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Moderate to Severe

Juvenile Idiopathic Arthritis

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Intermediate, Posterior and Panuveitis

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Psoriatic Arthritis

Moderate to Severe

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US-MULT-200777

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

WEEK 16

Picture what improvement could look like

SEE ACTUAL PSORIASIS PATIENTS TREATED
WITH SKYRIZI (risankizumab-rzaa)2

Photo depicts moderate to severe plaque psoriasis patient with affected body surface area ≥10% at baseline, outside of clinical trials.

PRIMARY DATA FROM PIVOTAL TRIALS

Week 16

Patient results after 2 doses at Week 16

Patient photos representing results captured at baseline and Week 16, outside of clinical trials. PASI and sPGA achievement undefined.2

The patients depicted here have moderate to severe plaque psoriasis with an affected body surface area ≥10%.

Photos courtesy of Dr. Meyer Horn.2

View Week 52 Results
Patient results after 2 doses of SKYRIZI® at Week 16
Patient condition before starting SKYRIZI® at Week 0

BEFORE | WEEK 0

AFTER | WEEK 16

Patient from Illinois

Week 16

Patient results after 2 doses at Week 16

Patient photos representing results captured at baseline and Week 16, outside of clinical trials. PASI and sPGA achievement undefined.2

The patients depicted here have moderate to severe plaque psoriasis with an affected body surface area ≥10%.

Photos courtesy of Matthew Insley, RPA-C.2

View Week 52 Results
Patient results after 2 doses of SKYRIZI® at Week 16
Patient condition before starting SKYRIZI® at Week 0

BEFORE | WEEK 0

AFTER | WEEK 16

Patient from New York

Week 16

Patient results after 2 doses at Week 16

Patient photos representing results captured at baseline and Week 16, outside of clinical trials. PASI and sPGA achievement undefined.2

The patients depicted here have moderate to severe plaque psoriasis with an affected body surface area ≥10%.

Photos courtesy of Victor Czerkasij, FNP-C.2

View Week 52 Results
Patient results after 2 doses of SKYRIZI® at week 16
Patient condition before starting SKYRIZI® at Week 0

BEFORE | WEEK 0

AFTER | WEEK 16

Patient from Tennessee

Week 16

Patient results after 2 doses at Week 16

Patient photos representing results captured at baseline and Week 16, outside of clinical trials. PASI and sPGA achievement undefined.2

The patients depicted here have moderate to severe plaque psoriasis with an affected body surface area ≥10%.

Photos courtesy of Dr. Ellen Frankel.2

View Week 52 Results
Patient results after 2 doses of SKYRIZI® at Week 16
Patient condition before starting SKYRIZI® at Week 0

BEFORE | WEEK 0

AFTER | WEEK 16

Patient from Rhode Island

Week 16 - Carousel - Image 1
Week 16 - Carousel - Image 2
Week 16 - Carousel - Image 3
Week 16 - Carousel - Image 4
Patient results after 5 doses SKYRIZI® at Week 52
Patient condition before starting SKYRIZI® at Week 0

BEFORE | WEEK 0

AFTER | WEEK 52

Patient from Illinois

Week 52

Patient results after 5 doses at Week 52

Patient photos representing results captured at baseline and Week 52, outside of clinical trials. PASI and sPGA achievement undefined.2

The patients depicted here have moderate to severe plaque psoriasis with an affected body surface area ≥10%.

Photos courtesy of Dr. Meyer Horn.2

View Week 16 Results

Well-Studied Safety Profile

across 4 pivotal trials1

Review Safety
Checklist Icon

Only 4 doses per year

3-month dosing after 2 initiation doses at
Weeks 0 and 4 (150 mg/dose)1

View dosing schedule
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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. SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc.
  2. Data on file, ABVRRTI70545.
  3. 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.
STUDY DESIGN STUDY DESIGN
BASELINE CHARACTERISTICS BASELINE CHARACTERISTICS

STUDY DESIGN – UltIMMa-1 and UltIMMa-21,3

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

SELECTED BASELINE CHARACTERISTICS3

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

BSA=Body Surface Area

PASI=Psoriasis Area and Severity Index

PBO=Placebo

PsA=Psoriatic Arthritis

RZB=Risankizumab-rzaa

TNFi=Tumor Necrosis Factor Inhibitor

UST=Ustekinumab

aStratification factors at randomization.

