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Please see Important Safety Information, including BOXED WARNING on Serious Infections and Malignancy.
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US-IMM-190099

The IL-23 inhibitor from AbbVie indicated for the treatment of moderate to severe plaque
psoriasis in adults who are candidates for systemic therapy or phototherapy1

For Healthcare
Professionals

Within its first year, SKYRIZI has reached >95% PREFERRED COVERAGE* FOR COMMERCIAL PATIENTS

>95% Coverage is referred coverage for commercial patients

>95%

National commercial health plan formulary status under the pharmacy benefit updated as of April 2020.2

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

VIEW NO-CHARGE PROGRAM CONSIDERATIONS
GET YOUR PATIENTS STARTED

SKYRIZI is listed as a preferred* product for nearly 70%
of national Medicare patients.2

Find SKYRIZI status by state with
the Formulary lookup tool

See which plans in your area include SKYRIZI on their preferred drug Formulary

    Formulary access for moderate to severe plaque psoriasis patients

    Coverage requirements and benefit designs vary by payer and may change over time. Please consult with payers directly for the most current reimbursement policies. The health plans and/or pharmacy benefit managers listed here have not endorsed and are not affiliated with this material.

    SKYRIZI® is the #1 prescribed biologic in new and switching plaque psoriasis patients

    As of 9/2019. New patients defined as bio-naïve; switch patients
    defined as bio-experienced switching biologics. Source: Integrated
    Symphony Health (PatientSource) and IQVIA (NPA, NSP) through
    proprietary method on diagnosis classification.

    Encourage your patients to enroll in

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    One-to-one support

    Nurse Ambassadors†

    Savings Card Icon

    Affordability:

    Commercially insured patients may pay as little as $5 per quarterly dose‡

    Speech Bubble Icon

    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.

    †Ambassadors do not provide medical advice and are trained to direct patients to speak with their healthcare professional about any treatment-related questions, 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

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    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 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.

    Pre-Treatment Evaluation for 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.

    Immunizations

    Prior to initiating SKYRIZI, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with SKYRIZI.

    Adverse Reactions

    Most common (≥1 %) adverse reactions associated with SKYRIZI include upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.

    Please see Full Prescribing Information.

    US-SKZD-190350

    REFERENCES

    1. SKYRlZI [package insert]. North Chicago, IL: AbbVie Inc.
    2. Data on file, AbbVie Inc. MMIT-reported lives. 2020.
    3. Data on file, AbbVie Inc. In-play patient share. 2020.

    INDICATIONS2

    Psoriatic Arthritis: HUMIRA is indicated, alone or in combination with non-biologic DMARDs, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis.

     

    Plaque Psoriasis: HUMIRA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

    IMPORTANT SAFETY INFORMATION2

    SERIOUS INFECTIONS

    Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

     

    Discontinue HUMIRA if a patient develops a serious infection or sepsis.

    Reported infections include:

    • Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before HUMIRA use and during therapy. Initiate treatment for latent TB prior to HUMIRA use.
    • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.
    • Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

    Carefully consider the risks and benefits of treatment with HUMIRA prior to initiating therapy in patients: 1. with chronic or recurrent infection, 2. who have been exposed to TB, 3. with a history of opportunistic infection, 4. who resided in or traveled in regions where mycoses are endemic, 5. with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HUMIRA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

    • Do not start HUMIRA during an active infection, including localized infections.
    • Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection.
    • If an infection develops, monitor carefully and initiate appropriate therapy.
    • Drug interactions with biologic products: A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. An increased risk of serious infections has been seen with the combination of TNF blockers with anakinra or abatacept, with no demonstrated added benefit in patients with RA. Concomitant administration of HUMIRA with other biologic DMARDs (e.g., anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions.

    MALIGNANCY

    Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including HUMIRA. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including HUMIRA. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.

    • Consider the risks and benefits of HUMIRA treatment prior to initiating or continuing therapy in a patient with known malignancy.
    • In clinical trials, more cases of malignancies were observed among HUMIRA-treated patients compared to control patients.
    • Non-melanoma skin cancer (NMSC) was reported during clinical trials for HUMIRA-treated patients. Examine all patients, particularly those with a history of prolonged immunosuppressant or PUVA therapy, for the presence of NMSC prior to and during treatment with HUMIRA.
    • In HUMIRA clinical trials, there was an approximate 3-fold higher rate of lymphoma than expected in the general U.S. population. Patients with chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk of lymphoma than the general population, even in the absence of TNF blockers.
    • Postmarketing cases of acute and chronic leukemia were reported with TNF blocker use. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving TNF blockers were lymphomas; other cases included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents.

