INDUCTION INDUCTION
MAINTENANCE MAINTENANCE
LONG-TERM DATA LONG-TERM DATA

WELL-STUDIED SAFETY PROFILE

Week 12 Safety Data from
Phase 2 and 3 Induction Trials1,5

  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 TREATMENT OF CROHN’S, DRUG-INDUCED LIVER INJURY DURING INDUCTION HAS BEEN REPORTED. FOR THE TREATMENT OF CROHN’S DISEASE AND ULCERATIVE COLITIS, EVALUATE LIVER ENZYMES AND BILIRUBIN LEVELS AT BASELINE AND DURING INDUCTION, (12 WEEKS) OF TREATMENT. MONITOR THEREAFTER ACCORDING TO ROUTINE PATIENT MANAGEMENT.1 SEE MORE

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

Click to view most common adverse reaction rates through week 12

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

Footnotes and Definitions
STUDY DESIGN & BASELINE CHARACTERISTICS
CLICK TO VIEW PsA/Ps SAFETY DATA

WELL-STUDIED SAFETY PROFILE

Week 52 Safety Data from
FORTIFY1,6,7,8

  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
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 CROHN’S, DRUG-INDUCED LIVER INJURY DURING INDUCTION HAS BEEN REPORTED. FOR THE TREATMENT OF CROHN’S DISEASE AND ULCERATIVE COLITIS, EVALUATE LIVER ENZYMES AND BILIRUBIN LEVELS AT BASELINE AND DURING INDUCTION, (12 WEEKS) OF TREATMENT. MONITOR THEREAFTER ACCORDING TO ROUTINE PATIENT MANAGEMENT.1 See More

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

Click to view most common adverse reaction rates through week 52

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.

Footnotes and Definitions
STUDY DESIGN & BASELINE CHARACTERISTICS
OPEN-LABEL EXTENSION STUDY DESIGN
CLICK TO VIEW PsA/Ps SAFETY DATA

WELL-STUDIED SAFETY PROFILE

~3 Years of Safety Data from FORTIFY7,10,11

 

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
MACEa		 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 TREATMENT OF CROHN’S, DRUG-INDUCED LIVER INJURY DURING INDUCTION HAS BEEN REPORTED. FOR THE TREATMENT OF CROHN’S DISEASE AND ULCERATIVE COLITIS, EVALUATE LIVER ENZYMES AND BILIRUBIN LEVELS AT BASELINE AND DURING INDUCTION, (12 WEEKS) OF TREATMENT. MONITOR THEREAFTER ACCORDING TO ROUTINE PATIENT MANAGEMENT.1 See More

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.

Click to view most common adverse reaction rates through week 52

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.

Footnotes and Definitions
STUDY DESIGN & BASELINE CHARACTERISTICS
OPEN-LABEL EXTENSION STUDY DESIGN
CLICK TO VIEW PsA/Ps SAFETY DATA