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 ~8 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

29

Clinical Trials
Across Indications2-6*


~135,000

Patients Prescribed
Worldwide since 2019
Starting with Ps7‡


6,618

Patients Evaluated
Across Treatment Arms2,8*§


16,754

Patient-Years
of Exposure2,8*

*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 CD to Date Across Indication Approval Trials


2,059

Patient-Years of Exposure from CD Clinical Programs to Date8


WELL-STUDIED SAFETY PROFILE

Week 12 Safety Data from
Phase 2 and 3 Induction Trials3,9

  POOLED INDUCTION TRIAL DATA POOLED INDUCTION TRIAL DATA
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 MACEa   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% OF SKYRIZI 180 MG SC PATIENTS AND 3% OF SKYRIZI 360 MG
SC PATIENTS DISCONTINUING THE TRIAL DUE TO ADVERSE EVENTS10

WELL-STUDIED SAFETY PROFILE

Week 52 Safety Data from
FORTIFY1,3,10,11

  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
MACEa
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 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.

WELL-STUDIED SAFETY PROFILE

Up to 2.75 Years of Safety Data from
FORTIFY1,3,10-13

  FORTIFY
  52 weeks Max Exposure:
2.75 Years
Median Exposure:
1.38 Years
Adverse Events
(AEs)
Placebo (Induction Responder) SKYRIZI
180 mg SC
SKYRIZI
360 mg SC
SKYRIZI
180/360 mg SC
  N=143
PYs=124.4
N=155
PYs=149.4
N=142
PYs=134.8
N=283
PYs=437.2
Treatment-Emergent AEs % % % %
Any AE 71 69 70 76
Serious AE 10 11 13 17
AE Leading to
Discontinuation
of Study Drug*
2 2 3 4
Death 0 0 0 0
AEs of Special
Interest
% (E/100 PYs) % (E/100 PYs) % (E/100 PYs) % (E/100 PYs)
Infections        
Infections 36
(60.3)
32
(50.2)
37
(60.8)
43
(52.2)
Serious
Infection
2
(2.4)
3
(2.7)
6
(7.4)
5.3
(3.9)
Opportunistic
Infection (Excluding
TB/Herpes Zoster)
0 0 1
(0.7)
0.7
(0.5)
Active TB 0 0 0 0
Herpes Zoster 1
(0.8)
1
(1.3)
0 0.7
(0.5)
Malignancy        
NMSC 1
(0.8)
0 0 0
Malignancy
(Excluding NMSC)
0 0 0 0.7
(0.5)
Cardiovascular
Events
       
Adjudicated
MACEa
1
(0.8)
0 1
(0.7)
0.4
(0.2)
Other        
Hypersensitivity
(Serious Events
Only)
0 0 0 0
Adjudicated
Anaphylactic
Reaction
0 0 0 0
Hepatic Events 2
(2.4)
3
(4.7)
5
(6.7)
4.6
(4.6)
Injection Site
Reaction
3
(4.8)
5
(10.0)
6
(13.4)
7
(11.7)

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 completed ADVANCE OR MOTIVATE, and the 52-week FORTIFY maintenance period were eligible to participate.

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

Well-understood safety profile and tolerability* with 4% of pooled SKYRIZI 180 mg/360 mg SC patients discontinuing the trial due to adverse events up to 2.75 years.12

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.