Table 3.
Treatment Emergent Adverse Events in 1118 Persons with PsA Exposed to Ixekizumab for Up to 3 Years
| Safety Outcomes up to 3 Years33 | Ixekizumab Exposed | Ixekizumab Exposed |
|---|---|---|
| (N=1118 Subjects in Total) | (%) | |
| Number of Subjects/People Affected Out of Total | Percentage of Subjects/People Affected Out of Total | |
| Deaths (none were adjudicated as related to ixekizumab) | 6 | 0.54 |
| Major Acute Cardiovascular events | 11 | 0.98 |
| Fatal MACE | 2 | 0.18 |
| Non-fatal myocardial infarction | 5 | 0.45 |
| Non-fatal stroke | 4 | 0.36 |
| Coronary artery disease | 3 | 0.27 |
| Cerebrovascular accident leading to treatment discontinuation | 2 | 0.18 |
| Malignancy (all considered SAE and led to discontinuation of the drug) | 14 | 1.25 |
| Non-melanoma skin cancer | 8 | 0.72 |
| Breast cancer | 2 | 0.18 |
| Prostate cancer | 1 | 0.09 |
| Malignant melanoma in situ | 1 | 0.09 |
| Metastatic renal cell carcinoma | 1 | 0.09 |
| Papillary thyroid cancer | 1 | 0.09 |
| Upper respiratory infection | 161 | 14.40 |
| Nasopharyngitis | 150 | 13.42 |
| Injection site reactions | 142 | 12.70 |
| Injection site erythema | 52 | 4.65 |
| Injection site pain | 18 | 1.61 |
| Injection site reactions leading to treatment discontinuation | 3 | 0.27 |
| Bronchitis | 81 | 7.25 |
| Bronchitis categorized as serious infection | 4 | 0.36 |
| Candida infections | 39 | 3.49 |
| Esophageal candidiasis | 2 | 0.18 |
| Depression | 29 | 2.59 |
| Latent TB | 19 | 1.70 |
| Latent TB leading to treatment discontinuation | 6 | 0.54 |
| Localized herpes zoster | 15 | 1.34 |
| Grade 3 neutropenia <1000 and >500 PMN/mm3 | 6 | 0.54 |
| Cholelithiasis | 5 | 0.45 |
| Pneumonia categorized as serious infection | 5 | 0.45 |
| Pneumonia leading to treatment discontinuation | 2 | 0.18 |
| Bronchitis | 4 | 0.36 |
| Myalgia leading to treatment discontinuation | 2 | 0.18 |
| Adjudicated IBD with no prior history | 2 | 0.18 |
| Septic arthritis leading to treatment discontinuation | 1 | 0.09 |
| Hepatitis B leading to treatment discontinuation | 1 | 0.09 |
| Cellulitis leading to treatment discontinuation | 1 | 0.09 |
| Dermatitis leading to treatment discontinuation | 1 | 0.09 |
| Otitis media leading to treatment discontinuation | 1 | 0.09 |
| Tooth abscess leading to treatment discontinuation | 1 | 0.09 |
| Urinary tract infection leading to treatment discontinuation | 1 | 0.09 |
| Subcutaneous abscess leading to treatment discontinuation | 1 | 0.09 |
| Tonsillitis leading to treatment discontinuation | 1 | 0.09 |