TABLE 4.
Summary of most common AEs (occurring in ≥5% of patients in either treatment group) through 5 years of cumulative exposure
| TIL 100 mg (n = 63) | TIL 200 mg (n = 66) | |
|---|---|---|
| Nasopharyngitis | 25 (8.6) | 39 (10.9) |
| Eczema | 10 (3.4) | 8 (2.2) |
| Hypertension | 8 (2.8) | 8 (2.2) |
| Influenza | 6 (2.1) | 10 (2.8) |
| Arthralgia | 3 (1.0) | 10 (2.8) |
| Dermatitis contact | 7 (2.4) | 3 (0.8) |
| Insomnia | 7 (2.4) | 1 (0.3) |
| Pruritis | 6 (2.1) | 5 (1.4) |
| Back pain | 4 (1.4) | 7 (1.9) |
| Urticaria | 5 (1.7) | 4 (1.1) |
| Constipation | 5 (1.7) | 2 (0.6) |
| Psoriasis | 2 (0.7) | 6 (1.7) |
| Skin papilloma | 5 (1.7) | 1 (0.3) |
| Diarrhea | 4 (1.4) | 5 (1.4) |
| Dental caries | 4 (1.4) | 4 (1.1) |
| Abdominal pain upper | 4 (1.4) | 2 (0.6) |
| Seborrheic keratosis | 4 (1.4) | 2 (0.6) |
| Alanine aminotransferase increased | 4 (1.4) | 2 (0.6) |
| Gamma‐glutamyltransferase increased | 4 (1.4) | 1 (0.3) |
| Rhinitis allergic | 4 (1.4) | 1 (0.3) |
| Pharyngitis | 2 (0.7) | 5 (1.4) |
| Acrochordon | 0 | 5 (1.4) |
| Headache | 3 (1.0) | 4 (1.1) |
| Pneumonia | 2 (0.7) | 4 (1.1) |
| Gastroenteritis | 2 (0.7) | 4 (1.1) |
| Large intestine polyp | 1 (0.3) | 4 (1.1) |
| Gastroesophageal reflux disease | 1 (0.3) | 4 (1.1) |
| Spinal osteoarthritis | 1 (0.3) | 4 (1.1) |
| Herpes zoster | 0 | 4 (1.1) |
| Upper respiratory tract infection | 3 (1.0) | 3 (0.8) |
| Bronchitis | 3 (1.0) | 2 (0.6) |
| Conjunctivitis | 3 (1.0) | 2 (0.6) |
| Hyperkeratosis | 3 (1.0) | 2 (0.6) |
| Cellulitis | 3 (1.0) | 1 (0.3) |
| Hyperuricemia | 3 (1.0) | 1 (0.3) |
| Dermal cyst | 3 (1.0) | 0 |
Data shown as n (n P100PY).
Abbreviations: AE, adverse event; P100PY, per 100 patient‐years; TIL, tildrakizumab.