Table 2.

Safety results in patients in the SPIRIT‐P3 study^*

	All‐ixekizumab combined (every 2 weeks) (n = 394)†	Randomized withdrawal ITT population‡
		Ixekizumab withdrawal (n = 79)	Ixekizumab every 2 weeks (n = 79)
Exposure, no. of person‐years	631.1	42.1	71.0
TEAEs	325 (82.5)	40 (50.6)	40 (50.6)
Mild	156 (39.6)	30 (38.0)	24 (30.4)
Moderate	144 (36.5)	9 (11.4)	14 (17.7)
Severe	25 (6.3)	1 (1.3)	2 (2.5)
Serious AE	28 (7.1)	2 (2.5)	1 (1.3)
Discontinuations due to AE	21 (5.3)	1 (1.3)	0 (0)
Deaths	2 (0.5)	0 (0)	0 (0)
Most frequent TEAEs§
Nasopharyngitis	70 (17.8)	4 (5.1)	11 (13.9)
Upper respiratory tract infection	65 (16.5)	4 (5.1)	9 (11.4)
Injection site reaction	62 (15.7)	0 (0)	1 (1.3)
Bronchitis	34 (8.6)	1 (1.3)	4 (5.1)
Urinary tract infection	21 (5.3)	3 (3.8)	1 (1.3)
Sinusitis	20 (5.1)	1 (1.3)	0 (0)
AEs of special interest¶
Infections	243 (61.7)	20 (25.3)	29 (36.7)
Serious infections	5 (1.3)	1 (1.3)	0 (0)
Injection site reactions	80 (20.3)	0 (0)	2 (2.5)
Hepatic events	37 (9.4)	3 (3.8)	6 (7.6)
Allergic reactions/hypersensitivity events#	25 (6.3)	0 (0)	3 (3.8)
Cytopenias	21 (5.3)	1 (1.3)	5 (6.3)
Depression	13 (3.3)	0 (0)	0 (0)
Cerebrocardiovascular events**	3 (0.8)	0 (0)	0 (0)
Malignancies	2 (0.5)	0 (0)	0 (0)
Inflammatory bowel disease**	1 (0.3)††	0 (0)	0 (0)

^*Except where indicated otherwise, values are the number (%). ITT = intent‐to‐treat; TEAEs = treatment‐emergent adverse events.

^† Patients who had at least 1 dose of ixekizumab.

^‡ Randomization to relapse or week 104.

^§ Defined as >5% of TEAEs reported in the all‐ixekizumab combined group.

^¶ Reported as AEs according to the high‐level term in Medical Dictionary for Regulatory Activities, v.21.1. Groups of AEs of special interest are shown. No events of interstitial lung disease were reported in any group.

^# No allergic reactions/hypersensitivity events were anaphylaxis events.

^**Adjudicated event.

^†† Crohn’s disease.