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US-MULT-230356
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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

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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.

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.

In psoriatic arthritis phase 3 trials, the incidence of hepatic events was higher with SKYRIZI compared to placebo.

 

SKYRIZI is available in a 150 mg/mL prefilled syringe and pen.

Please see Full Prescribing Information.

US-SKZD-210594

REFERENCE

  1. SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc.
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If you have any questions about AbbVie's SKYRIZIHCP.com website that have not been answered, click here. This website and the information contained herein is intended for use by US physicians only and is provided for informational purposes only.

US-SKZD-230396

Important Update to the Prescribing Information
for SKYRIZI® (risankizumab-rzaa) injection, for subcutaneous use1

On January 21, 2022, the Prescribing Information and Medication Guide for SKYRIZI (risankizumab-rzaa) was updated to add a Contraindication and a new Warning and Precaution for Serious Hypersensitivity Reactions.

The relevant sections of the Prescribing Information read as follows:

4 CONTRAINDICATIONS
SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to
risankizumab-rzaa or any of the excipients.

5 WARNINGS AND PRECAUTIONS
Section 5.1 Hypersensitivity Reactions
Serious hypersensitivity reactions, including anaphylaxis, have been reported with use of SKYRIZI. If a serious hypersensitivity reaction occurs, discontinue SKYRIZI and initiate appropriate therapy immediately.

17 PATIENT COUNSELING INFORMATION
Hypersensitivity Reactions
Advise patients to discontinue SKYRIZI and seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions.

The following information on important labeling revisions does not include all changes; please refer to the SKYRIZI Full Prescribing Information.

INDICATIONS AND IMPORTANT SAFETY INFORMATION 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.

Crohn's Disease: SKYRIZI is indicated for the treatment of moderately to severely active Crohn's disease 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

US-SKZD-210908

Transcript

SKYRIZI (risankizumab-rzaa)
Injection Training Video

 

Full Transcript

Hi, it’s good to be here with you. I’m Kate. And you are 1 of the many people who have been prescribed SKYRIZI. After starting on SKYRIZI, there were 2 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 1 full dose, 2 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, 1 dose is 2 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 1 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 1 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 1 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 1 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 1 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 1 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 1 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-210080

STUDY DESIGN STUDY DESIGN
BASELINE CHARACTERISTICS BASELINE CHARACTERISTICS

STUDY DESIGN – IMMvent9

Study design - IMMvent. Study design - IMMvent. Study design - 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 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

  1. 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

SELECTED BASELINE CHARACTERISTICS - IMMvent. SELECTED BASELINE CHARACTERISTICS - IMMvent. SELECTED BASELINE CHARACTERISTICS - IMMvent.

ADA=adalimumab

BSA=Body Surface Area

PASI=Psoriasis Area and Severity Index

PsA=Psoriatic Arthritis

RZB=risankizumab-rzaa

TNFi=Tumor Necrosis Factor Inhibitor

References

  1. 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.
  2. 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-220459

STUDY DESIGN STUDY DESIGN
BASELINE CHARACTERISTICS BASELINE CHARACTERISTICS

STUDY DESIGN—IMMhance1,10

Study design - IMMhance. Study design - IMMhance. Study design - 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 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

  1. SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc.
  2. 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

SELECTED BASELINE CHARACTERISTICS - IMMhance. SELECTED BASELINE CHARACTERISTICS - IMMhance. SELECTED BASELINE CHARACTERISTICS - IMMhance.

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

  1. 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.
  2. Data on file, AbbVie Inc. ABVRRTI68151.

 

US-SKZD-220459

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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.

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NO

 

US-SKZD-220457

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.

YES
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US-SKZ-220057

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.

YES
NO

 

US-SKZD-220459

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.

YES
NO

 

US-SKZD-220459

Bridge Program Update:

If your eligible, commercially insured patient receives an insurance denial due to step therapy requirements and you wish to appeal based on medical necessity:

  1. Make sure your patient has enrolled in the Skyrizi Complete program.
  2. Submit an appeal request within requirements and appropriate timeline.
Skyrizi Complete program

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.

 

US-SKZD-220459

STUDY DESIGN STUDY DESIGN
BASELINE CHARACTERISTICS BASELINE CHARACTERISTICS

STUDY DESIGN — UltIMMa-1 and UltIMMa-21,2

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

References

  1. SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc.
  2. 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

SELECTED BASELINE CHARACTERISTICS - UltIMMa-1 and UltIMMa-2. SELECTED BASELINE CHARACTERISTICS - UltIMMa-1 and UltIMMa-2. SELECTED BASELINE CHARACTERISTICS - UltIMMa-1 and UltIMMa-2.

