Table 1.
BE RADIANT randomised patientsa (N = 743) | BE RADIANT OLE patientsb (N = 654) | |
---|---|---|
Age (years), mean ± SD | 45.0 ± 14.5 | 45.0 ± 14.4 |
Male, n (%) | 486 (65.4) | 436 (66.7) |
White, n (%) | 695 (93.5) | 613 (93.7) |
Weight (kg), mean ± SD | 89.5 ± 20.7 | 89.7 ± 20.3 |
Duration of psoriasis (years), mean ± SD | 17.8 ± 12.7 | 18.0 ± 12.6 |
PASI, mean ± SD | 20.0 ± 7.1 | 19.9 ± 7.0 |
IGA score, n (%) | ||
3: Moderate | 508 (68.4) | 448 (68.5) |
4: Severe | 233 (31.4) | 204 (31.2) |
BSA (%), mean ± SD | 24.3 ± 14.9 | 24.2 ± 14.8 |
DLQI, mean ± SD | 11.0 ± 6.9 | 11.0 ± 7.0 |
DLQI, median | 11.0 | 10.0 |
DLQI (Item 1), n (%) | ||
0 | 20 (2.7) | 18 (2.8) |
1 | 171 (23.0) | 156 (23.9) |
2 | 314 (42.3) | 275 (42.0) |
3 | 238 (32.0) | 205 (31.3) |
DLQI item scores, median | ||
1: Itchy, sore, painful, or stinging | 2.0 | 2.0 |
2: Embarrassed | 2.0 | 2.0 |
3: Shopping, gardening | 1.0 | 1.0 |
4: Choice of clothing | 2.0 | 2.0 |
5: Social or leisure activities | 1.0 | 1.0 |
6: Sport | 0.0 | 0.0 |
7: Prevent/problem with working or studying | 0.0 | 0.0 |
8: Problems with partners or friends | 1.0 | 1.0 |
9: Sexual difficulties | 0.0 | 0.0 |
10: Treatment | 1.0 | 1.0 |
P-SIM item score, mean ± SD | ||
Itching | 6.7 ± 2.7 | 6.7 ± 2.8 |
Scaling | 6.7 ± 2.4 | 6.7 ± 2.4 |
Skin pain | 4.6 ± 3.2 | 4.6 ± 3.2 |
P-SIM item score, median | ||
Itching | 7.0 | 7.0 |
Scaling | 7.0 | 7.0 |
Skin pain | 5.0 | 5.0 |
Any prior systemic therapy, n (%) | 540 (72.7) | 478 (73.1) |
Prior biologic therapy, n (%) | 245 (33.0) | 219 (33.5) |
BSA body surface area, DLQI Dermatology Life Quality Index, IGA Investigator's Global Assessment, OLE open-label extension, PASI Psoriasis Area and Severity Index, P-SIM Psoriasis Symptoms and Impacts Measure, Q4W every 4 weeks, Q8W every 8 weeks, SD standard deviation
aPatients were initially randomised to bimekizumab 320 mg Q4W to Week 16, then Q4W or Q8W to Week 48, or to secukinumab 300 mg weekly to Week 4, then Q4W to Week 48
bBE RADIANT OLE patients completed the double-blinded maintenance treatment period and received ≥ 1 dose of bimekizumab treatment in the OLE