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*†

~135,000
Patients Prescribed
Worldwide since 2019
Starting with Ps7‡

6,313
Patients Evaluated
Across Treatment Arms2,8*§

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) |
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
FORTIFY1,3,10,11
FORTIFY | ||||
---|---|---|---|---|
Non-randomized | Randomized | |||
Adverse Events (AEs), % (E/100 PYs) |
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 (271.0) |
71 (297.3) |
69 (266.4) |
70 (267.1) |
Serious AE | 16 (31.4) |
10 (15.3) |
11 (18.7) |
13 (19.3) |
AE Leading to Discontinuation of Study Drug* |
6 (13.2) |
2 (2.4) |
2 (2.7) |
3 (4.5) |
Death | 0 | 0 | 0 | 0 |
AEs of Special Interest |
||||
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 | ||||
Malignant Tumors |
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 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 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.