Guselkumab

(Tremfya®)

Tremfya®

Drug updated on 9/4/2024

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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  • Tremfya (guselkumab) is indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, and for the treatment of adult patients with active psoriatic arthritis.
  • This summary is based on the review of 17 systematic review(s)/meta-analysis(es). [1-17]
  • Guselkumab (100 mg Q8W) showed comparable ACR 20, 50, and 70 response rates to IL-17A inhibitors and subcutaneous TNF inhibitors, with significant improvement in ACR20 response compared to placebo.
  • Guselkumab demonstrated superior PASI 75, 90, and 100 responses compared to placebo and adalimumab, and was among the top-performing drugs for PASI responses, comparable to risankizumab, brodalumab, and ixekizumab for PASI 100.
  • Guselkumab Q8W was effective in improving the modified van der Heijde-Sharp (vdH-S) score, showing similar effectiveness to risankizumab and superior to most other agents, except intravenous TNF therapies.
  • Guselkumab showed high efficacy in resolving enthesitis and dactylitis, comparable to IL-17A and IL-17RA inhibitors, and demonstrated high effectiveness in achieving clear or almost clear skin (PASI 90).
  • Guselkumab had a similar incidence of adverse events compared to placebo and adalimumab, with lower rates of adverse events compared to brodalumab and ixekizumab. The rates of adverse events leading to treatment discontinuation were low.
  • No statistical difference in serious adverse events was observed between guselkumab and placebo, with a comparable rate of serious adverse events to most other agents. Some reports indicated a higher rate of elevated transaminases compared to placebo.
  • Guselkumab showed no significant association with infections or serious infections compared to placebo or adalimumab. Elevated transaminases were noted as a specific safety concern.
  • There is no population types or subgroups information available in the reviewed studies.

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

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