Table 3.

Patients with adverse events^a

	Continuously treated (AE occurring in maintenance regardless of relapse status)		Withdrawal to relapse (AE before relapse or occurring in maintenance period for non‐relapsers)		Withdrawn, relapsed and retreated (AEs occurring during retreatment)
	IXEQ2W/Q4W N = 221	IXEQ4W/Q4W N = 195	IXEQ2W/PBO N = 211	IXEQ4W/PBO N = 191	IXEQ2W/PBO N = 176	IXEQ4W/PBO N = 157
Total person‐years	189.2	158.1	101.5	86.8	74.2	62.2
TEAE, n (%) [IR]	175 (79.2) [92.5]	156 (80.0) [98.7]	58 (27.5) [57.2]	70 (36.6) [80.6]	85 (48.3) [114.5]	78 (49.7) [125.3]
Mild	84 (38.0) [44.4]	55 (28.2) [34.8]	28 (13.3) [27.6]	42 (22.0) [48.4]	36 (20.5) [48.5]	46 (29.3) [73.9]
Moderate	74 (33.5) [39.1]	85 (43.6) [53.8]	24 (11.4) [23.7]	25 (13.1) [28.8]	38 (21.6) [51.2]	30 (19.1) [48.2]
Severe	17 (7.7) [9.0]	16 (8.2) [10.1]	6 (2.8) [5.9]	3 (1.6) [3.5]	11 (6.3) [14.8]	2 (1.3) [3.2]
Common TEAEs b , n (%) [IR]	—	—	—	—	—	—
Nasopharyngitis	38 (17.2) [20.1]	44 (22.6) [27.8]	4 (1.9) [3.9]	9 (4.7) [10.4]	15 (8.5) [20.2]	20 (12.7) [32.1]
Upper respiratory infection	22 (10.0) [11.6]	21 (10.8) [13.3]	4 (1.9) [3.9]	4 (2.1) [4.6]	12 (6.8) [16.2]	13 (8.3) [20.9]
Sinusitis	11 (5.0) [5.8]	7 (3.6) [4.4]	2 (0.9) [2.0]	1 (0.5) [1.2]	3 (1.7) [4.0]	4 (2.5) [6.4]
Arthralgia	13 (5.9) [6.9]	8 (4.1) [5.1]	6 (2.8) [5.9]	6 (3.1) [6.9]	2 (1.1) [2.7]	0 (0) [0]
Injection‐site reactionc	14 (6.3) [7.4]	13 (6.7) [8.2]	0 (0) [0]	0 (0) [0]	0 (0) [0]	2 (1.3) [3.2]
Headache	9 (4.1) [4.8]	12 (6.2) [7.6]	2 (0.9) [2.0]	1 (0.5) [1.2]	6 (3.4) [8.1]	3 (1.9) [4.8]
SAE, n (%) [IR]	10 (4.5) [5.3]	17 (8.7) [10.8]	6 (2.8) [5.9]	4 (2.1) [4.6]	6 (3.4) [8.1]	1 (0.6) [1.6]
Common SAEs, n (%) [IR] d	—	—	—	—	—	—
Fall	2 (0.9) [1.1]	0 (0) [0]	0 (0) [0]	0 (0) [0]	2 (1.1) [2.7]	0 (0) [0]
Osteoarthritis	0 (0) [0]	2 (1.0) [1.3]	0 (0) [0]	0 (0) [0]	0 (0) [0]	0 (0) [0]
Discontinuations of study drug due to AE (includes death), n (%) [IR]	8 (3.6) [4.2]	8 (4.1) [5.1]	2 (0.9) [2.0]	6 (3.1) [6.9]	0 (0) [0]	0 (0) [0]
TEAEs of special interest, n (%) [IR]	—	—	—	—	—	—
Infection	131 (59.3) [69.2]	111 (56.9) [70.2]	17 (8.1) [16.8]	23 (12.0) [26.5]	55 (31.3) [74.1]	54 (34.4) [86.8]
Injection‐site reactionse	21 (9.5) [11.1]	16 (8.2) [10.1]	2 (0.9) [2.0]	0 (0) [0]	2 (1.1) [2.7]	4 (2.5) [6.4]
Cerebro‐cardiovascular events	1 (0.5) [0.5]	3 (1.5) [1.9]	0 (0) [0]	1 (0.5) [1.2]	1 (0.6) [1.3]	0 (0) [0]
Malignancies	2 (0.9) [1.1]	0 (0) [0]	0 (0) [0]	1 (0.5) [1.2]	0 (0) [0]	0 (0) [0]
Depression	1 (0.5) [0.5]	5 (2.6) [3.2]	1 (0.5) [1.0]	1 (0.5) [1.2]	1 (0.6) [1.3]	0 (0) [0]
Crohn's disease	1 (0.5) [0.5]	0 (0) [0]	3 (1.4) [3.0]	0 (0) [0]	1 (0.6) [1.3]	0 (0) [0]
Ulcerative colitis	0 (0) [0]	1 (0.5) [0.6]	0 (0) [0]	0 (0) [0]	0 (0) [0]	0 (0) [0]

AE, adverse event; IR, exposure‐adjusted incidence rate; IXEQ2W, ixekizumab 80 mg every 2 weeks; IXEQ4W, ixekizumab 80 mg every 4 weeks; N, population size; n, number in group; PBO, placebo; SAE, serious adverse event; TEAE, treatment‐emergent adverse event.

^aPatients with multiple occurrences of these categories are counted once for each category.

^bOccurring in ≥5% of patients in any arm in any group.

^cPreferred term.

^dOccurring in ≥2 patients in any arm in any group.

^eA composite of several injection‐site reaction‐related preferred terms.