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
Evaluated in 24 clinical trials (4 PsA, 20 Ps)2*
Up to ~8 years of safety data in Ps, ~3 years in PsA2
The safety profile in PsA is generally consistent with the safety profile of patients with Ps (PsA Week 24, Ps Week 16)1
Robust Joint Efficacy: SKYRIZI met its primary endpoint (ACR20 at Week 24) in 2 clinical trials.1 ACR50/70, complete resolution of enthesitis/dactylitis, and minimal disease activity were achieved at Week 24. Response rates observed up to ~2 years in PsA1,3,4,6
Durable Skin Clearance: PASI 90 response was achieved at Week 24. Response rates observed up to ~2 years3,4,6
EXCEPTIONAL ACCESS & SUPPORT
>95% preferred† commercial and Medicare Part D first-line TIM coverage with no requirements of a prior biologic.5‡
National Commercial and Medicare Part D Formulary coverage under the pharmacy benefit as of April 2023.5
Skyrizi Complete provides exceptional 1:1 patient support
*Includes 4 PsA Phase 2-3 studies (including KEEPsAKE 1 and KEEPsAKE 2). Includes 20 Phase 1-4 studies in Ps encompassing 5 trials using integrated data evaluated at Week 16 (including UltlMMa-1, UltlMMa-2, IMMhance, and IMMvent), and 15 additional trials including LIMMitless.2
†SKYRIZI is on a preferred tier or otherwise has preferred status on the plan’s formulary.
‡Coverage requirements and benefit designs vary by payer and may change over time. Please consult with payers directly for the most current reimbursement policies.
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; PASI 90=≥90% improvement in Psoriasis Area and Severity Index; TIM=targeted immunomodulator.
KEEPsAKE 1:
ACR20
Week 24 (primary endpoint)§:
VS
KEEPsAKE 2:
ACR20
Week 24 (primary endpoint)§:
VS
ACR50
Week 24 (non-ranked secondary endpoint)||:
VS
ACR50
Week 24 (non-ranked secondary endpoint)||:
VS
STUDY DESIGN:
KEEPsAKE 1 was a 24-week, randomized, double-blind, placebo-controlled study of 964 csDMARD-IR adult patients with active PsA.1,7
KEEPsAKE 2 was a 24-week, randomized, double-blind, placebo-controlled study of 443 mixed-population (~50% csDMARD-IR, ~50% bio-IR) adult patients with active PsA.1,8
NRI-C=non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.
National Commercial and Medicare Part D Formulary coverage under the pharmacy benefit as of April 2023.5
†SKYRIZI is on a preferred tier or otherwise has preferred status on the plan's formulary.
‡Coverage requirements and benefit designs vary by payer and may change over time. Please consult with payers directly for the most current reimbursement policies.
NO CHARGE FOR ELIGIBLE, COMMERCIALLY INSURED PATIENTS EXPERIENCING INITIAL INSURANCE DENIAL FOR UP TO 24 MONTHS¶
Download or email Skyrizi Complete Enrollment and Prescription Form
¶Eligibility criteria: Available to patients aged 63 or younger with commercial insurance coverage. Patients must have a valid prescription for SKYRIZI® (risankizumab-rzaa) for an FDA approved indication and a denial of insurance coverage based on a prior authorization request on file along with a confirmation of appeal. Continued eligibility for the program requires the submission of an appeal of the coverage denial every 180 days. Program provides for SKYRIZI at no charge to patients for up to two years or until they receive insurance coverage approval, whichever occurs earlier, and is not contingent on purchase requirements of any kind. Program is not available to patients whose medications are reimbursed in whole or in part by Medicare, Medicaid, TRICARE, or any other federal or state program. Offer subject to change or discontinuance without notice. This is not health insurance and program does not guarantee insurance coverage. No claims for payment may be submitted to any third party for product dispensed by program. Limitations may apply.
#1 PRESCRIPTION ANALYSIS CALCULATED BY COMBINED PRESCRIPTION DATA ACROSS Ps AND PsA
For patients with psoriatic disease, defined as those with plaque psoriasis or psoriatic arthritis. Source of data: Integrated Symphony Health (PatientSource) as of 8/2022.9
4 DOSES PER YEAR1
4-dose-per-year biologic** for PsA & for Ps that offers a single-dose pen
**After Week 0 and Week 4 injections.
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