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.