    HYPERSENSITIVITY

    • Anaphylaxis and angioneurotic edema have been reported following HUMIRA administration. If a serious allergic reaction occurs, stop HUMIRA and institute appropriate therapy.

    HEPATITIS B VIRUS REACTIVATION

    • Use of TNF blockers, including HUMIRA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal.
    • Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy.
    • Exercise caution in patients who are carriers of HBV and monitor them during and after HUMIRA treatment.
    • Discontinue HUMIRA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming HUMIRA after HBV treatment.

    NEUROLOGIC REACTIONS

    • TNF blockers, including HUMIRA, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, optic neuritis, and Guillain-Barré syndrome.
    • Exercise caution when considering HUMIRA for patients with these disorders; discontinuation of HUMIRA should be considered if any of these disorders develop.
    • There is a known association between intermediate uveitis and central demyelinating disorders.

    HEMATOLOGIC REACTIONS

    • Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with HUMIRA.
    • Consider stopping HUMIRA if significant hematologic abnormalities occur.

    CONGESTIVE HEART FAILURE

    • Worsening and new onset congestive heart failure (CHF) has been reported with TNF blockers. Cases of worsening CHF have been observed with HUMIRA; exercise caution and monitor carefully.

    AUTOIMMUNITY

    • Treatment with HUMIRA may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.

    IMMUNIZATIONS

    • Patients on HUMIRA should not receive live vaccines.
    • Pediatric patients, if possible, should be brought up to date with all immunizations before initiating HUMIRA therapy.
    • Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. The safety of administering live or live-attenuated vaccines in infants exposed to HUMIRA in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants.

    ADVERSE REACTIONS

    • The most common adverse reactions in HUMIRA clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.

    Please see Full Prescribing Information.

    US-HUM-181930

     

     

    US-SKZD-190271

    Transcript
    SKYRIZI (risankizumab-rzaa) Injection Training Video

    Hi, it’s good to be here with you. I’m Kate. And you are one of the many people who have been prescribed SKYRIZI. After starting on SKYRIZI, there were two directions you could go: continue with in-office injections or inject at home.

     

    You had a discussion with your doctor, and have decided to inject at home.

     

    I’m going to show you how to do that...step by step, and address any questions you may have.

     

    Still, there are probably a million things you’d rather be doing right now than learning about injecting your medicine. I get it. But this video will be helpful. So, stay with it. Because, well, there’s more to making SKYRIZI a part of your life than just learning how to inject.

     

    When you sign up for Skyrizi Complete, you get a dedicated Nurse Ambassador.

     

    They will get to know you and help you start and stay on track with your treatment plan.

     

    So, let’s get started.

     

    Leave SKYRIZI at room temperature for 15 to 30 minutes before injecting.

     

    If you’re a little nervous, I totally get it. It may help you relax if you watch or listen to something that is soothing.

     

    First, wash your hands. Then get the things you need, and settle into a place where you feel relaxed.

     

    Now I’ll take you through the process step by step.

     

    Make sure you have everything you need laid out:

     

    2 alcohol swabs that are included in the package,

     

    2 cotton balls, you can also use gauze pads,

     

    your sharps container, which ensures your syringes are disposed of safely,

     

    and of course, your 2 SKYRIZI prefilled syringes.

     

    For one full dose, two injections are required.

     

    We’re going to break the injection process down into 4 simple steps.

     

    Let’s call them the 4 Ps.

     

    Pick the injection site.

     

    Prepare the syringe.

     

    Pinch the skin.

     

    And Push the plunger in.

     

    There’s an “R” too for “Repeat.” Remember, one dose is two injections.

     

    So, you will need to repeat the same injection steps for the second injection.

     

    Pick the injection site—your left or right thigh or your stomach.

     

    When you are using your second syringe, pick an injection site at least one inch away from the first site. Do not inject into the same site.

     

    If you choose your lower stomach area, make sure you inject at least 2 inches away from your belly button.

