Please see Important Safety Information, including BOXED WARNING on Serious Infections, Mortality, Malignancies, Major Adverse Cardiovascular Events, and Thrombosis.

Rheumatoid Arthritis

Psoriatic Arthritis

Ankylosing Spondylitis

Non-radiographic Axial Spondyloarthritis

Giant Cell Arteritis

Atopic Dermatitis

Ulcerative Colitis

Crohn’s Disease

Visit RINVOQhcp.com

Plaque Psoriasis

Psoriatic Arthritis

Ulcerative Colitis

Crohn's Disease

Visit SKYRIZIhcp.com

Please see Important Safety Information, including BOXED WARNING on Serious Infections and Malignancy.

Hidradenitis Suppurativa

Juvenile Idiopathic Arthritis

Pediatric Crohn's Disease

Pediatric Ulcerative Colitis

Pediatric Uveitis

Uveitis (Adult)

Other Indications

Visit HUMIRApro.com

US-MULT-250253

Immunology Therapies

Full Prescribing Information

Patient Site

SKYRIZI
CROHN'S DISEASE

Site Map

Efficacy

Safety

Dosing

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

Indications

Plaque Psoriasis: SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Psoriatic Arthritis: SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults.

Crohn's Disease: SKYRIZI is indicated for the treatment of moderately to severely active Crohn's disease in adults.

Ulcerative Colitis: SKYRIZI is indicated for the treatment of moderately to severely active ulcerative colitis in adults.

Important Safety Information

Hypersensitivity Reactions

SKYRIZI® (risankizumab-rzaa) is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients. Serious hypersensitivity reactions, including anaphylaxis, have been reported with the use of SKYRIZI. If a serious hypersensitivity reaction occurs, discontinue SKYRIZI and initiate appropriate therapy immediately.

Infection

SKYRIZI may increase the risk of infection. Do not initiate treatment with SKYRIZI in patients with a clinically important active infection until it resolves or is adequately treated.

In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing SKYRIZI. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, closely monitor and discontinue SKYRIZI until the infection resolves.

Tuberculosis (TB)

Prior to initiating treatment with SKYRIZI, evaluate for TB infection and consider treatment in patients with latent or active TB for whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after SKYRIZI treatment. Do not administer SKYRIZI to patients with active TB.

Hepatotoxicity in Treatment of Inflammatory Bowel Disease

Drug-induced liver injury was reported in a patient with Crohn’s disease who was hospitalized for a rash during induction dosing of SKYRIZI. For the treatment of Crohn's disease and ulcerative colitis, evaluate liver enzymes and bilirubin at baseline and during induction (12 weeks); monitor thereafter according to routine patient management. Consider an alternate treatment for patients with evidence of liver cirrhosis. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Instruct your patient to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction.

Administration of Vaccines

Avoid use of live vaccines in patients treated with SKYRIZI. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating SKYRIZI, complete all age-appropriate vaccinations according to current immunization guidelines.

Adverse Reactions

Most common (≥1%) adverse reactions associated with SKYRIZI in plaque psoriasis and psoriatic arthritis include upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.

In psoriatic arthritis phase 3 trials, the incidence of hepatic events was higher with SKYRIZI compared to placebo.

Most common (>3%) adverse reactions associated with SKYRIZI in Crohn’s disease are upper respiratory infections, headache, and arthralgia in induction and arthralgia, abdominal pain, injection site reactions, anemia, pyrexia, back pain, arthropathy, and urinary tract infection in maintenance.

Most common (≥3%) adverse reactions associated with SKYRIZI in ulcerative colitis are arthralgia in induction, and arthralgia, pyrexia, injection site reactions, and rash in maintenance.

Lipid Elevations: Increases from baseline and increases relative to placebo were observed at Week 4 and remained stable to Week 12 in patients treated with SKYRIZI in Crohn’s disease. Lipid elevations observed in patients with ulcerative colitis were similar to those in Crohn's disease.

Dosage Forms and Strengths: SKYRIZI (risankizumab-rzaa) is available in a 150 mg/mL prefilled syringe and pen, a 600 mg/10 mL single-dose vial for intravenous infusion, and a 180 mg/1.2 mL or 360 mg/2.4 mL single-dose prefilled cartridge with on-body injector.

INDICATIONS

Plaque Psoriasis: SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Psoriatic Arthritis: SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults.

Crohn's Disease: SKYRIZI is indicated for the treatment of moderately to severely active Crohn's disease in adults.

