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Durable efficacy in psoriasis achieved by SKYRIZI patients through to 4.5 years*2

84% of SKYRIZI patients achieved PASI 90 at 232 weeks*2

aBecause of differences in base study lengths, some patients enrolled in the LIMMitless study earlier than 52 weeks.

Adapted from Papp K, et al. 2021.

*Data from LIMMitless; an ongoing phase 3, single-arm, multicentre, international, open-label extension in which all patients receive SKYRIZI (150 mg) every 12 weeks. The 232 week analysis included patients who were initially randomized to receive SKYRIZI (150 mg) in 1 of 5 base phase II/III studies. Results from 232 week interim analysis including integrated data from five phase 2/3 studies (UltIMMA-1, UltIMMa-2, SustaIMM, IMMvent, and NCT03255382) and the LIMMitless study. Efficacy was assessed every 12 weeks by PASI 90, PASI 100, sPGA 0/1, mean PASI percent improvement. Quality of life was assessed every 24 weeks by DLQI 0/1. LOCF (last observation carried forward): used completed evaluation from the most recent visit to impute missing data at later visits. PASI 90 = 90% improvement in Psoriasis Area and Severity Index.

59% of SKYRIZI patients achieved PASI 100 at 232 weeks*2

Adapted from Papp K, et al. 2021.

*Data from LIMMitless; an ongoing phase 3, single-arm, multicentre, international, open-label extension in which all patients receive SKYRIZI (150 mg) every 12 weeks. The 232 week analysis included patients who were initially randomized to receive SKYRIZI (150 mg) in 1 of 5 base phase II/III studies. Results from 232 week interim analysis including integrated data from five phase 2/3 studies (UltIMMA-1, UltIMMa-2, SustaIMM, IMMvent, and NCT03255382) and the LIMMitless study. Efficacy was assessed every 12 weeks by PASI 90, PASI 100, sPGA 0/1, mean PASI percent improvement. Quality of life was assessed every 24 weeks by DLQI 0/1. LOCF (last observation carried forward): used completed evaluation from the most recent visit to impute missing data at later visits. PASI 90 = 90% improvement in Psoriasis Area and Severity Index.


Long-Term Benefit–Risk Profiles of Treatments for Moderate-to-Severe Plaque Psoriasis: A Network Meta-Analysis3

Results are not from a head-to-head study.

Limitations of NMAs

Network meta-analyses simultaneously analyze all direct and indirect evidence for comparisons of treatments across the network. The main consideration for limitations in a network meta-analysis are to ensure that the relative contributions of different sources of direct evidence, which may have different study limitations, are accounted for appropriately. Judgments should be made across comparisons, considering potential differences between the populations, treatments, and outcomes by the network meta-analysis.

Limitations of this study

The current analysis is limited to outcomes at 48-56 weeks. This analysis is based on data obtained from 215 RCTs from 689 publications. The results need to be validated using real-world data that reflect actual utilization and outcomes patterns in the psoriasis population to evaluate its generalisability.

Patients achieving PASI 90 (weeks 48-56)

Adapted from Armstrong et al 2022

Patients achieving PASI 100 (weeks 48-56)

Adapted from Armstrong et al 2022

 

Posterior median for Rate of Any Adverse Events (weeks 48-56)

Adapted from Armstrong et al 2022

Posterior median for the Rate of Any Serious Adverse Events (weeks 48-56)

Adapted from Armstrong et al 2022

Posterior median for the Rate of Adverse Events leading to Treatment Discontinuation

Adapted from Armstrong et al 2022

Objectives

Bayesian network meta-analyses (NMs) were conducted to compare the efficacy (at least a 75/90/100% reduction in PASI score from baseline) and safety outcomes (any adverse event [E], any serious AE (SAE), and AEs loading to treatment discontinuation) of each treatment evaluated between Weeks 48 and 56 after baseline.

This systematic literature review was originally conducted on December 4,2017, and updated on September 17, 2018, February 19, 2021, and May 2, 2021. The 2021 update incorporates recently licensed biologics in Europe and the US, covering all doses published in randomized controlled trials (RCTs).

Study selection

215 RCTs from 689 publications through May 2, 2021. A total of 14 studies were included in the MAs of long-term efficacy and safety outcomes, while 201 were excluded. The searched databases include Embase, MEDLINE, and the Cochrane library. Additional searches were conducted for the reference lists of included studies, conference proceedings, previous health technology assessment submissions, and clinical trial registries.

