Guselkumab

(Tremfya®)

Tremfya®

Drug updated on 12/11/2024

Dosage FormInjection (subcutaneous; 100 mg/mL)
Drug ClassInterleukin-23 blockers
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy
  • Indicated for the treatment of adult patients of active psoriatic arthritis.

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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]
  • Palmoplantar Pustulosis (PPP): Guselkumab showed efficacy in treating PPP, with a Palmoplantar Pustulosis Area and Severity Index (PPPASI)-50 response ranging from 57.4% to 78.3% at week 16. A network meta-analysis found a significant improvement in palmoplantar score (weighted mean difference of 31.73).
  • Psoriatic Arthritis (PsA): Guselkumab had a significantly higher the American College of Rheumatology (ACR)20 response rate compared to placebo (relative risk (RR) = 1.74) and demonstrated better skin efficacy (the Psoriasis Area and Severity Index (PASI) 90) than tumor necrosis factor (TNF) and Janus kinase (JAK) inhibitors. ACR responses were similar to IL-17 inhibitors, risankizumab, and upadacitinib.
  • Psoriasis: Guselkumab was more effective than adalimumab in achieving PASI 75, PASI 90, and Investigator's Global Assessment (IGA) 0/1 scores. It consistently ranked highly in network meta-analyses for achieving PASI 90 and PASI 100, outperforming biologics such as ustekinumab and anti-TNF agents.
  • Comparison with Other Drugs: Guselkumab was superior to ustekinumab, adalimumab, and certolizumab in achieving PASI 90 responses, with some comparisons showing risankizumab, ixekizumab, and brodalumab having higher PASI responses.
  • General Safety: Guselkumab had a similar incidence of adverse events (AEs) and serious adverse events (SAEs) compared to placebo and adalimumab. Common adverse effects included nasopharyngitis, headache, upper respiratory tract infection, and back pain.
  • Specific Adverse Effects: Elevated transaminases were more frequent in the guselkumab group compared to placebo, but there was no significant difference in the risk of infections or serious infections.
  • Guselkumab was effective and safe across various subgroups, including patients with PPP, PsA, and moderate-to-severe psoriasis. Clinically relevant findings include significant improvements in skin manifestations (PASI 90) for PsA patients and long-term efficacy and safety in moderate-to-severe psoriasis. Additionally, improvements in work productivity and activity impairment were noted in PsA patients.

Product Monograph / Prescribing Information

Document TitleYearSource
Tremfya (guselkumab) Prescribing Information.2024Janssen Biotech, Inc., Horsham, PA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
A systematic review of recent randomized controlled trials for palmoplantar pustulosis2024The Journal of Dermatological Treatment
Efficacy and safety of pharmacological treatment of psoriatic arthritis: a systematic literature research informing the 2023 update of the EULAR recommendations for the management of psoriatic arthritis2024Annals of the Rheumatic Diseases
Small-Molecule Inhibitors and Biologics for Palmoplantar Psoriasis and Palmoplantar Pustulosis: A Systematic Review and Network Meta-Analysis2024American Journal of Clinical Dermatology
Improvement in work productivity among psoriatic arthritis patients treated with biologic or targeted synthetic drugs: a systematic literature review and meta-analysis2024Arthritis Research & Therapy
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis2023The Cochrane Database of Systematic Reviews
Efficacy and safety of IL-23 inhibitors in the treatment of psoriatic arthritis: a meta-analysis based on randomized controlled trials2023Immunologic Research
Comparative effectiveness of guselkumab in psoriatic arthritis: updates to a systematic literature review and network meta-analysis2023Rheumatology (Oxford, England)
Adverse Effects of Anti-Interleukin-23 Agents Employed in Patients with Psoriasis: A Systematic Review2022Dermatology (Basel, Switzerland)
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis2022The Cochrane Database of Systematic Reviews
Targeted systemic therapies for psoriatic arthritis: a systematic review and comparative synthesis of short-term articular, dermatological, enthesitis and dactylitis outcomes2022RMD Open
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
Cost per responder analysis of guselkumab versus targeted therapies in the treatment of moderate to severe plaque psoriasis in Germany2022The 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
Short-Term Efficacy of Biologic Therapies in Moderate-to-Severe Plaque Psoriasis: A Systematic Literature Review and an Enhanced Multinomial Network Meta-Analysis2021Dermatology and Therapy
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis2021The Cochrane Database of Systematic Reviews
Relative efficacy and safety of secukinumab and guselkumab for the treatment of active psoriatic arthritis: A network meta-analysis2021International Journal of Clinical Pharmacology and Therapeutics
Comparative effectiveness of guselkumab in psoriatic arthritis: results from systematic literature review and network meta-analysis2021Rheumatology (Oxford, England)
Biologic disease modifying antirheumatic drugs and Janus kinase inhibitors in paediatric rheumatology - what we know and what we do not know from randomized controlled trials2021Pediatric Rheumatology Online Journal
Comparative safety and benefit-risk profile of biologics and oral treatment for moderate-to-severe plaque psoriasis: A network meta-analysis of clinical trial data2021 Journal of the American Academy of Dermatology
Network meta-analysis of biologic treatments for psoriasis using absolute Psoriasis Area and Severity Index values </=1, 2, 3 or 5 derived from a statistical conversion method2021Journal of the European Academy of Dermatology and Venereology
Cost per cumulative clinical benefit of biologic therapies for patients with plaque psoriasis: a systematic review2021Journal of Managed Care & Specialty Pharmacy
A Systematic Literature Review and Bucher Indirect Comparison: Tildrakizumab versus Guselkumab2020Journal of Health Economics and Outcomes Research
Assessing the Short-Term Efficacy and Safety of Guselkumab for Moderate-to-Severe Plaque Psoriasis: Meta-Analysis of Randomized Controlled Trials2020Journal of Immunology Research
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
Pharmacological treatment of psoriatic arthritis: a systematic literature research for the 2019 update of the EULAR recommendations for the management of psoriatic arthritis2020Annals of the Rheumatic Diseases
Efficacy of pharmacological treatment in rheumatoid arthritis: a systematic literature research informing the 2019 update of the EULAR recommendations for management of rheumatoid arthritis2020Annals of the Rheumatic Diseases
Comparison of Biologics and Oral Treatments for Plaque Psoriasis: A Meta-analysis2020JAMA Dermatology
Interventions for chronic palmoplantar pustulosis2020The Cochrane Database of Systematic Reviews
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-analysis2020Journal 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

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