Guselkumab meets primary endpoints in phase 3 psoriatic arthritis program
Johnson & Johnson’s Janssen Pharmaceutical said that its IL-23 p19 inhibitor TREMFYA (guselkumab) met the primary endpoints of American College of Rheumatology 20% improvement (ACR20) in two phase 3 trials in adults with active psoriatic arthritis.
Safety profiles observed for guselkumab in the two trials – DISCOVER 1 and 2 were in line with its previous studies and current prescribing information.
The DISCOVER program, which comprised the two randomized, double-blind, multicentre phase 3 trials, evaluated the efficacy and safety of guselkumab, administered subcutaneously in patients with active psoriatic arthritis, in comparison to placebo.
Apart from the primary endpoint of ACR20 response at week 24, various secondary endpoints were evaluated, including ACR50/70, disease activity (DAS-28 CRP), resolution of soft tissue inflammation (enthesitis and dactylitis), skin clearance (IGA), improvement in physical function (HAQ-DI), and quality of life (SF-36 PCS and MCS).
DISCOVER-2 also evaluated the effect on structural damage (vdH-S) as a major secondary endpoint.
The DISCOVER-1 clinical trial enrolled 381 participants which included those who had prior treatment with biologic anti-TNF biologics. The phase 3 trial continues through 52 weeks. On the other hand, the DISCOVER-2 clinical trial featured 739 bio-naive patients and continues for 100 weeks.
Data from the two clinical trials will be used for supporting the submissions to the US Food and Drug Administration and European Medicines Agency seeking approval of guselkumab as a treatment for psoriatic arthritis, which are expected for later this year.