Rheumatology
Moderate to Severe
Rheumatoid Arthritis
Active
Psoriatic Arthritis
Active
Ankylosing Spondylitis
Moderate to Severe
Juvenile Idiopathic Arthritis
Non-Infectious
Intermediate, Posterior and Panuveitis
Dermatology
Moderate to Severe
Chronic Plaque Psoriasis
Active
Psoriatic Arthritis
Moderate to Severe
Hidradenitis Suppurativa
Gastroenterology
Moderate to Severe
Crohn's Disease
Moderate to Severe
Pediatric Crohn's Disease
Moderate to Severe
Ulcerative Colitis
Moderate to Severe
Pediatric Ulcerative Colitis
Ophthalmology
Non-Infectious
Intermediate, Posterior and Panuveitis
SKYRIZI VS STELARA® (ustekinumab)1,2*
HEAD-TO-HEAD EFFICACY AT WEEK 16 IN 2
PIVOTAL PHASE 3 STUDIES
SKYRIZI EFFICACY VS STELARA® (ustekinumab)* AT WEEK 16 IN ULTIMMA-1 and ULTIMMA-2 (NRI)1,2
STUDY DESIGN:
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
*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.
STUDY DESIGN:
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
*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.
In an open-label extension
PATIENTS SWITCHED FROM STELARA® (ustekinumab)* TO SKYRIZI ACHIEVED HIGHER PASI 90 RATES AT 2.5 YEARS3,4
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.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.
73% OF PATIENTS ACHIEVED PASI 90 AFTER 1 DOSE (12 WEEKS) OF SKYRIZI3,4
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.4-7
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
PATIENTS WHO STARTED AND REMAINED ON SKYRIZI EXPERIENCED CONSISTENT PASI 90 RATES AT 2.5 YEARS3,4
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.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.
86% OF SKYRIZI PATIENTS ACHIEVED PASI 90 AT WEEK 52 AND 87% AT WEEK 1363,4
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.4-7
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
PATIENTS SWITCHED FROM STELARA® (ustekinumab)* TO SKYRIZI ACHIEVED HIGHER PASI 100 RATES AT 2.5 YEARS3,4
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.
STELARA is a registered trademark of Johnson & Johnson. See US Prescribing Information for further information.
51% OF SKYRIZI PATIENTS ACHIEVED COMPLETE CLEARANCE (PASI 100) AFTER 1 DOSE (12 WEEKS) OF SKYRIZI3,4
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.4-7
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
PATIENTS WHO STARTED AND REMAINED ON SKYRIZI EXPERIENCED CONSISTENT PASI 100 RATES AT 2.5 YEARS3,4
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.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.
61% OF SKYRIZI PATIENTS ACHIEVED COMPLETE CLEARANCE (PASI 100) AT WEEK 52 AND 63% AT WEEK 1363,4
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.4-7
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.
Have you transitioned your patients?
Offer your patients the new 150 mg/mL
SKYRIZI Pen or 150 mg/mL prefilled syringe1
IMPORTANT SAFETY INFORMATION AND INDICATION FOR SKYRIZI® (risankizumab-rzaa)1
Indication
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
Infection
SKYRIZI® (risankizumab-rzaa) 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.
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 include upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.
SKYRIZI is available in a 150 mg/mL prefilled syringe and pen.
Please see Full Prescribing Information.
US-SKZD-210127
REFERENCES
- SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc.
- Gordon KB, Strober B, Lebwohl M, et al. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. Lancet. 2018;392(10148):650-661.
- Data on file, ABVRRTI70545.
- Strober B, Eyerich K, Hong HC, et al. Long-term efficacy and safety of switching from ustekinumab to risankizumab: results from the open-label extension LIMMitless. Presented at: 28th European Academy of Dermatology and Venereology (EADV) Congress; October 9-13, 2019; Madrid, Spain.
- Papp K, Lebwohl M, Ohtsuki M, et al. Long-term efficacy and safety of continuous Q12W risankizumab: results from open-label extension study LIMMitless. Presented at: Virtual Annual Meeting of the American Academy of Dermatology; June 12-14, 2020.
- Leonardi C, Lebwohl M, Bachelez H, et al. Maintenance of response through 172 weeks of long-term continuous risankizumab treatment: an analysis of patients from UltIMMa-1 and UltIMMa-2. Presented at: Virtual Winter Clinical Dermatology Conference; January 15-20, 2021.
- Leonardi C, Bachelez H, Wu JJ, et al. Long-term safety of risankizumab in patients with moderate to severe psoriasis: analysis of pooled clinical trial data. Poster presented at: American Academy of Dermatology Annual Meeting; March 1-5, 2019; Washington, DC.
