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Janssen Reports Top-Line Phase 3 Results for TREMFYA®

June 20, 2019 By americanpharmaceuticalreview

The Janssen Pharmaceutical Companies of Johnson & Johnson announced top-line results from the Phase 3 DISCOVER 1 and 2 studies, which evaluated the efficacy and safety of guselkumab compared to placebo in adult patients with active moderate to severe psoriatic arthritis (PsA). Both studies met their primary endpoints of American College of Rheumatology 20 percent improvement (ACR20), and the safety profiles observed for guselkumab in the DISCOVER program were consistent with previous studies of guselkumab and TREMFYA® current prescribing information.

The DISCOVER program comprises the first-ever Phase 3 studies evaluating an IL-23 p19 inhibitor for the treatment of psoriatic arthritis, and data will be presented at upcoming scientific medical meetings. Data from the two DISCOVER studies will serve as the basis of submissions to the U.S. Food and Drug Administration and European Medicines Agency seeking approval of guselkumab as a treatment for psoriatic arthritis, which are anticipated for later this year.

The DISCOVER program consists of DISCOVER-1 and DISCOVER-2, two randomized, double-blind, multicenter Phase 3 studies designed to evaluate efficacy and safety of subcutaneous guselkumab in patients with active PsA compared to placebo. In addition to the primary endpoint of ACR20 response at week 24, multiple secondary endpoints were assessed that included ACR50/70, resolution of soft tissue inflammation (enthesitis and dactylitis), disease activity (DAS-28 CRP), improvement in physical function (HAQ-DI), skin clearance (IGA), and quality of life (SF-36 PCS and MCS). DISCOVER-2 also assessed effect on structural damage (vdH-S) as a key secondary endpoint.

DISCOVER-1 included 381 participants, including participants previously treated with anti-TNF biologics. The study continued through 52 weeks. DISCOVER-2 included 739 bio-naive participants and continued through 100 weeks.

Psoriatic arthritis (PsA) is a chronic, immune-mediated inflammatory disease characterized by joint inflammation, enthesitis, dactylitis and the skin lesions associated with psoriasis.1 It is estimated that at least one million Americans are living with PsA, and up to 30 percent of patients living with psoriasis can develop PsA.2 The disease causes pain, stiffness and swelling in and around the joints and commonly appears between the ages of 30 and 50, but can develop at any time.1 Though the exact cause of PsA is unknown, genes, the immune system and environmental factors are all believed to play a role in the onset of the disease.

TREMFYA® is a human monoclonal antibody developed by Janssen that selectively blocks the p19 subunit of interleukin (IL)-23 and is approved in the U.S., Canada, European Union, Japan and a number of other countries worldwide for the treatment of adult patients with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light). Ongoing trials include: two Phase 3 programs evaluating TREMFYA® in the treatment of active psoriatic arthritis, a Phase 2b program in Crohn's disease, and two Phase 2 programs – one for the treatment of Ulcerative Colitis and the other for the treatment of Hidradenitis Suppurativa.

The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to TREMFYA®.

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