Tremfya (Guselkumab) Drug Classification
Tremfya (guselkumab) is a fully human IgG1 lambda monoclonal antibody that selectively inhibits interleukin-23 (IL-23) by binding to its p19 subunit, making it an IL-23 inhibitor biologic agent. 1, 2
Mechanism of Action
- Guselkumab is a human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody with an approximate molecular weight of 147 kDa, produced in mammalian cell lines using recombinant DNA technology 2
- It works by blocking the p19 subunit of IL-23, disrupting the type 17 helper T cell/IL-17 pathway 3
- This selective inhibition of IL-23 distinguishes it from ustekinumab (which blocks both IL-12 and IL-23), allowing IL-12-dependent cascades to remain functional 4
FDA-Approved Indications
Tremfya is approved for treating adults with: 1, 2
- Moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy (FDA approval July 13,2017) 1
- Active psoriatic arthritis (FDA approval 2020) 5
- Moderately to severely active ulcerative colitis 2
- Moderately to severely active Crohn's disease 2
Drug Class Positioning
- Guselkumab is the first selective IL-23 inhibitor approved for psoriatic arthritis, representing a novel mechanism of action distinct from TNF-α inhibitors, IL-17 inhibitors, and the non-selective IL-12/23 inhibitor ustekinumab 5, 4
- It belongs to the broader category of biologic disease-modifying agents used in immune-mediated inflammatory diseases 1
Available Formulations
The drug is available as: 2
- Subcutaneous injection: 100 mg/mL solution in prefilled syringes, prefilled pens (TREMFYA PEN), or One-Press patient-controlled injectors
- Intravenous infusion: 10 mg/mL solution in 20 mL single-dose vials (used for induction dosing in ulcerative colitis and Crohn's disease) 2