Ustekinumab

(Stelara®)

Ustekinumab

Drug updated on 4/17/2024

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 antagonists
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult patients with moderate to severe plaque psoriasis (Ps) 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 Crohn’s 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).

Latest News

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Summary
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  • Ustekinumab (Stelara) demonstrates substantial efficacy in treating moderate to severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active Crohn's disease. It also is effective for adult patients with moderately to severely active ulcerative colitis and pediatric patients aged 6 years or older with moderate to severe plaque psoriasis.
  • The information is derived from a comprehensive review of 62 systematic reviews/meta-analyses focusing on safety, effectiveness, and considerations for specific populations including pediatric cases.
  • Compared to TNF-alpha antagonists like infliximab and adalimumab, ustekinumab has shown favorable results in some Crohn's disease cases, especially among biologic-experienced patients.
  • Maintenance therapy intervals using ustekinumab every 8 weeks or every 12 weeks revealed similar effectiveness outcomes in inflammatory bowel disease patients. However, most safety outcomes were significantly better with the longer interval of administration at every twelve weeks.
  • In comparison with other second-line biologics such as infliximab and vedolizumab used after first-line treatment failure in ulcerative colitis, ustekinumab was found to be less effective based on short-to-mid-term clinical remission rates post-treatment failure data analysis.
  • For fistulizing Crohn's Disease conditions, where abnormal connections form between different parts of the intestine due to its inflammation, the use of ustekinumab showed a maintenance response, but more dedicated studies are needed due to its certainty range being very low-to-moderate, suggesting limited evidence availability currently.
  • Ustekinumab's safety profile across multiple studies indicates it carries a comparable or lower risk than other systemic therapies, making it an attractive choice, particularly when long-term management is required.
  • The drug has been carefully expanded into younger population groups down to age six, showing promising results while maintaining attention towards their unique safety needs.
  • A significant amount of research has focused on assessing ustekinumab's effectiveness and safety in specific subsets of the population, including those with previous biologic therapy exposure, showcasing its viability as both a first-line option and as a subsequent choice after other treatments have failed.
  • The relevance of biomarkers in ustekinumab treatment was mentioned, highlighting the clinical attention towards therapeutic drug monitoring in Crohn's disease treatment. This suggests an evolving approach towards personalized medicine.

