Safety to week 16 and week 52
| n (%) (EAIR)* | Weeks 0–16 (double-blind period) | Weeks 16–52 (open-label period) | Weeks 0–52 (overall study period) | ||
| Placebo n=132 (PYAR: 42.5) | BKZ 160 mg Q4W n=267 (PYAR: 87.1) | Placebo/BKZ 160 mg Q4W† n=121 (PYAR: 80.3) | BKZ 160 mg Q4W n=267 (PYAR: 259.5) | BKZ 160 mg Q4W total† n=388 (PYAR: 339.8) | |
| Any TEAE | 44 (33.3) | 108 (40.4) | 68 (56.2) (127.7) | 175 (65.5) (125.4) | 243 (62.6) (126.0) |
| Severe TEAEs | 0 | 5 (1.9) | 3 (2.5) | 14 (5.2) | 17 (4.4) |
| Study discontinuation due to TEAEs | 0 | 2 (0.7) | 6 (5.0) (7.6) | 10 (3.7) (3.9) | 16 (4.1) (4.8) |
| Drug-related TEAEs | 4 (3.0) | 35 (13.1) | 21 (17.4) | 66 (24.7) | 87 (22.4) |
| Serious TEAEs | 0 | 5 (1.9) | 8 (6.6) (10.2) | 15 (5.6) (6.0) | 23 (5.9) (7.0) |
| Deaths | 0 | 0 | 1 (0.8)‡ | 0 | 1 (0.3)‡ |
| Most frequent adverse events§ | |||||
| SARS-CoV-2 (COVID-19) | 6 (4.5) | 5 (1.9) | 7 (5.8) (8.9) | 21 (7.9) (8.4) | 28 (7.2) (8.5) |
| Oral candidiasis | 0 | 7 (2.6) | 7 (5.8) (9.0) | 17 (6.4) (6.8) | 24 (6.2) (7.3) |
| Nasopharyngitis | 1 (0.8) | 10 (3.7) | 4 (3.3) (5.0) | 19 (7.1) (7.7) | 23 (5.9) (7.0) |
| Urinary tract infection | 3 (2.3) | 5 (1.9) | 4 (3.3) (5.1) | 19 (7.1) (7.7) | 23 (5.9) (7.0) |
| Infections | |||||
| Serious | 0 | 2 (0.7) | 3 (2.5) (3.8) | 4 (1.5) (1.6) | 7 (1.8) (2.1) |
| Opportunistic | 0 | 0 | 2 (1.7) (2.5)¶ | 0 | 2 (0.5) (0.6)¶ |
| Active TB | 0 | 0 | 0 | 0 | 0 |
| Uveitis | 0 | 0 | 0 | 0 | 0 |
| Neutropenia | 0 | 4 (1.5)** | 0 | 5 (1.9) (2.0)†† | 5 (1.3) (1.5)††‡‡ |
| Hypersensitivity | 1 (0.8) | 7 (2.6) | 4 (3.3) (5.1) | 15 (5.6) (6.0) | 19 (4.9) (5.8) |
| Injection site reactions | 0 | 3 (1.1) | 0 | 6 (2.2) (2.4) | 6 (1.5) (1.8) |
| Adjudicated suicidal ideation and behaviour | 0 | 0 | 0 | 0 | 0 |
| Liver function test changes/enzyme elevations | |||||
| ALT >3×ULN | 0 | 2 (0.7) | 0 | 8 (3.0) | 8 (2.1) |
| AST or ALT >3×ULN | 0 | 4 (1.5) | 2 (1.7) | 10 (3.7) | 12 (3.1) |
| Adjudicated MACE | 0 | 0 | 2 (1.7) (2.5)§§ | 0 | 2 (0.5) (0.6)§§ |
| Adjudicated IBD | 0 | 0 | 0 | 0 | 0 |
| Non-melanoma skin cancer | 1 (0.8) | 0 | 0 | 0 | 0 |
| Basal cell carcinoma | 1 (0.8) | 0 | 0 | 0 | 0 |
| Malignancies excluding non-melanoma skin cancer | 0 | 0 | 1 (0.8) (1.3) | 2 (0.7) (0.8) | 3 (0.8) (0.9) |
| Endometrial cancer stage I | 0 | 0 | 0 | 1 (0.4) (0.4) | 1 (0.3) (0.3) |
| Gastric cancer recurrent | 0 | 0 | 0 | 1 (0.4) (0.4)¶¶ | 1 (0.3) (0.3)¶¶ |
| Prostate cancer | 0 | 0 | 1 (0.8) (1.3) | 0 | 1 (0.3) (0.3) |
Safety set (all randomised subjects who received at least one dose of the study drug); one placebo-randomised patient withdrew from the study before receiving study drug.
*EAIRs are reported for treatment duration >16 weeks, where available.
†Includes patients who switched from placebo to BKZ and only includes TEAEs occurring while receiving BKZ.
‡Sudden death in a patient aged 54 years with a history of hypertension, aortic regurgitation, ECG changes reflective of coronary artery disease; no further information available.
§Most frequent adverse events are those occurring in ≥5% of patients in any study arm.
¶Two oesophageal candidiasis.
**Three neutropenia; one neutrophil count decreased.
††Four neutropenia; one neutrophil count decreased.
‡‡Four neutropenia events were grade 3; one neutropenia event was grade 2.
§§One sudden death; one cerebral haemorrhage.
¶¶A male patient aged 56 years with history of primary gastric cancer; permanently discontinued from the study.
ALT, alanine aminotransferase; AST, aspartate aminotransferase; BKZ, bimekizumab; EAIR, exposure-adjusted incident rate; IBD, inflammatory bowel disease; MACE, major adverse cardiovascular event; PYAR, patient‑years at risk; Q4W, every 4 weeks; TB, tuberculosis; TEAE, treatment-emergent adverse event; ULN, upper limit of normal.