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
IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)1
Indications
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
REFERENCE
- SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc.
STUDY DESIGN–IMMvent1
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
REFERENCE
- Reich K, Gooderham M, Thaçi D, et al. Efficacy and safety of continuous risankizumab or switching from adalimumab to risankizumab treatment in patients with moderate-to-severe plaque psoriasis: results from the phase 3 IMMvent trial. Poster presented at: American Academy of Dermatology Annual Meeting; March 1-5, 2019; Washington, DC.
SELECTED BASELINE CHARACTERISTICS1,2
ADA=Adalimumab
BSA=Body Surface Area
PASI=Psoriasis Area and Severity Index
PsA=Psoriatic Arthritis
RZB=Risankizumab-rzaa
TNFi=Tumor Necrosis Factor Inhibitor
REFERENCES
- Reich K, Gooderham M, Thaçi D, et al. Efficacy and safety of continuous risankizumab or switching from adalimumab to risankizumab treatment in patients with moderate-to-severe plaque psoriasis: results from the phase 3 IMMvent trial. Poster presented at: American Academy of Dermatology Annual Meeting; March 1-5, 2019; Washington, DC.
- Ryan C, Crowley J, Valdecantos WC, Wu T, Reich K. Efficacy of switching to risankizumab compared with continued adalimumab treatment in patients with moderate-to-severe plaque psoriasis. Poster presented at: 6th Congress of the Skin Inflammation and Psoriasis International Network; April 25-27, 2019; Paris, France.
US-SKZR-220084
STUDY DESIGN–IMMerge1
IMMerge was a Phase 3, global, multicenter, randomized, open-label, efficacy–assessor-blinded, active-comparator study that evaluated the safety and efficacy of SKYRIZI 150 mg vs COSENTYX 300 mg in moderate to severe plaque psoriasis subjects, who were candidates for systemic therapy.
The primary endpoints were
- PASI 90 at Week 16 (non-inferiority)
- PASI 90 at Week 52 (superiority)
Ranked secondary endpoints (all superiority)
- PASI 100 at Week 52
- sPGA 0/1 (clear/almost clear) at Week 52
- PASI 75 at Week 52
Key inclusion criteria
- ≥18 years with moderate to severe chronic plaque psoriasis (with or without psoriatic arthritis)
- Diagnosis of chronic plaque psoriasis ≥6 months before baseline visit
- Stable moderate to severe chronic plaque psoriasis at both screening and baseline
– ≥10% BSA involvement, PASI ≥12, and sPGA ≥3 - Must be a candidate for systemic therapy for active plaque psoriasis treatment, as assessed by the investigator
- Must be a candidate for treatment with secukinumab according to local label
- Must have had no prior exposure to risankizumab or secukinumab
Sourcing
In this study, 46 patients outside of the US received non–US-licensed secukinumab.
Data regarding comparability between US and non-US secukinumab are not publicly available.
BSA=Body Surface Area
PASI=Psoriasis Area and Severity Index
sPGA=static Physician's Global Assessment
REFERENCE
- Warren RB, Blauvelt A, Poulin Y, et al. Efficacy and safety of risankizumab vs. secukinumab in patients with moderate-to-severe plaque psoriasis (IMMerge): results from a phase III, randomized, open-label, efficacy-assessor-blinded clinical trial. Br J Dermatol. 2021;184(1):50-59. doi:10.1111/bjd.19341
SELECTED BASELINE CHARACTERISTICS1
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
- Warren RB, Blauvelt A, Poulin Y, et al. Efficacy and safety of risankizumab vs. secukinumab in patients with moderate-to-severe plaque psoriasis (IMMerge): results from a phase III, randomized, open-label, efficacy-assessor-blinded clinical trial. Br J Dermatol. 2021;184(1):50-59. doi:10.1111/bjd.19341
- Warren RB, Blauvelt A, Poulin Y, et al. Risankizumab vs secukinumab in patients with moderate-to-severe plaque psoriasis: a phase 3 trial. Presented at: American Academy of Dermatology Annual Meeting; March 20-24, 2020; Denver, CO.
US-SKZR-220084
STUDY DESIGN—IMMhance1,2
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 active 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
REFERENCES
- SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc.
- Blauvelt A, Leonardi CL, Gooderham M, et al. Efficacy and safety of continuous risankizumab therapy vs treatment withdrawal in patients with moderate to severe plaque psoriasis. JAMA Dermatol. 2020;156(6):649-658.
