Efficacy, safety, usability, and acceptability of risankizumab 150 mg formulation administered by prefilled syringe or by an autoinjector for moderate to severe plaque psoriasis

Figures & data

Figure 1. Patient disposition and study drug discontinuation in (A) study 1 and (B) study 2. AI: autoinjector; PFS: prefilled syringe.

Table 1. Patient demographics and baseline disease characteristics in study 1 and 2.

	Study 1		Study 2
Characteristic	Risankizumab 150 mg/mL PFS (n = 105)	Placebo (n = 52)	Risankizumab 150 mg/mL AI (N = 108)
Age, years, mean (SD)	49.3 (15.1)	48.8 (15.5)	49.2 (14.3)
Male, n (%)	59 (56.2)	28 (53.8)	66 (61.1)
Race, White, n (%)	87 (82.9)	44 (84.6)	95 (88.0)
Weight, kg, mean (SD)	96.9 (28.9)	91.7 (23.5)	93.3 (26.4)
BMI, kg/m^2, mean (SD)	33.3 (8.7)	31.6 (7.4)	32.0 (8.7)
Disease duration, years, mean (SD)	20.9 (13.8)	15.8 (11.8)	16.9 (13.1)
PASI, mean (SD)	21.5 (9.6)	21.1 (10.3)	19.8 (7.2)
sPGA, n (%)
Score 3	86 (81.9)	46 (88.5)	88 (81.5)
Score 4	19 (18.1)	6 (11.5)	20 (18.5)
BSA involvement, %, mean (SD)	28.3 (16.4)	28.2 (18.5)	25.5 (17.5)
Psoriatic arthritis, n (%)	26 (24.8)	11 (21.2)	19 (17.6)
Prior biologic therapy, n (%)	47 (44.8)	23 (44.2)	48 (44.4)

AI: autoinjector; BMI: body mass index; PASI: Psoriasis Area Severity Index; PFS: prefilled syringe; SD: standard deviation; sPGA: static physician global assessment; BSA: body surface area.

Figure 2. Proportion of patients achieving PASI 90, PASI 100, sPGA 0/1, and sPGA 0 at week 16 with risankizumab and placebo (study 1) and OL risankizumab (study 2). NRI analysis. AI: autoinjector; NRI: non-responder imputation; OL: open-label; PASI: Psoriasis Area Severity Index; PFS: prefilled syringe; sPGA: static physician’s global assessment.

Table 2. Percentage change from baseline in PASI over time.

	Study 1		Study 2
LS mean	Risankizumab 150 mg/mL PFS (n = 105)	Placebo (n = 52)	Risankizumab 150 mg/mL AI (N = 108)
Week 4	–50.6* (n = 101)	–14.5 (n = 50)	–61.6 (n = 107)
Week 16	–89.4* (n = 98)	–29.4 (n = 43)	–89.3 (n = 106)
Week 28	–	–	–95.5 (n = 100)

AI: autoinjector; LS: least squares; MRMMs: mixed-effect model repeat measurements; PASI: Psoriasis Area Severity Index; PFS: prefilled syringe.

MMRM analysis.

* p< .001 for placebo vs. risankizumab.

Figure 3. Mean SIAQ baseline PRE module domain scores and week 16 POST module domain scores and SIAQ POST module domain scores over time with risankizumab and placebo (study 1) and OL risankizumab (study 2). Observed case analysis. AI: autoinjector; BL: baseline; OL: open-label; PFS: prefilled syringe; SIAQ: Self-Injection Assessment Questionnaire.

Table 3. Treatment-emergent adverse events in study 1 and 2.

	Study 1		Study 2
n (%)	Risankizumab 150 mg/mL PFS (n = 105)	Placebo (n = 52)	Risankizumab 150 mg/mL AI (N = 108)
Any AE	22 (21.0)	11 (21.2)	47 (43.5)
Serious AE^a	1 (1.0)	0	6 (5.6)
Severe AE (grade 3 or 4)	1 (1.0)	0	8 (7.4)
AEs possibly related to study drug	6 (5.7)	2 (3.8)	16 (14.8)
AEs leading to discontinuation	0	1 (1.9)	1 (0.9)
Adjudicated MACE	0	0	0
Infections	6 (5.7)	3 (5.8)	30 (27.8)
Serious infections^b	0	0	2 (1.9)
Active tuberculosis	0	0	0
Malignancies	0	0	0
Malignancies excluding NMSC	0	0	0
Serious hypersensitivity	0	0	0
Injection site reaction	1 (1.0)	0	0
Deaths	0	0	0

AE: adverse event; AI: autoinjector; MACE: major adverse cardiac event; NMSC: non-melanoma skin cancer; PFS: prefilled syringe.

^a In study 1, one patient experienced one serious AE of acute pancreatitis; in study 2, six patients experienced seven serious AEs: appendicitis and prostatitis occurring in the same patient, and pyelonephritis, pyrexia, thermal burn, lumbar spinal stenosis, and atrial fibrillation.

^b Two patients experienced serious infections: appendicitis (n = 1) and pyelonephritis (n = 1).

Data availability statement

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