Table 6.
Comparison of incidence of antidrug antibodies (anti-risankizumab antibodies) and neutralizing antibodies to risankizumab over up to 52 weeks’ duration in Japanese and non-Japanese subjects with moderate-to-severe plaque psoriasis, GPP, EP, or psoriatic arthritis in global phase III or Japanese phase II/III studies
| Population | Japanese subjects who received at least one dose of risankizumab 75–150 mg SC | Non-Japanese subjects who received at least one dose of risankizumab 75–150 mg SC | ||
|---|---|---|---|---|
| Plaque psoriasis, GPP, or EP | Psoriatic arthritis | Plaque psoriasis | Psoriatic arthritis | |
| Evaluable subjects (n) | 228 | 11 | 1322 | 129 |
| ADA incidence (treatment-emergent) [n (%)] | 54 (23.7) | 1 (9.1) | 296 (22.4) | 16 (12.4) |
| NAb incidence (treatment-emergent) [n (%)] | 23 (10.9)a | 0 (0) | 177 (13.4) | 0 (0) |
Evaluable subjects: subjects with at least one reportable assessment at any time in the study post-baseline
NAb were assessed only when the ADA assessment was confirmed positive
ADA antidrug antibody (anti-risankizumab antibody), NAb neutralizing antibody, SC subcutaneously, GPP generalized pustular psoriasis, EP erythrodermic psoriasis
aBased on 211 evaluable Japanese subjects as NAb was not assessed in Study 10