TREMFYA

Indications

• Moderate to severe plaque psoriasis in adults
• Other inflammatory skin conditions characterized by IL-23 involvement

Dosage

Adults: Initial dose of 100 mg administered subcutaneously, followed by a second dose at week 4. Maintenance therapy consists of 100 mg every 8 weeks thereafter.

Mechanism of action

Guselkumab binds specifically to the p19 subunit of IL-23, inhibiting its interaction with the IL-23 receptor on the surface of immune cells. This blockade reduces the release of pro-inflammatory cytokines and chemokines, thereby modulating the inflammatory pathways involved in the pathogenesis of psoriasis and other related inflammatory diseases.

Pharmacodynamics

By inhibiting IL-23, guselkumab decreases the activation and proliferation of T-helper 17 (Th17) cells. This leads to a reduction in the inflammatory response and the clinical symptoms associated with psoriasis, such as erythema, scaling, and plaque formation. The clinical efficacy is generally observed within a few weeks of initiating therapy, with significant improvements often seen by week 16.

Pharmacokinetics

Guselkumab exhibits a biphasic elimination pattern with a terminal half-life of approximately 15 to 21 days. It reaches peak plasma concentrations within 5 to 7 days after subcutaneous administration. The drug is primarily eliminated via proteolytic pathways and does not undergo significant metabolism by cytochrome P450 enzymes. Population pharmacokinetic analyses suggest that factors such as body weight may influence the drug's clearance.

Adverse effects

• Injection site reactions
• Headache
• Pharyngitis
• Eosinophilia
• Conjunctivitis
• Serious infections

Interactions

• Live and live attenuated vaccines may be less effective when administered during or following treatment

Precautions

• Risk of infection, particularly helminth infections
• Patients should be up-to-date with vaccinations before starting treatment
• Monitor for signs of infection during therapy

Pregnancy

There are no adequate data from the use of dupilumab in pregnant women. The potential risk for humans is unknown.

Breast-feeding

It is unknown whether dupilumab is excreted in human milk. A decision should be made whether to discontinue breastfeeding or to discontinue dupilumab therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the mother.

Storage

Store in a refrigerator at 2–8°C. Do not freeze. Can be kept at room temperature (up to 25°C) for a maximum of 14 days.

Formulations

• Dupixent 300mg/2ml solution for injection pre-filled syringes
• Dupixent 200mg/1.14ml solution for injection pre-filled syringes