Active

Psoriatic Arthritis

Active

Ankylosing Spondylitis

Moderate to Severe

Juvenile Idiopathic Arthritis

Non-Infectious

Intermediate, Posterior and Panuveitis

Active

Psoriatic Arthritis

Moderate to Severe

Hidradenitis Suppurativa

Gastroenterology

Moderate to Severe

Crohn's Disease

Moderate to Severe

Pediatric Crohn's Disease

Moderate to Severe

Ulcerative Colitis

Moderate to Severe

Pediatric Ulcerative Colitis

Ophthalmology

Non-Infectious

Intermediate, Posterior and Panuveitis

Man in a blue swimsuit

Nothing less than the opportunity for

DURABLE CLEARANCE
for plaque psoriasis patients1,2

PASI 90 achieved by 81% of patients at 1 year1,2

  • SKYRIZI 150 mg (n=294)
  • USTEKINUMAB (n=99)
  • PLACEBO (n=98)

Participants received treatment at Week 0, Week 4, and every 12 weeks thereafter

PASI 90 at 1 year for UltIMMA-2 PASI 90 at 1 year for UltIMMA-2 PASI 90 at 1 year for UltIMMA-2

PASI 90 achieved by 82% of patients at 1 year1,2

  • SKYRIZI 150 mg (n=304)
  • USTEKINUMAB (n=100)
  • PLACEBO (n=102)

Participants received treatment at Week 0, Week 4, and every 12 weeks thereafter

PASI 90 at 1 year for UltIMMA-1 PASI 90 at 1 year for UltIMMA-1 PASI 90 at 1 year for UltIMMA-1

IN PATIENTS WHO ACHIEVED PASI 90 AT WEEK 16, 88% MAINTAINED PASI 90 AT 1 YEAR1,2

STUDY DESIGN:

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.1,2

NRI=Non-responder imputation; PASI 90=≥90% improvement in Psoriasis Area and Severity Index; sPGA 0/1=static Physician's Global Assessment of clear or almost clear.

CO-PRIMARY ENDPOINTS WERE PASI 90 AND sPGA 0/1 RESPONSE VS PLACEBO AT WEEK 161

sPGA 0/1 at Week 161,2:

UltIMMa-1:
SKYRIZI 88%, ustekinumab 63%, placebo 8%

UltIMMa-2:
SKYRIZI 84%, ustekinumab 62%, placebo 5%

Active Comparator

The ustekinumab used as a biologic active control in UltIMMa-1 and UltIMMa-2 was sourced from the European Union. Comparability between non–US-approved ustekinumab and US-approved ustekinumab has not been established. 

Before and after photos of SKYRIZI®- treated patients with moderate to severe plaque psoriasis from the UltIMMa-2 study with PASI 90 clearance.

Patient case study representing

IMPROVEMENT WITH SKYRIZI3

Photos of SKYRIZI-treated patients with moderate to severe plaque psoriasis from the UltIMMa-2 study

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open

CO-PRIMARY ENDPOINTS WERE PASI 90 AND sPGA 0/1 RESPONSE VS PLACEBO AT WEEK 161

sPGA 0/1 at Week 161,2:

UltIMMa-1:
SKYRIZI 88%, ustekinumab 63%, placebo 8%

UltIMMa-2:
SKYRIZI 84%, ustekinumab 62%, placebo 5%

Active Comparator

The ustekinumab used as a biologic active control in UltIMMa-1 and UltIMMa-2 was sourced from the European Union. Comparability between non–US-approved ustekinumab and US-approved ustekinumab has not been established.

Patient with Skyrizi Complete

PASI 100 achieved by 60% of patients at 1 year1,2

  • SKYRIZI 150 mg (n=294)
  • USTEKINUMAB (n=99)
  • PLACEBO (n=98)

Participants received treatment at Week 0, Week 4, and every 12 weeks thereafter

PASI 100 at 1 year for UltIMMA-2 PASI 100 at 1 year for UltIMMA-2 PASI 100 at 1 year for UltIMMA-2

PASI 100 achieved by 56% of patients at 1 year1,2

  • SKYRIZI 150 mg (n=304)
  • USTEKINUMAB (n=100)
  • PLACEBO (n=102)

Participants received treatment at Week 0, Week 4, and every 12 weeks thereafter

PASI 100 at 1 year for UltIMMA-1 PASI 100 at 1 year for UltIMMA-1 PASI 100 at 1 year for UltIMMA-1

IN PATIENTS WHO ACHIEVED PASI 100 AT WEEK 16, 80% MAINTAINED PASI 100 AT 1 YEAR1

STUDY DESIGN:

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.1,2

NRI=Non-responder imputation; PASI 100=100% improvement in Psoriasis Area and Severity Index; sPGA 0/1=static Physician's Global Assessment of clear or almost clear.

