Table 1.

Pharmacokinetic studies included in the analyses

Study	Study design and patient population	Risankizumab dose	Pharmacokinetic samplinga
1. [16] N = 39	Randomized, multicenter, double-blind, placebo-controlled, single-ascending-dose, two-stage, sequential-group (stage 1) and parallel-group (stage 2) phase I study in adult subjects with moderate-to-severe plaque psoriasis	Single dose IV: 0.01, 0.05, 0.25, 1, 3, or 5 mg/kg on day 1	− 0.5, 0.5, 1, 2, 4, 8, 16, 24, 48, and 72 h; days 8, 15, 29, 57, 85, 113, 141, and 169
		SC: 0.25 or 1 mg/kg on day 1
2. [17] N = 166	Randomized, multicenter, double-blind, active-controlledb, single- and multiple-dose, parallel-group phase II study in adult subjects with moderate-to-severe plaque psoriasis	Single dose SC: 18 mg at week 0	Week 0, 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 40, and 48
		Multiple doses SC: 90 or 180 mg at week 0, 4, and 16
3. [18, 19] N = 121	Randomized, multicenter, double-blind, placebo-controlled, multiple-dose, parallel-group, three-period phase II study in adult subjects with moderate-to-severe Crohn’s disease	Multiple doses IV Period 1: blinded 200 or 600 mg at week 0, 4, and 8	Week 0, 2, 4, 8, and 12, and for discontinuations, 23
		IV Period 2c: open-label 600 mg at week 14, 18, and 22	Week 14, 18, and 22
		SC Period 3d: open-label 180 mg at week 26, 34, 42, and 50	Week 26, 34, 42, 50, 52, and 65

IV intravenous, SC subcutaneous

^aOn dosing days, the blood sample was obtained before risankizumab was administered

^bUstekinumab 45 or 90 mg (SC) based on body weight, as per the prescribing information

^cOpen-label re-induction therapy for subjects who were (1) in deep remission at week 12 and experienced disease flare [Crohn’s Disease Endoscopic Activity Index of Severity score > 4 (in subjects with initial ileitis > 2)] within the next 2 weeks, or (2) who did not achieve deep remission at week 12

^dContinued therapy for subjects who were in clinical remission at week 26