     

    Wipe the injection site in a circular motion with the alcohol swab (before both injections). Don’t inject through clothes, or into skin that doesn’t look normal.

     

    Start with one syringe for the first injection. Now prepare the syringe.

     

    Holding the syringe with the needle pointing down, check the liquid in the syringe.

     

    It is normal to see one or more bubbles in the window.

     

    The liquid should look clear to slightly yellow and may contain tiny white or clear particles.

     

    DO NOT use if the liquid is cloudy or contains flakes or large particles.

     

    To remove the needle cover, hold the syringe in one hand.

     

    With the other hand, gently pull the needle cover straight off and throw it away.

     

    You may see a drop of liquid at the end of the needle. This is normal.

     

    DO NOT touch the needle with your fingers or let the needle touch anything.

     

    For this demonstration, I’ll be using a practice pad.

     

    Hold the body of the prefilled syringe in one hand between the thumb and index finger.

     

    Gently pinch the area of cleaned skin with your other hand and hold it firmly.

     

    Insert the needle into the skin at about a 45 degree angle using a quick, short movement. Hold the angle steady.

     

    Slowly push the plunger all the way in until all of the liquid is injected and the syringe is empty.

     

    Pull the needle out of the skin while keeping the syringe at the same angle. Release the plunger and allow the syringe to move up until the entire needle is covered by the needle guard.

     

    The syringe needle guard will not activate unless all the liquid has been injected.

     

    Press a cotton ball or gauze pad over the injection site and hold for 10 seconds.

     

    DO NOT rub the injection site. You may have slight bleeding. This is normal.

     

    Now that the syringe is empty, drop it into the sharps container.

     

    Repeat these injection steps for the second syringe immediately following your first injection. Do not inject into the same site.

     

    Be sure to pick a new site at least one inch away from your first injection.

     

    In a nutshell here’s what you did.

     

    You picked the injection site, prepared the syringe, pinched the skin, and pushed the plunger in. Then you did it again, using the second syringe.

     

    Okay, so now you know how to inject.

     

    After your starter doses at week 0 and week 4, SKYRIZI is dosed quarterly. That’s just 4 times a year or one dose for each season.

     

    It’s important you don’t forget.

     

    So, make sure you place reminders for ordering your medication and note your injection day on your calendar. You can also do this through the Skyrizi Complete App.

     

    The Skyrizi Complete Sharps Disposal and Mail-back Service ensures your syringes are disposed of safely and in a socially responsible way.

     

    There’s a bit to remember.

     

    But you’ll get the hang of it. And you can always refer to this video or call us.

     

    You’ve got this.

     

    US-SKZD-200213

     

    STUDY DESIGN STUDY DESIGN
    BASELINE CHARACTERISTICS BASELINE CHARACTERISTICS

    STUDY DESIGN—IMMvent9

    SKYRIZI Study Design for IMMvent SKYRIZI Study Design for IMMvent SKYRIZI Study Design for IMMvent

    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 one 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 HUMIRA 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

    Q2W=Once every 2 weeks

    Click to see HUMIRA® (adalimumab) Indication and Important Safety Information, including BOXED WARNING for Serious Infections and Malignancy

     

    US-SKZD-200213

    SELECTED BASELINE CHARACTERISTICS9,14

    SKYRIZI Selected Baseline Characteristics for IMMvent SKYRIZI Selected Baseline Characteristics for IMMvent SKYRIZI Selected Baseline Characteristics for IMMvent

     

    US-SKZD-200213

    STUDY DESIGN STUDY DESIGN
    BASELINE CHARACTERISTICS BASELINE CHARACTERISTICS

    STUDY DESIGN—IMMhance1,10,15

    SKYRIZI Study Design for IMMhance SKYRIZI Study Design for IMMhance SKYRIZI Study Design for IMMhance

    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.

