Tremfya (guselkumab) from Janssen is a prescription medicine for the treatment of adults with moderate-to-severe plaque psoriasis who may benefit from taking medicines or phototherapy (treatment with UV light).
Janssen announced that it was approved on July 13, 2017, as the first and only approved biologic therapy for the treatment of plaque psoriasis.
How Tremfya works
Tremfya is a human monoclonal antibody that blocks interleukin-23 (IL-23), one of the key proteins thought to be involved in the development of plaque psoriasis. The interaction between IL-23 and its receptor drives the differentiation and growth of special immune cells called Th17 cells, which produce inflammatory cytokines, or cell-signaling molecules that induce inflammation.
When IL-23 is blocked by Tremfya, the release of the pro-inflammatory cytokines is inhibited.
Tremfya in clinical trials
Two Phase 3 studies, VOYAGE-1 (NCT02207231) and VOYAGE-2 (NCT02207244) assessed the effectiveness and safety of Tremfya for the treatment of moderate-to-severe plaque psoriasis compared to Humira (adalimumab), another drug already approved for the treatment of plaque psoriasis. Participants were divided into three groups and received either Tremfya, Humira, or a placebo. The results showed that participants who received Tremfya experienced significant improvements in skin clearance and greater improvement in symptoms of plaque psoriasis including itch, pain, stinging, burning and skin tightness at week 16, compared to those who received a placebo. Better results in skin clearance also were demonstrated in the Tremfya group compared with the Humira group at weeks 16, 24, and 48.
Another Phase 3 study called NAVIGATE (NCT02203032) assessed the effectiveness and safety of Tremfya for the treatment of 875 participants with moderate-to-severe plaque psoriasis who had an inadequate response to Stelara (ustekinumab). At week 28, 31 percent of participants treated with Tremfya were considered cleared, or almost cleared, of psoriasis compared to only 14 percent of participants treated with Stelara.
A Phase 3 study (NCT03090100) called ECLIPSE is currently recruiting participants to evaluate the effectiveness of Tremfya compared to Cosentyx (secukinumab) for the treatment of moderate-to-severe plaque psoriasis.
Other details
It comes as a 100 mg under-the-skin injection to be used at weeks 0 and 4 and then every eight weeks.
The most common adverse reactions include upper respiratory tract infections, headache, injection site reactions, pain in the joints, diarrhea, gastroenteritis, fungal skin infections, and herpes simplex infections. Because the drug increases the risk of infection, it should not be started in people with an already active infection.
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