SELECTED BASELINE CHARACTERISTICS1,2
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
- Blauvelt A, Leonardi CL, Gooderham M, et al. Efficacy and safety of continuous risankizumab therapy vs treatment withdrawal in patients with moderate to severe plaque psoriasis. JAMA Dermatol. 2020;156(6):649-658.
- Data on file, AbbVie Inc. ABVRRTI68151.
US-SKZR-220084
STUDY DESIGN–UltIMMa-1 and UltIMMa-2 LIMMitless OLE1-5
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
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.
- Leonardi C, Lebwohl M, Bachelez H, et al. Maintenance of clinical response with continued risankizumab treatment for moderate-to-severe psoriasis through 232 weeks: interim analysis of the LIMMitless open-label extension study. Presented at: Fall Clinical Dermatology Conference; October 21-24, 2021; Las Vegas, NV; hybrid.
- 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.
- Papp K, Lebwohl M, Puig L, et al. Long-term efficacy and safety of continuous risankizumab every 12 weeks: an interim analysis from the open-label extension trial, LIMMitless. Presented at: Virtual European Academy of Dermatology and Venereology Congress; October 29-31, 2020.
SELECTED BASELINE CHARACTERISTICS1
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
- 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.
US-SKZR-220084
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.
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
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.
SELECTED BASELINE CHARACTERISTICS1
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:
- 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.
US-SKZR-220084
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.
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
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.
SELECTED BASELINE CHARACTERISTICS1
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:
- 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.
US-SKZR-220084
STUDY DESIGN—KEEPsAKE 1 and KEEPsAKE 21-5
KEEPsAKE 1: csDMARD-IR. KEEPsAKE 2: Mixed population (50% csDMARD-IR, 50% Bio-IR)
KEEPsAKE 1 (N=964) and KEEPsAKE 2 (N=443) were 2 randomized, double-blind, placebo-controlled studies to evaluate the efficacy and safety of SKYRIZI (150 mg) vs placebo over 24 weeks with an open-label extension for up to an additional 204 weeks in adult patients with active psoriatic arthritis.
In both studies, patients were randomized to receive SKYRIZI 150 mg or placebo at Weeks 0, 4, and 16. Starting from Week 28, all patients received SKYRIZI every 12 weeks. 59.6% of patients from both studies were receiving concomitant MTX, 11.6% were receiving concomitant non-biologic DMARDs other than MTX, and 28.9% were receiving SKYRIZI monotherapy.
Patients in KEEPsAKE 1 previously experienced an inadequate response, intolerance, or contraindication to ≥1 csDMARD. Patients in KEEPsAKE 2 were bio-IR and/or csDMARD-IR.
In both studies, similar responses were seen regardless of concomitant non-biologic DMARD use, number of prior non-biologic DMARDs, age, gender, race, and BMI. In KEEPsAKE 2, responses were seen regardless of prior biologic therapy.
*The first n-value is for KEEPsAKE 1; the second n-value is for KEEPsAKE 2.
†At Week 16, patients classified as nonresponders (defined as not achieving at least a 20% improvement in either or both tender joint count and swollen joint count at both Week 12 and Week 16 compared to baseline) had the option to add or modify rescue concomitant medications/therapy. Starting at Week 36, patients classified as nonresponders were discontinued from study drug.
‡To maintain the blind to the original treatment at Week 24, patients randomized to placebo received blinded risankizumab 150 mg, and patients randomized to risankizumab received blinded placebo.
Primary endpoint
- Proportion of subjects who achieved ACR20 response at Week 24
Select ranked secondary endpoints
- Change from baseline in HAQ-DI at Week 24
- Proportion of patients with PASI 90 response at Week 24a
- ACR20 response at Week 16
- Proportion of patients with MDA at Week 24
- Change from baseline in mNAPSI at Week 24b,c
- Resolution of enthesitis (pooled from KEEPsAKE 1 and KEEPsAKE 2) at Week 24d
- Resolution of dactylitis (pooled from KEEPsAKE 1 and KEEPsAKE 2) at Week 24e
Non-ranked secondary endpoints
- Proportion of patients who achieved ACR50 or ACR70 at Week 24
Key inclusion criteria
- ≥18 years of age
- Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) at the Screening Visit
- Clinical diagnosis of PsA with symptom onset ≥6 months prior to screening
- Diagnosis of active plaque psoriasis
- Inadequate response (lack of efficacy after minimum 12-week duration of therapy) to previous or current treatment with ≥1 csDMARD at maximally tolerated dose
ACR=American College of Rheumatology
Bio-IR=inadequate response or intolerance to a biologic
BMI=body mass index
csDMARD=conventional synthetic disease-modifying antirheumatic drugs
csDMARD-IR=intolerance or inadequate response to conventional synthetic disease-modifying antirheumatic drug(s)
LDI=Leeds Dactylitis Index
LEI=Leeds Enthesitis Index
mTSS=modified total Sharp Score
MTX=methotrexate
NRI-C=non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19
OLE=open-label extension
PASI=Psoriasis Area Severity Index
PBO=placebo
RZB=risankizumab-rzaa
aAmong patients with ≥3% body surface area affected by psoriasis at baseline.
