US-MULT-221082
The IL-23 inhibitor from AbbVie indicated for the treatment of
moderate to severe plaque psoriasis (Ps) in adults who are candidates for systemic
therapy or phototherapy and for adults with active psoriatic arthritis (PsA).1
IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)1
Indications
Plaque Psoriasis: SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Psoriatic Arthritis: SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults.
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.
INDICATIONS
Plaque Psoriasis: SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Psoriatic Arthritis: SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults.
Crohn's Disease: SKYRIZI is indicated for the treatment of moderately to severely active Crohn's disease in adults.
Please see Full Prescribing Information.
US-SKZG-220547
REFERENCE
- SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc.
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
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 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
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-SKZD-220457
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 28, 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
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: a phase 3 randomized clinical trial. JAMA Dermatol. 2020;156(6):649-658.
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.
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: a phase 3 randomized clinical trial. JAMA Dermatol. 2020;156(6):649-658.
- Data on file, AbbVie Inc. ABVRRTI68151.
US-SKZD-220457
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
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
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-SKZD-220457