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:
[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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