Summary of immunogenicity results (safety analysis population)
| Patients . | IM total∗ (n = 167) . | IV 25/25/50 mg/m2 MWF (n = 61) . |
|---|---|---|
| Patients with available ADA samples, n | 167 | 61 |
| Confirmed ADA+† | 82 (49) | 34 (56) |
| NAb+ | 4 (2) | 2 (3) |
| HSR‡ | 11 (7) | 12 (20) |
| ADA−§ | 85 (51) | 27 (44) |
| HSR‡ | 7 (4) | 4 (7) |
| Patients . | IM total∗ (n = 167) . | IV 25/25/50 mg/m2 MWF (n = 61) . |
|---|---|---|
| Patients with available ADA samples, n | 167 | 61 |
| Confirmed ADA+† | 82 (49) | 34 (56) |
| NAb+ | 4 (2) | 2 (3) |
| HSR‡ | 11 (7) | 12 (20) |
| ADA−§ | 85 (51) | 27 (44) |
| HSR‡ | 7 (4) | 4 (7) |
Data are n (%) unless otherwise specified. ADAs refer to anti-JZP458 antibodies.
The IM cohorts consisted of cohort 1a (25 mg/m2 MWF), cohort 1b (37.5 mg/m2 MWF), and cohort 1c (25/25/50 mg/m2 MWF).
Defined as patients with a positive result on the first test and a positive result on the confirmatory test.
HSR was defined as at least 1 TRAE of special interest for allergic reactions (including hypersensitivity and anaphylaxis).
Defined as patients with a negative result on the first test.