Ulcerative Colitis: SKYRIZI is indicated for the treatment of moderately to severely active ulcerative colitis in adults.

Please see Full Prescribing Information.

US-SKZG-240258

Study Design Study Design

Baseline Characteristics Baseline Characteristics

An extensive Phase 3 clinical program in Crohn’s Disease
1,419 PATIENTS ENROLLED ACROSS SKYRIZI TRIALS

The SKYRIZI efficacy study involved a 12-week induction phase followed by a 52-week maintenance phase. In the Advance and Motivate studies, patients received either SKYRIZI 600 mg or a placebo, with primary endpoints being endoscopic response and clinical remission at Week 12. Responders were then randomized for the Fortify study, where they received SKYRIZI 180 mg, 360 mg, or placebo for 52 weeks. The study also includes an open-label extension for Week 64 completers

^‡Advanced therapy in Crohn's is defined as biologics.

^†The total population in the ADVANCE and MOTIVATE studies includes patients dosed with risankizumab-rzaa 1200 mg IV, which did not demonstrate additional treatment benefit over the 600 mg dose and is not a recommended regimen.

^aThe advanced therapy-naïve subpopulation includes patients who were exposed to a biologic but did not have an inadequate response, loss of response, or intolerance to biologics (13%).

^bPrior advanced therapy failure includes inadequate response, loss of response, or intolerance to one or more biologics.

^cThe advanced therapy-naïve subpopulation includes patients who were exposed to a biologic but did not have an inadequate response, loss of response, or intolerance to biologics (8%).

^dClinical response was defined as a reduction of CDAI score ≥100 points from baseline.

Phase 3 Clinical program: Study Design Details^1-5

‏‏‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎‏‏‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎‏‏‎

ADVANCE
N=850

MOTIVATE
N=569

FORTIFY
N=382

CO-PRIMARY
ENDPOINTS

Endoscopic Response^a (>50% decrease in SES-CD) and Clinical Remission^b (CDAI <150) at Week 12

Endoscopic Response^a (>50% decrease in SES-CD) and Clinical Remission^b (CDAI <150) at Week 52

DURATION

12-week, randomized, double-blind, placebo-controlled, multi-center study

52-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

All patients may have received concomitant conventional therapies that included 5-aminosalicylates, immunomodulators, and Crohn's-related antibiotics

Patients taking corticosteroids at the start of FORTIFY had their therapy tapered

DOSING

IV infusion of SKYRIZI 600 mg, risankizumab-rzaa 1200 mg,^c or placebo at Weeks 0, 4, and 8

Subcutaneous injection of SKYRIZI 180 mg, SKYRIZI 360 mg, or placebo starting at Week 12 and every 8 weeks after

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), excluding the narrowing component
16-80 years old
Advanced therapy naïve^d or advanced therapy failure^e

Moderately to severely active

Crohn's disease:

CDAI 220-450
Average daily SF ≥4 or APS ≥2
SES-CD ≥6 (≥4 for isolated ileitis), excluding the narrowing component
16-80 years old
Advanced therapy failure^e

Moderately to severely active

Crohn's disease:

Entry and completion of ADVANCE or MOTIVATE. Completion includes the final endoscopy of ADVANCE or MOTIVATE
Achieved Clinical Response^f in ADVANCE or MOTIVATE studies

	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

	FORTIFY N=382
CO-PRIMARY ENDPOINTS	Endoscopic Response^a (>50% decrease in SES-CD) and Clinical Remission^b (CDAI <150) at Week 52
DURATION	52-week, randomized, double-blind, placebo-controlled, multi-center study
CONCOMITANT THERAPIES	All patients may have received concomitant conventional therapies that included 5-aminosalicylates, immunomodulators, and Crohn's-related antibiotics Patients taking corticosteroids at the start of FORTIFY had their therapy tapered
DOSING	Subcutaneous injection of SKYRIZI 180 mg, SKYRIZI 360 mg, or placebo starting at Week 12 and every 8 weeks after
INCLUSION CRITERIA	Moderately to severely active Crohn's disease: Entry and completion of ADVANCE or MOTIVATE. Completion includes the final endoscopy of ADVANCE or MOTIVATE Achieved Clinical Response^f in ADVANCE or MOTIVATE studies

^aEndoscopic response was defined as a decrease in SES-CD >50% from baseline, or a decrease of at least 2 points for subjects with a baseline score of 4 and isolated ileal disease, based on central reading. The sections evaluated on endoscopy are the: rectum, sigmoid and left colon, transverse colon, right colon and ileum (per SES-CD assessment).