Data analysis

Rankings were quantified by the surface under the cumulative ranking curve (SUCRA). The benefit-risk profiles of treatments were assessed by bidimensional plots of the NMA-estimated efficacy and safety outcomes.

Study funding

AbbVie Inc, funded the study and participated in the study design, research, analysis, data collection,  interpretation of data, review, and approval of the publication. No honoraria or payments were made for authorship.

Select definitions

SUCRA: The surface under the cumulative ranking curve, a simple transformation of the mean rank, is used to provide a hierarchy of the treatments and accounts both for the location and the variance of all relative treatment effects. The larger the SUCRA value, the better the rank of the treatment.

Clear/nearly clear: At least a 75/90/100% reduction in PSI score from baseline improvement in PASI.

Tolerability: Withdrawal due to any adverse event.

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Superior efficacy in psoriasis with fewer injections vs. secukinumab at 52 Weeks4,5

87% of SKYRIZI patients achieved PASI 90 at Week 52 after 5 doses compared with 57% of secukinumab patients after 16 doses†4,5

Adapted from Warren et al. 2020

Data from IMMerge, a phase III, global, multicentre, randomised, open-label, efficacy assessor-blinded active-comparator study in adult patients with moderate to severe plaque psoriasis.
NRI, non-responder imputation; PASI, Psoriasis Area and Severity Index. P-values for comparison vs secukinumab: *P<0.001 multiplicity controlled.
Data assessed for intent-to-treat population. Adjusted difference CI values: 96.25% at Week 16 and 95%; P values calculated from the Cochran-Mantel-Haenszel test, stratified by weight (≤100 kg vs >100 kg) and prior systemic biologic use for psoriasis.
Each dose for SKYRIZI given as two 75-mg subcutaneous injections, each dose for secukinumab given as two 150-mg subcutaneous injections.
SKYRIZI demonstrated superiority at Week 52 across primary and all ranked secondary endpoints.4,5
Co-primary endpoints were met:

  • Non-inferiority of SKYRIZI vs secukinumab at Week 16 (PASI 90: 74% vs 66%)
  • Superiority of SKYRIZI vs secukinumab at Week 52 (PASI 90: 87% vs 57%, P<0.001)

66% of SKYRIZI patients achieved PASI 100 at Week 52 after 5 doses compared with 40% of secukinumab patients after 16 doses†3,4

Adapted from Warren et al. 2020

Data from IMMerge, a phase III, global, multicentre, randomised, open-label, efficacy assessor-blinded active-comparator study in adult patients with moderate to severe plaque psoriasis.
NRI, non-responder imputation; PASI, Psoriasis Area and Severity Index. P-values for comparison vs secukinumab: *P<0.001 multiplicity controlled.
Data assessed for intent-to-treat population. Adjusted difference CI set at 95%; P values calculated from the Cochran-Mantel-Haenszel test, stratified by weight (≤100 kg vs >100 kg) and prior systemic biologic use for psoriasis.
Each dose for SKYRIZI given as two 75-mg subcutaneous injections, each dose for secukinumab given as two 150-mg subcutaneous injections.
All ranked secondary endpoints were met, including statistically significant superiority of SKYRIZI vs secukinumab at Week 52 (PASI 100: 66% vs 40%, P<0.001). Co-primary endpoints were met: PASI 90 at Week 16 (non-inferiority) and PASI 90 at Week 52 (superiority)3,4


Superior efficacy in psoriasis vs. ustekinumab6-8

Over 80% of patients achieve PASI 90 with SKYRIZI at 52 weeks.a7

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 with moderate to severe plaque psoriasis.7 
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).

At least twice as many patients achieve completely clear skin (PASI 100) with SKYRIZI vs. ustekinumab at 52 weeks.7

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.7
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).

More than 80% of SKYRIZI patients maintained PASI 90 through to 2.5 years6

UltIMMa open-label extension PASI 90 (LOCF)6

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.

More than 60% of SKYRIZI patients maintained PASI 100 through to 2.5 years6

UltlMMa open-label extension PASI 100 (LOCF)6

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.

Significantly higher rates of PASI 90 and sPGA O or 1 vs. placebo at Week 167,8

Co-primary endpoints: Proportion of patients who achieved PASI 90 response and sPGA of 0 or 1 (clear or almost clear) at Week 16 with SKYRIZI vs. placebo. Both co-primary endpoints were met in both studies (P<0.0001).


