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 ~7 Years of Clinical Experience ACROSS MULTIPLE INDICATIONS

Approved for 3 Indications: Starting with Plaque Psoriasis (Ps), Followed by Psoriatic Arthritis (PsA) and Crohn's Disease (CD)1,2

26

Clinical Trials
Across Indications2-6*


107,000

Patients Prescribed
Worldwide since 2019 in Plaque Psoriasis7‡


6,313

Patients Evaluated
Across Treatment Arms1,2*§


13,637

Patient-Years
of Exposure2,8*

*Safety data were evaluated for all patients receiving ≥1 dose of SKYRIZI from Phase 1-3 trials, including open-label extension and dose-ranging studies.


Safety Data Derived from the Largest Phase 3 Clinical Program in CD to Date


2,059

Patient-Years of Exposure from CD Clinical Programs to Date8


WELL-STUDIED SAFETY PROFILE

Week 12 Safety Data from
ADVANCE and MOTIVATE3,9

  ADVANCE MOTIVATE
Adverse Events
(AEs), n (%)
Placebo
IV

N=186
SKYRIZI
600 mg IV

N=373
Placebo
IV

N=207
SKYRIZI
600 mg IV

N=206
Treatment-Emergent AEs      
Any AE 105
(56)
210
(56)
137
(66)
98
(48)
Serious AE 28
(15)
27
(7)
26
(13)
10
(5)
Severe AE 18
(10)
22
(6)
25
(12)
7
(3)
AE Leading to
Discontinuation
of Study Drug*
14
(8)
9
(2)
17
(8)
2
(1)
Death 2
(1)
0 0 0
AEs of Special
Interest
     
Infections      
Infections 44
(24)
77
(21)
51
(25)
31
(15)
Serious Infection 7
(4)
3
(1)
5
(2)
1
(<1)
Opportunistic
Infection (Excluding
TB/Herpes Zoster)
0 0 3
(1)
0
Active TB 1
(1)
1
(<1)
0 0
Malignancy      
Malignant Tumors 0 0 0 0
Malignancy (Excluding NMSC) 0 0 0 0
Cardiovascular Events      
Adjudicated MACEa 0 0 0 0
Other      
Hypersensitivity (Serious Events Only) 0 1
(<1)
0 0
Adjudicated Anaphylactic Reaction 0 0 0 0
Hepatic Events 4
(2)
9
(2)
2
(1)
1
(<1)
Infusion-Related Reactions 1
(1)
4
(1)
3
(1)
1
(<1)

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

In the treatment of CD, drug-induced liver injury during induction has been reported. Monitor liver enzymes and bilirubin levels at baseline and, during induction, up to at least 12 weeks of treatment. Monitor thereafter according to routine patient management.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 and tolerability* with 2% of patients in ADVANCE and 1% of patients in MOTIVATE discontinuing the trial due to adverse events3

WELL-STUDIED SAFETY PROFILE

Week 52 Safety Data from
FORTIFY10,11

  FORTIFY
  Non-randomized Randomized
Adverse Events
(AEs), % (E/100 PYs)
Continuous Placebo Placebo (Induction Responder) SKYRIZI
360 mg SC
  N=81
PYs=60.5
N=143
PYs=124.4
N=142
PYs=134.8
Treatment-Emergent AEs      
Any AE 75
(271.0)
71
(297.3)
70
(267.1)
Serious AE 16
(31.4)
10
(15.3)
13
(19.3)
Severe AE 11
(19.8)
10
(16.1)
11
(14.1)
AE Leading to
Discontinuation
of Study Drug*
6
(13.2)
2
(2.4)
3
(4.5)
Death 0 0 0
AEs of Special
Interest
     
Infections      
Infections 33
(66.1)
36
(60.3)
37
(60.8)
Serious
Infection
4
(8.3)
2
(2.4)
6
(7.4)
Opportunistic
Infection (Excluding
TB/Herpes Zoster)
0 0 1
(0.7)
Active TB 0 0 0
Herpes Zoster 0 1
(0.8)
0
Malignancy      
Malignant
Tumors
0 1
(0.8)
0
Malignancy
(Excluding NMSC)
0 0 0
Cardiovascular
Events
     
Adjudicated
MACEa
0 1
(0.8)
1
(0.7)
Other      
Hypersensitivity
(Serious Events
Only)
0 0 0
Adjudicated
Anaphylactic
Reaction
0 0 0
Hepatic Events 1
(1.7)
2
(2.4)
5
(6.7)
Injection Site
Reaction
0 3
(4.8)
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 treatment of CD, drug-induced liver injury during induction has been reported. Monitor liver enzymes and bilirubin levels at baseline and, during induction, up to at least 12 weeks of treatment. Monitor thereafter according to routine patient management.1

WELL-STUDIED SAFETY PROFILE AND TOLERABILITY* WITH 3% OF PATIENTS DISCONTINUING THE TRIAL DUE TO ADVERSE EVENTS10

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.

Lab Monitoring

Treatment Considerations in Crohn's Disease1

A serious adverse reaction of drug-induced liver injury was reported in a patient with Crohn’s disease (ALT: 54x ULN, AST: 30x ULN, and total bilirubin: 2.2x ULN) following two intravenous doses of SKYRIZI 600 mg in conjunction with a rash that required hospitalization. The liver test abnormalities resolved following administration of steroids. SKYRIZI was subsequently discontinued.

Infections: SKYRIZI may increase the risk of infections. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If such an infection develops, monitor the patient closely and do not administer SKYRIZI until the infection resolves.

Tuberculosis (TB): Evaluate for TB infection prior to initiating treatment with SKYRIZI.

Vaccinations: Complete all age-appropriate vaccinations according to current immunization guidelines prior to initiating treatment with SKYRIZI.