SKYRIZI VS STELARA® (ustekinumab)1,2*

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

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 OLE5,8:

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.

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.


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 OLE5,8:

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.

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.

In an open-label extension

PATIENTS SWITCHED FROM STELARA® (ustekinumab)* TO SKYRIZI ACHIEVED HIGHER PASI 100 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.

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.

51% OF SKYRIZI PATIENTS ACHIEVED COMPLETE CLEARANCE (PASI 100) AFTER 1 DOSE (12 WEEKS) OF SKYRIZI3,4

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

Chart depicting 51% of patients achieved complete clearance (PASI 100) after 1 Dose (12 weeks) of SKYRIZI®. Chart depicting 51% of patients achieved complete clearance (PASI 100) after 1 Dose (12 weeks) of SKYRIZI®. Chart depicting 51% of patients achieved complete clearance (PASI 100) after 1 Dose (12 weeks) of SKYRIZI®.

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.

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.


In the randomized controlled trial and open-label extension

PATIENTS WHO STARTED AND REMAINED ON SKYRIZI EXPERIENCED CONSISTENT PASI 100 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.

61% OF SKYRIZI PATIENTS ACHIEVED COMPLETE CLEARANCE (PASI 100) AT WEEK 52 AND 63% AT WEEK 1363,4

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

Chart depicts 61% of patients achieved complete clearance (PASI 100) at week 52 and 63% at week 136. Chart depicts 61% of patients achieved complete clearance (PASI 100) at week 52 and 63% at week 136. Chart depicts 61% of patients achieved complete clearance (PASI 100) at week 52 and 63% at week 136.

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