Guselkumab

(Tremfya®)

Tremfya®

Drug updated on 5/17/2024

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.

Latest News

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Summary
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  • Guselkumab (Tremfya) is indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis and active psoriatic arthritis. It targets the interleukin-23 pathway, which plays a crucial role in psoriatic disease pathogenesis.
  • The information about this drug was derived from 17 systematic reviews/meta-analyses documents that provide comprehensive analysis regarding its safety and effectiveness compared to other systemic therapies and biologics.
  • In terms of skin efficacy, guselkumab has been highlighted for superior performance in achieving high Psoriasis Area and Severity Index responses, particularly PASI 90, compared to many other agents including TNF inhibitors and JAK inhibitors.
  • For arthritic efficacy in PsA cases, guselkumab demonstrated comparable American College of Rheumatology response rates to other biologics such as IL-17 inhibitors and TNF inhibitors.
  • Relative to other biologics/systemic therapies used for treating these conditions, guselkumab showed a similar rate of serious adverse events, presenting an overall favorable safety profile without significant increase in risk factors like serious infections.
  • Subgroup considerations reveal robust utility across various patient scenarios ranging from those previously untreated or those who had an inadequate response to prior treatments including different types of biologic drugs like ustekinumab.
  • The long-term analyses show sustained PASI responses over periods extending up to 48 weeks or more, along with stable safety profiles, indicating its suitability for long-term management plans.
  • In comparison studies against newer/older biologicals, guselkumab often ranks similarly on both efficacy and safety parameters, especially over longer durations, even though some IL-17 inhibitors may demonstrate slight superiority at certain endpoints.

Product Monograph / Prescribing Information

Document TitleYearSource
Tremfya (guselkumab) Prescribing Information.2023Janssen Biotech, Inc., Horsham, PA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Comparative effectiveness of guselkumab in psoriatic arthritis: updates to a systematic literature review and network meta-analysis.2023Rheumatology
Efficacy and safety of IL-23 inhibitors in the treatment of psoriatic arthritis: a meta-analysis based on randomized controlled trials.2023Immunologic Research
Targeted systemic therapies for psoriatic arthritis: a systematic review and comparative synthesis of short-term articular, dermatological, enthesitis and dactylitis outcomes.2022RMD Open
Targeted therapies for patients with moderate-to-severe psoriasis: a systematic review and network meta-analysis of PASI response at 1 year. 2022The Journal of Dermatological Treatment
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta‐analysis.2022The Cochrane Database of Systematic Reviews
Network meta-analysis comparing the efficacy of biologic treatments for achieving complete resolution of nail psoriasis.2021Journal 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-analysis.2021Dermatology and Therapy
Comparative efficacy and relative ranking of biologics and oral therapies for moderate-to-severe plaque psoriasis: a network meta-analysis.2021Dermatology and Therapy
Comparative effectiveness of guselkumab in psoriatic arthritis: results from systematic literature review and network meta-analysis.2021Rheumatology
Comparative safety and benefit-risk profile of biologics and oral treatment for moderate-to-severe plaque psoriasis: a network meta-analysis of clinical trial data.2021Journal of the American Academy of Dermatology
Number needed to treat network meta-analysis to compare biologic drugs for moderate-to-severe psoriasis.2020Advances in Therapy
Treatment of erythrodermic psoriasis with biologics: a systematic review.2020Journal of the American Academy of Dermatology
Targeted therapies for patients with moderate-to-severe psoriasis: a systematic review and network meta-analysis of PASI response at 1 year.2020Journal of Dermatological Treatment
Adjusted treatment comparisons between guselkumab and ustekinumab for treatment of moderate-to-severe plaque psoriasis: the COMPASS analysis.2020British Journal of Dermatology
Assessing the short-term efficacy and safety of guselkumab for moderate-to-severe plaque psoriasis: meta-analysis of randomized controlled trials.2020Journal of Immunology Research
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
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

Clinical Practice Guidelines