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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

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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

REFERENCE

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

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

 

US-SKZD-190271

STUDY DESIGN STUDY DESIGN
BASELINE CHARACTERISTICS BASELINE CHARACTERISTICS

STUDY DESIGN—IMMvent4

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:

  • Nonresponders (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

 

US-SKZD-190271

SELECTED BASELINE CHARACTERISTICS4,11

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

 

US-SKZD-190271

STUDY DESIGN STUDY DESIGN
BASELINE CHARACTERISTICS BASELINE CHARACTERISTICS

STUDY DESIGN—IMMhance1,6,12

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 secondary endpoints included

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

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

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 CHARACTERISTICS6,13

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

 

US-SKZD-190271

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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.

 

US-SKZD-190271




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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-190271




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-190271




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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