Table 3

Summary of safety findings

Through week 24Through 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 TEAE39 (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 TEAEs2 (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 TEAEs0000001 (1.3)000
Deaths due to TEAEs0000000000
Any TEAE of special interest*001 (1.3)00001 (1.3)1 (1.3)0
Any TEAE of clinical interest001 (1.3)00001 (1.3)2 (2.6)1 (1.3)
Serious TEAEs (≥1)
Hypertension02 (2.5)00002 (2.5)000
Osteoarthritis001 (1.3)01 (1.3)001 (1.3)01 (1.3)
Parathyroid tumour benign00001 (1.3)00001 (1.3)
Hypokalaemia001 (1.3)00001 (1.3)00
Ovarian cyst1 (1.3)00001 (1.3)0000
Ovarian cyst ruptured1 (1.3)00001 (1.3)0000
Syncope001 (1.3)00001 (1.3)00
Chronic tonsillitis0001 (1.3)00001 (1.3)0
Angina pectoris000000001 (1.3)0
Intraductal proliferative breast lesion000000001 (1.3)0
Lumbar radiculopathy000000001 (1.3)0
Chronic obstructive pulmonary disease0000000001 (1.3)
TEAEs of special or clinical interest (≥1)*
Pyelonephritis001 (1.3)00001 (1.3)00
Urinary tract infection001 (1.3)00001 (1.3)00
Depression0001 (1.3)00001 (1.3)1 (1.3)
AST increased000000001 (1.3)0
Blood bilirubin increased000000001 (1.3)0
Intraductal proliferative breast lesion000000001 (1.3)0
Most frequent TEAEs (≥5% through week 52)
Nasopharyngitis7 (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)
Headache4 (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)
Hypertension3 (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 infection2 (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)
Anxiety1 (1.3)4 (5.1)01 (1.3)1 (1.3)1 (1.3)5 (6.3)1 (1.3)2 (2.6)2 (2.5)
Sleep disorder1 (1.3)5 (6.3)01 (1.3)1 (1.3)1 (1.3)5 (6.3)01 (1.3)1 (1.3)
Diarrhoea0004 (5.1)001 (1.3)2 (2.6)6 (7.7)1 (1.3)
Nausea002 (2.6)1 (1.3)1 (1.3)004 (5.2)2 (2.6)1 (1.3)
Pharyngitis1 (1.3)02 (2.6)02 (2.5)1 (1.3)1 (1.3)3 (3.9)4 (5.1)2 (2.5)
Sinusitis01 (1.3)1 (1.3)02 (2.5)1 (1.3)2 (2.5)4 (5.2)1 (1.3)2 (2.5)
Urinary tract infection01 (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 increased01 (1.3)1 (1.3)03 (3.8)2 (2.6)1 (1.3)1 (1.3)1 (1.3)5 (6.3)
AST increased01 (1.3)1 (1.3)01 (1.3)2 (2.6)1 (1.3)1 (1.3)2 (2.6)5 (6.3)
Blood pressure increased1 (1.3)02 (2.6)002 (2.6)04 (5.2)00
Gamma-glutamyl transferase increased1 (1.3)1 (1.3)3 (3.9)01 (1.3)1 (1.3)1 (1.3)4 (5.2)1 (1.3)2 (2.5)
Arthralgia2 (2.6)003 (3.8)04 (5.1)004 (5.1)0
Back pain2 (2.6)02 (2.6)1 (1.3)2 (2.5)4 (5.1)02 (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.