The IL-23 inhibitor from AbbVie indicated for the treatment of moderately to severely active Crohn's disease (CD) in adults.¹

WELL-STUDIED Safety Profile

UP TO ~9 YEARS OF CLINICAL TRIAL EXPERIENCE ACROSS 4 INDICATIONS^1,2

Approved for 4 Indications: Starting With Plaque Psoriasis (Ps), Followed by Psoriatic Arthritis (PsA), Crohn’s Disease, and Ulcerative Colitis (UC)^1,2

Clinical Trials
Across Indications^1,2^*†

26,880

Patient-Years of Clinical Trial Exposure^2*‡

325,458

Patients Prescribed Worldwide Since 2019 Starting With Ps^3§

41,467

Patients Prescribed
Worldwide in Crohn’s^3§

*Safety data were evaluated for all patients receiving ≥1 dose of SKYRIZI from Phase 1-4 trials, including open-label extension and dose-ranging studies.

Safety Data Derived From the Largest Phase 3 Clinical Program in Crohn’s to Date Across Indication Approval Trials^II

^IIAs of August 2024.⁴

SAFETY PROFILE

INDUCTION INDUCTION

MAINTENANCE MAINTENANCE

LONG-TERM DATA LONG-TERM DATA

WELL-STUDIED SAFETY PROFILE

Week 12 Safety Data from
Phase 2 and 3 Induction Trials^1,5


Adverse Events (AEs)	Placebo IV N=432	SKYRIZI 600 mg IV^* N=620
Treatment-Emergent AEs	%	%
Any AE	63.4	54.7
Serious AE	15.5	6.6
AE Leading to Discontinuation of Study Drug^†	8.6	2.1
Death	0.5	0
AEs of Special Interest	%	%
Infections
Infections	24.8	19.7
Serious Infection	3.7	1.0
Opportunistic Infection (Excluding TB/Herpes Zoster)	0.7	0
Active TB	0.2	0.2
Malignancy
Malignant Tumors (Including NMSC)	0	0
Cardiovascular Events
Adjudicated MACE^a	0	0
Other
Hypersensitivity (Serious Events Only)	0.2	0.2
Adjudicated Anaphylactic Reaction	0	0
Hepatic Events	1.6	1.6
Infusion-Related Reactions	1.2	0.8

SKYRIZI IS CONTRAINDICATED IN PATIENTS WITH A HISTORY OF SERIOUS HYPERSENSITIVITY REACTION TO RISANKIZUMAB-RZAA OR ANY OF THE EXCIPIENTS.¹

In the CD 12-week induction studies, the most common adverse reactions (>3% of patients and at a higher rate than placebo) include upper respiratory infections, headache and arthralgia.¹

WELL-UNDERSTOOD SAFETY PROFILE AND TOLERABILITY^† WITH 2.1% OF SKYRIZI PATIENTS DISCONTINUING THE TRIAL DUE TO ADVERSE EVENTS⁹

WELL-STUDIED SAFETY PROFILE

Week 52 Safety Data from
FORTIFY^1,6,7,8

	FORTIFY
	Non-randomized	Randomized
Adverse Events (AEs)	Continuous Placebo	Placebo (Induction Responder)	SKYRIZI 180 mg SC	SKYRIZI 360 mg SC
	N=81 PYs=60.5	N=143 PYs=124.4	N=155 PYs=149.4	N=142 PYs=134.8
Treatment-Emergent AEs	%	%	%	%
Any AE	75	71	69	70
Serious AE	16	10	11	13
AE Leading to Discontinuation of Study Drug*	6	2	2	3
Death	0	0	0	0
AEs of Special Interest	% (E/100 PYs)	% (E/100 PYs)	% (E/100 PYs)	% (E/100 PYs)
Infections
Infections	33 (66.1)	36 (60.3)	32 (50.2)	37 (60.8)
Serious Infection	4 (8.3)	2 (2.4)	3 (2.7)	6 (7.4)
Opportunistic Infection (Excluding TB/Herpes Zoster)	0	0	0	1 (0.7)
Active TB	0	0	0	0
Herpes Zoster	0	1 (0.8)	1 (1.3)	0
Malignancy
NMSC	0	1 (0.8)	0	0
Malignancy (Excluding NMSC)	0	0	0	0
Cardiovascular Events
Adjudicated MACE^a	0	1 (0.8)	0	1 (0.7)
Other
Hypersensitivity (Serious Events Only)	0	0	0	0
Adjudicated Anaphylactic Reaction	0	0	0	0
Hepatic Events	1 (1.7)	2 (2.4)	3 (4.7)	5 (6.7)
Injection Site Reaction	0	3 (4.8)	5 (10.0)	6 (13.4)