Over 70% of patients reach DLQI 0 or 1 at one year with SKYRIZI

Compared with up to 47% with ustekinumaba8

How many of your patients could reach a point where psoriasis no longer affects their quality of life? 

Adapted from Gordon et al. 20188

P<0.0001 vs. ustekinumab

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.8
DLQI, Dermatology Life Quality Index
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).

How many of your patients could reach a point where psoriasis no longer affects their quality of life? 


Superior efficacy vs. adalimumab in psoriasis9

Significantly more patients achieve PASI 90 with SKYRIZI vs. adalimumab at 16 weeks.9

Proportion of patients achieving PASI 90 through to Week 16 in the IMMvent pivotal trial 

IMMvent was a phase III, randomised, double-blind, active-controlled study evaluating the efficacy and safety of SKYRIZI compared with adalimumab in adult patients with moderate to severe plaque psoriasis. SKYRIZI n=301. adalimumab n=304.
Co-primary endpoints for Part A - PASI 90 & sPGA 0/1 at Week 16. SKYRIZI vs. adalimumab were met P<0.001.
Intention to treat population.

Significantly more patients achieve PASI 100 with SKYRIZI vs. adalimumab at 16 weeks.9

Proportion of patients achieving PASI 100 through to Week 16 in the IMMvent pivotal trial 

IMMvent was a phase III, randomised, double-bllnd. active-controlled study evaluating the efficacy and safety of SKYRIZI compared with adalimumab In adult patients with moderate to severe plaque psoriasis. SKYRIZI n=301, adalimumab n=304.
Co-primary endpoints for Part A - PASI 90 & sPGA 0/1 at Week 16. SKYRIZI vs. adalimumab were met P<0.001.
Intention to treat population.

SKYRIZI significantly improved PASI 90 in inadequate or partial responders after switching from adalimumab9

66% of SKYRIZI patients achieved PASI 90 at Week 44 vs 21% continuing on adalimumab9

Inadequate or partial response In the IMMvent study was defined as >PASI 50 to <PASI 90 at Week 16 in patients receiving adalimumab.
Not depicted: IMMvent Part A (baseline to Week 16). SKYRIZI (n=301): adalimumab (n=304). PASI 90 at Week 16: SKYRIZI 72.4%; adalimumab 47.4% (P<0.001), Inadequate or partial responders only (≤PASI 50 to <PASI 90).
Co-primary endpoints for Part A - PASI 90 & sPGA 0/1 at Week 16. SKYRIZI vs. adalimumab were met P<0.001.
aPrimary endpoint for Part B, PASI 90 at Week 44 in re-randomised patients.

SKYRIZI significantly improved skin clearance (PASI 100) in inadequate or partial responders after switching from adalimumab9

40% of SKYRIZI patients achieved PASI 100 at Week 44 vs 7% continuing on adalimumab9

Inadequate or partial response In the IMMvent study was defined as ≥PASI 50 to <PASI 90 at Week 16 in patients receiving adalimumab. Not depicted: IMMvent Part A (baseline to Week 16). SKYRIZI (n=301); adalimumab (n=304). PASI 90 at Week 16: SKYRIZI 72.4%; adalimumab 47.4% (P<0.001). Inadequate or partial responders only (≥PASI 50 to <PASI 90) were rerandomised to Part B. Primary endpoint for Part B was PASI 90 at Week 44 with SKYRIZI vs. adalimumab among those with PASI 50-<PASI 90 after 16 weeks of adalimumab treatment. Part B endpoint was met (P<0.001).
Co-primary endpoints for Part A - PASI 90 & sPGA 0/1 at Week 16. SKYRIZI vs. adalimumab were met P<0.001.
aRanked secondary endpoint.


Durable control of psoriatic arthritis signs and symptoms10-12

Primary Endpoint ACR20 Response

*P<0.00111,12

Adapted from Kristensen et al. 2021

aBased on full analysis set, NRI-C was used for missing data.
bBased on full analysis set, NRI (as observed with imputation) was used for missing data.
Two randomized, double-blind, placebo-controlled studies assessing the safety and efficacy of 1,407 patients (964 in KEEPsAKE-1 and 443 in KEEPsAKE-2) ≥18 years old with active PsA.
DB, double-blind; NRI, nonresponder imputation; NRI-C, nonresponder imputation incorporating multiple imputation to handle missing data due to COVID-19; PBO, placebo.