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

  1. 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-220459

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.

 

 

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Transcript

 

 

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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 discuss setting patient expectations on efficacy and safety with SKYRIZI.

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 PASI 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 1,306 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.

 

 

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US-SKZD-220459

Transcript

SKYRIZI (risankizumab-rzaa) 150 mg/mL Pen Injection Video

 

Full Transcript

INJECTING WITH THE SKYRIZI PEN

DISCLAIMER

SUPER: This demonstration is a guide to injecting with the SKYRIZI Pen. Watch it and also read the entire SKYRIZI Instructions for Use leaflet, inserted with your medication package. Don’t try to inject SKYRIZI until your doctor has decided you can, and you’ve been shown the right way to inject. Please see Instructions for Use and Important Safety Information within the website. Please see accompanying full Prescribing Information, including Medication Guide, and discuss with your doctor.  

AUDIO: This demonstration is a guide to injecting with the SKYRIZI Pen. Watch it and also read the entire SKYRIZI Instructions for Use leaflet, inserted with your medication package. Don’t try to inject SKYRIZI until your doctor has decided you can, and you’ve been shown the right way to inject. 

A GUIDE TO INJECTING SKYRIZI

VIDEO: We see the patient comfortably seated on a chair at his dining table. Patient looks into camera and introduces himself. 

SUPER: MICHAEL

AUDIO: Hi, I’m Michael and I’m here to show you how to inject using a SKYRIZI Pen. If this is your first time, hello and welcome to the family. If you’ve done this before, great! I hope this is a helpful refresher.

VIDEO: Patient speaks to camera, points to “Lauren (Nurse Ambassador)” contact on phone. 

SUPER:  

Don’t have a Nurse Ambassador?*  

Call 1.866.SKYRIZI or visit www.SKYRIZI.com  

*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. 

AUDIO: So, I’ve been doing this for a while now, and I feel like I have a good handle on it. My doctor showed me how to inject when I first started, and I called Lauren (my Nurse Ambassador) and she helped me the first few times I did it at home by myself.  

CHAPTER 2: INJECTION PREP 

VIDEO: Patient walks to fridge, pulls out SKYRIZI package, shows to camera, places on counter. SUPERS rotate through on screen. 

SUPER: Do not warm SKYRIZI in any other way (for example, do not warm it in the microwave or in hot water). 

Do not use SKYRIZI if liquid has been frozen even if it has been thawed. 

AUDIO: Okay, let’s get into it! Now, I get my SKYRIZI by mail and I keep it in the fridge until I’m ready to inject. Here it is. Okay. Very important – I’ll leave it at room temperature and out of direct sunlight for 30 to 90 minutes before injecting. 

VIDEO: Patient puts in headphones. 

SUPER: 30 to 90 minutes 

Keep SKYRIZI in the original carton to protect from light until time to use. 

AUDIO: Now, this will take some time, so while I wait, I like to listen to some music. A good tune really helps to relax me.

VIDEO: Patient sits down at dining table with items needed. 

SUPER:  

Do not shake SKYRIZI  

Do not use if the SKYRIZI Pen has been dropped or damaged.

Do not use SKYRIZI if package perforations are broken. Return product to the pharmacy.

Do not remove the dark gray cap until right before injection.  

Do not use SKYRIZI if expiration date (EXP) has passed.  

SKYRIZI Pen, Instructions for Use, alcohol swab, not included in your package, cotton ball not included in your package, sharps container

AUDIO: Now that I’ve washed and dried my hands, I’m good to go. So, I take out everything I need: I’ve got my SKYRIZI Pen, I’ve got the Instructions for Use for reference. I’ve also got an alcohol swab, a cotton ball, and my sharps container. So, I do my injections here because there’s plenty of light and a lot of good space.  

CHAPTER 3:  HOW TO INJECT STEP BY STEP 

VIDEO: Patient points to 4 Ps graphic on package. 

AUDIO: Okay. I like to think about the injection process in 4 steps: the 4 Ps. You can see them right here on the package. Pick, pull, place, and press. 

SUPER: PICK the injection site 

AUDIO: First, I’ll pick my injection site. I’m going to go with my left thigh, but you can also inject into your stomach or your other thigh. 