 

US-SKZD-200400

In patients who achieved PASI 90 at Week 16...

88%

maintained PASI 90
at Week 521,2

(n=398/450)

MAINTENANCE OF RESPONSE

 

US-SKZD-200400

In patients who achieved PASI 100 at Week 16...

80%

maintained PASI
100 at Week 521

(n=206/258)

MAINTENANCE OF RESPONSE

 

US-SKZD-200213

MAINTENANCE OF RESPONSE,
ALL DATA ARE AS OBSERVED6

PASI 90
PASI 100

In patients who achieved PASI 90 at Week
52 and had available data at week 172

95%

maintained PASI 90
at Week 172

(n=383/402)

In patients who achieved PASI 100 at Week 52 and had available data at week 172

83%

maintained PASI
100 at Week 172

(n=238/288)

OLE limitations: In an open-label extension, there is a potential for enrichment of the long-term data in the remaining
patient populations since patients who are unable to tolerate or do not respond to the drug often drop out.

 

US-SKZD-200400

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

SELECTED BASELINE CHARACTERISTICS2

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

BSA=Body Surface Area

PASI=Psoriasis Area and Severity Index

PBO=Placebo

PsA=Psoriatic Arthritis

RZB=Risankizumab-rzaa

TNFi=Tumor Necrosis Factor Inhibitor

UST=Ustekinumab

aStratification factors at randomization.

 

US-SKZD-200400

STUDY DESIGN STUDY DESIGN
BASELINE CHARACTERISTICS BASELINE CHARACTERISTICS

STUDY DESIGN – UltIMMa-1 and UltIMMa-21,2,6-8

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

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.

LIMMitless is an ongoing, single-arm, multicenter, open-label extension study evaluating the long-term efficacy and safety of SKYRIZI (150 mg). Patients who completed UltIMMa-1 or -2, IMMvent, or IMMhance were eligible to participate.

Active Comparator

The active comparator (ustekinumab) used for these studies was sourced from the European Union.

OLE=Open-Label Extension

PASI=Psoriasis Area and Severity Index

PASI 90=≥90% improvement in Psoriasis Area and Severity Index

PASI 100=100% improvement in Psoriasis Area and Severity Index

sPGA=static Physician's Global Assessment

The co-primary endpoints were

  • Percentage of patients with at least a 90% improvement in the PASI score (PASI 90) at Week 16 compared to placebo
  • Percentage of patients with an sPGA score of clear or almost clear (0/1) at Week 16 compared to placebo

Key secondary endpoints included

  • PASI 90 and PASI 100 at Week 52 compared to ustekinumab

Key inclusion criteria

  • ≥18 years of age
  • Stable (≥6 months) moderate to severe chronic plaque psoriasis, with or without psoriatic arthritis
  • ≥10% body surface area, with a PASI score ≥12, and an sPGA score ≥3
  • Eligible for systemic therapy or phototherapy and ustekinumab therapy in accordance with local labels

OLE=Open-Label Extension

PASI=Psoriasis Area and Severity Index

PASI 90=≥90% improvement in Psoriasis Area and Severity Index

PASI 100=100% improvement in Psoriasis Area and Severity Index

sPGA=static Physician's Global Assessment

SELECTED BASELINE CHARACTERISTICS2

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

BSA=Body Surface Area

PASI=Psoriasis Area and Severity Index

PBO=Placebo

PsA=Psoriatic Arthritis

RZB=Risankizumab-rzaa

TNFi=Tumor Necrosis Factor Inhibitor

UST=Ustekinumab

aStratification factors at randomization.

 

US-SKZD-200400

 

US-SKZD-200400

 

US-SKZD-200400

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-200400

 

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 1 week after the initial dose over 44 weeks.