ACR50 Response Over Time

*P<0.00110,11

Adapted from Kristensen et al. 2021

aBased on full analysis set, NRI-C was used for missing data.
bBased on full analysis set, NRI (as observed with imputation) was used for missing data.
Two randomized, double-blind, placebo-controlled studies assessing the safety and efficacy of 1,407 patients (964 in KEEPsAKE-1 and 443 in KEEPsAKE-2) ≥18 years old with active PsA.
DB, double-blind; NRI, nonresponder imputation; NRI-C, nonresponder imputation incorporating multiple imputation to handle missing data due to COVID-19; PBO, placebo.

ACR70 Response Over Time

*P<0.00110,11

Adapted from Kristensen et al. 2021

aBased on full analysis set, NRI-C was used for missing data.
bBased on full analysis set, NRI (as observed with imputation) was used for missing data.
Two randomized, double-blind, placebo-controlled studies assessing the safety and efficacy of 1,407 patients (964 in KEEPsAKE-1 and 443 in KEEPsAKE-2) ≥18 years old with active PsA.
DB, double-blind; NRI, nonresponder imputation; NRI-C, nonresponder imputation incorporating multiple imputation to handle missing data due to COVID-19; PBO, placebo.

Resolution of Enthesitis with SKYRIZI at Week 5210

cPooled from KEEPsAKE 1 and KEEPsAKE 2.
dAmong patients with LEI >0
eAmong patients with LDI >0 

Resolution of Dactylitis with SKYRIZI at Week 5210


SKYRIZI efficacy vs ustekinumab in
psoriasis7

SKYRIZI efficacy vs secukinmab in psoriasis4,5

SKYRIZI efficacy vs adalimumab in
psoriasis9

References

  1. SKYRIZI: Summary of Product Characteristics.
  2. Papp K, et al. Long-Term Efficacy and Safety of Risankizumab for the Treatment of Moderate-to-Severe Plaque Psoriasis: Interim Analysis of the LIMMitless Open-Label Extension Trial Beyond 3.5 Years of Follow-Up. Poster 1354. Presented at the 30th European Academy of Dermatology and Venereology Congress, 29 September–2 October 2021, EADV Virtual Congress.
  3. Armstrong AW, et al. Long-Term Benefit–Risk Profiles of Treatments for Moderate-to-Severe Plaque Psoriasis: A Network Meta-Analysis. Dermatol Ther. 2022. 12:167-184. 
  4. Warren RB et al. Risankizumab vs Secukinumab in Patients with Moderate-to-Severe Plaque Psoriasis: A Phase 3 Trial, Presented at AAD 2020.
  5. Risankizumab versus secukinumab for subjects with moderate to severe plaque psoriasis. ClinicalTrials.gov identifier: NCT03478787. Updated September 20, 2019. Accessed March 2, 2020. https://clinicaltrials.gov/ct2/show/NCT03478787.
  6. Strober B, et al. Poster 1714, presented at the 28th European Academy of Dermatology and Venereology (EADV) Congress, 9-13 October 2019, Madrid, Spain.
  7. Lebwohl MD et al. Integrated analysis of UltIMMa 1&2. Poster presented at ADD March 2019 P8108.
  8. Gordon KB 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: 650-661.
  9. Reich K et al. Risankizumab compared with adalimumab in patients with moderate-to-severe plaque psoriasis (IMMvent): a randomised, double-blind, active-comparator-controlled phase 3 trial. Lancet 2019; 394: 576-586.
  10. Kristensen LE et al. Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 52-Week Results From the KEEPsAKE 1 and KEEPsAKE 2 Trials. Oral Presentation EADV 30th Congress 2021 - Anniversary Edition 29 Sept – 2 Oct 2021.
  11. Kristensen LE, et al. Ann Rheum Dis. 2021;80:1315-1316. 
  12. Östör A, et al. Ann Rheum Dis. 2021;80:138-139.

UK-RISN-220103. Date of preparation: May 2022. 


SKYRIZI® (risankizumab) is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.1
SKYRIZI® (risankizumab) alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs.1
The recommended dose of SKYRIZI is 150mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter.
SKYRIZI is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of psoriasis.
Some patients may not be suitable for SKYRIZI. You are advised to read the Prescribing Information (which can be found on tab above). Please also refer to the SKYRIZI Summary of Product Characteristics for important information including special warnings/precautions for use and summary of adverse reactions.
Study design information can be found on the Study Design page.

Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk.
Adverse events should also be reported to AbbVie on GBPV@abbvie.com