1) |
| HAQ-DI score | 1.2 (0.6) | 1.3 (0.7) | 1.2 (0.6) | 1.1 (0.6) | 1.1 (0.7) | 1.1 (0.6) | 1.1 (0.6) | 1.2 (0.7) | 1.1 (0.6) |
| Prior biologic use, n (%) | 44 (27.3) | 42 (26.6) | 46 (28.9) | 58 (36.0) | 54 (33.8) | 56 (34.4) | 102 (31.7) | 96 (30.2) | 102 (31.7) |
Data are mean (SD) unless otherwise specified.
BRO, brodalumab; BSA, body surface area; CRP, C reactive protein; HAQ-DI, Health Assessment Questionnaire-Disability Index; PASI, Psoriasis Area and Severity Index; PBO, placebo; PsA, psoriatic arthritis; Q2W, every 2 weeks.