bNot included in KEEPsAKE 2.
cAmong patients with nail psoriasis at baseline.
dDefined as LEI=0 among patients with LEI >0 at baseline. Prespecified analysis of pooled data from the KEEPsAKE 1 and KEEPsAKE 2 trials (RZB, n=444; PBO, n=448).
eDefined as LDI=0 among patients with LDI >0 at baseline. Prespecified analysis of pooled data from the KEEPsAKE 1 and KEEPsAKE 2 trials (RZB, n=188; PBO, n=204).
REFERENCES
- SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc.
- Kristensen LE, Keiserman M, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from KEEPsAKE 1. Presented at: Fall Clinical Dermatology Conference; October 21-24, 2021; Las Vegas, NV; hybrid.
- Östör AV, Van den Bosch F, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from KEEPsAKE 2. Presented at: Fall Clinical Dermatology Conference; October 21-24, 2021; Las Vegas, NV; hybrid.
- Kristensen LE, Keiserman M, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 1 trial. Ann Rheum Dis. 2022;81:225-231. doi:10.1136/annrheumdis-2021-221019
- Östör A, Van den Bosch F, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 2 trial. Ann Rheum Dis. 2022;81:351-358. doi:10.1136/annrheumdis-2021-221048
SELECTED BASELINE CHARACTERISTICS IN PsA CLINICAL TRIALS1,2
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
- Kristensen LE, Keiserman M, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 24 week results from the randomised double-blind, phase 3 KEEPsAKE 1 trial. Ann Rheum Dis. 2022;81:225-231. doi:10.1136/annrheumdis-2021-221019
- Östör A, Van den Bosch F, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 2 trial. Ann Rheum Dis. 2022;81:351-358. doi:10.1136/annrheumdis-2021-221048
US-SKZR-220084
US-SKZR-220084
ACR Response Criteria1-4
To achieve an ACR20, 50, or 70 response, a patient must have at least a 20%, 50%, or 70%, respectively, improvement in tender and swollen joint counts and three of five scores of individual elements:
- patient pain
- physician’s global assessment
- patient’s global assessment
- physical function (HAQ-DI)
- acute phase reactant (CRP)
REFERENCES
1. SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc. 2. Mease PJ, Antoni CE, Gladman DD, Taylor WJ. Psoriatic arthritis assessment tools in clinical trials. Ann Rheum Dis. 2005;64(suppl II):ii49-ii54. 3. Data on file, AbbVie Inc. ABVRRTI71868. 4. Mease P, Strand V, Gladman D. Functional impairment measurement in psoriatic arthritis: importance and challenges. Semin Arthritis Rheum. 2018;48(3):436-448.
US-SKZR-220084
ADVERSE EVENTS OF INTEREST THROUGH 16 WEEKS1-3
Ps (WEEK 16)
ACROSS 4 PIVOTAL TRIALS
Click to see HUMIRA® (adalimumab) Indication and Important Safety Information, including
BOXED WARNING for Serious Infections and Malignancy. See Full Prescribing Information.
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. See Full Prescribing Information for US-approved ustekinumab, which reflects different rates of adverse events from those observed for EU-approved ustekinumab in the UltIMMa trials.
Safety analyses were performed using a safety analysis set (all patients who received ≥1 dose of study drug). No safety data for adalimumab or placebo were obtained beyond Week 16.
aIncludes data from UltIMMa-1, UltIMMa-2, IMMhance, and IMMvent studies.
bIncludes data from UltIMMa-1, UltIMMa-2, and Phase 2 study 1311.2.
cSKYRIZI (150 mg), adalimumab, and placebo were only evaluated in Phase 3 trials; the ustekinumab group includes Phase 3 patients (N=199) in addition to Phase 2 patients (n=40).
dIncludes data from IMMvent study.
eIncludes data from UltIMMa-1, UltIMMa-2, and IMMhance studies.
