Find out more about the efficacy of SKYRIZI
Explore the durability of response with SKYRIZI through clinical trials and long-term data in psoriasis and psoriatic arthritis. Start by selecting a study from the menu below.
LONG-TERM DATA
HEAD-TO-HEAD TRIALS
SKYRIZI IN PsA
HEAD-TO-HEAD TRIALS:
SKYRIZI vs Ustekinumab (UltIMMa-1 + UltIMMa-2)
Superior efficacy in psoriasis vs ustekinumab2,5,6
Over 80% of patients achieve PASI 90 with SKYRIZI at 52 weeksa6
Proportion of patients (NRI) achieving PASI 90 through to Week 52 in UltIMMa-1 and UltIMMa-2.
Result from UltIMMa-1 and UltIMMa-2 integrated analysis, two Phase III double-blind randomised, placebo- and active-comparator controlled studies of SKYRIZI in adult patients withmoderate to severe plaque psoriasis.
aRanked secondary endpoint.
Co-primary endpoints were proportions of patients achieving PASI 90 and sPGA 0 or 1 at Week 16 with SKYRIZI vs. placebo. Both co-primary endpoints were met (P<0.0001).
NRI, non-responder imputation; PASI, Psoriasis Area and Severity Index.
At least twice as many patients achieve completely clear skin (PASI 100) with SKYRIZI vs ustekinumab at 52 weeks6
Proportion of patients (NRI) achieving PASI 100 through to Week 52 in UltIMMa-1 and UltIMMa-2.
Result from UltIMMa-1 and UltIMMa-2 integrated analysis, two Phase III double-blind randomised, placebo- and active-comparator controlled studies of SKYRIZI in adult patients with moderate to severe plaque psoriasis.
Co-primary endpoints were proportions of patients achieving PASI 90 and sPGA 0 or 1 at Week 16 with SKYRIZI vs placebo. Both co-primary endpoints were met (P<0.0001).
NRI, non-responder imputation; PASI, Psoriasis Area and Severity Index.
More than 80% of SKYRIZI patients maintained PASI 90 through to 2.5 years5
UltIMMa open-label extension PASI 90 (LOCF)5
Adapted from Strober B, et al. 2019.
The UltIMMa open-label extension is an ongoing, Phase III, single arm, multi-centre study assessing the long-term safety and efficacy of SKYRIZI, following 52-week completion of UltIMMa-1 and UltIMMa-2. Of the 598 patients randomised to SKYRIZI in UltIMMa-1 and UltIMMa-2, 525 entered UltIMMa open label extension and continued SKYRIZI 150mg every 12 weeks.
LOCF, last observation carried forward; PASI, Psoriasis Area and Severity Index.
More than 60% of SKYRIZI patients maintained PASI 100 through to 2.5 years5
UltlMMa open-label extension PASI 100 (LOCF)5
Adapted from Strober B, et al. 2019.
The UltIMMa open-label extension is an ongoing, Phase III, single arm, multi-centre study assessing the long-term safety and efficacy of SKYRIZI, following 52-week completion of UltIMMa-1 and UltIMMa-2. Of the 598 patients randomised to SKYRIZI in UltIMMa-1 and UltIMMa-2, 525 entered UltIMMa open label extension and continued SKYRIZI 150mg every 12 weeks.
LOCF, last observation carried forward; PASI, Psoriasis Area and Severity Index.
Over 70% of patients reach DLQI 0 or 1 at one year with SKYRIZI
Compared with up to 47% with ustekinumab*2
How many of your patients could reach a point where psoriasis no longer affects their quality of life?
UltIMMa-1
UltIMMa-2
P<0.0001 vs. ustekinumab
Adapted from Gordon KB, et al. 2018.
Data from UltlMMa-1 and UltlMMa-2: Two Phase III double-blind randomised, placebo- and active-comparator controlled studies of SKYRIZI in adult patients with moderate to severe plaque psoriasis.
DLQI, Dermatology Life Quality Index.
*Ranked secondary endpoint.
Co-primary endpoints were proportions of patients achieving PASI 90 and sPGA 0 or 1 at Week 16 with SKYRIZI vs placebo. Both co-primary endpoints were met (P<0.0001).
UltIMMa-1: n=506, UltIMMa-2: n=491
Efficacy and safety of SKYRIZI in adults with moderate to severe plaque psoriasis in 2 replicate double-blind, randomised, placebo controlled and ustekinumab controlled Phase III clinical trials.
