Placebo (n=414) | Bimekizumab 160 mg Q4W (n=698) | |
Patient characteristics | ||
Age, years, mean (SD) | 49.5 (12.2) | 49.1 (12.5) |
Male, n (%) | 187 (45.2) | 331 (47.4) |
BMI, kg/m2, mean (SD) | 29.4 (5.9) | 29.6 (6.7) |
BSA affected by psoriasis ≥3%, n (%) | 228 (55.1) | 393 (56.3) |
Time since first PsA diagnosis, years, mean (SD) | 6.8 (7.3)* | 7.4 (8.6)† |
Disease activity | ||
PASI score,‡ mean (SD) | 8.1 (6.0) | 9.1 (8.0) |
TJC (of 68 joints), mean (SD) | 17.8 (13.1) | 17.4 (12.5) |
SJC (of 66 joints), mean (SD) | 9.7 (7.6) | 9.2 (6.7) |
Enthesitis (LEI >0), n (%) | 106 (25.6)§ | 249 (35.7)¶ |
Dactylitis (LDI >0), n (%) | 47 (11.4)** | 90 (12.9)†† |
hs-CRP ≥6 mg/L, n (%) | 180 (43.5) | 276 (39.5) |
Patient-reported outcomes | ||
HAQ-DI, mean (SD) | 0.94 (0.64) | 0.88 (0.59)§ |
FACIT-Fatigue, mean (SD) | 36.1 (10.1) | 36.8 (10.0)§ |
Pain VAS, mean (SD) | 58.4 (23.8) | 55.4 (24.3)§ |
PsAID-12, mean (SD) | 4.2 (2.0) | 4.1 (2.0)§ |
PsAQoL, mean (SD) | 6.4 (5.1) | 6.0 (4.9)§ |
EQ-5D-3L VAS, mean (SD) | 54.2 (20.4) | 56.7 (20.0)§ |
EQ-5D-3L Utility (UK tariff), mean (SD) | 0.59 (0.25) | 0.61 (0.24)§ |
SF-36 PCS, mean (SD) | 36.6 (9.8) | 37.5 (9.3)§ |
SF-36 MCS, mean (SD) | 54.7 (9.2) | 54.4 (9.0)§ |
Randomised set.
*Data missing for 3 patients.
†Data missing for 9 patients.
‡In patients with psoriasis involving ≥3% of BSA at baseline.
§Data missing for 1 patient.
¶Data missing for 6 patients.
**Data missing for 2 patients.
††Data missing for 7 patients.
BMI, Body Mass Index; BSA, body surface area; FACIT, Functional Assessment of Chronic Illness Therapy; HAQ-DI, Health Assessment Questionnaire-Disability Index; hs-CRP, high-sensitivity C-reactive protein; LDI, Leeds Dactylitis Index; LEI, Leeds Enthesitis Index; MCS, Mental Component Summary; PASI, Psoriasis Area and Severity Index; PCS, Physical Component Summary; PsA, psoriatic arthritis; PsAID-12, Psoriatic Arthritis Impact of Disease-12; PsAQoL, Psoriatic Arthritis Quality of Life; Q4W, every 4 weeks; SF-36, Short-Form 36-item Health Survey; SJC, swollen joint count; TJC, tender joint count; VAS, Visual Analogue Scale.