The IL-23 inhibitor from AbbVie indicated for the treatment of adults with
active psoriatic arthritis (PsA) and for moderate to severe plaque psoriasis (Ps)
in adults who are candidates for systemic therapy or phototherapy.1
US-MULT-230356
The IL-23 inhibitor from AbbVie indicated for the treatment of adults with
active psoriatic arthritis (PsA) and for moderate to severe plaque psoriasis (Ps)
in adults who are candidates for systemic therapy or phototherapy.1
SKYRIZI VS STELARA® (ustekinumab)1,2*
HEAD-TO-HEAD EFFICACY AT WEEK 16 IN 2 PIVOTAL PHASE 3
STUDIES OF PATIENTS WITH Ps
UltIMMa-1 (N=506) and UltIMMa-2 (N=491) were replicate Phase 3, randomized, double-blind, placebo- and active-controlled studies to evaluate the efficacy and safety of SKYRIZI (150 mg) vs placebo over 16 weeks and biologic active control (45 mg or 90 mg, based on screening weight) over 52 weeks in adult patients with moderate to severe plaque psoriasis.1,2
EFFICACY ENDPOINTS (P<0.0001)1,2
NRI=Non-responder imputation.
Co-primary endpoints were PASI 90 and sPGA 0/1 response vs placebo at Week 16. Secondary endpoints included PASI 90 and sPGA 0/1 response vs STELARA* and PASI 100 response vs placebo and STELARA at Week 16.1,2
The ustekinumab used as a biologic active control in UltIMMa-1 and UltIMMa-2 was sourced from the European Union. Comparability between non–US-approved ustekinumab and US-approved ustekinumab has not been established.
STELARA is a registered trademark of Johnson & Johnson. See US Prescribing Information for further information.
UltIMMa-1 (N=506) and UltIMMa-2 (N=491) were replicate phase 3, randomized, double-blind, placebo- and active-controlled studies to evaluate the efficacy and safety of SKYRIZI (150 mg) vs placebo over 16 weeks and biologic active control (45 mg or 90 mg, based on screening weight) over 52 weeks in adult patients with moderate to severe plaque psoriasis.1,2
The ustekinumab used as a biologic active control in UltIMMa-1 and UltIMMa-2 was sourced from the European Union. Comparability between non–US-approved ustekinumab and US-approved ustekinumab has not been established.
STELARA is a registered trademark of Johnson & Johnson. See US Prescribing Information for further information.
STELARA is a registered trademark of Johnson & Johnson. See US Prescribing Information for further information.
LOCF=Last observation carried forward; OLE=Open-label extension; RCT=Randomized controlled trial.
In an open-label extension
KEY VARIABLES MEASURED EVERY 12 WEEKS THROUGH OLE5,6:
sPGA 0/1, sPGA 0, PASI 75, PASI 90, and PASI 100
Following completion of the RCT period, patients on blinded STELARA were switched to open-label SKYRIZI.4
LIMITATIONS:
In an open-label extension, there is potential for enrichment of the long-term data in the remaining patient populations since patients who are unable to tolerate or do not respond to the drug often drop out.
*ACTIVE COMPARATOR
The ustekinumab used as a biologic active control in UltIMMa-1 and UltIMMa-2 was sourced from the European Union. Comparability between non–US-approved ustekinumab and US-approved ustekinumab has not been established.
STELARA is a registered trademark of Johnson & Johnson. See US Prescribing Information for further information.
INTEGRATED RESULTS FROM ULTIMMA-1 & -2 PATIENTS (LOCF)
KEY VARIABLES MEASURED EVERY 12 WEEKS THROUGH OLE5,8:
sPGA 0/1, sPGA 0, PASI 75, PASI 90, and PASI 100
Following completion of the RCT period, patients on blinded STELARA were switched to open-label SKYRIZI.
LIMITATIONS:
In an open-label extension, there is potential for enrichment of the long-term data in the remaining patient populations since patients who are unable to tolerate or do not respond to the drug often drop out.
*ACTIVE COMPARATOR
The ustekinumab used as a biologic active control in UltIMMa-1 and UltIMMa-2 was sourced from the European Union. Comparability between non–US-approved ustekinumab and US-approved ustekinumab has not been established.
STUDY DESIGN:
The randomized controlled trial data shown here are integrated results from UltIMMa-1 and -2. The open-label extension (OLE) data are a sub-analysis of LIMMitless and include only patients from UltIMMa-1 and -2 who completed the RCT and then enrolled in the OLE. LIMMitless is an OLE for which patients who completed either UltIMMa trial, IMMhance, or IMMvent were eligible to participate.4,5,7,8
STELARA is a registered trademark of Johnson & Johnson. See US Prescribing Information for further information.
LOCF=Last observation carried forward; OLE=Open-label extension; RCT=Randomized controlled trial.
In the randomized controlled trial and open-label extension
KEY VARIABLES MEASURED EVERY 12 WEEKS THROUGH OLE5,6:
sPGA 0/1, sPGA 0, PASI 75, PASI 90, and PASI 100
Following completion of the RCT period, patients on blinded STELARA were switched to open-label SKYRIZI.4
LIMITATIONS:
In an open-label extension, there is potential for enrichment of the long-term data in the remaining patient populations since patients who are unable to tolerate or do not respond to the drug often drop out.
*ACTIVE COMPARATOR
The ustekinumab used as a biologic active control in UltIMMa-1 and UltIMMa-2 was sourced from the European Union. Comparability between non–US-approved ustekinumab and US-approved ustekinumab has not been established.
STELARA is a registered trademark of Johnson & Johnson. See US Prescribing Information for further information.
