Patient-reported outcomes (week 12 (FAS) and week 48 (DBS); MI)
| Mean (SD) | Placebo → | BKZ 16 mg → | BKZ 64 mg → | BKZ 160 mg (n=58) | BKZ 320 mg (n=61) | ||||
| BKZ 160 mg (n=24) | BKZ 320 mg (n=36) | BKZ 160 mg (n=31) | BKZ 320 mg (n=27) | BKZ 160 mg (n=34) | BKZ 320 mg (n=25) | ||||
| MOS Sleep Disturbance | Baseline | 45.3 (8.3) | 46.2 (6.8) | 48.4 (8.3) | 44.6 (10.0) | 47.6 (9.6) | 47.8 (7.5) | 47.3 (8.1) | 48.0 (8.9) |
| Change from baseline | Week 12 | 2.3 (8.4) | 1.8 (6.0) | 1.9 (8.4) | 4.7 (8.7) | 5.8 (7.9) | 4.7 (5.6) | 5.8 (6.2) | 6.6 (7.5) |
| Week 48 | 7.3 (7.8) | 6.9 (7.0) | 3.8 (7.9) | 8.8 (8.1) | 7.6 (8.9) | 6.7 (7.4) | 6.6 (6.3) | 6.7 (7.7) | |
| MOS Sleep Problems Index II | Baseline | 45.5 (8.1) | 45.3 (7.9) | 48.2 (8.7) | 42.4 (10.1) | 47.6 (9.4) | 47.5 (7.1) | 46.9 (7.5) | 47.2 (9.4) |
| Change from baseline | Week 12 | 2.1 (8.3) | 1.8 (6.8) | 2.2 (9.4) | 5.9 (9.3) | 5.9 (8.1) | 4.9 (6.1) | 5.6 (6.7) | 6.8 (7.5) |
| Week 48 | 7.6 (8.7) | 8.0 (9.1) | 4.1 (7.5) | 10.0 (9.0) | 8.1 (8.6) | 8.0 (7.2) | 6.5 (6.1) | 8.0 (7.92) | |
| ASQoL | Baseline | 8.4 (4.7) | 9.2 (4.7) | 8.4 (4.4) | 9.2 (4.1) | 7.9 (4.2) | 9.6 (4.0) | 8.4 (4.3) | 8.7 (4.3) |
| Change from baseline | Week 12 | −1.3 (5.5) | −1.3 (3.7) | −2.8 (5.2) | −1.9 (5.4) | −3.5 (3.6) | −5.0 (4.2) | −3.5 (4.3) | −4.6 (4.8) |
| Week 48 | −4.2 (5.6) | −5.3 (5.6) | −3.9 (4.6) | −5.0 (4.7) | −5.0 (4.1) | −6.3 (4.4) | −4.9 (4.1) | −5.4 (4.8) | |
| SF-36 PCS | Baseline | 32.8 (6.9) | 33.0 (8.4) | 32.5 (8.7) | 30.9 (6.5) | 31.9 (7.8) | 30.3 (5.6) | 33.0 (8.2) | 32.4 (7.7) |
| Change from baseline | Week 12 | 5.8 (6.9) | 2.0 (6.2) | 7.8 (7.4) | 7.4 (9.3) | 8.9 (8.8) | 9.5 (8.4) | 8.5 (7.6) | 8.2 (7.2) |
| Week 48 | 12.8 (9.4) | 10.9 (8.1) | 10.1 (7.4) | 12.6 (9.2) | 12.9 (10.2) | 13.4 (7.8) | 12.0 (9.1) | 12.0 (8.5) | |
| SF-36 MCS | Baseline | 54.0 (9.1) | 53.6 (8.7) | 54.6 (9.5) | 52.0 (7.8) | 55.8 (7.4) | 54.4 (7.2) | 53.8 (8.1) | 54.4 (8.5) |
| Change from baseline | Week 12 | −0.4 (8.5) | 0.3 (7.2) | −0.1 (7.9) | 3.8 (8.2) | 1.7 (6.9) | 4.0 (8.1) | 1.0 (7.4) | 3.4 (6.9) |
| Week 48 | 1.3 (10.2) | 1.5 (7.8) | 1.8 (7.8) | 6.2 (8.4) | 2.2 (6.6) | 4.0 (7.0) | 1.72 (8.2) | 3.0 (7.7) | |
ASQoL, Ankylosing Spondylitis Quality of Life; BKZ, bimekizumab; DBS, dose-blind set; FAS, full analysis set; SF-36 MCS, SF-36 mental component summary; MI, multiple imputation; MOS, Medical Outcomes Study; SF-36 PCS, SF-36 physical component summary; SF-36, 36-Item Short Form Questionnaire.