The IL-23 inhibitor from AbbVie indicated for the treatment of adults with
active psoriatic arthritis (PsA) and for moderate to severe plaque psoriasis (Ps)
in adults who are candidates for systemic therapy or phototherapy.1
SKYRIZI VS STELARA® (ustekinumab)1,2*
HEAD-TO-HEAD EFFICACY AT WEEK 16 IN 2 PIVOTAL PHASE 3
STUDIES OF PATIENTS WITH Ps
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
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.
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 WITH Ps SWITCHED FROM STELARA® (ustekinumab)* TO SKYRIZI ACHIEVED HIGHER PASI 90 RATES AT 2.5 YEARS3,4
KEY VARIABLES MEASURED EVERY 12 WEEKS THROUGH OLE5,6:
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 WITH Ps ACHIEVED PASI 90 AFTER 1 DOSE (12 WEEKS) OF SKYRIZI3,4
INTEGRATED RESULTS FROM ULTIMMA-1 & -2 PATIENTS (LOCF)
KEY VARIABLES MEASURED EVERY 12 WEEKS THROUGH OLE5,6:
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.4,5,7,8
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 WITH Ps WHO STARTED AND REMAINED ON SKYRIZI EXPERIENCED CONSISTENT PASI 90 RATES AT 2.5 YEARS3,4
KEY VARIABLES MEASURED EVERY 12 WEEKS THROUGH OLE5,6:
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 WITH Ps ACHIEVED PASI 90 AT WEEK 52 AND 87% AT WEEK 1363,4
INTEGRATED RESULTS FROM ULTIMMA-1 & -2 PATIENTS (LOCF)
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.4,5,7,8
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 an open-label extension
PATIENTS WITH Ps SWITCHED FROM STELARA® (ustekinumab)* TO SKYRIZI ACHIEVED HIGHER PASI 100 RATES AT 2.5 YEARS3,4
KEY VARIABLES MEASURED EVERY 12 WEEKS THROUGH OLE5,6:
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.
51% OF PATIENTS WITH Ps ACHIEVED COMPLETE CLEARANCE (PASI 100) AFTER 1 DOSE (12 WEEKS) OF SKYRIZI3,4
INTEGRATED RESULTS FROM ULTIMMA-1 & -2 PATIENTS (LOCF)
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.
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.4,5,7,8
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 WITH Ps WHO STARTED AND REMAINED ON SKYRIZI EXPERIENCED CONSISTENT PASI 100 RATES AT 2.5 YEARS3,4
KEY VARIABLES MEASURED EVERY 12 WEEKS THROUGH OLE5,6:
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 WITH Ps ACHIEVED COMPLETE CLEARANCE (PASI 100) AT WEEK 52 AND 63% AT WEEK 1363,4
INTEGRATED RESULTS FROM ULTIMMA-1 & -2 PATIENTS (LOCF)
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.4,5,7,8
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.
4 DOSES PER YEAR
4 doses per year after 2 initiation doses at Weeks 0 and 4 (150 mg/dose)1
