Johnson & Johnson (J&J) has shared positive results from a phase 3b study of Tremfya (guselkumab) in adults with psoriatic arthritis (PsA).
The APEX trial has been comparing the drug against placebo in patients with active PsA who are biologic naïve and have had an inadequate response to standard therapies.
The study met its primary endpoint, with Tremfya demonstrating a significant reduction in the signs and symptoms of the disease compared to placebo.
The major secondary endpoint was also achieved, with J&J’s drug significantly reducing progression of structural damage, as measured by radiographic progression at 24 weeks, compared to placebo.
Approximately 125 million people worldwide are affected by some form of psoriasis, a chronic inflammatory condition that typically affects the skin, nails and joints.
PsA, which causes pain, stiffness and swelling in and around the joints, affects around 30% of psoriasis patients and commonly appears between the ages of 30 and 50.
Already approved in major markets to treat certain cases of active PsA, Tremfya is designed to block IL-23, an important driver of the pathogenesis of inflammatory diseases, and bind to the CD64 receptor.
The drug is now the first IL-23 inhibitor to significantly reduce both the signs and symptoms and the progression of structural damage in adults living with active PsA, according to J&J.
Terence Rooney, vice president, rheumatology disease area leader, J&J Innovative Medicine, said: “This new top-line data highlights 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.”
APEX will continue to assess the sustained efficacy of Tremfya on inhibition of structural damage in patients with active PsA, J&J said.
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