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SEE THE POSSIBILITIES WITH SKYRIZI
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
PASI 90=≥90% improvement in Psoriasis Area and Severity Index; PASI 100=100% improvement in Psoriasis Area and Severity Index; sPGA 0/1=static Physician’s Global Assessment rating of clear or almost clear.
THE ONLY 4-DOSE-A-YEAR BIOLOGIC FOR PSORIASIS AND FOR PSORIATIC ARTHRITIS THAT OFFERS A SINGLE-DOSE PEN1
†Preferred means the product is placed on the plan’s preferred formulary tier. Preferred products may also require a step edit depending on the product’s label. Non-preferred products require a higher out-of-pocket cost or step edit or are placed on a higher tier.
Indication and Important Safety Information, including BOXED WARNING for Serious Infections and Malignancy.
‡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.8
§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.
At week 161,3: 75% of Skyrizi patients (n=220/294) achieved pasi 90 in the UltIMMa-2 study vs 2% of placebo patients (n=2/98);
84% of SKYRIZI patients achieved sPGA 0/1 vs 5% of placebo patients
UltlMMa-1 results at Week 16
PASI 90: SKYRIZI 75% (n=304), placebo 5% (n=102)
sPGA 0/1: SKYRIZI 88% (n=304), placebo 8% (n=102)
Co-primary endpoints for UltIMMa-1 and -2 were PASI 90 and sPGA 0/1 response vs placebo at Week 16.
P<0.0001 for comparisons of SKYRIZI vs placebo
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.1,3
At week 521,3: 81% of Skyrizi patients (n=237/294) achieved pasi 90 in the UltIMMa-2 study; placebo did not continue beyond Week 16
UltlMMa-1 results at Week 52
PASI 90: SKYRIZI 82% (n=249/304), placebo n/a
Co-primary endpoints for UltIMMa-1 and -2 were PASI 90 and sPGA 0/1 response vs placebo at Week 16.
P<0.0001 for comparisons of SKYRIZI vs placebo
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.1,3
4 doses
per year1
3-month dosing after 2 initiation
doses at Weeks 0 and 4 (150 mg/dose)1
Eligible patients may be able to access their SKYRIZI at no charge until their insurance plan covers SKYRIZI
National commercial health plan formulary status under the pharmacy benefit updated as of January 2022.5
||Preferred means the product is placed on the plan’s preferred formulary tier. Preferred products may also require a step edit depending on the product’s label. Non-preferred products require a higher out-of-pocket cost or step edit or are placed on a higher tier. Based on formulary status under the pharmacy benefit.
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.
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 alternative 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, injection site reactions, abdominal pain, 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, a 600 mg/10 mL intravenous infusion, and a 360 mg/2.4 mL single-dose prefilled cartridge with on-body injector.
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-220306
REFERENCES