Table 3.

Summary of safety findings

	Through week 24					Through week 52
	TIL 200 mg Q4W (n=78)	TIL 200 mg Q12W (n=79)	TIL 100 mg Q12W (n=77)	TIL 20 mg Q12W (n=78)	PBO Q4W (n=79)	TIL 200 mg Q4W (n=78)	TIL 200 mg Q12W (n=79)	TIL 100 mg Q12W (n=77)	TIL 20 mg →200 mg Q12W (n=78)	PBO→ TIL 200 mg Q12W (n=79)
Any TEAE	39 (50.0)	39 (49.4)	44 (57.1)	34 (43.6)	34 (43.0)	51 (65.4)	50 (63.3)	53 (68.8)	51 (65.4)	47 (59.5)
Serious TEAEs	2 (2.6)	2 (2.5)	2 (2.6)	1 (1.3)	2 (2.5)	2 (2.6)	2 (2.5)	2 (2.6)	4 (5.1)	3 (3.8)
Discontinuations due to TEAEs	0	0	0	0	0	0	1 (1.3)	0	0	0
Deaths due to TEAEs	0	0	0	0	0	0	0	0	0	0
Any TEAE of special interest*	0	0	1 (1.3)	0	0	0	0	1 (1.3)	1 (1.3)	0
Any TEAE of clinical interest	0	0	1 (1.3)	0	0	0	0	1 (1.3)	2 (2.6)	1 (1.3)
Serious TEAEs (≥1)
Hypertension	0	2 (2.5)	0	0	0	0	2 (2.5)	0	0	0
Osteoarthritis	0	0	1 (1.3)	0	1 (1.3)	0	0	1 (1.3)	0	1 (1.3)
Parathyroid tumour benign	0	0	0	0	1 (1.3)	0	0	0	0	1 (1.3)
Hypokalaemia	0	0	1 (1.3)	0	0	0	0	1 (1.3)	0	0
Ovarian cyst	1 (1.3)	0	0	0	0	1 (1.3)	0	0	0	0
Ovarian cyst ruptured	1 (1.3)	0	0	0	0	1 (1.3)	0	0	0	0
Syncope	0	0	1 (1.3)	0	0	0	0	1 (1.3)	0	0
Chronic tonsillitis	0	0	0	1 (1.3)	0	0	0	0	1 (1.3)	0
Angina pectoris	0	0	0	0	0	0	0	0	1 (1.3)	0
Intraductal proliferative breast lesion	0	0	0	0	0	0	0	0	1 (1.3)	0
Lumbar radiculopathy	0	0	0	0	0	0	0	0	1 (1.3)	0
Chronic obstructive pulmonary disease	0	0	0	0	0	0	0	0	0	1 (1.3)
TEAEs of special or clinical interest (≥1)*
Pyelonephritis	0	0	1 (1.3)	0	0	0	0	1 (1.3)	0	0
Urinary tract infection	0	0	1 (1.3)	0	0	0	0	1 (1.3)	0	0
Depression	0	0	0	1 (1.3)	0	0	0	0	1 (1.3)	1 (1.3)
AST increased	0	0	0	0	0	0	0	0	1 (1.3)	0
Blood bilirubin increased	0	0	0	0	0	0	0	0	1 (1.3)	0
Intraductal proliferative breast lesion	0	0	0	0	0	0	0	0	1 (1.3)	0
Most frequent TEAEs (≥5% through week 52)
Nasopharyngitis	7 (9.0)	1 (1.3)	4 (5.2)	5 (6.4)	5 (6.3)	9 (11.5)	3 (3.8)	6 (7.8)	8 (10.3)	7 (8.9)
Headache	4 (5.1)	1 (1.3)	5 (6.5)	5 (6.4)	2 (2.5)	5 (6.4)	4 (5.1)	7 (9.1)	5 (6.4)	3 (3.8)
Hypertension	3 (3.8)	5 (6.3)	1 (1.3)	2 (2.6)	4 (5.1)	5 (6.4)	6 (7.6)	1 (1.3)	2 (2.6)	5 (6.3)
Upper respiratory tract infection	2 (2.6)	4 (5.1)	3 (3.9)	2 (2.6)	1 (1.3)	4 (5.1)	8 (10.1)	5 (6.5)	7 (9.0)	1 (1.3)
Anxiety	1 (1.3)	4 (5.1)	0	1 (1.3)	1 (1.3)	1 (1.3)	5 (6.3)	1 (1.3)	2 (2.6)	2 (2.5)
Sleep disorder	1 (1.3)	5 (6.3)	0	1 (1.3)	1 (1.3)	1 (1.3)	5 (6.3)	0	1 (1.3)	1 (1.3)
Diarrhoea	0	0	0	4 (5.1)	0	0	1 (1.3)	2 (2.6)	6 (7.7)	1 (1.3)
Nausea	0	0	2 (2.6)	1 (1.3)	1 (1.3)	0	0	4 (5.2)	2 (2.6)	1 (1.3)
Pharyngitis	1 (1.3)	0	2 (2.6)	0	2 (2.5)	1 (1.3)	1 (1.3)	3 (3.9)	4 (5.1)	2 (2.5)
Sinusitis	0	1 (1.3)	1 (1.3)	0	2 (2.5)	1 (1.3)	2 (2.5)	4 (5.2)	1 (1.3)	2 (2.5)
Urinary tract infection	0	1 (1.3)	3 (3.9)	1 (1.3)	3 (3.8)	1 (1.3)	1 (1.3)	3 (3.9)	4 (5.1)	4 (5.1)
ALT increased	0	1 (1.3)	1 (1.3)	0	3 (3.8)	2 (2.6)	1 (1.3)	1 (1.3)	1 (1.3)	5 (6.3)
AST increased	0	1 (1.3)	1 (1.3)	0	1 (1.3)	2 (2.6)	1 (1.3)	1 (1.3)	2 (2.6)	5 (6.3)
Blood pressure increased	1 (1.3)	0	2 (2.6)	0	0	2 (2.6)	0	4 (5.2)	0	0
Gamma-glutamyl transferase increased	1 (1.3)	1 (1.3)	3 (3.9)	0	1 (1.3)	1 (1.3)	1 (1.3)	4 (5.2)	1 (1.3)	2 (2.5)
Arthralgia	2 (2.6)	0	0	3 (3.8)	0	4 (5.1)	0	0	4 (5.1)	0
Back pain	2 (2.6)	0	2 (2.6)	1 (1.3)	2 (2.5)	4 (5.1)	0	2 (2.6)	1 (1.3)	2 (2.5)

Data shown are n (%) for randomised patients who received ≥1 dose of study drug.

*AEs of special interest were major adverse cardiac events, malignancies and severe infections.

ALT, alanine aminotransferase; AST, aspartate aminotransferase; PBO, placebo; Q4W, every 4 weeks; Q12W, every 12 weeks; TEAE, treatment-emergent adverse event; TIL, tildrakizumab.