SKYRIZI IS CONTRAINDICATED IN PATIENTS WITH A HISTORY OF SERIOUS HYPERSENSITIVITY REACTION TO RISANKIZUMAB-RZAA OR ANY OF THE EXCIPIENTS.¹

In the CD 52-week maintenance study, the most common adverse reactions (>3% of patients and at a higher rate than placebo) include arthralgia, abdominal pain, injection site reactions, anemia, pyrexia, back pain, arthropathy, and urinary tract infection.¹

WELL-UNDERSTOOD SAFETY PROFILE AND TOLERABILITY* WITH 2% OF SKYRIZI 180 MG SC PATIENTS AND 3% OF SKYRIZI 360 MG SC PATIENTS DISCONTINUING THE TRIAL DUE TO ADVERSE EVENTS⁷

Continuous Placebo: Patients who responded to placebo in induction (CR-100)^† were not randomized and continued on placebo in maintenance. These patients were not included in the primary efficacy analysis.

Placebo (Induction Responders): Patients who achieved CDAI clinical response (CR-100)^† to SKYRIZI induction therapy and were randomized to receive placebo in the maintenance study.

WELL-STUDIED SAFETY PROFILE

~3 Years of Safety Data from FORTIFY^7,10,11

	Maintenance FORTIFY Crohn’s at Week 52			Long-Term Safety in Crohn’s Max Exposure: 9.23 yrs Median Exposure: 3.2 yrs Mean Exposure: 2.85 yrs
ADVERSE EVENTS (AEs)	Placebo (Induction Responder) N=143, PYs=124.4	SKYRIZI 180 mg SC N=155, PYs=149.4	SKYRIZI 360 mg SC N=142, PYs=134.8	SKYRIZI 180/360 mg SC N=1853, PYs=5646.6
TREATMENT-EMERGENT AEs	E/100 PY	E/100 PY	E/100 PY	E/100 PY
Any AE	559.2	270.8	275	239.8
Serious AE	68.2	18	18.3	16.6
AE Leading to Discontinuation of Study Drug	29.6	3.5	4.3	3.2
Death	0	0	0	0.1
AEs Of Special Interest	E/100 PY	E/100 PY	E/100 PY	E/100 PY
Infections
Infections	60.3	50.2	60.8	46.7
Serious Infection	2.4	2.7	7.4	2.8
Opportunistic Infection (Excluding TB/Herpes Zoster)	0	0	0.7	0.4
Active Tuberculosis (TB)	0	0	0	<0.1
Herpes Zoster	0.8	1.3	0	0.7
Malignancy
NMSC	0.8	0	0	0.2
Malignancy (Excluding NMSC)	0	0	0	0.4
Cardiovascular Events
Adjudicated MACE^a	0.8	0	0.7	0.2
Other
Hypersensitivity (Serious Events Only)	0	0	0	<0.1
Adjudicated Anaphylactic Reaction	0	0	0	0
Hepatic Events	2.4	4.7	6.7	4.4
Injection Site Reaction	4.8	10.0	13.5	5.7

SKYRIZI IS CONTRAINDICATED IN PATIENTS WITH A HISTORY OF SERIOUS HYPERSENSITIVITY REACTION TO RISANKIZUMAB-RZAA OR ANY OF THE EXCIPIENTS.¹

IN THE CD 52-WEEK MAINTENANCE STUDY, THE MOST COMMON ADVERSE REACTIONS (>3% OF PATIENTS AND AT A HIGHER RATE THAN PLACEBO) INCLUDE ARTHRALGIA, ABDOMINAL PAIN, INJECTION SITE REACTIONS, ANEMIA, PYREXIA, BACK PAIN, ARTHROPATHY, AND URINARY TRACT INFECTION.¹

FORTIFY OLE STUDY DESIGN: AN ONGOING, TWO ARM, MULTICENTER, OPEN-LABEL EXTENSION OF PHASE 3 STUDIES EVALUATING THE LONG-TERM EFFICACY AND SAFETY OF SKYRIZI (180 MG OR 360 MG SC). PATIENTS WHO ACHIEVED CLINICAL RESPONSE IN ADVANCE OR MOTIVATE AT WEEK 12 AND COMPLETED THE 52 WEEK FORTIFY MAINTENANCE PERIOD WERE ELIGIBLE TO PARTICIPATE.⁷

LONG-TERM SAFETY DATA PRESENTED INCLUDES PATIENTS WITH VARYING LENGTHS OF TREATMENT EXPOSURE.