- A study to assess the safety and efficacy of risankizumab for maintenance in moderate to severe plaque psoriasis (LIMMITLESS). Clinicaltrials.gov identifier: NCT03047395. https://www.clinicaltrials.gov/ct2/show/NCT03047395?term=risankizumab&cond=Psoriasis&draw=2&rank=8. Accessed January 4, 2021.
STUDY DESIGN – UltIMMa-1 and UltIMMa-21,2
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. SKYRIZI (150 mg) was given as 2 subcutaneous injections at Weeks 0, 4, 16, 28, and 40. Patients were randomized 3:1:1 to receive SKYRIZI, ustekinumab, or placebo. At Week 16, patients on placebo were switched to SKYRIZI.
Active Comparator
The active comparator (ustekinumab) used for these studies was sourced from the European Union.
OLE=Open-Label Extension
PASI=Psoriasis Area and Severity Index
PASI 90=≥90% improvement in Psoriasis Area and Severity Index
PASI 100=100% improvement in Psoriasis Area and Severity Index
sPGA=static Physician's Global Assessment
The co-primary endpoints were
- Percentage of patients with at least a 90% improvement in the PASI score (PASI 90) at Week 16 compared to placebo
- Percentage of patients with an sPGA score of clear or almost clear (0/1) at Week 16 compared to placebo
Key secondary endpoints included
- PASI 90 and PASI 100 at Week 52 compared to ustekinumab
Key inclusion criteria
- ≥18 years of age
- Stable (≥6 months) moderate to severe chronic plaque psoriasis, with or without psoriatic arthritis
- ≥10% body surface area, with a PASI score ≥12, and an sPGA score ≥3
- Eligible for systemic therapy or phototherapy and ustekinumab therapy in accordance with local labels
OLE=Open-Label Extension
PASI=Psoriasis Area and Severity Index
PASI 90=≥90% improvement in Psoriasis Area and Severity Index
PASI 100=100% improvement in Psoriasis Area and Severity Index
sPGA=static Physician's Global Assessment
SELECTED BASELINE CHARACTERISTICS2
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.
US-SKZD-200400
STUDY DESIGN – UltIMMa-1 and UltIMMa-21,2,5-7
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. SKYRIZI (150 mg) was given as 2 subcutaneous injections at Weeks 0, 4, 16, 28, and 40. Patients were randomized 3:1:1 to receive SKYRIZI, ustekinumab, or placebo. At Week 16, patients on placebo were switched to SKYRIZI.
LIMMitless is an ongoing, single-arm, multicenter, open-label extension study evaluating the long-term efficacy and safety of SKYRIZI (150 mg). Patients who completed UltIMMa-1 or -2, IMMvent, or IMMhance were eligible to participate.
Active Comparator
The active comparator (ustekinumab) used for these studies was sourced from the European Union.
OLE=Open-Label Extension
PASI=Psoriasis Area and Severity Index
PASI 90=≥90% improvement in Psoriasis Area and Severity Index
PASI 100=100% improvement in Psoriasis Area and Severity Index
sPGA=static Physician's Global Assessment
The co-primary endpoints were
- Percentage of patients with at least a 90% improvement in the PASI score (PASI 90) at Week 16 compared to placebo
- Percentage of patients with an sPGA score of clear or almost clear (0/1) at Week 16 compared to placebo
Key secondary endpoints included
- PASI 90 and PASI 100 at Week 52 compared to ustekinumab
Key inclusion criteria
- ≥18 years of age
- Stable (≥6 months) moderate to severe chronic plaque psoriasis, with or without psoriatic arthritis
- ≥10% body surface area, with a PASI score ≥12, and an sPGA score ≥3
- Eligible for systemic therapy or phototherapy and ustekinumab therapy in accordance with local labels
OLE=Open-Label Extension
PASI=Psoriasis Area and Severity Index
PASI 90=≥90% improvement in Psoriasis Area and Severity Index
PASI 100=100% improvement in Psoriasis Area and Severity Index
sPGA=static Physician's Global Assessment
SELECTED BASELINE CHARACTERISTICS2
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.
US-SKZD-200400
STUDY DESIGN – UltIMMa-1 and UltIMMa-21,2
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. SKYRIZI (150 mg) was given as 2 subcutaneous injections at Weeks 0, 4, 16, 28, and 40. Patients were randomized 3:1:1 to receive SKYRIZI, ustekinumab, or placebo. At Week 16, patients on placebo were switched to SKYRIZI.
Active Comparator
The active comparator (ustekinumab) used for these studies was sourced from the European Union.