Part A (baseline to Week 16): Patients received either SKYRIZI 150mg, ustekinumab 45/90mg, or placebo.
Part B (Weeks 16 to 52): SKYRIZI and ustekinumab patients continued on treatment
Study design
UltIMMa-1 and UltIMMa-2 were replicate Phase Ill, randomised, double-blind, placebo-controlled and active comparator-controlled trials done at 139 sites. Eligible patients were 18 years or older, with moderate to severe chronic plaque psoriasis. In each study, patients were stratified by weight and previous exposure to TNF inhibitor and randomly assigned (3:1:1) by use of interactive response technology to receive 150mg risankizumab, 45mg or 90mg ustekinumab (weight-based per label), or placebo.
*Dosing of ustekinumab was 90mg for patients weighing over 100kg.
OLE, open-label extension; PASI, Psoriasis Area Severity Index; sPGA, static Physicians’ Global Assessment; TNF, tumour necrosis factor.
Co-primary endpoints:
Co-primary endpoints were proportions of patients achieving PASI 90 and sPGA 0 or 1 at Week 16 with SKYRIZI vs placebo. Both coprimary endpoints were met (P<0.0001).
Ranked secondary endpoints:
1st sPGA 0 (clear) at Week 16 vs placebo
2nd PASI 100 at Week 16 vs placebo 3rd DLQI 0 or 1 at Week 16 vs placebo 4th PSS 0 at Week 16 vs placebo
5th PASI 90 at Week 16 vs placebo
6th sPGA 0/1 (clear or almost clear) at Week 16 vs ustekinumab
7th PASI 100 at Week 16 vs ustekinumab
8th sPGA 0 (clear) at Week 16 vs ustekinumab
9th PASI 90 at Week 52 vs ustekinumab 10th PASI 100 at Week 52 vs ustekinumab
11th sPGA 0 (clear) at Week 52 vs ustekinumab
12th PASI 75 at Week 12 vs ustekinumab
13th sPGA 0/1 (clear or almost clear) at Week 12 vs ustekinumab
14th DLQI 0 or 1 at Week 16 vs ustekinumab
15th Change from baseline in PSS at Week 16 vs placebo
All ranked secondary endpoints were met.
*Dosing of ustekinumab was 90mg for patients weighing over 100kg.
DLQI, Dermatology Life Quality Index; PASI, Psoriasis Area Severity Index; PSS, psoriasis symptom scale; sPGA, static Physicians’ Global Assessment.
UltiMMa-1 and UltiMMa-2 OLE baseline demographics2
*Stratlflcation factors for randomisation. Data are mean (SD) or n (%) unless otherwise specified.
BMI, body mass index; BSA, body surface area; DLQI, Dermatology Life Quality Index; OLE, open-label extension; PASI, Psoriasis Area and Severity Index; SD, standard deviation; sPGA, static Physician’s Global Assessment; TNF, tumour necrosis factor.
SKYRIZI demonstrated a consistent safety profile in the UltiMMa OLE at 2.5 years⁵
Adapted from Strober B. et al. 2019.
aEvents with onset after the first dose of risankizumab until 20 weeks after last dose of risankizumab. E/100PY, events per 100 patient years.
†Deaths were reported as not related to treatment.
Featured content
The York Experience
Dr Keith Wu and Pauline Stopford- Taylor revisit their experience setting up a specialist service in York. They also illustrate the convenience in dosing and impact of SKYRIZI by sharing their treatment journey with a patient whose psoriasis of the hands was affecting his ability to act as a primary carer for his wife.
UK-RISN-240176. Date of preparation May 2024.
References
- Reich K, et al. Lancet 2019; 394: 576-586.
- Gordon KB, et al. Lancet 2018; 392: 650-661.
- Warren RB, et al. Risankizumab vs Secukinumab in Patients with Moderate-to-Severe Plaque Psoriasis: A Phase 3 Trial, Presented at AAD 2020.
- SKYRIZI: Summary of Product Characteristics.
- Strober B, et al. Poster 1714, presented at the 28th European Academy of Dermatology and Venereology (EADV) Congress, 9-13 October 2019, Madrid, Spain.
- Lebwohl MD, et al. Integrated analysis of UltIMMa 1&2. Poster presented at AAD March 2019; P8108.
UK-RISN-240139. Date of preparation: May 2024.