Table 2.
Efficacy of subcutaneous risankizumab in adults with moderate to severe plaque psoriasis at week 16 (part A) in pivotal phase III trials
| Trial | Treatment (no. of pts) | PASI (% pts) | sPGA (% pts) | DLQI 0 or 1 (% pts) | PSS 0 (% pts) | |||
|---|---|---|---|---|---|---|---|---|
| 75 | 90a | 100 | 0 | 0 or 1a | ||||
| UltIMMa-1 [15] | RIS (304) | 89*† | 75**††† | 36**††† | 37**††† | 88**††† | 66**††† | 29**†† |
| UST (100) | 76 | 42 | 12 | 14 | 63 | 43 | 15 | |
| PL (102) | 9 | 5 | 0 | 2 | 8 | 8 | 2 | |
| UltIMMa-2 [15] | RIS (294) | 91*††† | 75**††† | 51**††† | 51**††† | 84**††† | 67**†† | 31**†† |
| UST (99) | 70 | 48 | 24 | 25 | 62 | 47 | 15 | |
| PL (98) | 6 | 2 | 2 | 3 | 5 | 4 | 0 | |
| IMMvent [16] | RIS (301) | 91‡ | 72‡ | 40‡ | 41‡ | 84‡ | 66‡ | |
| ADA (304) | 72 | 47 | 23 | 23 | 60 | 49 | ||
| IMMhance [17] | RIS (407) | 89* | 73* | 47* | 46* | 84* | 65* | |
| PL (100) | 8 | 2 | 1 | 1 | 7 | 3 | ||
Efficacy analyses were conducted in the intention-to-treat populations
ADA adalimumab, DLQI Dermatology Life Quality Index, PASI Psoriasis Area and Severity Index, PASI x improvement of ≥ x% from baseline in PASI score, PL placebo, PSS Psoriasis Symptom Scale, pts patients, RIS risankizumab, sPGA static Physician’s Global Assessment, UST ustekinumab
*p < 0.001, **p < 0.0001 vs PL; †p < 0.01, ††p ≤ 0.001, †††p < 0.0001 vs UST; ‡p < 0.0001 vs ADA
aCo-primary endpoint