The Part A co-primary endpoints were

  • PASI 90 and sPGA 0/1 at Week 16 compared to HUMIRA

Part B

Patients originally randomized to SKYRIZI received it throughout the study (Parts A & B). Among patients originally randomized to receive HUMIRA, those with a PASI 50 but less than PASI 90 response were re-randomized 1:1 to switch to SKYRIZI or continue HUMIRA.

The Part B primary endpoint was

  • PASI 90 at Week 44 among those with PASI 50 to <90 after 16 weeks of adalimumab treatment

Key secondary endpoints included

  • PASI 100 at Week 16
  • PASI 100 at Week 44 for patients who were re-randomized at Week 16

Key inclusion criteria

  • ≥18 years of age
  • Diagnosis of chronic plaque psoriasis ≥6 months before Week 0
  • Stable moderate to severe chronic plaque psoriasis based on ≥10% body surface area, with a PASI score ≥12, and an sPGA score ≥3
  • Eligible for adalimumab therapy in accordance with local labels

OLE=Open-Label Extension

PASI=Psoriasis Area and Severity Index

PASI 90=≥90% improvement in Psoriasis Area and Severity Index

PASI 100=100% improvement in Psoriasis Area and Severity Index

Q2W=Once every 2 weeks

sPGA=static Physician's Global Assessment

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

OLE=Open-Label Extension

PASI=Psoriasis Area and Severity Index

PASI 90=≥90% improvement in Psoriasis Area and Severity Index

PASI 100=100% improvement in Psoriasis Area and Severity Index

Q2W=Once every 2 weeks

sPGA=static Physician's Global Assessment

SELECTED BASELINE CHARACTERISTICS9,14

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

ADA=Adalimumab

BSA=Body Surface Area

PASI=Psoriasis Area and Severity Index

PsA=Psoriatic Arthritis

RZB=Risankizumab-rzaa

TNFi=Tumor Necrosis Factor Inhibitor

 

US-SKZD-200400

STUDY DESIGN STUDY DESIGN
BASELINE CHARACTERISTICS BASELINE CHARACTERISTICS

STUDY DESIGN – IMMhance1,10

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 up to Week 88, with a final follow-up at Week 104.

The Part B primary endpoint was

  • Percentage of patients with an sPGA 0/1 at 1 year

Key inclusion criteria

  • ≥18 years of age
  • Diagnosis of chronic moderate to severe plaque psoriasis ≥6 months before Week 0
  • Stable plaque psoriasis based on ≥10% body surface area, with a PASI score ≥12 and an sPGA score ≥3
  • Eligible for systemic therapy or phototherapy

Key secondary endpoints included

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

DLQI=Dermatology Life Quality Index

OLE=Open-Label Extension

PASI=Psoriasis Area and Severity Index

PASI 75=≥75% improvement in Psoriasis Area and Severity Index

PASI 90=≥90% improvement in Psoriasis Area and Severity Index

PASI 100=100% improvement in Psoriasis Area and Severity Index

Q12W=Once every 12 weeks

sPGA=static Physician's Global Assessment

SELECTED BASELINE CHARACTERISTICS10

SKYRIZI® Selected Baseline Characteristics for IMMhance SKYRIZI® Selected Baseline Characteristics for IMMhance SKYRIZI® Selected Baseline Characteristics for 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.

 

US-SKZD-200400

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US-SKZD-200400

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-200400

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

Eligible patients must have commercial insurance, a valid prescription for SKYRIZI® (risankizumab-rzaa) for an FDA approved indication, a denial of insurance coverage based on a prior authorization request along with an appeal on file. Continued eligibility for the program requires the submission of an appeal of the coverage denial every 90 days. Program provides 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-200400

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

SELECTED BASELINE CHARACTERISTICS2

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

BSA=Body Surface Area

PASI=Psoriasis Area and Severity Index

PBO=Placebo

PsA=Psoriatic Arthritis

RZB=Risankizumab-rzaa

TNFi=Tumor Necrosis Factor Inhibitor

UST=Ustekinumab

aStratification factors at randomization.

 

US-SKZD-200400

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 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.

 

 

US-SKZD-190188

If emailing to yourself, please provide only your own information.

Optional:

 

US-SKZD-200400

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