INTEGRATED RESULTS FROM ULTIMMA-1 & -2 PATIENTS (LOCF)
KEY VARIABLES MEASURED EVERY 12 WEEKS THROUGH OLE5:
sPGA 0/1, sPGA 0, PASI 75, PASI 90, and PASI 100
Following completion of the RCT period, patients on blinded STELARA were switched to open-label SKYRIZI.4
LIMITATIONS:
In an open-label extension, there is potential for enrichment of the long-term data in the remaining patient populations since patients who are unable to tolerate or do not respond to the drug often drop out.
*ACTIVE COMPARATOR
The ustekinumab used as a biologic active control in UltIMMa-1 and UltIMMa-2 was sourced from the European Union. Comparability between non–US-approved ustekinumab and US-approved ustekinumab has not been established.
STUDY DESIGN:
The randomized controlled trial data shown here are integrated results from UltIMMa-1 and -2. The open-label extension (OLE) data are a sub-analysis of LIMMitless and include only patients from UltIMMa-1 and -2 who completed the RCT and then enrolled in the OLE. LIMMitless is an OLE for which patients who completed either UltIMMa trial, IMMhance, or IMMvent were eligible to participate.4,5,7,8
STELARA is a registered trademark of Johnson & Johnson. See US Prescribing Information for further information.
LOCF=Last observation carried forward; OLE=Open-label extension; RCT=Randomized controlled trial.
Well-Studied Safety Profile
across 4 pivotal trials1
4 DOSES PER YEAR
4 doses per year after 2 initiation doses at Weeks 0 and 4 (150 mg/dose)1
Psoriatic Arthritis: SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults.
Plaque Psoriasis: SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
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 Crohn’s 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, 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.
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.
Dosage Forms and Strengths: SKYRIZI is available in a 150 mg/mL prefilled syringe and pen, and a 600 mg/10 mL single-dose vial for intravenous infusion.
Please see Full Prescribing Information.
US-SKZG-220547
REFERENCES
US-SKZD-210080
REFERENCE
ADA=Adalimumab
BSA=Body Surface Area
PASI=Psoriasis Area and Severity Index
PsA=Psoriatic Arthritis
RZB=Risankizumab-rzaa
TNFi=Tumor Necrosis Factor Inhibitor
REFERENCES
US-SKZR-220084
BSA=Body Surface Area
PASI=Psoriasis Area and Severity Index
RZB=Risankizumab-rzaa
SEC=Secukinumab
sPGA=static Physician's Global Assessment
aMean baseline body weight was 92 kg in the secukinumab group and 91.1 kg in the risankizumab group.2
bStratification factors at randomization.
REFERENCES
US-SKZR-220084
BSA=Body Surface Area
PASI=Psoriasis Area and Severity Index
PBO=Placebo
PsA=Psoriatic Arthritis
RZB=Risankizumab-rzaa
TNFi=Tumor Necrosis Factor Inhibitor
aStratification factors at randomization.
REFERENCES
US-SKZR-220084
BSA=Body Surface Area
PASI=Psoriasis Area and Severity Index
PBO=Placebo
PsA=Psoriatic Arthritis
RZB=Risankizumab-rzaa
TNFi=Tumor Necrosis Factor Inhibitor
UST=Ustekinumab
aStratification factors at randomization.
REFERENCE
US-SKZR-220084
US-SKZD-220459
BSA=Body Surface Area
PASI=Psoriasis Area and Severity Index
PBO=Placebo
PsA=Psoriatic Arthritis
RZB=Risankizumab-rzaa
TNFi=Tumor Necrosis Factor Inhibitor
UST=Ustekinumab
aStratification factors at randomization.
REFERENCE:
US-SKZR-220084
BSA=Body Surface Area
PASI=Psoriasis Area and Severity Index
PBO=Placebo
PsA=Psoriatic Arthritis
RZB=Risankizumab-rzaa
TNFi=Tumor Necrosis Factor Inhibitor
UST=Ustekinumab
aStratification factors at randomization.
REFERENCE:
US-SKZR-220084
US-SKZ-220108
US-SKZ-220107
aBased on 68 joints.
bBased on 66 joints.
BMI=body mass index
BSA=body surface area
csDMARD=conventional synthetic disease-modifying antirheumatic drugs
mTSS=modified Total Sharp Score
MTX=methotrexate
NSAID=nonsteroidal anti-inflammatory drug
PBO=placebo
PsA=psoriatic arthritis
RZB=risankizumab-rzaa
BMI=body mass index
BSA=body surface area
csDMARD=conventional synthetic disease-modifying antirheumatic drugs
mTSS=modified Total Sharp Score
MTX=methotrexate
NSAID=nonsteroidal anti-inflammatory drug
PBO=placebo
PsA=psoriatic arthritis
RZB=risankizumab-rzaa
REFERENCES
US-SKZR-220084
US-SKZR-220084
REFERENCES
US-SKZR-220084
REFERENCES
US-SKZR-220084
aBased on 68 joints.
bBased on 66 joints.
BMI=body mass index; BSA=body surface area; csDMARD=conventional synthetic disease-modifying antirheumatic drug; DMARD=disease-modifying antirheumatic drugs; HAQ-DI=health assessment questionnaire disability index; LDI=Leeds Dactylitis Index; LEI=Leeds Enthesitis Index; mTSS=modified total Sharp score; MTX=methotrexate; NSAIDs=nonsteroidal anti-inflammatory drugs; PASl=Psoriasis Area and Severity Index; PsA=psoriatic arthritis.
REFERENCES
US-SKZR-220180