Table 7.
PASI and sPGA0/1 responses by ADA status at weeks 16 and 52 in subjects treated with risankizumab 150 mg SC at weeks 0 and 4, and every 12 weeks thereafter in global phase III studies
| Efficacy response (NRI) | Week 16 (placebo-controlled) [n = 1000] | Week 52 (ustekinumab-controlled) [n = 598] | ||||
|---|---|---|---|---|---|---|
| ADA-negative [n = 819] | ADA-positive with ADA titer < 128 [n = 174] | ADA-positive with ADA titer ≥128 [n = 7] | ADA-negative [n = 456] | ADA-positive with ADA titer < 128 [n = 136] | ADA-positive with ADA titer ≥128 [N = 6] | |
| PASI 75 | 735 (89.7) | 155 (89.1) | 5 (71.4) | 414 (90.8) | 130 (95.6) | 4 (66.7) |
| PASI 90 | 610 (74.5) | 131 (75.3) | 2 (28.6) | 377 (82.7) | 106 (77.9) | 3 (50.0) |
| PASI 100 | 372 (45.4) | 76 (43.7) | 1 (14.3) | 270 (59.2) | 75 (55.1) | 1 (16.7) |
| sPGA 0/1 | 695 (84.9) | 150 (86.2) | 4 (57.1) | 385 (84.4) | 120 (88.2) | 2 (33.3) |
Data are expressed as n (%)
There were additional subjects who developed treatment-emergent ADA response with ADA titers ≥ 128 in phase III studies; however, these subjects did not receive the proposed clinical regimen of risankizumab (150 mg SC at weeks 0 and 4, and every 12 weeks thereafter), and hence were not included in this analysis
ADA antidrug antibody, NRI non-responder imputation, PASI Psoriasis Area and Severity Index, sPGA static Physicians Global Assessment, SC subcutaneous