Summary of safety results (SS)
| Double-blind period | Overall treatment period | |||||||
| Placebo Q4W (n=60) n* (%) (#) | BKZ 16 mg Q4W (n=61) n* (%) (#) | BKZ 64 mg Q4W (n=58) n* (%) (#) | BKZ 160 mg Q4W (n=63) n* (%) (#) | BKZ 320 mg Q4W (n=61) n* (%) (#) | BKZ 160 mg Q4W (n=149) n (EAIR) | BKZ 320 mg Q4W (n=150) n (EAIR) | All BKZ† (n=303) n (EAIR) | |
| Any TEAE | 26 (43.3) (41) | 26 (42.6) (50) | 17 (29.3) (33) | 20 (31.7) (33) | 29 (47.5) (61) | 103 (168.7) | 122 (221.1) | 235 (186.2) |
| Nasopharyngitis | 0 | 2 (3.3) (2) | 1 (1.7) (1) | 3 (4.8) (3) | 0 | 13 (12.0) | 19 (16.6) | 34 (13.7) |
| Pharyngitis | 0 | 0 | 0 | 2 (3.2) (2) | 1 (1.6) (1) | 11 (10.0) | 7 (6.1) | 18 (7.1) |
| Bronchitis | 1 (1.7) (1) | 0 | 2 (3.4) (2) | 0 | 0 | 4 (3.6) | 12 (10.4) | 18 (7.1) |
| Upper respiratory tract infection | 1 (1.7) (1) | 0 | 1 (1.7) (1) | 0 | 1 (1.6) (1) | 5 (4.5) | 11 (9.5) | 17 (6.7) |
| Oral candidiasis | 0 | 0 | 0 | 0 | 3 (4.9) (3) | 8 (7.2) | 8 (7.0) | 16 (6.3) |
| Serious TEAEs | 2 (3.3) (2) | 0 | 2 (3.4) (5) | 1 (1.6) (2) | 0 | 5 (4.4) | 6 (5.1) | 13 (5.1) |
| Permanent withdrawal of study medication due to TEAEs | 1 (1.7) (1) | 2 (3.3) (2) | 1 (1.7) (1) | 1 (1.6) (2) | 2 (3.3) (2) | 7 (6.2) | 10 (8.7) | 20 (7.9) |
| Drug-related TEAEs | 6 (10.0) (8) | 9 (14.8) (12) | 6 (10.3) (10) | 7 (11.1) (8) | 12 (19.7) (17) | 48 (52.0) | 54 (58.7) | 110 (54.0) |
| Death | 0 | 0 | 0 | 1 (1.6) (1) | 0 | 1 (0.9) | 0 | 1 (0.4) |
| TEAEs of special interest | 5 (8.3) (5) | 9 (14.8) (10) | 6 (10.3) (9) | 3 (4.8) (3) | 5 (8.2) (7) | |||
| Opportunistic infection | 0 | 1 (1.6) (1) | 0 | 0 | 0 | 0 | 0 | 1 (0.38) |
| Candida infections | 0 | 0 | 0 | 0 | 3 (4.9) (3) | 10 (9.1) | 9 (7.9) | 19 (7.5) |
| Neutropenia | 0 | 0 | 0 | 0 | 0 | 1 (0.9) | 0 | 1 (0.4) |
| Severe hypersensitivity reactions | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Suicide ideation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Psychiatric disorder | 2 (3.3) (2) | 1 (1.6) (1) | 0 | 0 | 0 | 0 | 0 | 1 (0.3) |
| Major cardiovascular events | 0 | 0 | 0 | 1 (1.6) (1) | 0 | 2 (1.8) | 0 | 2 (0.8) |
| Hepatic events | 2 (3.3) (2) | 6 (9.8) (6) | 4 (6.9) (7) | 1 (1.6) (1) | 1 (1.6) (2) | 13 (12.1) | 12 (10.4) | 33 (13.6) |
| ALT increased | 0 | 1 (1.6) (1) | 1 (1.7) (1) | 0 | 1 (1.6) (1) | 5 (4.5) | 6 (5.1) | 13 (5.1) |
| AST increased | 0 | 0 | 1 (1.7) (1) | 0 | 1 (1.6) (1) | 3 (2.7) | 5 (4.3) | 9 (3.5) |
| GGT increased | 1 (1.7) (1) | 2 (3.3) (2) | 2 (3.4) (3) | 0 | 0 | 6 (5.4) | 4 (3.4) | 13 (5.1) |
| Hepatic enzyme increased | 1 (1.7) (1) | 2 (3.3) (2) | 1 (1.7) (1) | 0 | 0 | 0 | 3 (2.5) | 6 (2.3) |
| Malignancies | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Inflammatory bowel disease | 0 | 1 (1.6) (1) | 0 | 0 | 0 | 1 (0.9) | 2 (1.7) | 4 (1.5) |
In addition, one patient received doses of 160 and 320 mg in error and was therefore included in both the 160 and 320 mg groups, but only once in the all-BKZ group; (#) the number of individual occurrences of the AE.
*Number of patients reporting at least one TEAE.
†The all-BKZ group included 5 patients who received BKZ in the double-blind period but did not receive BKZ 160 or 320 mg: 2 patients in the 16 mg group and 2 patients in the 64 mg group discontinued before re-randomisation; 1 patient in the 16 mg group did not start the dose-blind period.
ALT, alanine aminotransferase; AST, aspartate aminotransferase; BKZ, bimekizumab; EAIR, exposure-adjusted incidence rate per 100 patient-years; GGT, gamma-glutamyltransferase; Q4W, every 4 weeks; SS, safety set; TEAE, treatment-emergent adverse event.