Tremfya going after psoriatic arthritis

[Fred]

Janssen Pharmaceutical have released phase 3 results of Tremfya (guselkumab) for psoriatic arthritis.

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Janssen Pharmaceutical 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.

Source: jnj.com

Tremfya (guselkumab)