    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 and phototherapy

    Key secondary endpoints included

    • PASI 75 at Week 16
    • PASI 100 at Week 16
    • sPGA 0 at Week 16
    • DQLI 0/1 at Week 16

    DLQI=Dermatology Quality of Life 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
    sPGA=static Physician's Global Assessment

    Q12W=Once every 12 weeks

    SELECTED BASELINE CHARACTERISTICS10,16

    SKYRIZI Selected Baseline Characteristics for IMMhance SKYRIZI Selected Baseline Characteristics for IMMhance SKYRIZI Selected Baseline Characteristics for IMMhance

     

    US-SKZD-200213

    YOU ARE LEAVING SKYRIZIHCP.COM

    You are leaving the SKYRIZIHCP.com website and connecting to a site that is not under the control of AbbVie. AbbVie is not responsible for the contents of any such site or any further links from such site. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply the endorsement of the linked site by AbbVie. You should also be aware that the linked site may be governed by its own set of terms and conditions and privacy policy for which AbbVie has no responsibility.

     

    Conversely, the presence of this link does not imply the linked site's endorsement of SKYRIZIHCP.com or AbbVie.

     

    US-SKZD-200213

    YOU ARE LEAVING SKYRIZIHCP.COM

    You are about to enter a site that is for U.S. Healthcare Professionals Only.

     

    By selecting "Continue" below, you certify that you are a Healthcare Professional and that you wish to proceed to the Healthcare Professionals Only section on the AbbVie Medical Information site. Products or treatments described on this site are available in the U.S. but may not be available in all other countries. I am a licensed Healthcare Professional and wish to proceed to the Healthcare Professionals Only AbbVie Medical Information Site.

     

    US-SKZD-200213

    You are about to enter a site that is for U.S. Healthcare Professionals Only.

    By selecting "Yes" below, you certify that you are a Healthcare Professional and that you wish to proceed to the Healthcare Professionals Only section on the AbbVie Medical Information site. Products or treatments described on this site are available in the U.S. but may not be available in all other countries. I am a licensed Healthcare Professional and wish to proceed to the Healthcare Professionals Only AbbVie Medical Information Site.

     

    Yes
    No



    YOU ARE LEAVING SKYRIZIHCP.COM

    You are leaving the SKYRIZIHCP.com website and connecting to a site that is not under the control of AbbVie. AbbVie is not responsible for the contents of any such site or any further links from such site. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply the endorsement of the linked site by AbbVie. You should also be aware that the linked site may be governed by its own set of terms and conditions and privacy policy for which AbbVie has no responsibility.

     

    Conversely, the presence of this link does not imply the linked site's endorsement of SKYRIZIHCP.com or AbbVie.

     

    US-SKZD-200213

    YOU ARE LEAVING SKYRIZIHCP.COM

    You are leaving the SKYRIZIHCP.com website and connecting to a site that is not under the control of AbbVie. AbbVie is not responsible for the contents of any such site or any further links from such site. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply the endorsement of the linked site by AbbVie. You should also be aware that the linked site may be governed by its own set of terms and conditions and privacy policy for which AbbVie has no responsibility.

     

    Conversely, the presence of this link does not imply the linked site's endorsement of SKYRIZIHCP.com or AbbVie.

     

    US-SKZD-200213

    Select the product you would like to learn more about.

     

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    US-IMM-190077

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    RINVOQ™ for HCPs
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    US-IMM-190077

    Select the product you would like to learn more about.

     

    RINVOQ™ for HCPs
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    HUMIRA® for HCPs
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    US-IMM-190077

    Select the product you would like to learn more about.

     

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    US-IMM-190077

    As with all no-charge programs, considerations include:

    • FIXED

    program duration§

    • ONGOING PAs AND APPEALS

    to maintain eligibility

    • Program-mandated

    distribution processes

    §Program duration may be limited by manufacturer terms and conditions.

     

    US-SKZD-200213

    STUDY DESIGN STUDY DESIGN
    BASELINE CHARACTERISTICS BASELINE CHARACTERISTICS

    STUDY DESIGN – UltIMMa-1 and UltIMMa-21,21,21,8

    SKYRIZI® Study Design for UltIMMa-1 and UltIMMa-2 SKYRIZI® Study Design for UltIMMa-1 and UltIMMa-2 SKYRIZI® Study Design for UltIMMa-1 and UltIMMa-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

     

    US-SKZD-200213

    SELECTED BASELINE CHARACTERISTICS228

    SKYRIZI® Selected Baseline Characteristics for UltIMMA-1 and UltIMMA-2 SKYRIZI® Selected Baseline Characteristics for UltIMMA-1 and UltIMMA-2 SKYRIZI® Selected Baseline Characteristics for UltIMMA-1 and UltIMMA-2

     

    US-SKZD-200213

    Transcript

    High Levels of Durable Skin Clearance

    Uncovering Clearance

    Watch Jeff Crowley, MD and Jennifer Soung, MD walk through the PASI 90 and PASI 100 data through 1 year of treatment with SKYRIZI.