^bClinical remission was defined as a CDAI score <150 points.

^cThe 1200 mg IV induction dose did not demonstrate additional treatment benefit over the 600 mg IV dose and is not a recommended regimen.

^dThe advanced therapy-naïve subpopulation includes patients who were exposed to a biologic but did not have an inadequate response, loss of response, or intolerance to biologics (13%).

^ePrior advanced therapy failure includes inadequate response, loss of response, or intolerance to one or more biologics.

^fClinical response was defined as a reduction of CDAI score ≥100 points from baseline.

APS=abdominal pain score; CDAl=Crohn's disease activity index; IV=intravenous; SC=subcutaneous; SES-CD=simple endoscopic score for Crohn's disease; SF=stool frequency

References

SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc.
D’Haens G, Panaccione R, Baert F, et al. Risankizumab as induction therapy for Crohn’s disease: results from the phase 3 ADVANCE and MOTIVATE induction trials. Lancet. 2022;399(10340):2015-2030.
Data on File, AbbVie Inc. ABVRRTI74525.
Ferrante M, Panaccione R, Baert F, et al. Risankizumab as maintenance therapy for moderately to severely active Crohn’s disease: results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. Lancet. 2022;399(10340):2031-2046.
Daperno M, D’Haens G, Van Assche G, et al. Development and validation of a new, simplified endoscopic activity score for Crohn’s disease: the SES-CD. Gastrointestinal Endoscopy. 2004;60(4);505-512.

US-SKZG-250512

Phase 3 clinical program: baseline characteristics^1,2

ADVANCE

Placebo

N=175

SKYRIZI 600 mg IV

N=336

Male, n (%)

88
(50)

189
(56)

Age (years),
mean (SD)

37.1
(13.4)

38.3
(13.3)

Disease duration
(years), mean (SD)

8.2
(7.1)

9.0
(8.8)

Disease location

lleal only, n (%)

19
(11)

52
(15)

Colonic only, n (%)

70
(40)

115
(34)

lleal-colonic, n (%)

86
(49)

169
(50)

hs-CRP (mg/L),
median (IQR)

8.4
(2.8-21.9)

7.3
(2.8-21.8)

CDAI, mean (SD)

319.2
(59.4)

311.2
(62.4)

SES-CD, mean (SD)

13.8
(6.8)

14.7
(7.7)

Corticosteroid
use, n (%)

50
(29)

102
(30)

Advanced therapy*-failure history

0, n (%)

78
(45)

141
(42)

1, n (%)

41
(23)

100
(30)

>1, n (%)

56
(32)

95
(28)

MOTIVATE

Placebo

N=187

SKYRIZI 600 mg IV

N=191

Male, n (%)

99
(53)

92
(48)

Age (years),
mean (SD)

39.3
(13.5)

40.2
(13.6)

Disease duration
(years), mean (SD)

12.5
(9.7)

10.9
(7.7)

Disease location

lleal only, n (%)

26
(14)

33
(17)

Colonic only, n (%)

73
(39)

75
(39)

lleal-colonic, n (%)

88
(47)

83
(43)

hs-CRP (mg/L),
median (IQR)

9.4
(3.6-28.2)

9.3
(3.5-23.0)

CDAI, mean (SD)

319.6
(69.8)

310.7
(63.6)

SES-CD, mean (SD)

15.0
(8.1)

14.4
(7.6)

Corticosteroid
use, n (%)

68
(36)

65
(34)

Advanced therapy*-failure history

0, n (%)

1, n (%)

88
(47)

92
(48)

>1, n (%)

99
(53)

99
(52)

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)

FORTIFY

Placebo (Induction Responder)
N=164

SKYRIZI 360mg SC
N=141

Disease duration (years), mean (SD)

9.6 (8.8)

9.3 (8.1)

Baseline immunomodulator use, n (%)

40 (24.4)

40 (28.4)

Baseline steroid use, n (%)

51 (31.1)

42 (29.8)

Biologics failure history

0, n (%)

41 (25.0)

39 (27.7)

1, n (%)

60 (36.6)

51 (36.2)

>1, n (%)

63 (38.4)

51 (36.2)

Baseline CDAI, mean (SD)

307.4 (64.9)

308.9 (61.1)

Baseline SES-CD, mean (SD)

14.0 (7.1)

14.3 (7.4)

Baseline SF, mean (SD)

5.8 (2.7)

5.9 (2.6)

Baseline APS, mean (SD)

1.9 (0.5)

