Table 2

Safety outcomes (FAS)

PlaceboBimekizumab (mg)
n=1480/40/40
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 TEAEs10 (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 TEAEs0001 (5.0) (3)01 (3.1) (3)1 (2.6) (3)
Discontinuations due to TEAEs0000000
Drug-related TEAEs4 (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 TEAEs1 (7.1) (1)001 (5.0) (3)1 (16.7) (1)2 (6.3) (4)2 (5.3) (4)
All deaths0000000
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 disorders2 (14.3)1 (16.7)2 (33.3)2 (10.0)2 (33.3)6 (18.8)7 (18.4)
 Neutropenia1 (7.1)1 (16.7)2 (33.3)02 (33.3)4 (12.5)5 (13.2)
 Anaemia2 (14.3)002 (10.0)02 (6.3)2 (5.3)
Gastrointestinal disorders2 (14.3)1 (16.7)1 (16.7)1 (5.0)2 (33.3)4 (12.5)5 (13.2)
 Abdominal pain1 (7.1)1 (16.7)002 (33.3)2 (6.3)3 (7.9)
 Diarrhoea1 (7.1)1 (16.7)002 (33.3)2 (6.3)3 (7.9)
 Nausea0001 (5.0)1 (16.7)2 (6.3)2 (5.3)
Infections and infestations5 (35.7)1 (16.7)1 (16.7)8(40.0)4 (66.7)13 (40.6)14 (36.8)
 Nasopharyngitis4 (28.6)1 (16.7)1 (16.7)2 (10.0)3 (50.0)6 (18.8)7 (18.4)
 Conjunctivitis001 (16.7)1 (5.0)1 (16.7)3 (9.4)3 (7.9)
 Otitis media001 (16.7)01 (16.7)2 (6.3)2 (5.3)
Investigations1 (7.1)04 (66.7)02 (33.3)6 (18.8)6 (15.8)
 Alanine aminotransferase increased1 (7.1)04 (66.7)02 (33.3)6 (18.8)6 (15.8)
 Aspartate aminotransferase increased004 (66.7)02 (33.3)6 (18.8)6 (15.8)
 Gamma-glutamyltransferase increased001 (16.7)01 (16.7)2 (6.3)2 (5.3)
Musculoskeletal and connective tissue disorders3 (21.4)1 (16.7)002 (33.3)2 (6.3)3 (7.9)
 Psoriatic arthropathy3 (21.4)1 (16.7)001 (16.7)1 (3.1)2 (5.3)
Nervous system disorders2 (14.3)2 (33.3)1 (16.7)3 (15.0)2 (33.3)6 (18.8)8 (21.1)
 Headache1 (7.1)1 (16.7)1 (16.7)3 (15.0)2 (33.3)6 (18.8)7 (18.4)
 Dizziness01 (16.7)01 (5.0)01 (3.1)2 (5.3)
 Paresthesia1 (7.1)1 (16.7)001 (16.7)1 (3.1)2 (5.3)
Respiratory, thoracic and mediastinal disorders1 (7.1)01 (16.7)1 (5.0)2 (33.3)4 (12.5)4 (10.5)
 Oropharyngeal pain001 (16.7)01 (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.