Table 2.
Percentage of Adverse Events in the 3 RCTs
| COAST V | COAST W | COAST X | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| ADA q2W % | IXE q2W % | IXE q4W % | Placebo % | IXE q2W % | IXE q4W % | Placebo % | IXE q2W % | IXE q4W % | |||
| TEAE | 49 | 43 | 42 | 49 | 60.2 | 64 | 57 | 77 | 66 | ||
| Mild | 31 | 34 | 27 | 17.3 | 23.5 | 29.8 | |||||
| Moderate | 16 | 7 | 15 | 25 | 32.7 | 30.7 | |||||
| Severe | 2 | 2 | 0 | 6.7 | 4.1 | 3.5 | 4 | 7 | 1 | ||
| Discontinuation due to AE | 1 | 4 | 0 | 1.9 | 3.1 | 8.8 | 2 | 1 | 1 | ||
| SAEs | 3 | 1 | 1 | 4.8 | 3.1 | 3.5 | 1 | 1 | 2 | ||
| Death | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | ||
| Common TEAE | |||||||||||
| Nasopharyngitis | 7 | 6 | 7 | 8 | 16 | 19 | |||||
| Upper respiratory tract infection | 2 | 5 | 9 | 2.9 | 4.1 | 7.9 | 4 | 6 | 4 | ||
| AE of interest | |||||||||||
| Grade 3 or 4 neutropenia | 1 | 0 | 0 | 0 | 0 | 0.9 | 1 | 0 | 0 | ||
| Infections | 21 | 20 | 20 | 9.6 | 23.5 | 29.8 | 29 | 42 | 40 | ||
| Serious infections | 1 | 1 | 1 | 0 | 0 | 1.8 | 0 | 0 | 1 | ||
| Candida infections | 1 | 0 | 0 | 0 | 2 | 0 | 1 | 0 | 0 | ||
| Herpes zoster | 0 | 0 | 0.9 | 1 | 0 | 2 | |||||
| Reactivated tuberculosis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| ISR | 8 | 13 | 4 | 1 | 8.2 | 2.6 | 7 | 25 | 19 | ||
| Allergic reactions | 4 | 4 | 4 | 1 | 6.1 | 2.6 | 4 | 3 | 4 | ||
| Potential anaphylaxis | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | ||
| Hepatic | 2 | 1 | 1 | 1.9 | 1 | 4.4 | 6 | 5 | 3 | ||
| Cerebrocardiovascular events | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 1 | 0 | ||
| Malignancies | 0 | 0 | 0 | 0 | 0 | 0.9 | 0 | 0 | 0 | ||
| Anterior uveitis | 0 | 0 | 1 | 0 | 3.1 | 1.8 | 2 | 2 | 1 | ||
| Crohn’s disease | 0 | 1 | 0 | 0 | 0 | 1.7 | 0 | 0 | 1 | ||
| Ulcerative colitis | 0 | 0 | 0 | 0 | 0 | 0.8 | 1 | 0 | 0 | ||
| Depression | 1 | 0 | 0 | 4.8 | 2 | 0 | 0 | 4 | 0 | ||
| Psoriasis | 1 | 0 | 0 | 0 | 0 | 1 | |||||
Abbreviations: TEAE, treatment emergent adverse events; AE, adverse events; SAE, serious adverse events; ISR, injection site reactions.