HUMIRA® for HCPs
SkyRizi™ for HCPs
RINVOQ™ for HCPs

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

Nothing less than the opportunity for DURABLE CLEARANCE

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 WEEK 521,2

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 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. 

Patient case study representing

IMPROVEMENT WITH SKYRIZI3

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

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

 

VIEW PATIENT IMAGES BELOW

close

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 WEEK 521

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 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.

Patient case study representing

IMPROVEMENT WITH SKYRIZI4

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

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

 

VIEW PATIENT IMAGES BELOW

close

Nothing less than the opportunity for RAPID RESPONSE

On average, patients saw 58% clearer skin
4 weeks after 1st dose5*

Integrated results from UltIMMa-1 and UltIMMa-25

After 1 dose

58%

MEAN PASI IMPROVEMENT

WEEK 4

(n=598)

VS 9% for placebo

(n=200)

PASI 90 after 1 dose
(Week 4) was 6%

After 2 doses

91%

MEAN PASI IMPROVEMENT

WEEK 16

(n=598)

VS 10% for placebo

(n=200)

PASI 90 after 2 doses
(Week 16) was 75%

After 5 doses

95%

MEAN PASI IMPROVEMENT

WEEK 52

(n=598)

No placebo after 16 weeks

()

PASI 90 after 5 doses
(Week 52) was 81%

Endpoints for SKYRIZI: Co-primary (PASI 90 and sPGA 0/1 at Week 16), select secondary endpoints (PASI 90 at Week 52), pre-specified non-ranked endpoints (PASI 90 at Week 4, mean change in PASI from baseline at all time points). Limitations: Non-ranked endpoints were not controlled for multiplicity. These pre-specified, non-ranked endpoints were not powered to detect a statistical difference. Therefore, treatment differences cannot be regarded as statistically significant.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 over 52 weeks in adult patients with moderate to severe plaque psoriasis.1,2


Mean PASI improvement is an assessment of the average improvement from baseline to a set point in time in psoriatic signs of redness, thickness, scale, and body surface area of involvement.6

*As measured by change in PASI score from baseline; last observation carried forward.

SKYRIZI mean PASI improvements over Weeks 4, 16, and 52

See what clearer skin can look like 4 WEEKS AFTER 1 DOSE AND BEYOND WITH SKYRIZI7

Patient case studies representing mean PASI improvement through 52 weeks of dosing

BASELINE

PASI OF TRUNK=16

Baseline PASI of trunk (chest)
Baseline PASI of trunk (back)

After 1 dose

Week 4 – PASI=6

63%

PASI IMPROVEMENT FROM BASELINE

1 dose Week 4 PASI improvement trunk (chest)
After 1 dose, Week 4 with 63% PASI improvement (back)

After 2 doses

Week 16 – PASI=2

88%

PASI IMPROVEMENT FROM BASELINE

After 2 doses, Week 16 with 88% PASI improvement (chest)
After 2 doses, Week 16 with 88% PASI improvement (back)

After 5 doses

Week 52 – PASI=1

94%

PASI IMPROVEMENT FROM BASELINE

5 doses Week 52 PASI improvement trunk (back)
After 5 doses, Week 52 with 94% PASI improvement (back)

Images are of clinical trial patients. Individual results may vary.

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 over 52 weeks in adult patients with moderate to severe plaque psoriasis.1,2


Mean PASI improvement is an assessment of the average improvement from baseline to a set point in time in psoriatic signs of redness, thickness, scale, and body surface area of involvement.6

SKYRIZI elimination in clinical trials

For a typical participant, terminal elimination half-life of
SKYRIZI was 28 days with systemic clearance of 0.31 L/day1

Well-Studied Safety Profile

across 4 pivotal trials1

SKYRIZI safety profile across 4 pivotal studies

Only 4 doses per year

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

SKYRIZI 3-Month Dosing
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, ABVRRTI67286.
  4. Data on file, ABVRRTI67283.
  5. Lebwohl M, Bachelez H, Valdecantos WC, Wu T, Gordon K. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis: an integrated analysis of UltIMMa-1 and UltlMMa-2. Poster presented at: American Academy of Dermatology Annual Meeting; March 1-5, 2019; Washington, DC.
  6. Vender R, Lovell P. A practical understanding of mean percent PASI reduction for biologics. J Am Acad Dermatol. 2008;58(2)(suppl 2):AB5.
  7. Data on file, ABVRRTI67285.
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