JnJ seeks USFDA approval for Tremfya label update

The submission is supported by the Phase 3b APEX study in patients with active PsA, which achieved both its primary endpoint of reducing joint symptoms (ACR20) and its major secondary endpoint of inhibited progression of structural damage as measured by change in the modified van der Heijde-Sharp (vdH-S) score at 24 weeks, compared to placebo in bio-naïve patients. These data were recently presented at the European Alliance of Associations for Rheumatology (EULAR) 2025 Congress.

“Psoriatic arthritis is a complex disease that can lead to severe and irreversible joint damage, which is why we are dedicated to developing innovative therapies that comprehensively address the long-term impact as well as the everyday challenges of this condition,” said Brandee Pappalardo, Ph.D., M.P.H., Vice President, Medical Affairs, Dermatology & Rheumatology, Johnson & Johnson Innovative Medicine. “With this new evidence, TREMFYA would become the first and only IL-23 inhibitor proven to provide symptom control and to significantly inhibit the progression of joint damage in patients living with active PsA.”

Data from the APEX study were consistent with the well-established safety profile of TREMFYA. Additional data will be presented at future medical meetings.

TREMFYA is a fully-human, dual-acting monoclonal antibody approved to treat PsA that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including active PsA.

APEX is a multicenter, randomized, double-blind, placebo-controlled study in patients with active PsA who are biologic naïve and have had an inadequate response to standard therapies (e.g., csDMARDs, apremilast, and/or NSAIDs). The treatment duration includes a 24-week, double-blind, placebo-controlled period, followed by a 24-week active treatment period. For patients who agree to enter the long-term extension, an additional 2 years of active treatment period is scheduled prior to the final safety follow-up.

Psoriatic arthritis (PsA) is a chronic, immune-mediated, inflammatory disease characterized by peripheral joint inflammation, enthesitis (pain where the bone, tendon and ligament meet), dactylitis (a type of inflammation in the fingers and toes that can result in a swollen, sausage-like appearance), axial disease and the skin lesions associated with plaque psoriasis (PsO). The disease causes pain, stiffness and swelling in and around the joints; it commonly appears between the ages of 30 and 50, but can develop at any age. Nearly half of patients with PsA experience moderate fatigue and about one-third suffer from severe fatigue as measured by the modified fatigue severity scale. In patients with PsA, comorbidities such as obesity, cardiovascular disease, anxiety and depression are often present. Studies show up to 30% of people with plaque PsO also develop PsA.

Developed by Johnson & Johnson, TREMFYA is an approved fully-human, dual-acting monoclonal antibody designed to neutralize inflammation at the cellular source by blocking IL-23 and binding to CD64 (a receptor on cells that produce IL-23). Findings for dual-acting are limited to in vitro studies that demonstrate guselkumab binds to CD64, which is expressed on the surface of IL-23 producing cells in an inflammatory monocyte model. The clinical significance of this finding is not known.

TREMFYA is a prescription medicine approved in the U.S. to treat:

• adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light).
• adults with active psoriatic arthritis.
• adults with moderately to severely active ulcerative colitis.
• adults with moderately to severely active Crohn’s disease.

TREMFYA is approved in Europe, Canada, Japan, and a number of other countries for the treatment of adults with moderate-to-severe plaque psoriasis and for the treatment of adults with active psoriatic arthritis.