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Guselkumab

(Tremfya®)

Tremfya®

Drug updated on 3/28/2024

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

Indication

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

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, demonstrating significant improvements in Psoriasis Area and Severity Index (PASI) scores across various trials.
  • A total of 18 systematic reviews/meta-analyses were reviewed to evaluate the safety and effectiveness of guselkumab compared to other drugs used for treating these conditions.
  • Compared to IL-17 inhibitors such as ixekizumab, secukinumab, brodalumab, guselkumab often showed lower short-term PASI responses but was noted for its ability to reach PASI 90 outcomes with moderately high certainty.
  • In comparison with Risankizumab, another IL-23 inhibitor, guselkumb was sometimes rated lower in terms of achieving PASI outcomes after one year; however it demonstrated better efficacy than some anti-TNFs particularly in nail psoriasis.
  • For active psoriatic arthritis patients specifically, data suggests that Guselkamub's efficacy is comparable to IL -17A and subcutaneous TNF inhibitors regarding arthritis symptoms but offers superior skin outcome results.
  • Racial or ethnic differences on drug efficacy were not extensively covered within the documents reviewed; however there are indications suggesting variations among different ethnic groups which necessitates further research.
  • Guselakumb has a good safety profile similar to other biologics used for these conditions; common adverse events include nasopharyngitis upper respiratory tract infections injection site reactions headache diarrhea yet no significant difference from placebo group was observed concerning serious adverse events risk indicating an acceptable long term safety profile.
  • In conclusion based on available evidence from systematic reviews meta analyses Guslekamb stands as a competitive option among biologic treatments especially considering long term management strategies due its favorable benefit-risk ratio.

Product Monograph / Prescribing Information

Document TitleYearSource
Tremfya (guselkumab) Prescribing Information.2020Janssen Biotech, Inc., Horsham, PA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Clinical and pharmacoeconomic combined report.2023CADTH
Efficacy and safety of nail psoriasis targeted therapies: a systematic review.2023American Journal of Clinical Dermatology
Guselkumab for treating active psoriatic arthritis after inadequate response to DMARDs. 2022NICE
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta‐analysis.2022Cochrane Database of Systematic Reviews
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
Targeted systemic therapies for psoriatic arthritis: a systematic review and comparative synthesis of short-term articular, dermatological, enthesitis and dactylitis outcomes.2022RMD Open
Assessment report: Tremfya.2021EMA
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
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta‐analysis. 2021Cochrane Database of Systematic Reviews
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
Racial/ethnic differences in treatment efficacy and safety for moderate‑to‑severe plaque psoriasis: a systematic review.2021Archives of Dermatological Research
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
Network meta-analysis comparing the efficacy of biologic treatments for achieving complete resolution of nail psoriasis.2021Journal of Dermatological Treatment
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
Number needed to treat network meta-analysis to compare biologic drugs for moderate-to-severe psoriasis.2020Advances in 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
Treatment of plaque psoriasis with IL-23p19 blockers: a systematic review and meta-analysis.2019International Immunopharmacology
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
Guselkumab for treating moderate to severe plaque psoriasis.2018NICE
Clinical review report: guselkumab (Tremfya).2018CADTH
A systematic review and meta-analysis of the efficacy and safety of the interleukin (IL)-12/23 and IL-17 inhibitors ustekinumab, secukinumab, ixekizumab, brodalumab, guselkumab and tildrakizumab for the treatment of moderate to severe plaque psoriasis.2018Journal of Dermatological Treatment
Targeted immunomodulators for the treatment of moderate-to-severe plaque psoriasis: effectiveness and value. 2018ICER

Clinical Practice Guidelines

Document TitleYearSource
Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics.2019Journal of the American Academy of Dermatology