IBD=inflammatory bowel disease; MACE=major adverse cardiovascular event; NMSC=nonmelanoma skin cancer; Ps=psoriasis; TB=tuberculosis.
STELARA is a registered trademark of Johnson & Johnston. See US prescribing information for further information.
REFERENCES
- 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.
- Strober B, Blauvelt A, Menter A, et al. Risankizumab treatment is associated with low and consistent infection rates over time 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.
- Reich K, Gordon KB, Tyring S, et al. Malignancy rates in patients with moderate to severe psoriasis during treatment with risankizumab: analysis of pooled clinical trial data. Presented at: American Academy of Dermatology Annual Meeting; March 1-5, 2019; Washington, DC.
US-SKZR-220084
ADVERSE EVENTS OF INTEREST IN Ps THROUGH 52 WEEKS1-3
UltIMMa-1 & UltIMMa-2 POOLED DATA
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. See Full Prescribing Information for US-approved ustekinumab, which reflects different rates of adverse events from those observed for EU-approved ustekinumab in the UltIMMa trials.
Safety analyses were performed using a safety analysis set (all patients who received ≥1 dose of study drug). No safety data for adalimumab or placebo were obtained beyond Week 16.
aIncludes data from UltIMMa-1 and UltIMMa-2 studies.
STELARA is a registered trademark of Johnson & Johnson. See US Prescribing Information for further information.
REFERENCES
- SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc.
- Data on file, AbbVie Inc. ABVRRTI68164.
- Lebwohl M, Bachelez H, Valdecantos WC, Wu T, Gordon K. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis: an integrated analysis of UltIMMa-1 and UltIMMa-2. Poster presented at: American Academy of Dermatology Annual Meeting; March 1-5, 2019; Washington, DC.
US-SKZR-220084
STUDY DESIGN—KEEPsAKE 1 AND KEEPsAKE 21-7
*The first n-value is for KEEPsAKE 1; the second n-value is for KEEPsAKE 2.
†At Week 16, subjects classified as nonresponders (defined as not achieving at least a 20% improvement in either or both tender joint count and swollen joint count at both Week 12 and Week 16 compared to baseline) had the option to add or modify rescue concomitant medications/therapy. Starting at Week 36, subjects classified as nonresponders were discontinued from study drug.
‡To maintain the blind to the original treatment at Week 24 subjects randomized to placebo received blinded SKYRIZI 150 mg, and subjects randomized to SKYRIZI received blinded placebo.
KEEPsAKE 1: csDMARD-IR. KEEPsAKE 2: Mixed population (~50% csDMARD-IR, ~50% Bio-IR)
csDMARD-IR population: Inadequate response (lack of efficacy after minimum 12-week duration of therapy) or intolerance to previous or current treatment with at least 1 csDMARD at maximally tolerated dose; Bio-IR population: Inadequate response (lack of efficacy after minimum 12-week duration of therapy) or intolerance to treatment with 1 or 2 biologic therapies intended to treat PsA
KEEPsAKE 1 (N=964) and KEEPsAKE 2 (N=443) were 2 randomized, double-blind, placebo-controlled studies that evaluated the efficacy and safety of SKYRIZI (150 mg) vs placebo over 24 weeks with an open-label extension for up to an additional 292 weeks in adult patients with active psoriatic arthritis.
In both studies, subjects were randomized to receive SKYRIZI 150 mg or placebo at Weeks 0, 4, and 16. Starting at Week 28, all subjects received SKYRIZI every 12 weeks. 59.6% of subjects from both studies received concomitant MTX, 11.6% received concomitant nonbiologic DMARDs other than MTX, and 28.9% received SKYRIZI monotherapy.
In both studies, similar responses were seen regardless of concomitant nonbiologic DMARD use, number of prior nonbiologic DMARDs, age, gender, race, and BMI.
In KEEPsAKE 2, responses were seen regardless of prior biologic therapy.
In KEEPsAKE 1, bilateral radiographs of hands and feet were included at screening, baseline, Week 24, Week 52, Week 100, and Week 148.
