{"id":833994,"date":"2025-04-04T08:48:32","date_gmt":"2025-04-04T12:48:32","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/tremfya-guselkumab-is-the-first-and-only-il-23-inhibitor-to-significantly-reduce-both-the-signs-and-symptoms-and-the-progression-of-structural-damage-in-adults-living-with-active-psoriatic-art\/"},"modified":"2025-04-04T08:48:32","modified_gmt":"2025-04-04T12:48:32","slug":"tremfya-guselkumab-is-the-first-and-only-il-23-inhibitor-to-significantly-reduce-both-the-signs-and-symptoms-and-the-progression-of-structural-damage-in-adults-living-with-active-psoriatic-art","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/tremfya-guselkumab-is-the-first-and-only-il-23-inhibitor-to-significantly-reduce-both-the-signs-and-symptoms-and-the-progression-of-structural-damage-in-adults-living-with-active-psoriatic-art\/","title":{"rendered":"TREMFYA\u00ae (guselkumab) is the first and only IL-23 inhibitor to significantly reduce both the signs and symptoms and the progression of structural damage in adults living with active psoriatic arthritis"},"content":{"rendered":"
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PR Newswire<\/p>\n<\/p><\/div>\n

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\n TREMFYA\u00ae<\/sup> demonstrated clinically meaningful and statistically significant efficacy in patients with active psoriatic arthritis at risk for structural damage in Phase 3b<\/span> study <\/i>\n <\/p>\n

\n Topline results demonstrate efficacy across multiple domains at Week 24, reinforcing TREMFYA\u00ae<\/sup> as a first-line treatment option for patients with active psoriatic arthritis<\/i>\n <\/p>\n

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\n SPRING HOUSE, Pa.<\/span>
\n <\/span>, April 4, 2025<\/span><\/span> \/PRNewswire\/ — Johnson & Johnson (NYSE: JNJ) today announced that the TREMFYA\u00ae<\/sup> (guselkumab) Phase 3b<\/span> APEX study achieved both its primary endpoint (ACR20a<\/sup>) of reducing signs and symptoms and its major secondary endpoint of reducing progression of structural damage as measured by radiographic progression at 24 weeks, in adults living with active psoriatic arthritis (PsA), compared to placebo.1<\/sup><\/p>\n

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\n \"(PRNewsfoto\/Johnson
\n <\/a>\n <\/p>\n<\/p><\/div>\n

TREMFYA\u00ae<\/sup> is the first and only 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 psoriatic arthritis.2,3,4,5,6<\/sup><\/p>\n

In the Phase 3b<\/span> APEX study, TREMFYA\u00ae<\/sup>-treated patients also exhibited significantly less progression of structural damage versus patients receiving placebo at Week 24 as assessed by the PsA modified van der Heijde-Sharp (vdH-S) score, which includes joint space narrowing and erosion subscores. Data were consistent with the well-established safety profile of TREMFYA\u00ae<\/sup> with no new safety signals identified.1 <\/sup><\/p>\n

“Psoriatic arthritis can be a progressive and debilitating disease, and without early identification and treatment, patients may experience irreversible joint damage that significantly impacts their daily activities,”\u00a0said Terence Rooney<\/span>, Vice President, Rheumatology Disease Area Leader, Johnson & Johnson Innovative Medicine. “These new topline data highlight the importance of addressing both inflammation and structural damage at the source as early as possible. As the only IL-23 treatment to show significant inhibition of structural damage, TREMFYA equips healthcare providers with critical data so their patients do not have to compromise their future joint health.”<\/p>\n

APEX is a Phase 3b<\/span> study with long-term extension data through three years that will further assesses the sustained efficacy of TREMFYA\u00ae<\/sup> on inhibition of structural damage in patients with active PsA. Results from the APEX study are being prepared for presentation at upcoming medical congresses.<\/p>\n

\n Editor’s notes:\u00a0<\/b>\u00a0<\/p>\n

a.\u00a0 ACR20 response is defined as both at least 20 percent improvement from baseline in the number of tender and number of swollen joints, and a 20 percent improvement from baseline in three of the following five criteria: patient GA, physician GA, functional ability measure (HAQ-DI), patient-reported pain using a visual analog scale, and erythrocyte sedimentation rate or C-reactive protein.7<\/sup><\/p>\n

\n ABOUT APEX STUDY (NCT04882098<\/a>)<\/b>\n <\/p>\n

APEX is a multicenter, randomized, double-blind, placebo-controlled study in patients with active PsA who are biologic na\u00efve 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, followed by a 12-week safety follow-up 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.8<\/sup><\/p>\n

\n ABOUT PSORIATIC ARTHRITIS<\/b>\n <\/p>\n

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).9,10,11<\/sup> 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.12<\/sup> 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.13<\/sup> In patients with PsA, comorbidities such as obesity, cardiovascular disease, anxiety and depression are often present.14<\/sup> Studies show up to 30% of people with plaque PsO also develop PsA.11<\/sup>\u00a0<\/p>\n

\n ABOUT TREMFYA\u00ae<\/sup> (guselkumab)<\/b>\n <\/p>\n

Developed by Johnson & Johnson, TREMFYA\u00ae<\/sup>\u00a0is the first 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<\/i>\u00a0studies 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.<\/p>\n

TREMFYA\u00ae<\/sup>\u00a0is a prescription medicine approved in the U.S. to treat:<\/p>\n