LONG-TERM SAFETY: INCLUDES DATA FOR PATIENTS WHO RECEIVED ≥1 DOSE OF SKYRIZI IN PHASE 1, 2, AND 3 CROHN’S STUDIES.

Placebo (Induction Responders): Patients who achieved CDAI clinical response (CR-100)^†to SKYRIZI induction therapy and were randomized to receive placebo in the maintenance study.

HAVE YOU SEEN THE ENDOSCOPIC
AND CLINICAL RESULTS?

EXPLORE EFFICACY

HAVE YOU SEEN SKYRIZI'S
DOSING SCHEDULE?

REVIEW DOSING

	PsA (WEEK 24) ACROSS 2 PIVOTAL TRIALS^1,2		Ps (WEEK 16) ACROSS 4 PIVOTAL TRIALS^3-5
	SKYRIZI^a N=707 % (n)	Placebo^a N=700 % (n)	SKYRIZI^b N=1,306 % (n)	Placebo^c N=300 % (n)
Any Serious Adverse Event	3.0 (21)	4.4 (31)	2.4 (31)	4.0 (12)
Any Infection	19.0 (134)	19.3 (135)	22.1 (288)	14.7 (44)
Serious Infections	1.0 (7)	1.6 (11)	0.4 (5)	0.3 (1)
Active TB	0.0	0.0	0.0	0.3 (1)
Any Malignancy	0.1 (1)	0.6 (4)	0.5 (6)	0.3 (1)
Malignancy (Excluding NMSC)	0 (0)	0.3 (2)	0.2 (3)	0 (0)
Adjudicated MACE	0.1 (1)	0 (0)	<0.1 (1)	0.3 (1)

Adverse Reactions Reported in >3% of Subjects and at a Higher Rate than Placebo	Placebo N=143 n (%)	SKYRIZI 180 mg SC^a N=155 n (%)	SKYRIZI 360 mg SC^a N=142 n (%)
Adverse Drug Reactions
Arthralgia	12 (8.4)	13 (8.4)	13 (9.2)
Abdominal pain^b	6 (4.2)	9 (5.8)	12 (8.5)
Injection site reactions^c,d	4 (2.8)	7 (4.5)	8 (5.6)
Anemia	6 (4.2)	7 (4.5)	7 (4.9)
Pyrexia	4 (2.8)	4 (2.6)	7 (4.9)
Back pain	3 (2.1)	3 (1.9)	6 (4.2)
Arthropathy	2 (1.4)	1 (0.6)	5 (3.5)
Urinary tract infection	4 (2.8)	1 (0.6)	5 (3.5)

Adverse Reactions Reported in >3% of Subjects and at a Higher Rate than Placebo	Placebo N=432 n (%)	SKYRIZI 600 mg IV^a N=620 n (%)
Adverse Drug Reactions
Upper respiratory infections^b	40 (9.3)	66 (10.6)
Headache^c	24 (5.6)	41 (6.6)
Arthralgia	19 (4.4)	31 (5.0)

	ADVANCE N=850
CO-PRIMARY ENDPOINTS	Endoscopic Response^a (>50% decrease in SES-CD) and Clinical Remission^b (CDAI <150) at Week 12
DURATION	12-week, randomized, double-blind, placebo-controlled, multi-center study
CONCOMITANT THERAPIES	All patients may have received concomitant conventional therapies that included 5-aminosalicylates, immunomodulators, corticosteroids, and Crohn's-related antibiotics
DOSING	IV infusion of SKYRIZI 600 mg, risankizumab-rzaa 1200 mg,^c or placebo, at Weeks 0, 4, and 8
INCLUSION CRITERIA	Moderately to severely active Crohn's disease: CDAI 220-450 Average daily SF ≥4 or APS ≥2 SES-CD ≥6 (≥4 for isolated ileitis), exluding the narrowing component 16-80 years old Advanced therapy naïve^d or advanced therapy failure^e

	MOTIVATE N=569
CO-PRIMARY ENDPOINTS	Endoscopic Response^a (>50% decrease in SES-CD) and Clinical Remission^b (CDAI <150) at Week 12
DURATION	12-week, randomized, double-blind, placebo-controlled, multi-center study
CONCOMITANT THERAPIES	All patients may have received concomitant conventional therapies that included 5-aminosalicylates, immunomodulators, corticosteroids, and Crohn's-related antibiotics
DOSING	IV infusion of SKYRIZI 600 mg, risankizumab-rzaa 1200 mg,^c or placebo, at Weeks 0, 4, and 8
INCLUSION CRITERIA	Moderately to severely active Crohn's disease: CDAI 220-450 Average daily SF ≥4 or APS ≥2 SES-CD ≥6 (≥4 for isolated ileitis), exluding the narrowing component 16-80 years old Advanced therapy failure^e

