The Janssen Pharmaceutical Companies of Johnson & Johnson has reported positive complete efficacy and safety data from the Phase III clinical trial of selective Interleukin (IL)-23 inhibitor therapy, Tremfya (guselkumab), to treat active psoriatic arthritis (PsA).
A fully human monoclonal antibody, Tremfya acts on the p19 subunit of IL-23, which is associated with the pathogenesis of inflammatory diseases.
The double-blind, randomised, multicentre Phase III DISCOVER–2 trial assessed the efficacy and safety of subcutaneous dose of Tremfya in biologic-naïve subjects with active PsA.
It enrolled 739 subjects who received the treatment and were followed up for nearly two years.
Among the Tremfya-treated subjects with an ACR20/50/70 response at week 52, 91% and 87% received the drug every four weeks (q4w) and every eight weeks (q8w), respectively, and sustained an ACR20 response at week 100.
An ACR50 response was maintained in nearly 83% of q4w and 79% of q8w subjects while 72% and 80% had an ACR70 response.
From week 0-100, reduced rates of radiographic progression were reported in both dosing regimens of the antibody.
At week 100, the rates of enthesitis and dactylitis resolution demonstrated that improvement in the signs and symptoms of arthritis were durable for two years.
In addition, 62% and 55% of the subjects in the q4w and q8w arms, respectively, attained a complete skin clearance with an Investigator Global Assessment (IGA) score of zero.
Approximately 76% and 72% in the q4w and q8w arms attained an IGA score of zero or one.
Furthermore, 38% and 40% of the subjects who received Tremfya q4w and q8w, respectively, attained minimal disease activity criteria at week 100.
The data from the trial is in line with the already reported safety profile of Tremfya.
Janssen Research and Development vice-president and rheumatology disease area leader Alyssa Johnsen said: “The response rates in the DISCOVER-2 trial demonstrate the ability of Tremfya to improve the signs and symptoms of psoriatic arthritis for people who live with the challenges of this disease.
“Psoriatic arthritis is a chronic disease, so patients need treatment options with durable efficacy and an established safety profile. We are proud to deliver the first two-year results for a selective IL-23 inhibitor therapy in PsA.”
In October 2020, Janssen reported that open-label extension data from Phase III VOYAGE 1 study of Tremfya demonstrated increased rates of skin clearance in plaque psoriasis patients.