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

SKYRIZI VS STELARA® (ustekinumab)1,2*

HEAD-TO-HEAD EFFICACY AT WEEK 16 IN
2 PIVOTAL PHASE 3 STUDIES

Woman in a blue dress holds up her arms in celebration

SKYRIZI EFFICACY VS STELARA® (ustekinumab)* AT WEEK 16 IN ULTIMMA-1 and ULTIMMA-2 (NRI)1,2

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

EFFICACY ENDPOINTS (P<0.0001)1,2

Chart depicting SKYRIZI® EFFICACY VS STELARA® (ustekinumab) AT WEEK 16 IN ULTIMMA-1 and ULTIMMA-2

NRI=Non-responder imputation.

Co-primary endpoints were PASI 90 and sPGA 0/1 response vs placebo at Week 16. Secondary endpoints included PASI 90 and sPGA 0/1 response vs STELARA* and PASI 100 response vs placebo and STELARA at Week 16.1,2

*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.

STELARA is a registered trademark of Johnson & Johnson. See US Prescribing Information for further information.

Switching to SKYRIZI from STELARA at Week 52

NRI=Non-responder imputation.

Co-primary endpoints were PASI 90 and sPGA 0/1 response vs placebo at Week 16. Secondary endpoints included PASI 90 and sPGA 0/1 response vs STELARA* and PASI 100 response vs placebo and STELARA at Week 16.1,2

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

*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.

STELARA is a registered trademark of Johnson & Johnson. See US Prescribing Information for further information.

In an open-label extension

PATIENTS SWITCHED FROM STELARA® (ustekinumab)* TO SKYRIZI ACHIEVED HIGHER PASI 90 RATES AT 2.5 YEARS3,4

KEY VARIABLES MEASURED EVERY 12 WEEKS THROUGH OLE5,8:

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

Following completion of the RCT period, patients on blinded STELARA were switched to open-label SKYRIZI.4

LIMITATIONS:

In an open-label extension, there is 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.

*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.

STELARA is a registered trademark of Johnson & Johnson. See US Prescribing Information for further information.

73% OF PATIENTS ACHIEVED PASI 90 AFTER 1 DOSE (12 WEEKS) OF SKYRIZI3,4

INTEGRATED RESULTS FROM ULTIMMA-1 & -2 PATIENTS (LOCF)

Chart depicting 73% of patients achieved PASI 90 after 1 dose at Week 12 of SKYRIZI® Chart depicting 73% of patients achieved PASI 90 after 1 dose at Week 12 of SKYRIZI® Chart depicting 73% of patients achieved PASI 90 after 1 dose at Week 12 of SKYRIZI®

KEY VARIABLES MEASURED EVERY 12 WEEKS THROUGH OLE5:

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

Following completion of the RCT period, patients on blinded STELARA were switched to open-label SKYRIZI.4

LIMITATIONS:

In an open-label extension, there is 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.

*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.

 

STUDY DESIGN:

The randomized controlled trial data shown here are integrated results from UltIMMa-1 and -2. The open-label extension (OLE) data are a sub-analysis of LIMMitless and include only patients from UltIMMa-1 and -2 who completed the RCT and then enrolled in the OLE. LIMMitless is an OLE for which patients who completed either UltIMMa trial, IMMhance, or IMMvent were eligible to participate.4-7

STELARA is a registered trademark of Johnson & Johnson. See US Prescribing Information for further information.

LOCF=Last observation carried forward; OLE=Open-label extension; RCT=Randomized controlled trial.

In the randomized controlled trial and open-label extension

PATIENTS WHO STARTED AND REMAINED ON SKYRIZI EXPERIENCED CONSISTENT PASI 90 RATES AT 2.5 YEARS3,4

KEY VARIABLES MEASURED EVERY 12 WEEKS THROUGH OLE5,8:

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

Following completion of the RCT period, patients on blinded Stelara were switched to open-label SKYRIZI.4

LIMITATIONS:

In an open-label extension, there is 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.

*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.

STELARA is a registered trademark of Johnson & Johnson. See US Prescribing Information for further information.

86% OF SKYRIZI PATIENTS ACHIEVED PASI 90 AT WEEK 52 AND 87% AT WEEK 1363,4

INTEGRATED RESULTS FROM ULTIMMA-1 & -2 PATIENTS (LOCF)

Chart depicting 86% of patients achieved PASI 90 at Week 52 and 87% at week 136 who started and remained on SKYRIZI® Chart depicting 86% of patients achieved PASI 90 at Week 52 and 87% at week 136 who started and remained on SKYRIZI® Chart depicting 86% of patients achieved PASI 90 at Week 52 and 87% at week 136 who started and remained on SKYRIZI®

KEY VARIABLES MEASURED EVERY 12 WEEKS THROUGH OLE5:

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

Following completion of the RCT period, patients on blinded Stelara were switched to open-label SKYRIZI.4

LIMITATIONS:

In an open-label extension, there is 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.

*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.

STELARA is a registered trademark of Johnson & Johnson. See US Prescribing Information for further information.

STUDY DESIGN:

The randomized controlled trial data shown here are integrated results from UltIMMa-1 and -2. The open-label extension (OLE) data are a sub-analysis of LIMMitless and include only patients from UltIMMa-1 and -2 who completed the RCT and then enrolled in the OLE. LIMMitless is an OLE for which patients who completed either UltIMMa trial, IMMhance, or IMMvent were eligible to participate.4-7

LOCF=Last observation carried forward; OLE=Open-label extension; RCT=Randomized controlled trial.


Well-Studied Safety Profile

across 4 pivotal trials1

Checklist Icon

Only 4 doses per year

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

Calendar icon
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. 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, ABVRRTI70545.
  4. Strober B, Eyerich K, Hong HC, et al. Long-term efficacy and safety of switching from ustekinumab to risankizumab: results from the open-label extension LIMMitless. Presented at: 28th European Academy of Dermatology and Venereology (EADV) Congress; October 9-13, 2019; Madrid, Spain.
  5. 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: Virtual Annual Meeting of the American Academy of Dermatology; June 12-14, 2020.
  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. 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.
  8. 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 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