Guselkumab Shown to Reduce Structural Damage in Psoriatic Arthritis
Patients treated with the therapy showed significantly less progression of structural damage compared to patients who received placebo at week 24.
Positive topline results were announced from a phase 3b trial evaluating the efficacy and safety of guselkumab (Tremfya) in adult patients with active psoriatic arthritis (PsA), Johnson and Johnson announced in a release.1
Guselkumab Shown to Reduce Structural Damage in Psoriatic Arthritis / and.one - stock.adobe.com
Results from the APEX study (NCT04882098) showed that guselkumab met its primary endpoint of reducing signs and symptoms of psoriatic arthritis as measured by the American College of Rheumatology (ACR) response. The therapy also met its key secondary endpoint of reducing progression of structural damage as measured by radiographic progression at 24 weeks.
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“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,” said Terence Rooney, vice president of rheumatology, and immunology disease area leader at Johnson and Johnson Innovative Medicine, said in a release.1 “These new topline data highlight the importance of addressing both inflammation and structural damage at the source as early as possible.”
Guselkumab is the first and only fully-human, dual-acting monoclonal antibody that is approved to treat PsA. The therapy blocks interleukin-23 (IL-23) and also binds to the receptor CD64, which is on cells that produce IL-23. Guselkumab is currently approved to treat moderate to severe plaque psoriasis in adult patients, active psoriatic arthritis in adult patients, moderately to severely active ulcerative colitis in adult patients, and moderately to severely active Crohn’s disease in adult patients.
APEX is a multicenter, randomized, double-blind, placebo-controlled phase 3b study evaluating the efficacy and safety of guselkumab in adult patients with PsA. The study includes 3 periods: a 24 week, double-blind, placebo-controlled treatment period; a 24 week active treatment period; and a 12 week safety follow-up period. Patients in the trial can also agree to enter a 2 year, long-term extension active treatment period.
The study cohort includes 1054 patients who are biologic naïve and have had an inadequate response to standard therapies. The study found that, in addition to reducing signs and symptoms of PsA, patients treated with guselkumab showed significantly less progression of structural damage compared to patients who received placebo at week 24. Additionally, the safety profile was consistent with previous data and no new safety signals were identified in the study period.
“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,” Rooney said in a release.1
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