    Full Transcript

    Please see Safety Considerations at the end of this video and review the full Prescribing Information available at SKYRIZIHCP.com.

    Dr. Soung: Biologics have helped many patients with moderate to severe plaque psoriasis by offering additional treatment options for clearing skin.
    Dr. Crowley: Today, Dr. Soung and I are going to share with you the key features of SKYRIZI and how it's helped patients like ours.

    In 2 pivotal trials, UltIMMa-1 and UltIMMa-2, SKYRIZI was proven to deliver high levels of clearance in patients with moderate to severe plaque psoriasis, with 4 doses a year after 2 initial doses.

    The co-primary endpoints in the trials were PASI 90 and sPGA O or 1 at Week 16 for SKYRIZI versus placebo. SKYRIZI met both co-primary endpoints in each trial. In addition to placebo, SKYRIZI was evaluated against a biologic active comparator, ustekinumab, which was sourced from the European Union. Comparability between non–US-approved ustekinumab and US-approved ustekinumab has not been established.

    Dr. Soung: Let's take a look at SKYRIZl's 52-week data.

    Here we see in this chart SKYRIZl's PASI 90 efficacy over 52 weeks from the pooled UltlMMa-1 and -2 trials. I want to bring your attention to the dosing schedule you see on the x-axis as indicated by an arrow.

    After 2 doses of SKYRIZI, 75% of patients achieved PASI 90 at Week 16, compared to 4% for placebo. The dosing schedule is every 12 weeks for maintenance. At 1 year after 5 doses, the proportion of patients achieving PASI 90 increases to 81%.

    In addition, SKYRIZI also maintained response over time. 88% of patients who saw PASI 90 results at Week 16 maintained PASI 90 at Week 52.

    Many of my patients tell me that completely clear skin matters. Let's take a look at the PASI 100 responses from the pooled UltlMMa-1 and -2 trials.

    43% of SKYRIZl-treated patients achieved PASI 100 at Week 16 after just 2 doses, compared to 1% with placebo. In 1 year, after just 5 doses, 58% of SKYRIZl-treated patients achieved PASI 100.

    Dr. Crowley: Safety is another important consideration for patients and providers alike. SKYRIZI has a well-studied safety profile across 4 pivotal trials, with a total of 1,306 patients receiving SKYRIZI. Here we see the rates of adverse events through Week 16. In the trials, the SKYRIZI safety profile was similar to that of EU-sourced ustekinumab.

    Rates of adverse events with SKYRIZI through 52 weeks were similar to the safety profile observed during the first 16 weeks.

    With SKYRIZI, warnings and precautions include risk of infections, tuberculosis, and avoiding the use of live vaccines. There are no labeled warnings or precautions on malignancy, inflammatory bowel disease, or depression.

    In summary, SKYRIZI offers patients with moderate to severe plaque psoriasis the opportunity for high levels of durable skin clearance with a well-studied safety profile, making it an excellent treatment option.

    Dr. Soung: The fact that the majority of patients during the trials were completely clear at 1 year is exciting for our patients.

    Indication

    SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

    Safety Considerations

    SKYRIZI may increase the risk of infection. Instruct patients to report signs or symptoms of clinically important infection during treatment. Should such an infection occur, discontinue SKYRIZI until infection resolves. Evaluate patients for tuberculosis infection prior to initiating treatment with SKYRIZI. Avoid use of live vaccines in SKYRIZI patients.

    Please see additional Important Safety Information at the bottom of this page. Please see full Prescribing Information by clicking the link at the top of this page.

     

     

    US-SKZD-190187

    Transcript

     

     

    US-SKZD-200190

    Transcript

    Expectation Setting and Mean PASI Data

    Clear Conversations

    Hear from Cynthia Trickett, PA-C, MPAS and Jason M. Cheyney, PA-C, MPAS as they cover how they discuss SKYRIZI skin clearance and safety data with patients.

