Guselkumab at the 2017 ACR Annual Meeting in San Diego

Guselkumab is a monoclonal antibody that targets the p19 subunit of IL-23. Guselkumab is marketed by Janssen-Cilag under the name of TREMFYA^® [maybe Xzkrkplk would have been easier to memorize]. The FDA approved TREMFYA™ (guselkumab) for the treatment of moderate to severe plaque psoriasis in July 2017 [1] and the EMA did equally in November 2017 [2].

Guselkumab showed up at the 2017 ACR Annual Meeting in San Diego with just one study [3].

A.A. Deodhar and colleagues presented a phase 2a study: “Efficacy and Safety Results of Guselkumab in Patients with Active Psoriatic Arthritis over 56 Weeks from a Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study.” The authors concluded: “In pts [patients] with active PsA [psoriatic arthritis] and ≥3% BSA [body surface area] of psoriasis, GUS [guselkumab] demonstrated substantial benefits on joint symptoms, physical function, psoriasis, enthesitis, dactylitis, and quality of life, and efficacy was well-maintained through wk56 [week 56]. GUS was well-tolerated with no unexpected safety findings in this population after ~1 year of exposure.”

This study tells us that we might have a new drug against psoriatic arthritis and maybe then also against ankylosing spondylitis within a couple of years. There have to be some more phase 3 studies in arthritis ans spondyloarthritis before getting approval by FDA and EMA. I don’t think that Janssen-Cilag will not try to get approval for the treatment of psoriatic arthritis and ankylosing spondylitis.

Links and References:

[1] https://www.jnj.com/media-center/press-releases/janssen-announces-us-fda-approval-of-tremfya-guselkumab-for-the-treatment-of-moderate-to-severe-plaque-psoriasis

[2] https://www.presseportal.de/pm/16998/3795787

[3] Deodhar AA, Gottlieb AB, Boehncke WH, Dong B, Wang Y, Zhuang Y, Barchuk W, Xu XL, Hsia E. Efficacy and Safety Results of Guselkumab in Patients with Active Psoriatic Arthritis over 56 Weeks from a Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). http://acrabstracts.org/abstract/efficacy-and-safety-results-of-guselkumab-in-patients-with-active-psoriatic-arthritis-over-56-weeks-from-a-phase-2a-randomized-double-blind-placebo-controlled-study/. Accessed March 8, 2018.

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