What is Tremfya (guselkumab)?

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Last updated: March 21, 2025 • View editorial policy

From the Guidelines

Tremfya (guselkumab) is a prescription biologic medication that is primarily used to treat moderate to severe plaque psoriasis in adults, with a recommended dose of 100 mg by subcutaneous injection at week 0, week 4, and every 8 weeks thereafter, as supported by the highest quality evidence from 2019 1, 2.

Key Characteristics of Tremfya

  • It is a fully human IgG1 lambda monoclonal antibody that blocks the p19 subunit of IL-23, a protein involved in inflammation associated with psoriasis.
  • The medication is administered via a prefilled syringe or One-Press injector device, which patients can use at home after initial guidance from healthcare providers.
  • Improvement in symptoms typically begins within weeks, with maximum benefit often seen after several months of consistent treatment.

Efficacy and Safety

  • Multiple RCTs, including the VOYAGE 2 study, have established the efficacy of guselkumab in treating moderate-to-severe psoriasis, with a higher percentage of patients achieving PASI 90 compared to adalimumab or placebo 1.
  • Common side effects may include upper respiratory infections, headaches, injection site reactions, joint pain, diarrhea, and gastroenteritis.
  • As an immunosuppressant, patients should be screened for tuberculosis before starting treatment and monitored for infections during therapy.

Recommendations

  • Guselkumab is recommended as a monotherapy treatment option for use in adult patients with moderate-to-severe plaque psoriasis, with a strength of recommendation of A, according to the joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics 2.
  • The recommended dose of guselkumab is 100 mg by self-administered subcutaneous injection at week 0, week 4, and every 8 weeks thereafter, with a strength of recommendation of A 2.

From the Research

Definition and Mechanism of Action

  • Tremfya, also known as guselkumab, is a human immunoglobulin G1 λ (IgG1λ) monoclonal antibody (mAb) that blocks the interleukin-23 (IL-23)-mediated signalling pathway 3, 4, 5, 6, 7.
  • It is a selective IL-23 inhibitor that targets the p19 subunit of IL-23, disrupting the type 17 helper T cell/IL-17 pathway 4, 5, 6, 7.

Approval and Indications

  • Guselkumab is approved for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy 3, 4, 5, 6, 7.
  • It is the first in its class to be approved for this indication in several countries, including the USA and EU 3.

Efficacy and Safety

  • Clinical trials have demonstrated the efficacy and safety of guselkumab in the treatment of moderate-to-severe plaque psoriasis, with benefits maintained for up to 2 years 3.
  • Guselkumab has shown promising results in head-to-head trials, including superiority to adalimumab and ustekinumab in some measures 3, 5, 6.
  • The most common adverse event associated with guselkumab is nasopharyngitis, and it is generally well tolerated 6, 7.

References

Research

Guselkumab: A Review in Moderate to Severe Plaque Psoriasis.

American journal of clinical dermatology, 2018

Research

Guselkumab for the Treatment of Psoriasis.

BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2018

Research

Guselkumab for the treatment of moderate-to-severe plaque psoriasis.

Expert review of clinical pharmacology, 2018

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.