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 has reached
>95% PREFERRED COVERAGE* FOR COMMERCIAL PATIENTS2
National commercial health plan formulary status under the pharmacy benefit updated as of January 2021.2
If you have determined that SKYRIZI
is the appropriate treatment, preferred coverage* could mean:
EXCEPTIONAL access*
for commercial patients
Standard PRIOR AUTHORIZATION (PA) and appeal processes
potential for one-time PA/appeal approval
SKYRIZI is listed as a preferred* product for >70%
of national Medicare patients as of January 1, 2021.2
One-to-one support
Nurse Ambassadors†
Affordability
Commercially insured patients may pay as little as $5 per quarterly dose‡
Access
Insurance specialists are there to help your patients navigate their coverage
*Formulary Definitions: Preferred/Step 1 means the product is placed on the plan’s preferred formulary. Non-preferred products require higher out-of-pocket cost or step edit, or are placed on a higher tier. First-line refers to a preferred or parity formulary status. Coverage means placed on formulary without a step edit through other biologics. For SKYRIZI, this could include coverage on a non-preferred tier, which may result in higher out-of-pocket cost. Based on formulary status under the pharmacy benefit.
†Nurse Ambassadors are provided by AbbVie and do not work under the direction of your health care professional (HCP) or give medical advice. They are trained to direct patients to their HCP for treatment-related advice, including further referrals.
‡Terms and Conditions apply. This benefit covers SKYRIZI® (risankizumab-rzaa). Eligibility: Available to patients with commercial prescription insurance coverage for SKYRIZI who meet eligibility criteria. Co-pay assistance program is not available to patients receiving prescription reimbursement under any federal, state, or government-funded insurance programs (for example, Medicare [including Part D], Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense, or Veterans Affairs programs) or where prohibited by law or by the patient’s health insurance provider. If at any time a patient begins receiving prescription drug coverage under any such federal, state, or government-funded healthcare program, patient will no longer be able to use the Skyrizi Complete Savings Card and patient must call Skyrizi Complete at 1.866.SKYRIZI to stop participation. Patients residing in or receiving treatment in certain states may not be eligible. Patients may not seek reimbursement for value received from the Skyrizi Complete program from any third-party payers. Offer subject to change or discontinuance without notice. Restrictions, including monthly maximums, may apply. Patients who are members of insurance plans that claim to reduce or eliminate their patients' out of pocket co-pay, co-insurance, or deductible obligations for certain prescription drugs based upon the availability of, or patient's enrollment in, manufacturer sponsored co-pay assistance for such drugs (often termed "maximizer" programs) will have an annual maximum program benefit of $6,000.00 per calendar year. This assistance offer is not health insurance. To learn about AbbVie’s privacy practices and your privacy choices, visit www.abbvie.com/privacy.html
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
- SKYRlZI [package insert]. North Chicago, IL: AbbVie Inc.
- Data on file, AbbVie Inc. MMIT-reported lives. January 2021.
- Data on file, AbbVie Inc. In-play patient share. November 2020.
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