Table 2.
Summary of treatment-emergent adverse events in the single ascending dose and multiple ascending dose studies.
| n (%) | SAD (healthy volunteers) |
MAD (patients with SLE) |
||
|---|---|---|---|---|
| NKTR-358 (n = 76) | Placebo (n = 24) | NKTR-358 (n = 36) | Placebo (n = 12) | |
| Any TEAEs | 63 (83) | 6 (25) | 35 (97) | 7 (58) |
| Grade 3–4 | 1 (1)a | 0 | 1 (3)b | 0 |
| Grade 5 | 0 | 0 | 0 | 0 |
| Any treatment-related TEAEs | 55 (72) | 2 (8) | 33 (92) | 1 (8) |
| Serious TEAEs | 1 (1)a | 0 | 1 (3)b | 0 |
| TEAEs leading to discontinuation | 0 | 0 | 1 (3)c | 0 |
| Injection site-related TEAEs | ||||
| Injection site erythema | 50 (66) | 0 | 28 (78) | 0 |
| Injection site pain | 34 (45) | 0 | 8 (22) | 0 |
| Injection site swelling | 17 (22) | 0 | 2 (6) | 0 |
| Injection site pruritus | 11 (14) | 0 | 22 (61) | 0 |
| Injection site induration | 5 (7) | 0 | 2 (6) | 0 |
| Injection site reaction | 0 | 0 | 14 (39) | 0 |
| Injection site warmth | 0 | 0 | 5 (14) | 0 |
| Injection site edema | 0 | 0 | 3 (8) | 0 |
| Most common TEAEs | ||||
| Headache | 9 (12) | 5 (21) | 1 (3) | 0 |
| Back pain | 4 (5) | 1 (4) | 0 | 1 (8) |
| Urinary tract infection | 1 (1) | 0 | 4 (11) | 2 (17) |
| Nasopharyngitis | 0 | 0 | 3 (8) | 0 |
| Eosinophilia | 0 | 0 | 3 (8) | 0 |
| Insomnia | 0 | 0 | 3 (8) | 0 |
| Fatigue | 0 | 0 | 2 (6) | 0 |
| Maculo-papular rash | 0 | 0 | 2 (6) | 0 |
| Sinusitis | 0 | 0 | 2 (6) | 0 |
Abbreviations: MAD: multiple ascending dose; SAD: single ascending dose; SLE: systemic lupus erythematosus; TEAE: treatment-emergent adverse event.
a
Grade 4 attempted suicide not considered related to study drug.
b
Grade 3 migraine not considered related to study drug.
c
Treatment-related grade 2 eosinophilia.