Before and after photos of SKYRIZI®-treated patients with moderate to severe plaque psoriasis from the UltIMMa-2 study with PASI 100 clearance

Patient case study representing

IMPROVEMENT WITH SKYRIZI5

Before and after photos of SKYRIZI-treated patients with moderate to severe plaque psoriasis from the UltIMMa-2 study

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

As of 1/2021. New patients defined as bio-naïve; switch patients defined as bio-experienced switching biologics. Source: Integrated Symphony Health (PatientSource) and IQVIA (NSP) through proprietary method on diagnosis classification.4

Nothing less than the opportunity for CONSISTENT PASI 90/100 RATES OVER 3+ YEARS

PASI 90 and PASI 100 achievement at week 172 in
the open-label extension (OLE)6

INTEGRATED RESULTS FROM UltIMMa-1 AND UltIMMa-2
ALL DATA ARE AS OBSERVED

PASI 90 and PASI 100 achievement at Week 172 or OLE PASI 90 and PASI 100 achievement at Week 172 or OLE PASI 90 and PASI 100 achievement at Week 172 or OLE

The data presented here are a sub-analysis of the LIMMitless OLE and include only patients from UltIMMa-1 and -2 who were originally randomized to SKYRIZI, completed the RCT, and enrolled in the OLE. LIMMitless is an ongoing open-label extension for which patients who completed either UltIMMa trial, IMMvent, or IMMhance were eligible to participate.6-8

A MAJORITY OF PATIENTS WHO ACHIEVED PASI 90 AND 100 AT WEEK 52 MAINTAINED RESPONSE AT WEEK 172 (AS OBSERVED DATA)6

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.

STUDY DESIGN:

LIMMitless is an ongoing, single-arm, multicenter, open-label extension of phase 2 and 3 studies 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.6-8

KEY VARIABLES (as measured every 12 weeks through Week 172) of OLE7,9

sPGA 0/1, sPGA 0, PASI 75, PASI 90, and PASI 100

Well-Studied Safety Profile

across 4 pivotal trials1

Checklist Icon

Now available

The 150 mg/mL SKYRIZI Pen and
150 mg/mL prefilled syringe1

SKYRIZI® Pen and pre-filled syringe icon

Have you transitioned your patients?

Offer your patients the new 150 mg/mL
SKYRIZI Pen or 150 mg/mL prefilled syringe1

SKYRIZI® Pen and pre-filled syringe icon
ISI and Indication
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® (risankizumab-rzaa) 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.

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

Please see Full Prescribing Information.

US-SKZD-210127

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.
  3. Data on file, ABVRRTI67286.
  4. Data on file, AbbVie Inc. In-play patient share. January 2021.
  5. Data on file, ABVRRTI67283.
  6. Leonardi C, Lebwohl M, Bachelez H, et al. Maintenance of response through 172 weeks of long-term continuous risankizumab treatment: an analysis of patients from UltIMMa-1 and UltIMMa-2. Presented at: Virtual Winter Clinical Dermatology Conference; January 15-20, 2021.
  7. Papp K, Lebwohl M, Ohtsuki M, et al. Long-term efficacy and safety of continuous Q12W risankizumab: results from open-label extension study LIMMitless. Presented at the Virtual Annual Meeting of the American Academy of Dermatology; June 12-14, 2020.
  8. Leonardi C, Bachelez H, Wu JJ, et al. Long-term safety of risankizumab in patients with moderate to severe psoriasis: analysis of pooled clinical trial data. Poster presented at: American Academy of Dermatology Annual Meeting; March 1-5, 2019; Washington, DC.
  9. A study to assess the safety and efficacy of risankizumab for maintenance in moderate to severe plaque psoriasis (LIMMITLESS). Clinicaltrials.gov identifier: NCT03047395. https://www.clinicaltrials.gov/ct2/show/NCT03047395?term=risankizumab&cond=Psoriasis&draw=2&rank=8. Accessed January 4, 2021.
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® (risankizumab-rzaa) 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.

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

Please see Full Prescribing Information.

US-SKZD-210127