ANIMATION: 2 inches graphic animates. 

SUPER: 2 INCHES

AUDIO: If you choose your stomach, make sure that you inject at least 2 inches away from your belly button. 

VIDEO: Patient demonstrates step. 

ANIMATION: SUPERS rotate through on screen. 

SUPER:  

Do not touch or blow on the injection site after it is cleaned. Allow the skin to dry before injecting. 

Do not inject through clothes. 

AUDIO: Grab your alcohol swab, and clean your skin in a circular motion, like this, and let it dry.

VIDEO: Patient holds Pen upright, removes cap. SUPERS rotate through on screen. 

SUPER: Do not inject into skin that is sore, bruised, red, hard, scarred, has stretch marks.

PULL the cap off

AUDIO: Now, I hold the Pen with the dark gray cap pointing up. I pull the cap straight off and throw it away.

VIDEO: Patient demonstrates steps and holds inspection window to camera

SUPER: Do not use if the liquid is cloudy or contains flakes or large particles. 

AUDIO: Now I check the liquid through the inspection window. It should look clear to slightly yellow and may contain tiny white or clear particles. It’s normal to see one or more bubbles in the liquid.

VIDEO: Patient demonstrates steps and points to green button. 

AUDIO: So, I hold my Pen with my fingers on the gray grips. See? And I turn the Pen so that the white needle sleeve points toward my injection site and I can see the green activator button. 

VIDEO: Patient demonstrates step. 

SUPER: 

PLACE Pen on site 

90°

AUDIO: I gently squeeze my skin at my injection site to make a raised area and hold it firmly. Then I place the white needle sleeve straight against my injection site at a 90-degree angle. 

VIDEO: Patient demonstrates steps based on copy. 15-second countdown graphic. 

SUPER: PRESS the button

AUDIO: Now I can see the green activator button and inspection window. The Pen only activates if the white needle sleeve is pressed down against me before pressing the green activator button. A loud “click” means the start of the injection. (SFX: PEN CLICK) There it goes. 

VIDEO: Patient demonstrates step.  

15-second countdown graphic.  

Close-up overlay of yellow indicator in inspection window. 

AUDIO: And hold it like that for 15 seconds. I’ll keep pressing the Pen down against my skin until I hear a second “click” or the yellow indicator has filled the inspection window — either one signals the injection is complete. (SFX: PEN CLICK) And there it goes. 

VIDEO: Patient demonstrates steps based on copy. 

AUDIO: When it’s over, I slowly pull the Pen straight out from my skin. (SFX: PEN CLICK) You might notice one last click. And look at this — see how the white needle sleeve covers the needle tip? 

VIDEO: Patient speaks to camera. SUPERS rotate through on screen. 

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

AUDIO: And that’s it! Now, I press a cotton ball where I injected — you can also use a gauze pad.

VIDEO: Patient demonstrates steps. 

SUPER: Do not rub the injection site. You may have slight bleeding. This is normal. 

AUDIO: And I drop my used Pen in one of these sharps disposal containers. 

VIDEO: Patient places the sharps container on closet shelf. 

AUDIO: There — safe and sound, and also out of reach. Another injection complete!  

CHAPTER 4: HELPFUL TIPS FOR SELF-INJECTING

ANIMATION: Text animates on screen for each step. 

SUPER:  

PICK the injection site 

PULL the cap off 

PLACE Pen on site 

PRESS the button 

AUDIO: To recap, I prepare myself and my space, pick an injection site, pull the cap off the Pen, place the Pen on the injection site, press the button to inject,

SUPER: DISCARD used Pen

AUDIO: And safely discard the used Pen. That’s the whole injection process! 

VIDEO: Patient speaks to camera 

AUDIO: When I started injecting at home, it didn’t take me long to get it down. Lauren, my Nurse Ambassador, she suggested I create a routine — inject at the same time and place. I also like to treat myself after each injection — maybe I’ll cycle or listen to a new album. 

VIDEO: Patient points to App on phone.

AUDIO: This Skyrizi Complete App helps me stay on track and I don’t know what I’d do without it. I used it to log my first starter dose so I knew when to take my second starter dose 4 weeks later. 

VIDEO: Patient points to App on phone.

AUDIO: And you can set reminders for future doses, too, since, after 2 starter doses, 

VIDEO: Patient speaks to camera 

SUPER: 1 INJECTION 4x A YEAR

AUDIO: SKYRIZI is only 1 injection, 4 times a year.