1.8 (0.5)

Baseline FCP, median (min,max)

794.5
(30, 11378)

1543.0
(30, 14649)

Baseline hs-CRP, median (min,max) (mg/L)

7.6
(0.3, 181)

10.1
(0.3, 129)

‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎‏‏‎ ‎

CDAI at Week 0, mean (SD)

133.6 (80.6)

137.2 (67.7)

SES-CD at Week 0, mean (SD)

7.6
(0.3, 181)

8.5 (7.3)

SF at Week 0, mean (SD)

1.8 (1.8)

2.1 (1.8)

APS at Week 0, mean (SD)

0.7 (0.6)

FCP at Week 0, median (min,max) (mg/kg)

307
(30, 28013)

424
(30, 14804)

hs-CRP at Week 0, median (min,max) (mg/L)

4.1
(0.2, 53.4)

3.9
(0.2, 258)

Includes randomized subjects who received at least one dose of study drug, who had baseline eligible SES-CD ≥6 (≥4 for isolated ileal disease), and who received 12-week SKYRIZI IV treatment.

*Advanced therapy in Crohn’s is defined as biologics.

APS=abdominal pain score; CDAI=Crohn’s disease activity index; FCP=fecal calprotectin; hs-CRP=high-sensitivity C-reactive protein; IQR=interquartile range; IV=intravenous; SC=subcutaneous; SD=standard deviation; SES-CD=simple endoscopic score for Crohn’s disease; SF=stool frequency

References

D’Haens G, Panaccione R, Baert F, et al. Risankizumab as induction therapy for Crohn’s disease: results from the phase 3 ADVANCE and MOTIVATE induction trials. Lancet. 2022;399(10340):2015-2030.
Data on File, AbbVie Inc. ABVRRTI74525.

US-SKZG-250512

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

Hypersensitivity Reactions, Infections, Tuberculosis (TB), Hepatotoxicity in Treatment of Inflammatory Bowel Disease, Administration of Vaccines

Hypersensitivity Reactions

SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients. Serious hypersensitivity reactions, including anaphylaxis, have been reported with the use of SKYRIZI. If a serious hypersensitivity reaction occurs, discontinue SKYRIZI and initiate appropriate therapy immediately.

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

Hypersensitivity Reactions, Infections, Tuberculosis (TB), Hepatotoxicity in Treatment of Inflammatory Bowel Disease, Administration of Vaccines

Hypersensitivity Reactions

SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients. Serious hypersensitivity reactions,

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

Hypersensitivity Reactions, Infections, Tuberculosis (TB), Hepatotoxicity in Treatment of Inflammatory Bowel Disease, Administration of Vaccines

Hypersensitivity Reactions

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

Hypersensitivity Reactions, Infections, Tuberculosis (TB), Hepatotoxicity in Treatment of Inflammatory Bowel Disease, Administration of Vaccines

Hypersensitivity Reactions

SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients. Serious hypersensitivity reactions,

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

Indications

Plaque Psoriasis: SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Psoriatic Arthritis: SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults.

Crohn's Disease: SKYRIZI is indicated for the treatment of moderately to severely active Crohn's disease in adults.

Ulcerative Colitis: SKYRIZI is indicated for the treatment of moderately to severely active ulcerative colitis in adults.

Important Safety Information

Hypersensitivity Reactions

Infection

SKYRIZI may increase the risk of infection. Do not initiate treatment with SKYRIZI in patients with a clinically important active infection until it resolves or is adequately treated.

Tuberculosis (TB)

Hepatotoxicity in Treatment of Inflammatory Bowel Disease

Administration of Vaccines

Adverse Reactions

In psoriatic arthritis phase 3 trials, the incidence of hepatic events was higher with SKYRIZI compared to placebo.

Most common (≥3%) adverse reactions associated with SKYRIZI in ulcerative colitis are arthralgia in induction, and arthralgia, pyrexia, injection site reactions, and rash in maintenance.

INDICATIONS

Plaque Psoriasis: SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Psoriatic Arthritis: SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults.

Crohn's Disease: SKYRIZI is indicated for the treatment of moderately to severely active Crohn's disease in adults.

Ulcerative Colitis: SKYRIZI is indicated for the treatment of moderately to severely active ulcerative colitis in adults.

Please see Full Prescribing Information.

US-SKZG-240258

SKYRIZI CROHN'S DISEASE

Site Map

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 INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)1

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

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

SKYRIZI
CROHN'S DISEASE

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 INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)¹

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

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