Nothing less than the opportunity for

DURABLE SKIN 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

ULTIMMA-2 Study: PASI 90 achieved by 81% of patients at 1 year. ULTIMMA-2 Study: PASI 90 achieved by 81% of patients at 1 year. ULTIMMA-2 Study: PASI 90 achieved by 81% of patients at 1 year.

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

ULTIMMA-1 Study: PASI 90 achieved by 82% of patients at 1 year. ULTIMMA-1 Study: PASI 90 achieved by 82% of patients at 1 year. ULTIMMA-1 Study: PASI 90 achieved by 82% of patients at 1 year.

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

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.

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

ULTIMMA-2 Study: PASI 100 achieved by 60% of patients at 1 year. ULTIMMA-2 Study: PASI 100 achieved by 60% of patients at 1 year. ULTIMMA-2 Study: PASI 100 achieved by 60% of patients at 1 year.

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

ULTIMMA-1 Study: PASI 100 achieved by 56% of patients at 1 year. ULTIMMA-1 Study: PASI 100 achieved by 56% of patients at 1 year. ULTIMMA-1 Study: PASI 100 achieved by 56% of patients at 1 year.

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.

Patient case study representing

IMPROVEMENT WITH SKYRIZI3

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

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

*As of 10/2021. 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.

Nothing less than the opportunity forCONSISTENT PASI 90/100 RATES OVER 4+ YEARS

PASI 90 and PASI 100 achievement at week 232 in
the open-label extension (OLE)5

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

PASI 90 and PASI 100 achievement at week 232 in the open-label extension (OLE). PASI 90 and PASI 100 achievement at week 232 in the open-label extension (OLE). PASI 90 and PASI 100 achievement at week 232 in the open-label extension (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.5-7

PASI 90 AND PASI 100 RESPONSE RATES MAINTAINED AT WEEK 232 (OLE) (AS OBSERVED DATA)5

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.5-7

KEY VARIABLES (as measured every 12 weeks through Week 172) of OLE6,8

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

ON AVERAGE, PATIENTS SAW 58% CLEARER SKIN
4 WEEKS AFTER 1ST DOSE9 INTEGRATED RESULTS FROM UltIMMa-1 AND UltIMMa-2 AT SPECIFIC TIME POINTS5,9

After 1 dose
Week 4

58%

MEAN PASI IMPROVEMENT†‡

(n=598)

VS 9% for placebo

(n=200)

PASI 90 AT Week 4 was 6%

After 2 doses
Week 16

91%

MEAN PASI IMPROVEMENT†‡

(n=598)

VS 10% for placebo

(n=200)

PASI 90 AT Week 16 was 75%

After 5 doses
Week 52

95%

MEAN PASI IMPROVEMENT†‡

(n=598)

placebo N/A

()

PASI 90 AT Week 52 was 81%

Open-Label Extension (OLE), AS OBSERVED5

After 19 doses
Week 232

97%

MEAN PASI IMPROVEMENT

(n=426)

Placebo N/A

()

()

MAINTENANCE OF RESPONSE1: 88% of PASI 90 responders at Week 16 maintained response at Week 52.

As measured by change in PASI score from baseline; analysis conducted using last observation carried forward (LOCF) method.

Regardless of how missing data were handled, results were consistent at timepoints evaluated.

LIMITATIONS: Mean change in PASI at all time points and PASI 90 response at Week 4 were pre-specified, non-ranked endpoints and were not adjusted for multiplicity. Therefore, treatment differences cannot be regarded as statistically significant.

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.

LIMMitless is an open-label extension for which patients who completed UltIMMa-1 or -2, IMMvent, or IMMhance were eligible to participate. The data presented here are a sub-analysis of LIMMitless and include only patients from UltIMMa-1 and -2. 525 patients from UltIMMa-1 and -2 have enrolled in LIMMitless at this time.5-7

STUDY DESIGNS:

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 at 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

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.5-7

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.10

See what clearer skin can look like 4 WEEKS AFTER 1 DOSE AND BEYOND WITH SKYRIZI11

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

BASELINE

PASI OF TRUNK=16

Before and After: Baseline PASI of chest.
Before and After: Baseline PASI of back.

AFTER 1 DOSE

WEEK 4 – PASI=6

63%

PASI IMPROVEMENT FROM BASELINE

Before and After: 1 dose Week 4 PASI improvement of chest.
Before and After: 1 dose Week 4 PASI improvement of back.

AFTER 2 DOSES

WEEK 16 – PASI=2

88%

PASI IMPROVEMENT FROM BASELINE

Before and After: 2 doses Week 16 PASI improvement of chest.
Before and After: 2 doses Week 16 PASI improvement of back.

AFTER 5 DOSES

WEEK 52 – PASI=1

94%

PASI IMPROVEMENT FROM BASELINE

Before and After: 5 doses Week 52 PASI improvement of chest.
Before and After: 5 doses Week 52 PASI improvement of 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 (45 mg or 90 mg, based on screening weight) over 52 weeks in adult patients with moderate to severe chronic plaque psoriasis.1,2


Mean PASI improvement is an assessment of the population-level average percentage improvement from baseline in PASI score.10

SKYRIZI (risankizumab-rzaa)
elimination in clinical trials

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


Safety Profile Established

in Ps and PsA1