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Ustekinumab

(Stelara®)

Stelara®

Drug updated on 12/11/2024

Dosage FormInjection (subcutaneous; 45 mg/0.5 mL or 90 mg/mL); Injection (intravenous; 130 mg/26 mL [5 mg/mL])
Drug ClassInterleukin-12 and -23 antagonists
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • IIndicated for the treatment of adult patients with moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy
  • Indicated for adults patient with active psoriatic arthritis (PsA)
  • Indicated for adult patients with moderately to severely active Crohns disease (CD)
  • Indicated for adult patients with moderately to severely active ulcerative colitis
  • Indicated for the treatment of pediatric patients 6 years and older with moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy, or active psoriatic arthritis (PsA).

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Summary
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  • This summary is based on the review of 32 systematic review(s)/meta-analysis(es). [1-31]
  • Psoriasis Treatment Effectiveness: Ustekinumab demonstrated lower effectiveness in achieving the Psoriasis Area and Severity Index (PASI) 90 compared to infliximab, bimekizumab, ixekizumab, and risankizumab in psoriasis patients.
  • Major Adverse Cardiovascular Events (MACE): Ustekinumab was associated with an increased risk of MACE compared to placebo (odds ratio (OR), 3.15; 95% credible interval (CrI), 1.01-13.35).
  • Cost-Effectiveness in Psoriatic Arthritis: Ustekinumab was found to be cost-effective compared to multiple treatments for psoriatic arthritis in Sweden.
  • Pediatric Psoriasis: Ustekinumab showed superior PASI75 response rates in pediatric psoriasis patients compared to placebo.
  • Common adverse effects in Phase III trials included nasopharyngitis, headache, and upper respiratory tract infections.
  • In pediatric psoriasis, Ustekinumab had the fewest adverse effects among biologics evaluated, indicating a favorable safety profile for children.
  • For non-white participants with atopic dermatitis and psoriasis, Ustekinumab showed no significant differential response or safety concerns; in patients with immune-mediated inflammatory diseases (IMIDs) such as inflammatory bowel disease, rheumatoid arthritis, psoriasis/psoriatic arthritis, and ankylosing spondylitis, Ustekinumab was associated with an increased risk of MACE; in pediatric psoriasis, Ustekinumab was effective and had few adverse effects; in elderly psoriasis patients (65+ years), it was effective with a good safety profile, though with a higher incidence of serious adverse events than in younger populations.

Product Monograph / Prescribing Information

Document TitleYearSource
Stelara (ustekinumab) Prescribing Information.2024Janssen Biotech, Inc., Titusville, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Risk of Major Adverse Cardiovascular Events in Immune-Mediated Inflammatory Disorders on Biologics and Small Molecules: Network Meta-Analysis2024Clinical gastroenterology and hepatology
Response to Biologic Therapy in Skin of Colour Participants With Moderate-to-Severe Psoriasis and Atopic Dermatitis: A Systematic Review2024 Journal of Cutaneous Medicine and Surgery
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis2023The Cochrane Database of Systematic Reviews
Cost-effectiveness analysis of bimekizumab for the treatment of active psoriatic arthritis in Sweden2023Journal of Medical Economics
Efficacy and safety of biological agents for the treatment of pediatric patients with psoriasis: A bayesian analysis of six high-quality randomized controlled trials2022Frontiers in Immunology
Targeted therapies for patients with moderate-to-severe psoriasis: a systematic review and network meta-analysis of PASI response at 1 year2022The Journal of Dermatological Treatment
Network meta-analysis comparing the efficacy of biologic treatments for achieving complete resolution of nail psoriasis2022The Journal of Dermatological Treatment
Number Needed to Treat Network Meta-Analysis to Compare Biologic Drugs for Moderate-to-Severe Psoriasis2022Advances in Therapy
Efficacy of Systemic Biologic Drugs in Pediatric Psoriasis: Evidence From Five Selected Randomized Clinical Trials2022Frontiers in Pharmacology
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis2022The Cochrane Database of Systematic Reviews
Biologic Disease-Modifying Antirheumatic Drugs for Preventing Radiographic Progression in Psoriatic Arthritis: A Systematic Review and Network Meta-Analysis2022Pharmaceutics
Adverse Effects of Anti-Interleukin-23 Agents Employed in Patients with Psoriasis: A Systematic Review2022Dermatology
Biologics Can Significantly Improve Dermatology Life Quality Index (DLQI) in Psoriatic Patients: A Systematic Review2022Psoriasis
Impact of Biological Agents on Imaging and Biomarkers of Cardiovascular Disease in Patients with Psoriasis: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Trials2021The Journal of Investigative Dermatology
Cost per cumulative clinical benefit of biologic therapies for patients with plaque psoriasis: a systematic review2021Journal of Managed Care & Specialty Pharmacy
Comparison of cumulative clinical benefits of biologics for the treatment of psoriasis over 16 weeks: Results from a network meta-analysis2020 Journal of the American Academy of Dermatology
FDA Approved Biologics: Can Etanercept and Ustekinumab be Considered a First-Line Systemic Therapy for Pediatric/Adolescents in Moderate to Severe Psoriasis? A Systematic Review2020Cureus
Biologic therapies targeting the interleukin (IL)-23/IL-17 immune axis for the treatment of moderate-to-severe plaque psoriasis: a systematic review and meta-analysis2020Journal of the European Academy of Dermatology and Venereology
Adjusted treatment COMPArisons between guSelkumab and uStekinumab for treatment of moderate-to-severe plaque psoriasis: the COMPASS analysis2020The British Journal of Dermatology
Short-term effectiveness of biologics in patients with moderate-to-severe plaque psoriasis: A systematic review and network meta-analysis2020Journal of Dermatological Science
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis2020The Cochrane Database of Systematic Reviews
Biologic Treatment in Elderly Patients With Psoriasis: A Systematic Review2020Journal of Cutaneous Medicine and Surgery
Biological DMARD efficacy in psoriatic arthritis: a systematic literature review and meta-analysis on articular, enthesitis, dactylitis, skin and functional outcomes2020Clinical and Experimental Rheumatology
Efficacy and safety of biologics in psoriatic arthritis: a systematic literature review and network meta-analysis2020RMD Open
Effectiveness and Safety of Systemic Therapy for Psoriasis in Older Adults: A Systematic Review2020JAMA Dermatology
Indirect comparison of anti-interleukin 17 targeted biological treatments for moderate-to-severe psoriasis2020Journal of clinical Pharmacy and Therapeutics
A network meta-analysis for the comparison of efficacy and safety of interleukin (IL)-23 targeted drugs in the treatment of moderate to severe psoriasis2020Dermatologic therapy
Efficacy of Brodalumab for Moderate to Severe Plaque Psoriasis: A Canadian Network Meta-Analysis2020Journal of Cutaneous Medicine and Surgery
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 Trials2019Journal of Immunology Research
Treatment of plaque psoriasis with IL-23p19 blockers: A systematic review and meta-analysis2019International immunopharmacology
Comparative efficacy and safety of targeted DMARDs for active psoriatic arthritis during induction therapy: A systematic review and network meta-analysis2019Seminars in Arthritis and Rheumatism

Clinical Practice Guidelines

Document TitleYearSource
Tuscany consensus for the treatment of moderate-severe psoriasis: update and focus on practical guidelines for place in therapy of anti-IL-17 and anti-IL-23 biologics.2022Italian Journal of Dermatology and Venereology
 Japanese guidance for use of biologics for psoriasis (the 2019 version)2020The Journal of Dermatology