Ustekinumab-aekn

(Selarsdi®)

Ustekinumab-aekn

Drug updated on 10/18/2024

Dosage FormInjection (subcutaneous; 45 mg/0.5 mL, 90 mg/mL)
Drug ClassInterleukin-12 and -23 antagonists
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult patients with moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy
  • Indicated for the treatment of adult patients with active psoriatic arthritis (PsA)
  • 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
  • Indicated for the treatment of pediatric patients 6 years and older with 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). [1-32]
  • Psoriasis: Ustekinumab demonstrated higher PASI75 (HAQ (Health Assessment Questionnaire)-DI (Disability Index)) and PASI90 response rates compared to placebo but was generally less effective than newer biologics (ixekizumab, bimekizumab, and risankizumab) for achieving PASI90 and PASI100 (RD (Radiographic Damage)).
  • Psoriatic Arthritis: Ustekinumab showed improvements in ACR (PsARC) response criteria but was less effective in some studies compared to infliximab and golimumab. Its efficacy in preventing radiographic progression was lower than adalimumab and infliximab.
  • Atopic Dermatitis: No significant differences were observed in treatment outcomes for SOC (Standard of Care) populations compared to dupilumab.
  • Pediatric Psoriasis: Ustekinumab showed the best efficacy and lowest adverse effects among biologics in children.
  • Ustekinumab was generally well-tolerated, with common adverse events including nasopharyngitis, headaches, and upper respiratory tract infections. Serious adverse events were comparable to placebo.
  • Grade 3 and 4 adverse effects, both immunological and non-immunological, were noted but were overall well-tolerated.
  • There was no significant increase in the risk of major adverse cardiovascular events (MACE) compared to placebo, and the safety profile was similar to other biologics, including adalimumab, infliximab, and secukinumab.
  • There is no population types or subgroups information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Selarsdi (ustekinumab-aekn) Prescribing Information.2024Teva Pharmaceuticals Parsippany, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
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
Risk of Major Adverse Cardiovascular Events in Immune-Mediated Inflammatory Disorders on Biologics and Small Molecules: Network Meta-Analysis2024Clinical gastroenterology and hepatology
Cost-effectiveness analysis of bimekizumab for the treatment of active psoriatic arthritis in Sweden2023Journal of Medical Economics
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis2023The Cochrane Database of Systematic Reviews
Biologic Disease-Modifying Antirheumatic Drugs for Preventing Radiographic Progression in Psoriatic Arthritis: A Systematic Review and Network Meta-Analysis2022Pharmaceutics
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
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
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis2022The Cochrane Database of Systematic Reviews
Efficacy of Systemic Biologic Drugs in Pediatric Psoriasis: Evidence From Five Selected Randomized Clinical Trials2022Frontiers in Pharmacology
Number Needed to Treat Network Meta-Analysis to Compare Biologic Drugs for Moderate-to-Severe Psoriasis2022Advances in Therapy
Network meta-analysis comparing the efficacy of biologic treatments for achieving complete resolution of nail psoriasis2022The Journal of Dermatological Treatment
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
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
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis2021The Cochrane Database of Systematic Reviews
Cost per cumulative clinical benefit of biologic therapies for patients with plaque psoriasis: a systematic review2021Journal of Managed Care & Specialty Pharmacy
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
Effectiveness and Safety of Systemic Therapy for Psoriasis in Older Adults: A Systematic Review2020JAMA Dermatology
Short-term effectiveness of biologics in patients with moderate-to-severe plaque psoriasis: A systematic review and network meta-analysis2020Journal of Dermatological Science
Efficacy of Brodalumab for Moderate to Severe Plaque Psoriasis: A Canadian Network Meta-Analysis2020Journal of Cutaneous Medicine and Surgery
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
Indirect comparison of anti-interleukin 17 targeted biological treatments for moderate-to-severe psoriasis2020Journal of clinical Pharmacy and Therapeutics
Efficacy and safety of biologics in psoriatic arthritis: a systematic literature review and network meta-analysis2020RMD Open
Biological DMARD efficacy in psoriatic arthritis: a systematic literature review and meta-analysis on articular, enthesitis, dactylitis, skin and functional outcomes2020Clinical and Experimental Rheumatology
Biologic Treatment in Elderly Patients With Psoriasis: A Systematic Review2020Journal of Cutaneous Medicine and Surgery
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis2020The Cochrane Database of Systematic Reviews
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
Adjusted treatment COMPArisons between guSelkumab and uStekinumab for treatment of moderate-to-severe plaque psoriasis: the COMPASS analysis2020The British Journal of Dermatology
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
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

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