VIDEO: Patient points to phone. 

App notification reminder appears on phone screen.

AUDIO: And when I get those reminders, I know to contact my specialty pharmacy to get my next injection on time. 

SUPER: Get sharps containers for no additional cost at www.SKYRIZI.com or call 1.866.SKYRIZI

AUDIO: And don’t forget about the Skyrizi Complete sharps disposal and mail-back service. I signed up online, so once my sharps container gets full, I request a new one, which is sent to me with a box to send my full one back. It’s so convenient and it doesn’t cost me anything. 

VIDEO: Patient speaks to camera

SUPER: CALL 1.866.SKYRIZI FOR 24/7 SUPPORT WITH SKYRIZI COMPLETE

AUDIO: I’m lucky that my family’s always around if I need help. I’ve got Skyrizi Complete, too. Like Lauren, who has answers to my questions,

VIDEO: Patient points to App on phone.

AUDIO: And a pretty awesome App! 

VIDEO: Patient speaks to camera. 

AUDIO: You’ve got this. 

VIDEO: SAFETY CONSIDERATIONS1

SKYRIZI may cause serious side effects, including:

  • Serious allergic reactions: Stop using SKYRIZI and get emergency medical help right away if you get any symptoms of a serious allergic reaction.

  • Infections: SKYRIZI may increase your risk of infections. Before starting treatment, your doctor should check you for infections and tuberculosis. Tell your doctor right away if you have an infection or symptoms of one.

Do not use SKYRIZI if you are allergic to risankizumab-rzaa or any of the ingredients in SKYRIZI.

Also, tell your doctor if you plan to or recently received a vaccine.

REFERENCE: 1. SKYRIZI [package insert]. North Chicago, IL: AbbVie, Inc.

US-SKZD-220457

Transcript

SKYRIZI (risankizumab-rzaa) 150 mg/mL Prefilled Syringe Injection Video

 

Full Transcript

SYRINGE INJECTION VIDEO

DISCLAIMER 

SUPER: This demonstration is a guide to injecting with the SKYRIZI prefilled syringe. Watch it and also read the entire SKYRIZI Instructions for Use leaflet, inserted with your medication package. Don’t try to inject SKYRIZI until your doctor has decided you can, and you’ve been shown the right way to inject. Please see Instructions for Use and Important Safety Information within the website. Please see accompanying full Prescribing Information, including Medication Guide, and discuss with your doctor. 

AUDIO: This demonstration is a guide to injecting with the SKYRIZI prefilled syringe. Watch it and also read the entire SKYRIZI Instructions for Use leaflet, inserted with your medication package. Don’t try to inject SKYRIZI until your doctor has decided you can, and you’ve been shown the right way to inject 

VIDEO: A GUIDE TO INJECTING SKYRIZI

VIDEO: We see the patient comfortably seated on a couch in their living room. Patient looks into camera and introduces himself. 

SUPER: MAYA

AUDIO: Hey there! I’m Maya and I’m here to walk you through how to inject yourself with SKYRIZI. Now, if it’s your first time, don’t worry! If it’s not your first time, I hope you pick up some new tips while you’re here.

VIDEO: Patient speaks to camera, points to “Bryan (Nurse Ambassador)” contact on phone.  

SUPER:  

Don’t have a Nurse Ambassador?*  

Call 1.866.SKYRIZI or visit www.SKYRIZI.com 

*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.  

AUDIO: Now, I’ve done this a few times by myself, but my doctor originally walked me through how to inject, and I called Bryan, who’s my Nurse Ambassador, when I first started injecting on my own at home.  

VIDEO: Patient stands and walks out of frame. INJECTION PREP

VIDEO: Patient walks to fridge, pulls out SKYRIZI package, shows to camera, places on counter. SUPERS rotate through on screen. 

SUPER: Do not warm SKYRIZI in any other way (for example, do not warm it in a microwave or in hot water).  

Do not use SKYRIZI if liquid has been frozen even if it has been thawed.  

15 to 30 minutes 

Keep SKYRIZI in the original carton to protect from light until time to use. 

AUDIO: Alright, let’s get started. So, when my SKYRIZI comes in the mail, it goes straight in the fridge. Now, before I inject, I let it sit out for 15 to 30 minutes, out of direct sunlight, to get to room temperature. And while I wait, I try to relax. 

VIDEO: Patient sits down on couch with items needed on the table in front of her, SUPERS rotate through on screen. Supply names animate on screen next to each item, as she speaks their names. 

