Tremfya (guselkumab) for the Treatment of Plaque Psoriasis, United States of America
Tremfya™ (guselkumab) is a biologic approved for the treatment of adults living with moderate to severe plaque psoriasis.
The human monoclonal antibody drug was developed by US-based company Janssen Biotech, which submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) for the approval of Tremfya™ in November 2016.
Janssen received FDA approval in July 2017, after an expedited regulatory review following application of a priority review voucher.
Marketing approval for Tremfya™ is currently under review in the EU, Japan, and other countries.
Plaque psoriasis disease details
Plaque psoriasis is an autoimmune inflammatory disorder characterised by inflamed red lesions or plaques that are itchy and painful. The plaques are commonly found on the scalp, knees, elbows, and lower back.
An estimated 7.5 million people in the US are affected by plaque psoriasis, with 80% of patients suffering from a mild to moderate form of the disease. Around 20% have a moderate to severe form.
Tremfya's mechanism of action
Tremfya™ contains a human monoclonal antibody, which selectively inhibits the release of pro-inflammatory cytokines and chemokines called interleukin (IL)-23.
The drug is available in 100mg / ml injections, which can be administered subcutaneously.
Clinical trials on Tremfya
FDA approval of Tremfya™ was based on results obtained from a clinical development programme, which included more than 2,000 patients in the phase III VOYAGE 1, VOYAGE 2, and NAVIGATE studies.
The VOYAGE 1 clinical trials were conducted in 101 sites, while the VOYAGE 2 trials were conducted in 115 sites including Canada and the US.
Results from the two studies showed that patients with moderate to severe plaque psoriasis treated with Tremfya™ showed significant efficacy. The clinical studies demonstrated that patients treated with Tremfya™ achieved 90% clearer skin, while more than 80% of patients demonstrated either clear or almost cleared skin at week 16.
The clinical studies also showed improvement in Tremfya™ administered patients with psoriasis on the scalp, and a decrease of symptoms such as itching, pain, stinging, and burning at week 16.
The clinical studies further demonstrated that nine out of ten patients treated with Tremfya™ achieved clear skin and achieved Psoriasis Area and Severity Index (PASI) 90 at week 28, which was continued to week 48.
In the VOYAGER 2 clinical study, Tremfya™ was compared with Humira®. The study results showed more than seven out of ten patients treated with Tremfya™ reported at least 90% clear skin compared to four out of ten patients treated with Humira®. The patients treated with Tremfya™ achieved superior skin clearance (PASI 90) compared to Humira®.
The NAVIGATE clinical study was a randomised, double-blind, multi-centre study, which evaluated the efficacy and safety of Tremfya™ compared to Stelara® (ustekinumab) in patients who continued to experience mild to severe skin symptoms following 16 weeks of treatment with Stelara®.
Patients who switched to Tremfya™ showed greater improvement in their psoriasis between weeks 28 and 40. Approximately 31% of the patients treated with Tremfya™ were considered cleared or almost cleared compared to 14% of STELARA®-treated patients.