Risankizumab

(Skyrizi®)

Risankizumab

Drug updated on 9/4/2024

Dosage FormInjection (subcutaneous; 150 mg/mL); Injection (intravenous; 60 mg/mL)
Drug ClassInterleukin-23 antagonists
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
  • Indicated for the treatment of active psoriatic arthritis in adults.
  • Indicated for the treatment of moderately to severely active Crohn's disease in adults.

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Summary
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  • Skyrizi (risankizumab) is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, the treatment of active psoriatic arthritis in adults, and the treatment of moderately to severely active Crohn's disease in adults.
  • This summary is based on the review of 31 systematic review(s)/meta-analysis(es). [1-31]
  • Psoriatic Arthritis (PsA): Risankizumab significantly improved ACR20 response rates (RR 1.760, 95% CI 1.568-1.977, P<0.001) and MDA response rates (RR 1.827, 95% CI 1.048-3.184, P<0.05) compared to placebo. Additionally, it improved health-related quality of life metrics including SF-36, HAQ-DI, and FACIT-F scores.
  • Crohn’s Disease (CD): Risankizumab was effective in inducing clinical remission, with RR 0.66 (95% CI 0.52-0.85) in biologic-naïve and RR 0.74 (95% CI 0.67-0.82) in biologic-experienced patients. In a real-world study, 70% of CD patients achieved clinical remission by week 12, with 63% achieving corticosteroid-free remission.
  • Psoriasis: Risankizumab demonstrated high efficacy in achieving PASI 75, 90, and 100 scores, with sustained responses over 44-60 weeks. Network meta-analyses showed its PASI 90 and PASI 100 rates were comparable to or superior to other biologics such as ixekizumab, brodalumab, and guselkumab.
  • In Psoriatic Arthritis (PsA), risankizumab showed no significant differences in serious adverse events (SAE) and serious treatment-emergent adverse events (STEAE) when compared to placebo, with similar overall adverse event (AE) incidence between the two groups.
  • For Crohn's Disease (CD), risankizumab demonstrated a favorable safety profile, with most adverse effects being mild and a decreased risk of serious adverse events compared to placebo in both induction and maintenance trials.
  • In Psoriasis, risankizumab had a low incidence of adverse events, with no significant differences in serious adverse events (SAE) compared to placebo. Long-term studies indicated the lowest rates of adverse events leading to treatment discontinuation and serious adverse events.
  • There is no population types or subgroups information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Skyrizi (risankizumab-rzaa) Prescribing Information.2024AbbVie Inc., North Chicago, IL

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Efficacy and safety of risankizumab in patients with psoriatic arthritis: a systematic review and meta-analysis of randomized controlled trials.2024Rheumatology and Therapy
Improvement in work productivity among psoriatic arthritis patients treated with biologic or targeted synthetic drugs: a systematic literature review and meta-analysis.2024Arthritis Research & Therapy
The efficacy and safety of biologic drugs in the treatment of moderate-severe Crohn’s disease: a systematic review.2023Pharmaceuticals
Efficacy of biological therapies and small molecules in induction and maintenance of remission in luminal Crohn's disease: systematic review and network meta-analysis.2023Gut
Efficacy and safety of IL-12/23 and IL-23 inhibitors for Crohn’s disease: systematic review and meta-analysis.2023Digestive Diseases and Sciences
Safety and efficacy of risankizumab in Crohn’s disease: prospective real-world experience and systematic literature review.2023Gastroenterology & Hepatology
Efficacy and safety of IL-23 inhibitors in the treatment of psoriatic arthritis: a meta-analysis based on randomized controlled trials.2023Immunologic Research
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.2022Cochrane Database of Systematic Reviews
Comparative effectiveness of guselkumab in psoriatic arthritis: updates to a systematic literature review and network meta-analysis.2022Rheumatology
Efficacy of bimekizumab and other biologics in moderate to severe plaque psoriasis: a systematic literature review and a network meta-analysis.2022Dermatology and Therapy
Targeted therapies for patients with moderate-to-severe psoriasis: a systematic review and network meta-analysis of PASI response at 1 year.2022Journal of Dermatological Treatment
A systematic review with meta-analysis of comparative efficacy and safety of risankizumab and ustekinumab for psoriasis treatment.2022Journal of Immunology Research
Anti-drug antibodies of IL-23 inhibitors for psoriasis: a systematic review.2022Journal of the European Academy of Dermatology & Venerology
Adverse effects of anti-interleukin-23 agents employed in patients with psoriasis: a systematic review.2022Dermatology
Comparative efficacy and safety of biologics in moderate to severe plaque psoriasis: a multiple-treatments meta-analysis.2021Journal of the German Society of Dermatology
Efficacy and safety of risankizumab in moderate to severe psoriasis: a systematic review and meta‐analysis.2021Dermatologic Therapy
Comparative safety and benefit-risk profile of biologics and oral treatment for moderate-to-severe plaque psoriasis: a network meta-analysis of clinical trial data.2021Journal of the American Academy of Dermatology
Comparative efficacy and relative ranking of biologics and oral therapies for moderate-to-severe plaque psoriasis: a network meta-analysis.2021Dermatology and Therapy
Short-term efficacy of biologic therapies in moderate to-severe plaque psoriasis: a systematic literature review and an enhanced multinomial network meta-analysis.2021Dermatology and Therapy
Comparative efficacy and safety of biologic therapies for moderate-to-severe Crohn's disease: a systematic review and network meta-analysis.2021The Lancet Gastroenterology & Hepatology
Network meta-analysis of biologic treatments for psoriasis using absolute Psoriasis Area and Severity Index values ≤1, 2, 3.2021Journal of European Academy of Dermatology
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.2021Cochrane Database of Systematic Reviews
Systematic review on rapidity of onset of action for interleukin-17 and interleukin-23 inhibitors for psoriasis.2020Journal of the European Academy of Dermatology and Venereology
Short-term effectiveness of biologics in patients with moderate-to -severe plaque psoriasis: a systematic review and network meta-analysis.2020Journal of Dermatological Science
Targeted therapies for patients with moderate-to-severe psoriasis: a systematic review and network meta-analysis of PASI response at 1 year. 2020Journal of Dermatological Treatment
A network meta-analysis for the comparison of efficacy and safety of interleukin (IL)-23 targeted drugs in the treatment of moderate to severe psoriasis.2020Dermatologic Therapy
Comparison of biologics and oral treatments for plaque psoriasis: a meta-analysis.2020JAMA Dermatology
Meta-analyses of clinical efficacy of risankizumab and adalimumab in chronic plaque psoriasis: supporting evidence of risankizumab superiority.2020Clinical Pharmacology and Therapeutics
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.2020Cochrane Database of Systematic Reviews
Assessing the relative efficacy of interleukin-17 and interleukin-23 targeted treatments for moderate-to-severe plaque psoriasis: a systematic review and network meta-analysis of PASI response.2019PLOS One
Short-term efficacy and safety of IL-17, IL-12/23, and IL-23 inhibitors brodalumab, secukinumab, ixekizumab, ustekinumab, guselkumab, tildrakizumab, and risankizumab for the treatment of moderate to severe plaque psoriasis: a systematic review and network meta-analysis of randomized controlled trials.2019Journal of Immunology Research

Clinical Practice Guidelines

Document TitleYearSource
Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics.2019Journal of the American Academy of Dermatology