SUPER: 

Do not shake SKYRIZI.

Do not use SKYRIZI if the syringe has been dropped or damaged. 

Do not use SKYRIZI if package perforations are broken. Return product to the pharmacy. 

Do not remove the needle cover until right before injection. 

Do not use SKYRIZI if expiration date (EXP) has passed.  

SKYRIZI syringe, with cardboard sleeve removed, alcohol swab not included in your package, Instructions for Use, cotton ball not included in your package, sharps container

AUDIO: Okay, that should be enough time. So, once my hands are clean, I like to put out everything that I’ll need. So, I have my SKYRIZI syringe. I have an alcohol swab, which I got from my local pharmacy. I also have the Instructions for Use, just in case. And I also like to grab a cotton ball (I had some right in my medicine cabinet) and then a sharps container. Now, I like this spot because there’s a lot of space and I don’t have to leave my couch.

VIDEO: HOW TO INJECT step-by-step

VIDEO: Patient points to 4 Ps graphic on package. 

AUDIO: So, it helps me to break down the injection process into 4 simple steps: the 4 Ps. And you can see them here on the package. We have: pick, prepare, pinch, push. Okay? 

SUPER: PICK the injection site 

AUDIO: So, first, I pick my injection site. So, I’ll go with my left thigh. But, you can also pick your right thigh or your lower stomach. 

ANIMATION: 2 inches graphic animates. 

SUPER: 2 INCHES

AUDIO: But, if you choose your stomach, make sure to inject at least 2 inches away from your belly button. Okay? 

VIDEO: Patient demonstrates step. 

AUDIO: So, you want to grab your alcohol swab to clean your skin in a circular motion, like this okay, and let it dry.

VIDEO: Patient holds syringe with needle pointing down, removes cap to check liquid, shows to camera. SUPERS rotate through on screen.

SUPER: 

Do not touch or blow on the injection site after it is cleaned. Allow the skin to dry before injecting. 

Do not inject through clothes. 

Do not inject into skin that is sore, bruised, red, hard, scarred, or has stretch marks. 

Do not use if the liquid is cloudy or contains flakes or large particles.

AUDIO: Now, I hold my syringe with the needle facing down, and I check the liquid inside to make sure that everything looks okay. It should be clear to slightly yellow, which it is. See that? There are a few bubbles in there, but that’s normal. Looks like we’re good to go!

VIDEO: Patient removes the needle cover by holding the syringe in one hand and gently pulling the needle cover straight off with the other hand. 

SUPER:  

PREPARE the syringe  

Do not hold or pull plunger when removing the needle cover.  

Do not touch the needle with your fingers or let the needle touch anything.

AUDIO: Alright, so I hold my syringe in one hand, and I take the needle cover off with the other hand, okay? Like this, and then you want to throw it away. You see? You may see a drop of liquid at the end of the needle, which is normal, okay?

VIDEO: Patient demonstrates steps.

SUPER: 

PINCH the skin 

AUDIO: So, I’ve got my syringe in one hand, and with the other hand, I’m gently pinching the area of my cleaned skin to hold firmly.

VIDEO: Patient demonstrates step.

SUPER:  

PUSH the plunger in 

45° 

AUDIO: Now I’ll inject the needle into my skin at about a 45-degree angle using a quick, short movement — like this. Now, holding the angle steady, I slowly push the plunger in all the way until all of the liquid is injected, and the syringe is empty. There we go. 

VIDEO: Patient demonstrates step.

AUDIO: Now, I pull the needle out of my skin while keeping the syringe at the same angle, like this. I release the plunger to allow the syringe to move up.

VIDEO: Patient points to needle guard on syringe. 

AUDIO: Until the entire needle is covered up by the needle guard. See how that works? The needle guard won’t come back down unless all the liquid has been injected.

VIDEO: Patient demonstrates step. SUPERS rotate through on screen. 

SUPER: 

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. 

AUDIO: Alright, so now, I press my cotton ball where I just injected, and that’s it! 

VIDEO: Patient demonstrates step. 

SUPER:  

Do not rub the injection site. You may have slight bleeding. This is normal. 

AUDIO: I drop my used syringe in one of these handy sharps disposal containers. Voilá – safe and sound. 

VIDEO: Patient places the sharps container on closet shelf.  

AUDIO: Now I’ll just put it back out of reach. Just like that, another injection complete.  

