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.