Plaque psoriasis: SKYRIZI (risankizumab) is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.1
Psoriatic arthritis: SKYRIZI alone or in combination with methotrexate, 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
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Long-Term Benefit–Risk Profiles of Treatments for Moderate-to-Severe Plaque Psoriasis: A Network Meta-Analysis2
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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References
- SKYRIZI: Summary of Product Characteristics.
- 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.
- 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 ADD March 2019 P8108.
- 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.
- Warren RB et al. Risankizumab vs Secukinumab in Patients with Moderate-to-Severe Plaque Psoriasis: A Phase 3 Trial, Presented at AAD 2020.
- 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.
- 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.
UK-RISN-220211. Date of preparation: July 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 [email protected]