OLE=Open-Label Extension
PASI=Psoriasis Area and Severity Index
PASI 90=≥90% improvement in Psoriasis Area and Severity Index
PASI 100=100% improvement in Psoriasis Area and Severity Index
sPGA=static Physician's Global Assessment
The co-primary endpoints were
- Percentage of patients with at least a 90% improvement in the PASI score (PASI 90) at Week 16 compared to placebo
- Percentage of patients with an sPGA score of clear or almost clear (0/1) at Week 16 compared to placebo
Key secondary endpoints included
- PASI 90 and PASI 100 at Week 52 compared to ustekinumab
Key inclusion criteria
- ≥18 years of age
- Stable (≥6 months) moderate to severe chronic plaque psoriasis, with or without psoriatic arthritis
- ≥10% body surface area, with a PASI score ≥12, and an sPGA score ≥3
- Eligible for systemic therapy or phototherapy and ustekinumab therapy in accordance with local labels
OLE=Open-Label Extension
PASI=Psoriasis Area and Severity Index
PASI 90=≥90% improvement in Psoriasis Area and Severity Index
PASI 100=100% improvement in Psoriasis Area and Severity Index
sPGA=static Physician's Global Assessment
SELECTED BASELINE CHARACTERISTICS2
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.
US-SKZD-200400
STUDY DESIGN – UltIMMa-1 and UltIMMa-21,2,6-8
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. SKYRIZI (150 mg) was given as 2 subcutaneous injections at Weeks 0, 4, 16, 28, and 40. Patients were randomized 3:1:1 to receive SKYRIZI, ustekinumab, or placebo. At Week 16, patients on placebo were switched to SKYRIZI.
LIMMitless is an ongoing, single-arm, multicenter, open-label extension study evaluating the long-term efficacy and safety of SKYRIZI (150 mg). Patients who completed UltIMMa-1 or -2, IMMvent, or IMMhance were eligible to participate.
Active Comparator
The active comparator (ustekinumab) used for these studies was sourced from the European Union.
OLE=Open-Label Extension
PASI=Psoriasis Area and Severity Index
PASI 90=≥90% improvement in Psoriasis Area and Severity Index
PASI 100=100% improvement in Psoriasis Area and Severity Index
sPGA=static Physician's Global Assessment
The co-primary endpoints were
- Percentage of patients with at least a 90% improvement in the PASI score (PASI 90) at Week 16 compared to placebo
- Percentage of patients with an sPGA score of clear or almost clear (0/1) at Week 16 compared to placebo
Key secondary endpoints included
- PASI 90 and PASI 100 at Week 52 compared to ustekinumab
Key inclusion criteria
- ≥18 years of age
- Stable (≥6 months) moderate to severe chronic plaque psoriasis, with or without psoriatic arthritis
- ≥10% body surface area, with a PASI score ≥12, and an sPGA score ≥3
- Eligible for systemic therapy or phototherapy and ustekinumab therapy in accordance with local labels
OLE=Open-Label Extension
PASI=Psoriasis Area and Severity Index
PASI 90=≥90% improvement in Psoriasis Area and Severity Index
PASI 100=100% improvement in Psoriasis Area and Severity Index
sPGA=static Physician's Global Assessment
SELECTED BASELINE CHARACTERISTICS2
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.
US-SKZD-200400
STUDY DESIGN – IMMvent9
IMMvent was a phase 3, randomized, double-blind, double-dummy, active-controlled study to evaluate the efficacy and safety of SKYRIZI (150 mg) compared to HUMIRA® (adalimumab) in adult patients with moderate to severe plaque psoriasis over 44 weeks.
Patients treated with adalimumab during Part A:
- Non-responders (PASI <50) at Week 16 (n=38) were treated with SKYRIZI during Part B
- PASI 90 responders at Week 16 (n=144) continued treatment with adalimumab during Part B
- PASI 50 to <PASI 90 were re-randomized to either continue adalimumab or switch to SKYRIZI
Part A
In the first phase, patients were randomized 1:1 to either SKYRIZI (150 mg), given as a subcutaneous injection at Weeks 0 and 4 and every 12 weeks thereafter or HUMIRA, given as a subcutaneous injection, with an initial dose of 80 mg followed by 40 mg every other week starting 1 week after the initial dose over 44 weeks.
The Part A co-primary endpoints were
- PASI 90 and sPGA 0/1 at Week 16 compared to HUMIRA
Part B
Patients originally randomized to SKYRIZI received it throughout the study (Parts A & B). Among patients originally randomized to receive HUMIRA, those with a PASI 50 but less than PASI 90 response were re-randomized 1:1 to switch to SKYRIZI or continue HUMIRA.
