TABLE 3.
Summary of AEs and AEs of special interest through 5 years of cumulative exposure
| TIL 100 mg (n = 63) | TIL 200 mg (n = 66) | |
|---|---|---|
| Any AE | 56 (19.3) | 63 (17.5) |
| SAEs | 15 (5.2) | 13 (3.6) |
| Discontinuations due to AEs | 5 (1.7) | 3 (0.8) |
| Deaths due to AEs | 0 | 0 |
| SAEs (≥1) | ||
| Angina pectoris | 1 (0.3) | 1 (0.3) |
| Atrial fibrillation | 1 (0.3) | 0 |
| Hypertensive heart disease | 1 (0.3) | 0 |
| Cataract | 0 | 1 (0.3) |
| Macular fibrosis | 0 | 1 (0.3) |
| Anal fissure | 1 (0.3) | 0 |
| Colitis ischemic | 0 | 1 (0.3) |
| AEs of special interest | ||
| Severe infections | 3 (1.0) | 5 (1.4) |
| Malignancies | 2 (0.7) | 2 (0.6) |
| Nonmelanoma skin cancer | 0 | 0 |
| Melanoma skin cancer | 0 | 0 |
| Confirmed MACE | 4 (1.4) | 1 (0.3) |
| Hypersensitivity reaction | 2 (0.7) | 1 (0.3) |
| Injection site erythema | 0 | 1 (0.3) |
| Injection site pain | 1 (0.3) | 0 |
| Injection site pruritis | 0 | 1 (0.3) |
Data shown as n (n P100PY).
Abbreviations: AE, adverse event; MACE, major adverse cardiovascular event; P100PY, per 100 patient‐years; SAE, serious AE; TIL, tildrakizumab.