Table 2.
Safety outcomes (FAS)
| Placebo | Bimekizumab (mg) | ||||||
| n=14 | 80/40/40 n=6 |
160/80/80 n=6 |
240/160/160 n=20 |
560/320/320 n=6 |
Top three doses n=32 |
Total n=38 |
|
| n (%) (*) | |||||||
| Any TEAEs | 10 (71.4) (27) | 2 (33.3) (10) | 5 (83.3) (28) | 13 (65.0) (24) | 6 (100) (41) | 24 (75.0) (93) | 26 (68.4) (103) |
| Serious TEAEs | 0 | 0 | 0 | 1 (5.0) (3) | 0 | 1 (3.1) (3) | 1 (2.6) (3) |
| Discontinuations due to TEAEs | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Drug-related TEAEs | 4 (28.6) (6) | 1 (16.7) (4) | 5 (83.3) (18) | 6 (30.0) (7) | 5 (83.3) (12) | 16 (50.0) (37) | 17 (44.7) (41) |
| Severe TEAEs | 1 (7.1) (1) | 0 | 0 | 1 (5.0) (3) | 1 (16.7) (1) | 2 (6.3) (4) | 2 (5.3) (4) |
| All deaths | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| MedDRA (v18.0) SOC PT | |||||||
| Any TEAE† | 10 (71.4) | 2 (33.3) | 5 (83.3) | 13 (65.0) | 6 (100) | 24 (75.0) | 26 (68.4) |
| Blood and lymphatic system disorders | 2 (14.3) | 1 (16.7) | 2 (33.3) | 2 (10.0) | 2 (33.3) | 6 (18.8) | 7 (18.4) |
| Neutropenia | 1 (7.1) | 1 (16.7) | 2 (33.3) | 0 | 2 (33.3) | 4 (12.5) | 5 (13.2) |
| Anaemia | 2 (14.3) | 0 | 0 | 2 (10.0) | 0 | 2 (6.3) | 2 (5.3) |
| Gastrointestinal disorders | 2 (14.3) | 1 (16.7) | 1 (16.7) | 1 (5.0) | 2 (33.3) | 4 (12.5) | 5 (13.2) |
| Abdominal pain | 1 (7.1) | 1 (16.7) | 0 | 0 | 2 (33.3) | 2 (6.3) | 3 (7.9) |
| Diarrhoea | 1 (7.1) | 1 (16.7) | 0 | 0 | 2 (33.3) | 2 (6.3) | 3 (7.9) |
| Nausea | 0 | 0 | 0 | 1 (5.0) | 1 (16.7) | 2 (6.3) | 2 (5.3) |
| Infections and infestations | 5 (35.7) | 1 (16.7) | 1 (16.7) | 8(40.0) | 4 (66.7) | 13 (40.6) | 14 (36.8) |
| Nasopharyngitis | 4 (28.6) | 1 (16.7) | 1 (16.7) | 2 (10.0) | 3 (50.0) | 6 (18.8) | 7 (18.4) |
| Conjunctivitis | 0 | 0 | 1 (16.7) | 1 (5.0) | 1 (16.7) | 3 (9.4) | 3 (7.9) |
| Otitis media | 0 | 0 | 1 (16.7) | 0 | 1 (16.7) | 2 (6.3) | 2 (5.3) |
| Investigations | 1 (7.1) | 0 | 4 (66.7) | 0 | 2 (33.3) | 6 (18.8) | 6 (15.8) |
| Alanine aminotransferase increased | 1 (7.1) | 0 | 4 (66.7) | 0 | 2 (33.3) | 6 (18.8) | 6 (15.8) |
| Aspartate aminotransferase increased | 0 | 0 | 4 (66.7) | 0 | 2 (33.3) | 6 (18.8) | 6 (15.8) |
| Gamma-glutamyltransferase increased | 0 | 0 | 1 (16.7) | 0 | 1 (16.7) | 2 (6.3) | 2 (5.3) |
| Musculoskeletal and connective tissue disorders | 3 (21.4) | 1 (16.7) | 0 | 0 | 2 (33.3) | 2 (6.3) | 3 (7.9) |
| Psoriatic arthropathy | 3 (21.4) | 1 (16.7) | 0 | 0 | 1 (16.7) | 1 (3.1) | 2 (5.3) |
| Nervous system disorders | 2 (14.3) | 2 (33.3) | 1 (16.7) | 3 (15.0) | 2 (33.3) | 6 (18.8) | 8 (21.1) |
| Headache | 1 (7.1) | 1 (16.7) | 1 (16.7) | 3 (15.0) | 2 (33.3) | 6 (18.8) | 7 (18.4) |
| Dizziness | 0 | 1 (16.7) | 0 | 1 (5.0) | 0 | 1 (3.1) | 2 (5.3) |
| Paresthesia | 1 (7.1) | 1 (16.7) | 0 | 0 | 1 (16.7) | 1 (3.1) | 2 (5.3) |
| Respiratory, thoracic and mediastinal disorders | 1 (7.1) | 0 | 1 (16.7) | 1 (5.0) | 2 (33.3) | 4 (12.5) | 4 (10.5) |
| Oropharyngeal pain | 0 | 0 | 1 (16.7) | 0 | 1 (16.7) | 2 (6.3) | 2 (5.3) |
n, number of patients reporting at least one TEAE within an SOC/PT.
*Number of individual occurrences of the TEAE in that category.
†TEAEs that occurred in two or more patients in the bimekizumab total group are reported.
FAS, full analysis set; MedDRA, Medical Dictionary for Regulatory Activities; PT, preferred term; SOC, system organ class; TEAE, treatment-emergent adverse event.