    Full Transcript

    Please see Safety Considerations at the end of this video and review the full Prescribing Information available at SKYRIZIHCP.com.

    Cynthia: When my patients start a biologic, having clear conversations on efficacy and safety are essential. Two common questions I get from patients are "How fast will this treatment work?" and "What are the risks?"

    In 2 pivotal trials, UltlMMa-1 and UltlMMa-2, SKYRIZI demonstrated high levels of skin clearance in patients with moderate to severe plaque psoriasis.

    The co-primary endpoints in the trials were PASI 90 and sPGA O or 1 at Week 16 for SKYRIZI versus placebo. In both trials, the co-primary endpoints were met.

    SKYRIZI patients also saw rapid responses. with results seen as early as Week 4.

    Jason: It can be difficult at times for patients to understand PASI 90 data. Another way to help explain clinical trial results to patients is mean PASI.

    Mean PASI improvement is the average improvement in skin clearance from baseline—it's what the average patient experienced in the clinical trials, measured at set time periods. 

    When discussing efficacy with my patients starting SKYRIZI, I incorporate mean PASI, which was a pre-specified non-ranked endpoint in the clinical trials.

    I let my patients know that in the clinical trials, the average skin clearance on SKYRIZI was 58% from baseline at 4 weeks after just 1 dose. 91% clearance at 16 weeks after 2 doses, and 95% at 1 year after the 5th dose. In comparison, the PASI 90 response at Week 4 was 6%.

    Individual results may vary for patients. 88% of PAS/ 90 responders at Week 16 maintained their response at Week 52.

    Here, you can see rapid skin clearance on an actual patient from the UltlMMa-2 trial. As early as Week 4, this patient saw a 63% improvement in their skin after just 1 dose of SKYRIZI. At Week 16, the patient had 88% clearer skin, and at 1 year, the patient had 94% clearer skin from baseline.

    Cynthia: In addition, SKYRIZI is dosed 4 times a year after 2 initiation doses—with 2 injections per dose. Patients have the flexibility to receive injections in-office or to self-inject after proper training.

    Communicating the risks and benefits of a biologic like SKYRIZI is important. SKYRIZI has a well-studied safety profile across 4 pivotal trials, with a total of 1306 patients receiving SKYRIZI. The adverse events through Week 16 included upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.

    With all biologics, I discuss important safety considerations. With SKYRIZI, I let patients know that warnings and precautions include risk of infections, tuberculosis, and avoiding the use of live vaccines.

    There are no labeled warnings or precautions around malignancy, IBD, or depression. Also, there is no routine monitoring after an initial TB test.

    Jason: In summary, I can communicate to my patients that SKYRIZI is proven to deliver high levels of skin clearance, including results as early as 4 weeks.

    Cynthia: In addition, SKYRIZl's dosing schedule and well-studied safety profile are important pieces of my clear conversations with patients.

    Indication

    SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

    Safety Considerations

    SKYRIZI may increase the risk of infection. Instruct patients to report signs or symptoms of clinically important infection during treatment. Should such an infection occur, discontinue SKYRIZI until infection resolves. Evaluate patients for tuberculosis infection prior to initiating treatment with SKYRIZI. Avoid use of live vaccines in SKYRIZI patients.

    Please see additional Important Safety Information at the bottom of this page. Please see full Prescribing Information by clicking the link at the top of this page.

     

     

    US-SKZD-190188

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    US-SKZD-200213

    IMPORTANT SAFETY INFORMATION AND INDICATION FOR SKYRIZI® (risankizumab-rzaa)1
    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. 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.
    IMPORTANT SAFETY INFORMATION AND INDICATION FOR SKYRIZI® (risankizumab-rzaa)1
    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
    IMPORTANT SAFETY INFORMATION AND INDICATION FOR SKYRIZI® (risankizumab-rzaa)1
    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. 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.
    IMPORTANT SAFETY INFORMATION AND INDICATION FOR SKYRIZI® (risankizumab-rzaa)1
    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
    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 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.

    Pre-Treatment Evaluation for 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.

    Immunizations

    Prior to initiating SKYRIZI, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with SKYRIZI.

    Adverse Reactions

    Most common (≥1 %) adverse reactions associated with SKYRIZI include upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.

    Please see Full Prescribing Information.

    US-SKZD-190350