Table 3

Summary of safety in the randomised withdrawal safety population* (weeks 24–64)

Withdrawn to placebo
N=53
IXE Q4W
N=47
IXE Q2W
N=54
Combined IXE
N=101
TEAE28 (52.8%)20 (42.6%)24 (44.4%)44 (43.6%)
 Mild14 (26.4%)13 (27.7%)11 (20.4%)24 (23.8%)
 Moderate9 (17.0%)4 (8.5%)13 (24.1%)17 (16.8%)
 Severe5 (9.4%)3 (6.4%)03 (3.0%)
Serious AE1 (1.9%)2 (4.3%)2 (3.7%)4 (4.0%)
Discontinuation due to AE002 (3.7%)2 (2.0%)
Death0000
TEAEs of special interest
Infections18 (34.0%)8 (17.0%)13 (24.1%)21 (20.8%)
 Serious infections002 (3.7%)2 (2.0%)
 Opportunistic infections0000
 Candidiasis0000
Injection-site reactions01 (2.1%)3 (5.6%)4 (4.0%)
IBD (adjudicated)†0000
Anterior uveitis3 (5.7%)2 (4.2%)3 (5.6%)5 (4.9%)
Allergic reactions/hypersensitivities‡3 (5.7%)02 (3.7%)2 (2.0%)
Cytopenia01 (2.1)01 (1.0%)
Hepatic events2 (3.8%)2 (4.3%)1 (1.9%)3 (3.0%)
Adjudicated cerebrocardiovascular events1 (1.9%)000
 MACE0000
Malignancies0000
Depression01 (2.1%)01 (1.0%)
  • Data are presented as n (%).

  • *Includes all randomly assigned patients who entered the randomised withdrawal-retreatment period and received at least one dose of study treatment after randomisation in the randomised withdrawal-retreatment period. Data after retreatment were excluded.

  • †Includes adjudicated Crohn’s disease and ulcerative colitis. Events of suspected IBD were confirmed by adjudication by an external clinical events committee with expertise in IBD. EPIdemiologique des Maladies de l’Appareil Digestif (EPIMAD) criteria for adjudication of suspected IBD define ‘probable’ and ‘definite’ classifications as confirmed cases.

  • ‡No anaphylaxis was reported.

  • AE, adverse event; IBD, inflammatory bowel disease; IXE, ixekizumab; MACE, major adverse cardiovascular event; Q2W, every 2 weeks; Q4W, every 4 weeks; TEAE, treatment-emergent adverse event.