Ustekinumab

(Stelara®)

Ustekinumab

Drug updated on 8/25/2023

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

Indication

  • For the treatment adult patients with moderate to severe plaque psoriasis (Ps) who are candidates for phototherapy or systemic therapy, active psoriatic arthritis (PsA), moderately to severely active Crohn’s disease (CD), or moderately to severely active ulcerative colitis.
  • For the treatment 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).

Product Monograph / Prescribing Information

Document TitleYearSource
Stelara (ustekinumab) Prescribing Information.2022Janssen Biotech, Inc., Horsham, PA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Efficacy, effectiveness, and safety of ustekinumab for the treatment of ulcerative colitis: a systematic review.2023Inflammatory Bowel Diseases
Real-world evidence of the effectiveness and safety of ustekinumab for the treatment of Crohn’s disease: systematic review and meta-analysis of observational studies.2022Journal of Clinical Medicine
A systematic review with meta-analysis of comparative efficacy and safety of risankizumab and ustekinumab for psoriasis treatment.2022Journal of Immunology Research
Effectiveness of reinduction and/or dose escalation of ustekinumab in Crohn’s disease: a systematic review and meta-analysis.2021Clinical Gastroenterology and Hepatology
Alternative uses of ustekinumab for non-indicated dermatological conditions: a systematic review.2021Archives of Dermatological Research
Is ustekinumab effective in refractory Crohn’s disease of the pouch and chronic pouchitis? A systematic review.2021Digestive Diseases and Sciences
Targeted immune modulators for ulcerative colitis: effectiveness and value.2020ICER
Clinical review report: ustekinumab (Stelara/Stelara I.V.)2020CADTH
Assessment report: Stelara.2020EMA
Efficacy of ustekinumab vs. advanced therapies for the treatment of moderately to severely active ulcerative colitis: a systematic review and network meta-analysis.2020Current Medical Research and Opinion
Effectiveness and safety of ustekinumab for the treatment of Crohn’s disease in real-life experiences: a meta-analysis of observational studies.2019Expert Opinion on Biological Therapy
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
Effectiveness and safety of ustekinumab for crohn's disease; systematic review and pooled analysis of real-world evidence.2019Digestive and Liver Disease

Clinical Practice Guidelines