Product Monograph / Prescribing Information

Document TitleYearSource
Stelara (ustekinumab) Prescribing Information.2024Janssen Biotech, Inc., Horsham, PA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
A bibliometric and visual analysis of the use of ustekinumab in Crohn's disease using CiteSpace.2024Frontiers in Pharmacology
Comparative effectiveness and safety of ustekinumab at different intervals of maintenance phase in inflammatory bowel disease: a systematic review and meta-analysis.2024European Journal of Gastroenterology & Hepatology
Selection strategy of second-line biologic therapies in adult patients with ulcerative colitis following prior biologic treatment failure: systematic review and meta-analysis.2024Pharmacological Research
Pharmacological therapies for the management of fistulizing Crohn's disease: a systematic review and meta-analysis.2023Journal of Crohn’s and Colitis
Comparative efficacy of advanced therapies for achieving endoscopic outcomes in Crohn’s disease: a systematic review and network meta-analysis.2023Clinical Gastroenterology & Hepatology
The use of ultrasound to detect enthesitis as a potential guide for intervention in patients with psoriasis at risk of psoriatic arthritis: a systematic review.2023International Journal of Dermatology
Comparative speed of early symptomatic remission with advanced therapies for moderate-to-severe ulcerative colitis: a systematic review and network meta-analysis.2023American Journal of Gastroenterology
Efficacy and safety of IL-12/23 and IL-23 inhibitors for Crohn's disease: systematic review and meta-analysis.2023Digestive Diseases and Sciences
Network meta-analysis on efficacy and safety of different biologics for ulcerative colitis.2023BMC Gastroenterology
Comparative of the effectiveness and safety of biological agents, small molecule drugs, and microbiome therapies in ulcerative colitis: systematic review and network meta-analysis.2023Medicine Open
Use of biologics for the management of Crohn's disease: IG-IBD technical review based on the GRADE methodology.2023Digestive and Liver Disease
Biosimilars for the treatment of psoriasis: a systematic review of clinical trials and observational studies.2023JAMA Dermatology
The comparative efficacy and safety of biologics and small molecules for treating patients with ulcerative colitis in Portugal: a systematic literature review and network meta-analysis.2023European Review for Medical and Pharmacological Sciences
Comparative onset of effect of biologics and small molecules in moderate-to-severe ulcerative colitis: a systematic review and network meta-analysis.2023EClinicalMedicine
Comparative efficacy of advanced treatments in biologic-naïve or biologic-experienced patients with ulcerative colitis: a systematic review and network meta-analysis.2023International Journal of Clinical Pharmacy
Systematic review and meta-analysis: association between preoperative ustekinumab and surgical complications in Crohn's disease patients.2023European Surgical Research
Systematic literature review of real-world evidence on dose escalation and treatment switching in ulcerative colitis.2023ClinicoEconomics and Outcomes Research
Comparative efficacy of biologic therapies for inducing response and remission in fistulizing Crohn’s disease: systematic review and network meta-analysis of randomized controlled trials.2023Inflammatory Bowel Diseases
The efficacy and safety of biologic drugs in the treatment of moderate-severe crohn’s disease: a systematic review.2023Pharmaceuticals
An indirect comparison of efficacy including histologic assessment and safety in biologic therapy in ulcerative colitis: Systemic review and network meta-analysis.2023PLoS One
Real-world effectiveness of ustekinumab for patients with ulcerative colitis: a systematic review and meta-analysis.2023Nagoya Journal of Medical Science
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 stekinumab and stekinumab for psoriasis treatment.2022Journal of Immunology Research
Biologic disease-modifying antirheumatic drugs for preventing radiographic progression in psoriatic arthritis: a systematic review and network meta-analysis.2022Pharmaceutics
Risk of hospitalization for serious infection after initiation of ustekinumab or other biologics in patients with psoriasis or psoriatic arthritis.2022Arthritis Care & Research
Is ustekinumab effective in refractory Crohn's disease of the pouch and chronic pouchitis? A systematic review.2022Digestive Diseases and Sciences
Adherence and persistence to biological drugs for psoriasis: systematic review with meta-analysis.2022Journal of Clinical Medicine
Efficacy and safety of biologics and small molecule drugs for patients with moderate-to-severe ulcerative colitis: a systematic review and network meta-analysis.2022The Lancet Gastroenterology & Hepatology
Ustekinumab in the treatment of patients with hidradenitis suppurativa: multicenter case series and systematic review.2022Journal of Dermatological Treatment
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
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
Biologics for pediatric psoriasis: a systematic review and meta-analysis.2021Pediatric Dermatology
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
Ustekinumab is effective for perianal fistulising Crohn's disease: a real-world experience and systematic review with meta-analysis.2021BMJ Open Gastroenterology
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 trials.2021Journal of Investigative Dermatology
Postoperative outcomes after preoperative ustekinumab exposure in patients with Crohn's disease: a systematic review and meta-analysis.2021Annals of Gastroenterology
Dose adjustment of biologic treatments for moderate-to-severe plaque psoriasis in the real world: a systematic review.2021Dermatology and Therapy
Ustekinumab does not increase risk of adverse events: a meta-analysis of randomized controlled trials.2021Digestive Diseases and Sciences
Concomitant use of an immunomodulator with ustekinumab as an induction therapy for Crohn's disease: a systematic review and meta-analysis.2021Journal of Gastroenterology and Hepatology
Twelve-week secukinumab treatment is consistently efficacious for moderate-to-severe psoriasis regardless of prior biologic and non-biologic systemic treatment: Post hoc analysis of six randomised trials.2021Journal of the European Academy of Dermatology and Venereology
Efficacy of ustekinumab for active perianal fistulizing Crohn's disease: a systematic review and meta-analysis of the current literature.2021Scandinavian Journal of Gastroenterology
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
Efficacy of brodalumab for moderate to severe plaque psoriasis: a Canadian network meta-analysis.2020Journal of Cutaneous Medicine and Surgery
Comparing the efficacy and tolerability of biologic therapies in psoriasis: an updated network meta-analysis.2020British Journal of Dermatology
First- and second-line pharmacotherapies for patients with moderate to severely active ulcerative colitis: an updated network meta-analysis.2020Clinical Gastroenterology and Hepatology
Phenotypic switch to eczema in patients receiving biologics for plaque psoriasis: a systematic review.2020Journal of the European Academy of Dermatology and Venereology
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
Efficacy and safety of biologics in psoriatic arthritis: a systematic literature review and network meta-analysis.2020RMD Open
Treatment algorithms for Crohn's disease.2020Digestion
Treatment of dactylitis and enthesitis in psoriatic arthritis with biologic agents: a systematic review and metaanalysis.2020Journal of Rheumatology
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
Comparative efficacy and safety of targeted DMARDs for active psoriatic arthritis during induction therapy: a systematic review and network meta-analysis.2019Digestive and Liver Disease
Efficacy and safety of systemic treatments in psoriatic arthritis: a systematic review, meta-analysis and GRADE evaluation.2019Journal of the European Academy of Dermatology and Venereology
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
Treatment of plaque psoriasis with IL-23p19 blockers: a systematic review and meta-analysis.2019International Immunopharmacology
Association of HLA-C*06:02 status with differential response to ustekinumab in patients with psoriasis: a systematic review and meta-analysis.2019JAMA Dermatology
Long-term efficacy of novel therapies in moderate-to-severe plaque psoriasis: a systematic review and network meta-analysis of PASI response.2019Journal of the European Academy of Dermatology and Venereology
Time until onset of action when treating psoriatic arthritis: meta-analysis and novel approach of generating confidence intervals.2019Rheumatology International
Dual biological therapy with anti-TNF, vedolizumab or ustekinumab in inflammatory bowel disease: a systematic review with pool analysis.2019Scandinavian Journal of Gastroenterology
Comparative efficacy and safety of thirteen biologic therapies for patients with moderate or severe psoriasis: a network meta-analysis.2019Journal of Pharmacological Sciences

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