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	Withdrawn to placebo N=53	IXE Q4W N=47	IXE Q2W N=54	Combined IXE N=101
TEAE	28 (52.8%)	20 (42.6%)	24 (44.4%)	44 (43.6%)
Mild	14 (26.4%)	13 (27.7%)	11 (20.4%)	24 (23.8%)
Moderate	9 (17.0%)	4 (8.5%)	13 (24.1%)	17 (16.8%)
Severe	5 (9.4%)	3 (6.4%)	0	3 (3.0%)
Serious AE	1 (1.9%)	2 (4.3%)	2 (3.7%)	4 (4.0%)
Discontinuation due to AE	0	0	2 (3.7%)	2 (2.0%)
Death	0	0	0	0
TEAEs of special interest
Infections	18 (34.0%)	8 (17.0%)	13 (24.1%)	21 (20.8%)
Serious infections	0	0	2 (3.7%)	2 (2.0%)
Opportunistic infections	0	0	0	0
Candidiasis	0	0	0	0
Injection-site reactions	0	1 (2.1%)	3 (5.6%)	4 (4.0%)
IBD (adjudicated)†	0	0	0	0
Anterior uveitis	3 (5.7%)	2 (4.2%)	3 (5.6%)	5 (4.9%)
Allergic reactions/hypersensitivities‡	3 (5.7%)	0	2 (3.7%)	2 (2.0%)
Cytopenia	0	1 (2.1)	0	1 (1.0%)
Hepatic events	2 (3.8%)	2 (4.3%)	1 (1.9%)	3 (3.0%)
Adjudicated cerebrocardiovascular events	1 (1.9%)	0	0	0
MACE	0	0	0	0
Malignancies	0	0	0	0
Depression	0	1 (2.1%)	0	1 (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.