Janssen Pharmaceuticals has announced that new data from two phase 3 trials Discover-1 and Discover-2 showed that TREMFYA (guselkumab) maintained improvements in multiple clinical outcomes in adult patients with active psoriatic arthritis (PsA).
The Janssen Pharmaceutical Companies of Johnson & Johnson said that new data from two Phase 3 clinical trials, Discover-1 and Discover-2, showed that TREMFYA (guselkumab) demonstrated improvements in multiple clinical outcomes, including joint symptoms, skin symptoms, soft tissue inflammation, physical function and reduction in radiographic progression at week 52 in adult patients with active psoriatic arthritis (PsA). According to Janssen, Guselkumab is currently not licensed for the treatment of PsA and is undergoing evaluation for this use by the European Medicines Agency (EMA). Janssen said data from the two studies in the Discover programme formed the basis of the validated filing on October 11, 2019 to the EMA in the European Union (EU) for approval of guselkumab for the treatment of adult patients with active PsA. The Primary endpoint results were recently published in weekly peer-reviewed general medical journal, The Lancet.
“Those who are living with active psoriatic arthritis are faced with debilitating symptoms and inflammation which may ultimately lead to irreversible damage to the joints”, said Christopher Ritchlin, M.D., M.P.H., Chief of the Division of Allergy, Immunology and Rheumatology and Director of the Clinical Immunology Research Centre at the University of Rochester Medical Centre in Rochester, New York, and lead investigator of the Discover-1 study. “Findings from the Discover-1 and Discover-2 studies are encouraging for patients and physicians alike who may be seeking new treatment options that utilise mechanisms of action different to antitumour necrosis factor (TNF) alpha biologics to combat the multi-faceted combination of symptoms presented by psoriatic arthritis”, he added.
Discover-1 and Discover-2 sought to evaluate the efficacy and safety of guselkumab compared to placebo. Discover-1 included patients who were biologic-naïve or had previously been exposed to anti-TNF alpha biologics, while Discover-2 included patients who were biologic-naïve only; it also assessed radiographic progression of joint damage. In both studies, patients were randomised to guselkumab 100mg every four weeks (q4w) or every eight weeks (q8w) for one year, or to placebo with crossover to guselkumab q4w at week 24 through one year. Janseen said these findings are being presented as poster tours (SAT0397/SAT0402) at this year’s European League Against Rheumatism (EULAR) E-Congress, at which the company is sharing data in a total of 32 abstracts.