Janssen Pharmaceutical of Johnson & Johnson released new long-term data from the open-label period of its Phase III VOYAGE 1 clinical trial. The trial was evaluating Tremfya (guselkumab) in moderate to severe plaque psoriasis. Results were presented at the 39th Fall Clinical Dermatology Conference held in Las Vegas, Nevada.
Tremfya is a monoclonal antibody that binds to the p19 subunit of interleukin (IL)-23. It has been approved in the U.S., Europe, Japan and several other countries for adults with moderate to severe plaque psoriasis. IL-23 drives inflammation in several diseases, including psoriasis. The Tremfya development program includes two Phase III trials looking at Tremfya for active psoriatic arthritis, a Phase IIb/III study in Crohn’s disease, a Phase IIb/III trial in ulcerative colitis, and two other Phase II studies, one evaluating biologic combination therapy in ulcerative colitis and the other for Hidradenitis Suppurativa.
The extended-label trial looked at patients for four years after the initial trial. The patients were initially randomized to receive either Tremfya or placebo, but at 16 weeks everyone received Tremfya. The VOYAGE 1 study found that 82% of patients receiving Tremfya in a combined group of individuals that initially received Tremfya or placebo then crossed over to Tremfya at week 16 showed at least a 90% improvement in the Psoriasis Area Severity Index (PASI 90) and an Investigator’s Global Assessment (IGA) score of cleared (0) or minimal disease (1) at week 204, which is four years.
“Dermatologists and psoriasis patients benefit from long-term efficacy and safety studies like VOYAGE 1,” said Andrew Blauvelt, president, Oregon Medical Research Center, and VOYAGE 1 study steering committee member. “When approaching treatment for a lifelong, chronic condition like psoriasis, it’s important to be informed about how available medicines work over time. These findings demonstrated maintenance of PASI 90 and IGA 0/1 response rates for four years in adults with moderate-to-severe plaque psoriasis.”
Psoriasis is an immune-mediated illness that is marked by an overproduction of skin cells. This results in raised, red, scaly plaques that can be itchy or painful. About 8 million people in the U.S. have the disease and about 125 million individuals worldwide. About a quarter of those are considered moderate to severe.
Co-primary endpoints of the trial were the proportions of patients receiving Tremfya versus placebo that hit IGA 0/1 and PASI 90 at week 16. Secondary endpoints were evaluated at week 16, 24, and 48. The open-label extension trial started at week 52 and is still ongoing.
More data from the open-label extension period showed that PASI 100, IGA 0/1, and IGA 0 clear skin responses were consistent at the year (52 week) mark and the four-year (204 week) mark in the combined patient groups. No new safety issues were observed.
“We are excited about these findings as they provide additional data for Tremfya over time in adults living with plaque psoriasis,” said Newman Yeilding, head of Immunology Development, Janssen Research & Development. “In our ongoing commitment to psoriasis patients, we are not only directing efforts towards the discovery and development of new treatment options for dermatologic conditions, we are also recognizing the importance of observing therapies like Tremfya over the long-term.”