Table 3.

Safety overview: treatment withdrawal period (responder population) and Retreatment Period (relapse population) in patients with plaque psoriasis (UNCOVER‐J)

AE, n (%)	Treatment withdrawal period (no ixekizumab; n = 70)	Retreatment period (IXE Q4W; n = 59)
DEAEs/TEAEsa	39 (55.7)	52 (88.1)
AE leading to discontinuation	1 (1.4)	3 (5.1)
Deaths	0	0
SAEs	3 (4.3)	8 (13.6)
AESI	20 (28.6)	40 (67.8)
Infections	15 (21.4)	34 (57.6)
Hepatic	5 (7.1)	8 (13.6)
Allergic reactions/hypersensitivity	4 (5.7)	11 (18.6)
Malignancies	1 (1.4)	0
Injection‐site reaction	0	2 (3.4)
Cytopenias	0	0
Depression	0	1 (1.7)
Cerebrocardiovascular disease	0	1 (1.7)
Pneumocystis jirovecii pneumonia	0	0
Interstitial lung disease	0	0

^aDEAEs are reported for the Treatment Withdrawal Period and TEAEs are reported for the Retreatment Period.

Patients with multiple occurrences of the same event were counted under the highest severity; in the case where the severity has an additional category ‘more severe than baseline’ collected, the ‘more severe than baseline’ and ‘severe’ categories were combined for analysis and presentation.

Of the 70 patients who entered the Treatment Withdrawal Period, three patients did not enter the following Retreatment Period (one patient who discontinued owing to an AE before Week 100 but did not relapse; one patient who discontinued owing to a physician decision before Week 100 and relapsed; one patient who relapsed before Week 100 but did not enter the Retreatment Period owing to a physician decision). Of these 70 patients, 61 patients relapsed during the Treatment Withdrawal Period. A total of 59 patients who relapsed during the Treatment Withdrawal Period and who entered the following Retreatment Period were included in the relapse population.

AE, adverse event; AESI, adverse event of special interest; DEAE, drug‐free‐emergent adverse event; IXE Q4W, 80 mg ixekizumab every 4 weeks; SAE, serious adverse event; TEAE, treatment‐emergent adverse event.