VIDEO: HELPFUL TIPS for self-injecting

ANIMATION/SUPER: 

PICK the injection site 

PREPARE the syringe  

PINCH the skin 

PUSH the plunger in  

Text animates on screen for each step. 

AUDIO: So, to recap, I prepare myself and my space. I pick an injection site, prepare the syringe, pinch the skin, push the plunger in.

VIDEO: Patient demonstrates step. 

AUDIO: And safely discard the syringe. That’s the whole injection process! 

VIDEO: Patient speaks to camera. 

AUDIO: Now, it seemed tricky at first, but I got it down soon enough. And Bryan, my Nurse Ambassador, he recommended I create a routine — injecting at the same time, same place — that sort of thing. I also do something nice for myself after each injection — maybe I’ll paint as a reward. 

VIDEO: Patient holds up phone to camera. 

AUDIO: Oh, and this Skyrizi Complete App has helped me so much. 

VIDEO: Patient points to App on phone. 

AUDIO: I mean I used it to log my first starter dose so I knew when to take my second starter dose 4 weeks later. You can set reminders for future doses, too. 

VIDEO: Patient speaks to camera.

SUPER: 1 INJECTION 4x A YEAR

AUDIO: Since, after 2 starter doses, SKYRIZI is only 1 injection 4 times a year. 

VIDEO: Patient points to phone. 

App notification reminder appears on phone screen. 

AUDIO: And when I get those reminders, I know to contact my specialty pharmacy to get my next injection on time. 

VIDEO: Patient speaks to camera. 

SUPER: Get sharps containers for no additional cost at www.SKYRIZI.com or call 1.866.SKYRIZI

AUDIO: Oh, and I can’t forget about the Skyrizi Complete sharps disposal and mail-back service. 

ANIMATION: SUPER animates over sharps container 

SUPER: Get sharps containers for no additional cost at www.SKYRIZI.com or call 1.866.SKYRIZI 

FULL

AUDIO: Once my sharps container gets full, I request a new one that’s sent to me with a box to mail this one back. I signed up for the service online, and it doesn’t cost me anything! 

VIDEO: Patient speaks to camera. SUPER animates on screen.  

SUPER: CALL 1.866.SKYRIZI FOR 24/7 SUPPORT WITH SKYRIZI COMPLETE

AUDIO: I’m lucky to have people around to support me. I’ve got Skyrizi Complete on my team, too. Like Bryan, who’s such a good listener, 

VIDEO: Patient picks up phone from table.   

SUPER: CALL 1.866.SKYRIZI FOR 24/7 SUPPORT WITH SKYRIZI COMPLETE

AUDIO: and this App! 

VIDEO: Patient speaks to camera.   

AUDIO: There’s always someone to reach out to if you need help. You’ve got this. 

VIDEO: SAFETY CONSIDERATIONS1

SKYRIZI may cause serious side effects, including:

  • Serious allergic reactions: Stop using SKYRIZI and get emergency medical help right away if you get any symptoms of a serious allergic reaction.

  • Infections: SKYRIZI may increase your risk of infections. Before starting treatment, your doctor should check you for infections and tuberculosis. Tell your doctor right away if you have an infection or symptoms of one.

Do not use SKYRIZI if you are allergic to risankizumab-rzaa or any of the ingredients in SKYRIZI.

Also, tell your doctor if you plan to or recently received a vaccine.

REFERENCE: 1. SKYRIZI [package insert]. North Chicago, IL: AbbVie, Inc.

US-SKZD-220457

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

Hypersensitivity Reactions, Infections, Tuberculosis (TB), Administration of Vaccines
Hypersensitivity Reactions
SKYRIZI 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

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

Hypersensitivity Reactions, Infections, Tuberculosis (TB), Administration of Vaccines
Hypersensitivity Reactions
SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients. Serious hypersensitivity reactions,

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

Hypersensitivity Reactions, Infections, Tuberculosis (TB), Administration of Vaccines
Hypersensitivity Reactions
SKYRIZI 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

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

Hypersensitivity Reactions, Infections, Tuberculosis (TB), Administration of Vaccines
Hypersensitivity Reactions
SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients. Serious hypersensitivity reactions,

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.

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.

In psoriatic arthritis phase 3 trials, the incidence of hepatic events was higher with SKYRIZI compared to placebo.

 

SKYRIZI is available in a 150 mg/mL prefilled syringe and pen.

Please see Full Prescribing Information.

US-SKZD-210594