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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

SITE MAP

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

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.

STUDY DESIGN STUDY DESIGN
BASELINE CHARACTERISTICS BASELINE CHARACTERISTICS

STUDY DESIGN—IMMvent10

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-200061

SELECTED BASELINE CHARACTERISTICS10,15

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

 

US-SKZD-200061

STUDY DESIGN STUDY DESIGN
BASELINE CHARACTERISTICS BASELINE CHARACTERISTICS

STUDY DESIGN—IMMhance1,11,16

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 CHARACTERISTICS11,17

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

 

US-SKZD-200061

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-200061

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-200061




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-200061

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-200061

Select the product you would like to learn more about.

 

HUMIRA® for HCPs
Visit HUMIRA®
SkyRizi™ for HCPs
Visit Skyrizi™

US-IMM-190077

Select the product you would like to learn more about.

 

RINVOQ™ for HCPs
Visit RINVOQ™
HUMIRA® for HCPs
Visit HUMIRA®

US-IMM-190077

Select the product you would like to learn more about.

 

RINVOQ™ for HCPs
Visit RINVOQ™
HUMIRA® for HCPs
Visit HUMIRA®

US-IMM-190077

Select the product you would like to learn more about.

 

HUMIRA® for HCPs
Visit HUMIRA®
SkyRizi™ for HCPs
Visit Skyrizi™

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.

STUDY DESIGN STUDY DESIGN
BASELINE CHARACTERISTICS BASELINE CHARACTERISTICS

STUDY DESIGN – UltIMMa-1 and UltIMMa-21,21,21,9

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-200061

SELECTED BASELINE CHARACTERISTICS229

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-200061

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