Janssen Eyes Another Approval for Tremfya After Hitting Trial Endpoints
After hitting the American College of Rheumatology 20% (ACR20) improvement mark in two Phase III trials, Janssen Pharmaceutical is planning to seek regulatory approval for Tremfya in adult patients with active moderate to severe psoriatic arthritis.
Friday morning, Janssen Pharmaceutical, a division of Johnson & Johnson, said both DISCOVER-1 and -2 studies met the primary endpoints as defined by the American College of Rheumatology. The trials were designed to evaluate the efficacy and safety of subcutaneous guselkumab in patients with active psoriatic arthritis compared to placebo. Janssen added that the safety profiles remained consistent with other Tremfya trials, as well as current prescriber labeling. Janssen’s DISCOVER program includes the first-ever Phase III studies evaluating an IL-23 p19 inhibitor for the treatment of psoriatic arthritis, the company said. While Janssen is already eying regulatory approval preparations, industry watchers will have to wait for the company to release trial data. Full results of the two DISCOVER trials will be presented at upcoming scientific medical meetings, Janssen said.
Tremfya, a human monoclonal antibody that selectively blocks the p19 subunit of interleukin (IL)-23, has already been approved for the treatment of adult patients with moderate to severe plaque psoriasis who may benefit from systemic therapy or phototherapy.
Psoriatic arthritis is a chronic, immune-mediated inflammatory disease characterized by joint inflammation, enthesitis, dactylitis and the skin lesions associated with psoriasis. It is estimated that at least one million Americans are living with psoriatic arthritis and up to 30% of patients living with psoriasis can develop psoriatic arthritis. The disease causes pain, stiffness and swelling in and around the joints.
DISCOVER-1 included 381 participants, including participants previously treated with anti-TNF biologics. The study continued through 52 weeks. DISCOVER-2 included 739 bio-naive participants and continued through 100 weeks. In addition to the primary endpoint of ACR20, Both the DISCOVER-1 and DISCOVER-2 trials included multiple secondary endpoints. Those secondary endpoints included ACR50/70, resolution of soft tissue inflammation (enthesitis and dactylitis), disease activity, improvement in physical function, skin clearance and quality of life, the company noted. DISCOVER-2 also assessed the effect on structural damage as a key secondary endpoint, Janssen added.
Janssen’s Tremfya data was announced a day after the company presented data at the Annual European Congress of Rheumatology regarding the treatment of psoriatic arthritis. Harnessing real-world evidence, Janssen said treatment should target more than skin and joints. The company showed that treatment with either ustekinumab (Stelara) or TNFi’s (tumor necrosis factor inhibitors) leads to considerable and comparable numbers of patients reaching low disease activity (LDA) or remission, after six months of treatment.