TREMFYA Becomes First IL-23 Inhibitor to Reduce Structural Damage in Psoriatic Arthritis

Johnson & JohnsonView company profile announced that TREMFYA® (guselkumabSearch drug) has achieved significant clinical milestones in the treatment of active psoriatic arthritisSearch disease (PsA), becoming the first and only IL-23Search term inhibitor to demonstrate reduction in both disease symptoms and structural damage progression.

Breakthrough Results in Phase 3b APEX Study

The Phase 3b APEX study met both its primary endpoint of reducing signs and symptoms (ACR20) and its major secondary endpoint of reducing progression of structural damage at 24 weeks in adults with active psoriatic arthritisSearch disease, compared to placebo.

TREMFYASearch drug-treated patients exhibited significantly less progression of structural damage versus placebo recipients as assessed by the PsA modified van der Heijde-Sharp (vdH-S) score, which measures joint space narrowing and erosion. This achievement marks a significant advancement in the management of PsA, a chronic inflammatory disease that can cause irreversible joint damage if left untreated.

"Psoriatic arthritisSearch disease 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," said Terence Rooney, Vice President, Rheumatology Disease Area Leader at Johnson & JohnsonView company profile Innovative Medicine. "These new topline data highlight the importance of addressing both inflammation and structural damage at the source as early as possible."

Unique Mechanism of Action

TREMFYASearch drug is distinguished by its dual-acting mechanism as the first fully-human monoclonal antibody approved for PsA that blocks interleukin-23 (IL-23Search term) while also binding to CD64Search term, a receptor on cells that produce IL-23. This cytokine is a known driver of immune-mediated diseases including active psoriatic arthritisSearch disease.

The antibody was originally developed using MorphoSysView company profile' antibody technology platform. Johnson & JohnsonView company profile now maintains exclusive worldwide marketing rights to TREMFYASearch drug following a series of business transactions that saw MorphoSys sell its royalty rights to Royalty Pharma, which subsequently sold the remaining rights to an undisclosed buyer believed to be Johnson & Johnson.

Study Design and Patient Population

The APEX trial specifically enrolled biologic-naïve patients who had inadequate responses to standard therapies such as conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), apremilast, or nonsteroidal anti-inflammatory drugs (NSAIDs).

The study design includes a 24-week double-blind, placebo-controlled period, followed by a 24-week active treatment period and a 12-week safety follow-up. For patients entering the long-term extension, an additional two years of active treatment is scheduled before final safety assessment.

Expanding Treatment Portfolio

TREMFYASearch drug is already approved for multiple indications including:

• Moderate to severe plaque psoriasis in adults
• Active psoriatic arthritis in adults
• Moderately to severely active ulcerative colitis in adults
• Moderately to severely active Crohn's disease in adults

The drug has previously demonstrated efficacy in Crohn's diseaseSearch disease, where it outperformed StelaraSearch drug in endoscopic endpoints during earlier clinical trials.

Safety Profile

Data from the APEX study were consistent with TREMFYASearch drug's well-established safety profile, with no new safety signals identified. This reinforces the medication's position as a valuable treatment option for patients with active PsA.

Clinical Implications

Psoriatic arthritisSearch disease affects approximately 30% of people with plaque psoriasisSearch disease and is characterized by joint inflammation, enthesitis, dactylitis, axial disease, and skin lesions. The condition typically appears between ages 30 and 50, causing pain, stiffness, and swelling in and around joints.

Nearly half of PsA patients experience moderate fatigue, and about one-third suffer from severe fatigue. Comorbidities such as obesity, cardiovascular disease, anxiety, and depression are common among these patients.

The ability to address both symptomatic relief and structural damage progression positions TREMFYASearch drug as a potentially first-line treatment option for appropriate patients with active PsA.

Johnson & JohnsonView company profile plans to present detailed results from the APEX study at upcoming medical congresses, which will provide further insights into TREMFYASearch drug's efficacy profile and long-term benefits for patients with psoriatic arthritisSearch disease.