Clinical Evaluation of Risankizumab in the Treatment of Adults with Moderately to Severely Active Crohn’s Disease: Patient Selection and Reported Outcomes

Figures & data

Figure 1 Mechanism of action of risankizumab (used with permission from AbbVie, Inc.).

Figure 2 (A–C) Risankizumab on-body injector (used with permission from AbbVie, Inc.) (A). On-body injector front view (B). On-body injector back view (C). Prefilled cartridge.

Table 1 Risankizumab Clinical Trial Results for Co-Primary Endpoints of Clinical Remission and Endoscopic Response in Induction (ADVANCE and MOTIVATE) and Maintenance (FORTIFY)

Induction Clinical Trial Endpoints
ADVANCE: Week 12	Placebo (n=175)	Risankizumab 600 mg IV (n=336)	p value*	Risankizumab 1200 mg IV (n=339)	p value*
Clinical remission: CDAI	43 (24.6%)	152 (45.2%)	<0.0001	141 (41.6%)	<0.0001
Clinical remission: SF/AP Score	38 (21.7%)	146 (43.5%)	<0.0001	139 (41.0%)	<0.0001
Endoscopic Response	21 (12.0%)	135 (40.2%)	<0.0001	109 (32%)	<0.0001
MOTIVATE: Week 12	Placebo (n=187)	Risankizumab 600 mg IV (n=336)	p value*	Risankizumab 1200 mg IV (n=339)	p value*
Clinical remission: CDAI	37 (19.8%)	80 (41.9%)	<0.0001	77 (40.3%)	<0.0001
Clinical remission: SF/AP Score	36 (19.3%)	66 (34.6%)	0.0007	76 (39.8%)	<0.0001
Endoscopic Response	21 (11.2%)	55 (28.8%)	<0.0001	65 (34.0%)	<0.0001
Maintenance Clinical Trial Endpoints
FORTIFY: Week 52	Withdrawal (Placebo SQ)(n=164)	Risankizumab 180 mg SQ (n=157)	p value**	Risankizumab 360 mg SQ (n=141)	p value**
Clinical remission: CDAI	67 (40.9%)	87 (55.4%)	0.0031	74 (52.5%)	0.0054
Clinical remission: SF/AP Score	65 (39.6%)	73 (46.5%)	0.12	73 (51.8%)	0.0037
Endoscopic Response	36 (22.0%)	74 (47.1%)	<0.0001	66 (46.8%)	<0.0001

Notes: *p value compared to placebo; **p value compared to withdrawal (subcutaneous placebo).

Abbreviations: CDAI, Crohn’s Disease Activity Index; SF/AP, stool frequency and abdominal pain; IV, intravenous; SQ, subcutaneous.

Table 2 Adverse Events for Patients on FDA Approved Dosing for Risankizumab Compared to Placebo in Phased 3 Trials for Risankizumab

	ADVANCE: Risankizumab Induction (12 wks)		MOTIVATE: Risankizumab Induction (12 wks)		FORTIFY: Maintenance Study (52 wks)
	600 mg IV (n=373)	Placebo (n=186)	600 mg IV (n=206)	Placebo (n=207)	180 mg SQ (n=179)	360 mg SQ (n=179)	SQ Placebo (n=184)
Overall Adverse events
Adverse events (AE)	210 (56%)	105 (56%)	98 (48%)	137 (66%)	128 (72%)	129 (72%)	135 (73%)
Severe adverse events	22 (6%)	18 (10%)	7 (3%)	25 (12%)	12 (7%)	21 (12%)	23 (13%)
Serious adverse events	27 (7%)	28 (15%)	10 (5%)	16 (13%)	22 (12%)	24 (13%)	23 (13%)
AE leading to discontinuation of drug	9 (2%)	14 (8%)	2 (1%)	17 (8%)	3 (2%)	6 (3%)	6 (3%)
Adverse events of safety interest
Serious infections	3 (1%)	7 (4%)	1 (<1%)	5 (2%)	5 (3%)	8 (4%)	7 (4%)
Opportunistic infections	0	0	0	3 (1%)	1 (1%)	1 (1%)	0
Herpes Zoster	2 (1%)	0	0	1 (<1%)	2 (1%)	0	1 (1%)
Active Tuberculosis	1 (<1%)	1 (1%)	0	0	0	0	0
COVID-19	1 (<1%)	1 (1%)	0	0	1 (1%)	4 (2%)	1 (1%)
Adjudicated MACE events	0	0	0	0	0	1 (1%)	1 (1%)
Malignancies (overall)	0	0	0	0	1 (1%)	1 (1%)	1 (1%)
Infusion-related reactions	4 (1%)	1 (1%)	1 (<1%)	3 (1%)
Injection-site reactions					9 (5%)	11 (6%)	9 (5%)
Serious hypersensitivity reactions	1 (<1%)	0	0	0	0	0	0
Hepatic events†	9 (2%)	4 (2%)	1 (<1%)	2 (1%)	5 (3%)	7 (4%)	4 (2%)
Death	0	2 (1%)	0	0	0	0	0

Notes: †All hepatic events were identified with search criteria covering the standardised MedDRA (Medical Dictionary for Regulatory Activities) queries of “hepatic failure, fibrosis and cirrhosis and other liver damagerelated conditions”, “hepatitis, non-infectious”, “cholestasis and jaundice of hepatic origin”, “liver related investigations, signs and symptoms”, and “liver-related coagulation and bleeding disturbances.”

Abbreviations: SQ, Subcutaneous; IV, Intravenous; MACE, major adverse cardiovascular event.