The Part B primary endpoint was
- PASI 90 at Week 44 among those with PASI 50 to <90 after 16 weeks of adalimumab treatment
Key secondary endpoints included
- PASI 100 at Week 16
- PASI 100 at Week 44 for patients who were re-randomized at Week 16
Key inclusion criteria
- ≥18 years of age
- Diagnosis of chronic plaque psoriasis ≥6 months before Week 0
- Stable moderate to severe chronic plaque psoriasis based on ≥10% body surface area, with a PASI score ≥12, and an sPGA score ≥3
- Eligible for adalimumab therapy in accordance with local labels
OLE=Open-Label Extension
PASI=Psoriasis Area and Severity Index
PASI 90=≥90% improvement in Psoriasis Area and Severity Index
PASI 100=100% improvement in Psoriasis Area and Severity Index
Q2W=Once every 2 weeks
sPGA=static Physician's Global Assessment
Click to see HUMIRA® (adalimumab) Indication and Important Safety Information, including BOXED WARNING for Serious Infections and Malignancy
OLE=Open-Label Extension
PASI=Psoriasis Area and Severity Index
PASI 90=≥90% improvement in Psoriasis Area and Severity Index
PASI 100=100% improvement in Psoriasis Area and Severity Index
Q2W=Once every 2 weeks
sPGA=static Physician's Global Assessment
SELECTED BASELINE CHARACTERISTICS9,14
ADA=Adalimumab
BSA=Body Surface Area
PASI=Psoriasis Area and Severity Index
PsA=Psoriatic Arthritis
RZB=Risankizumab-rzaa
TNFi=Tumor Necrosis Factor Inhibitor
US-SKZD-200400
STUDY DESIGN – IMMhance1,10
IMMhance was a phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the impact of treatment withdrawal and re-treatment of SKYRIZI compared to placebo in adult patients with moderate to severe plaque psoriasis.
Part A
In the first phase, patients were randomized 4:1 to SKYRIZI (150 mg), given as a subcutaneous injection at baseline, 4 weeks later, and every 12 weeks thereafter, or placebo.
The Part A co-primary endpoints were
- PASI 90 and sPGA 0/1 at Week 16
Part B
In the second phase of this study (Week 28 through Week 104), patients originally randomized to SKYRIZI who achieved sPGA 0/1 at Week 28 were re-randomized (1:2) to SKYRIZI (maintenance) or placebo (withdrawal). Beginning at Week 32, patients with sPGA ≥2 continued on SKYRIZI (150 mg) once every 12 weeks up to Week 88, with a final follow-up at Week 104.
The Part B primary endpoint was
- Percentage of patients with an sPGA 0/1 at 1 year
Key inclusion criteria
- ≥18 years of age
- Diagnosis of chronic moderate to severe plaque psoriasis ≥6 months before Week 0
- Stable plaque psoriasis based on ≥10% body surface area, with a PASI score ≥12 and an sPGA score ≥3
- Eligible for systemic therapy or phototherapy
Key secondary endpoints included
- PASI 75 at Week 16
- PASI 100 at Week 16
- sPGA 0 at Week 16
- DLQI 0/1 at Week 16
DLQI=Dermatology Life Quality Index
OLE=Open-Label Extension
PASI=Psoriasis Area and Severity Index
PASI 75=≥75% improvement in Psoriasis Area and Severity Index
PASI 90=≥90% improvement in Psoriasis Area and Severity Index
PASI 100=100% improvement in Psoriasis Area and Severity Index
Q12W=Once every 12 weeks
sPGA=static Physician's Global Assessment
SELECTED BASELINE CHARACTERISTICS10
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.
US-SKZD-200400
STUDY DESIGN – UltIMMa-1 and UltIMMa-21,2
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. SKYRIZI (150 mg) was given as 2 subcutaneous injections at Weeks 0, 4, 16, 28, and 40. Patients were randomized 3:1:1 to receive SKYRIZI, ustekinumab, or placebo. At Week 16, patients on placebo were switched to SKYRIZI.
Active Comparator
The active comparator (ustekinumab) used for these studies was sourced from the European Union.
OLE=Open-Label Extension
PASI=Psoriasis Area and Severity Index
PASI 90=≥90% improvement in Psoriasis Area and Severity Index
PASI 100=100% improvement in Psoriasis Area and Severity Index
sPGA=static Physician's Global Assessment
The co-primary endpoints were
- Percentage of patients with at least a 90% improvement in the PASI score (PASI 90) at Week 16 compared to placebo
- Percentage of patients with an sPGA score of clear or almost clear (0/1) at Week 16 compared to placebo
Key secondary endpoints included
- PASI 90 and PASI 100 at Week 52 compared to ustekinumab
Key inclusion criteria
- ≥18 years of age
- Stable (≥6 months) moderate to severe chronic plaque psoriasis, with or without psoriatic arthritis
- ≥10% body surface area, with a PASI score ≥12, and an sPGA score ≥3
- Eligible for systemic therapy or phototherapy and ustekinumab therapy in accordance with local labels
OLE=Open-Label Extension
PASI=Psoriasis Area and Severity Index
PASI 90=≥90% improvement in Psoriasis Area and Severity Index
PASI 100=100% improvement in Psoriasis Area and Severity Index
sPGA=static Physician's Global Assessment
SELECTED BASELINE CHARACTERISTICS2
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.
US-SKZD-200400