Primary endpoint
- Proportion of subjects who achieved ACR20 response at Week 24
Ranked key secondary endpoints
- Change from baseline in HAQ-DI at Week 24
- Proportion of patients with PASI 90 at Week 24a
- Proportion of patients with ACR20 response at Week 16
- Proportion of patients with MDA at Week 24
- Change from baseline in mNAPSI at Week 24b
- Percentage of patients who achieved resolution of enthesitis at Week 24 (Pooled KEEPsAKE 1 and 2)c
- Percentage of patients who achieved resolution of dactylitis at Week 24 (Pooled KEEPsAKE 1 and 2)d
- Mean change from baseline in PsA-mTSS at Week 24
Non-ranked secondary endpoints
- Proportion of patients who achieved ≥50% and ≥70% improvement in ACR50/70 at Week 24
Key inclusion criteria
- ≥18 years of age
- Clinical diagnosis of PsA with symptom onset ≥6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) at the Screening Visit
- Active disease defined as ≥5 tender joints and ≥5 swollen joints
- Active plaque psoriasis with at least 1 psoriatic plaque of ≥2 cm diameter or nail changes consistent with psoriasis
- KEEPsAKE 1: History of inadequate response or intolerance to at least 1 csDMARD therapy
- KEEPsAKE 2: History of inadequate response or intolerance to 1 or 2 biologic therapies and/or csDMARD
aIn the subset of subjects with a body surface area (BSA) ≥3% at baseline.
bIn the subset of subjects with nail psoriasis at baseline.
cIn the subset of subjects with enthesitis at the LEI sites at baseline.
dIn the subset of subjects with dactylitis at the LDI sites at baseline.
ACR=American College of Rheumatology; ACR20=improvement of at least 20% in tender joint count, swollen joint count, and at least 3 other core criteria; ACR50=improvement of at least 50% in tender joint count, swollen joint count, and at least 3 other core criteria; ACR70=improvement of at least 70% in tender joint count, swollen joint count, and at least 3 other core criteria; Bio-lR=inadequate response or intolerance to a biologic; BMI=body mass index; csDMARD=conventional synthetic disease-modifying antirheumatic drugs; csDMARD-IR=intolerance or inadequate response to conventional synthetic disease-modifying antirheumatic drugs; DMARD=disease-modifying antirheumatic drug; HAQ-Dl=health assessment questionnaire disability index; LDI=Leeds Dactylitis Index; LEI=Leeds Enthesitis Index; MDA=minimal disease activity; mNAPSl=modified Nail Psoriasis Severity Index; mTSS=modified Total Sharp Score; MTX=methotrexate; OLE=open-label extension; PASI 90=≥90% improvement in Psoriasis Area and Severity Index; PsA=psoriatic arthritis.
REFERENCES
- SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc.
- Kristensen LE, Keiserman M, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 1 trial. Ann Rheum Dis. 2022;81(2):225-231. doi:10.1136/annrheumdis-2021-221019
- Östör A, Van den Bosch F, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 2 trial. Ann Rheum Dis. 2022;81(3):351-358. doi:10.1136/annrheumdis-2021-221048
- Kristensen LE, Keiserman M, Papp K, et al. Long-term efficacy and safety of risankizumab for csDMARD-IR patients with active psoriatic arthritis: 148-week results from the KEEPsAKE 1 trial. Poster presented at: American College of Rheumatology Convergence; November 10-15, 2023; San Diego, CA.
- Östör A, Van den Bosch F, Papp K, et al. Long-term efficacy and safety of risankizumab for active psoriatic arthritis: 148-week results from the KEEPsAKE 2 trial. Poster presented at: American College of Rheumatology Convergence; November 10-15, 2023; San Diego, CA.
- Kristensen LE, Keiserman M, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from KEEPsAKE 1. Poster presented at: Fall Clinical Dermatology Conference; October 21-24, 2021; Las Vegas, NV; hybrid.
- Östör A, Van den Bosch F, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from KEEPsAKE 2. Poster presented at: Fall Clinical Dermatology Conference; October 21-24, 2021; Las Vegas, NV; hybrid.
SELECTED BASELINE CHARACTERISTICS1,2
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
- Kristensen LE, Keiserman M, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 1 trial. Ann Rheum Dis. 2022;81:225-231. doi:10.1136/annrheumdis-2021-221019
- Östör A, Van den Bosch F, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 2 trial. Ann Rheum Dis. 2022;81:351-358. doi:10.1136/annrheumdis-2021-221048
US-SKZR-230150