	PsA LONG-TERM^* (UP TO ~4 YEARS OF EXPOSURE)¹	Ps (WEEK 52)²	Ps LONG-TERM (UP TO ~9 YEARS OF EXPOSURE)¹
	INTEGRATED ANALYSIS OF 4 CLINICAL TRIALS	INTEGRATED ANALYSIS OF 2 CLINICAL TRIALS	INTEGRATED ANALYSIS OF 20 CLINICAL TRIALS
	N=1,542 PYs=3,803.3 Events/100 PYs	N=598 PYs=618.0 Events/100 PYs	N=3,658 PYs=13,329.3 Events/100 PYs
Any Serious Adverse Event	8.6	9.4	7.4
Serious Infections	1.5	1.8	1.1
Active TB	0.0	0.0	<0.1
Any Malignancy	1.0	0.5	1.2
Malignancy (Excluding NMSC)	0.5	0.0	0.6
Adjudicated MACE	0.3	0.3	0.5

FORTIFY		Placebo (Induction Responder) N=130	SKYRIZI 180 mg SC N=135	SKYRIZI 360 mg SC N=117
BASELINE OF INDUCTION (ADVANCE, MOTIVATE)
	Male, n (%)	72 (55.4)	62 (45.9)	67 (57.3)
	Age (years), mean (SD)	38.0 (12.8)	39.2 (14.7)	36.2 (12.6)
	Disease duration (years), mean (SD)	9.6 (8.2)	10.6 (10.2)	8.6 (7.1)
	Disease location
	lleal only, n (%)	18 (14)	12 (9)	13 (11)
	Colonic only, n (%)	49 (38)	63 (47)	52 (44)
	lleal-colonic, n (%)	63 (49)	60 (44)	52 (44)
	Baseline immunomodulatorimmuno- modulator use, n (%)	33 (25.4)	37 (27.4)	34 (29.1)
	Baseline steroid use, n (%)	40 (30.8)	47 (34.8)	36 (30.8)
	Advanced therapy*-failure history
	0, n (%)	31 (23.8)	40 (29.6)	34 (29.1)
	1, n (%)	49 (37.7)	34 (25.2)	42 (35.9)
	>1, n (%)	50 (38.5)	61 (45.2)	41 (35.0)
	Baseline CDAI, mean (SD)	314.2 (64.2)	327.6 (68.2)	316.2 (59.6)
	Baseline SES-CD, mean (SD)	14.1 (7.1)	14.9 (7.2)	14.3 (7.0)
	Baseline SF, mean (SD)	5.8 (2.7)	6.2 (3.1)	5.9 (2.7)
	Baseline APS, mean (SD)	1.9 (0.5)	2.0 (0.4)	1.9 (0.5)
	Baseline FCP (mg/kg), median (min,max)	904.0 (30, 11378)	1666.0 (30, 28800)	1622.0 (30, 14649)
	Baseline hs-CRP (mg/L), median (min,max)	7.9 (0.3, 181)	8.7 (0.4, 151)	10.6 (0.3, 129)

Week 0 of Maintenance
	CDAI at Week 0, mean (SD)	111.6 (69.5)	117.6 (66.8)	125.4 (62.7)
	SES-CD at Week 0, mean (SD)	7.3 (6.4)	7.8 (6.4)	8.3 (7.3)
	SF at Week 0, mean (SD)	1.4 (1.7)	2.1 (1.9)	1.9 (1.7)
	APS at Week 0, mean (SD)	0.6 (0.5)	0.6 (0.5)	0.6 (0.5)
	FCP (mg/kg) at Week 0, median (min,max)	300.0 (30, 22912)	361 (30, 28800)	485.5 (30, 14804)
	hs-CRP (mg/L) at Week 0, median (min,max)	3.6 (0, 42)	3.7 (0, 48)	4.0 (0, 258)

WELL-STUDIED Safety Profile

UP TO ~9 YEARS OF CLINICAL TRIAL EXPERIENCE ACROSS 4 INDICATIONS1,2

WELL-STUDIED SAFETY PROFILE

SKYRIZI IS CONTRAINDICATED IN PATIENTS WITH A HISTORY OF SERIOUS HYPERSENSITIVITY REACTION TO RISANKIZUMAB-RZAA OR ANY OF THE EXCIPIENTS.1

