A new therapy has approved by the TGA for treatment of adults with moderate to severe plaque psoriasis
Tremfya (guselkumab) is the first biologic approved in Australia that selectively blocks interleukin (IL)-23, a cytokine that plays a critical role in the pathogenesis of plaque psoriasis.
Its approval by the TGA is based on clinical program results that demonstrated more than 80% (IGA 0/1; p<.001) of patients with moderate to severe plaque psoriasis treated with Tremfya achieved clear or almost clear skin after three doses at Week 16.
The medication is administered as a single 100mg subcutaneous injection once every eight weeks, after starter doses at weeks 0 and 4.
Associate Professor Peter Foley, clinical dermatologist and Director of Research at the Skin & Cancer Foundation Inc, said psoriasis can be a debilitating condition with significant impact on quality of life.
“Psoriasis is a systemic immune disease; patients typically have multiple co-morbidities, and the prescribing protocol is complex. This means moderate to severe plaque psoriasis may be less than optimally treated,” he explained.
“We still have no cure for psoriasis so a significant unmet medical need remains. New and different treatments such as Tremfya, that may offer improved and sustained benefits, are vital for patients and healthcare professionals.”
Tremfya (guselkumab) targets interleukin 23 (IL-23), compared with Stelara (ustekinumab) which targets both IL-23 and IL-12, said Professor Foley.
Adverse events occurring in ≥5% of patients across the two clinical studies included nasopharyngitis, upper respiratory tract infection, headache and arthralgia.
Meanwhile patients treated with the medication showed improvements in psoriasis involving the scalp, hands and feet and in symptoms including itch, pain, stinging, burning and skin tightness at Week 16.
“There is a consensus that the most effective assessment of psoriasis requires both PASI physical scoring and quality of life measures (DLQI) given the significant impact psoriasis has on so many aspects of patients’ lives,” said Professor Foley.
Psoriasis patients may experience depression and anxiety which can be increased due to treatment failure, the stigma associated with visible skin lesions, and the fluctuating course of the disease.
It is estimated that psoriasis affects about 2.6% of Australians. The most common form is plaque psoriasis, affecting over 80% of those living with the condition.
Main points for pharmacists
- Tremfya (guselkumab) is administered as one subcutaneous injection (prefilled syringe) at week 0 and week 4, then every 8 weeks.
- Drug to be kept refrigerated, not frozen. Remove from refrigerator 30 minutes before injection.
- Do not shake.
- Dispose of needle in sharps container.
- No live vaccines (same as other biologics) when on therapy.
- Defer dose and speak to treating dermatologists or LMO if any signs of infection.
- Ensure patient attends scheduled review appointments due to the strict time windows.