In the CD 12-week induction studies, the most common adverse reactions (>3% of patients and at a higher rate than placebo) include upper respiratory infections, headache and arthralgia.1

WELL-STUDIED SAFETY PROFILE

SKYRIZI IS CONTRAINDICATED IN PATIENTS WITH A HISTORY OF SERIOUS HYPERSENSITIVITY REACTION TO RISANKIZUMAB-RZAA OR ANY OF THE EXCIPIENTS.1

In the CD 52-week maintenance study, the most common adverse reactions (>3% of patients and at a higher rate than placebo) include arthralgia, abdominal pain, injection site reactions, anemia, pyrexia, back pain, arthropathy, and urinary tract infection.1

WELL-STUDIED SAFETY PROFILE

SKYRIZI IS CONTRAINDICATED IN PATIENTS WITH A HISTORY OF SERIOUS HYPERSENSITIVITY REACTION TO RISANKIZUMAB-RZAA OR ANY OF THE EXCIPIENTS.1

IN THE CD 52-WEEK MAINTENANCE STUDY, THE MOST COMMON ADVERSE REACTIONS (>3% OF PATIENTS AND AT A HIGHER RATE THAN PLACEBO) INCLUDE ARTHRALGIA, ABDOMINAL PAIN, INJECTION SITE REACTIONS, ANEMIA, PYREXIA, BACK PAIN, ARTHROPATHY, AND URINARY TRACT INFECTION.1

LONG-TERM SAFETY: INCLUDES DATA FOR PATIENTS WHO RECEIVED ≥1 DOSE OF SKYRIZI IN PHASE 1, 2, AND 3 CROHN’S STUDIES.

ADVANCE N=850

MOTIVATE N=569

FORTIFY N=382

ADVANCE

Placebo

SKYRIZI 600 mg IV

MOTIVATE

Placebo

SKYRIZI 600 mg IV

FORTIFY

Placebo (Induction Responder)

SKYRIZI 180 mg SC

SKYRIZI 360 mg SC

FORTIFY

Placebo (Induction Responder) N=164

SKYRIZI 360mg SC N=141

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)1

IMPORTANT SAFETY INFORMATION AND INDICATION FOR SKYRIZI® (risankizumab-rzaa)1

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)1

IMPORTANT SAFETY INFORMATION AND INDICATION FOR SKYRIZI® (risankizumab-rzaa)1

UP TO ~9 YEARS OF CLINICAL TRIAL EXPERIENCE ACROSS 4 INDICATIONS^1,2

SKYRIZI IS CONTRAINDICATED IN PATIENTS WITH A HISTORY OF SERIOUS HYPERSENSITIVITY REACTION TO RISANKIZUMAB-RZAA OR ANY OF THE EXCIPIENTS.¹

In the CD 12-week induction studies, the most common adverse reactions (>3% of patients and at a higher rate than placebo) include upper respiratory infections, headache and arthralgia.¹

SKYRIZI IS CONTRAINDICATED IN PATIENTS WITH A HISTORY OF SERIOUS HYPERSENSITIVITY REACTION TO RISANKIZUMAB-RZAA OR ANY OF THE EXCIPIENTS.¹

In the CD 52-week maintenance study, the most common adverse reactions (>3% of patients and at a higher rate than placebo) include arthralgia, abdominal pain, injection site reactions, anemia, pyrexia, back pain, arthropathy, and urinary tract infection.¹

SKYRIZI IS CONTRAINDICATED IN PATIENTS WITH A HISTORY OF SERIOUS HYPERSENSITIVITY REACTION TO RISANKIZUMAB-RZAA OR ANY OF THE EXCIPIENTS.¹

IN THE CD 52-WEEK MAINTENANCE STUDY, THE MOST COMMON ADVERSE REACTIONS (>3% OF PATIENTS AND AT A HIGHER RATE THAN PLACEBO) INCLUDE ARTHRALGIA, ABDOMINAL PAIN, INJECTION SITE REACTIONS, ANEMIA, PYREXIA, BACK PAIN, ARTHROPATHY, AND URINARY TRACT INFECTION.¹

ADVANCE
N=850

MOTIVATE
N=569

FORTIFY
N=382

Placebo
(Induction Responder)

SKYRIZI
180 mg SC

SKYRIZI
360 mg SC

Placebo (Induction Responder)
N=164

SKYRIZI 360mg SC
N=141

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)¹

IMPORTANT SAFETY INFORMATION AND INDICATION FOR SKYRIZI® (risankizumab-rzaa)¹

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)¹

IMPORTANT SAFETY INFORMATION AND INDICATION FOR SKYRIZI® (risankizumab-rzaa)¹