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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Risankizumab at the 2017 ACR Annual Meeting in San Diego

Risankizumab is a humanized IgG1 monoclonal antibody that inhibits interleukin-23 by specifically targeting the p19 subunit. It is also called BI 655066 or ABBV-066. There are quite a lot of competing compounds targeting IL-23 or IL-17 to treat psoriasis and psoriatic arthritis [PsA]. The market for psoriatic arthritis is much smaller than for rheumatoid arthritis, but any new drug is welcome, because some patients who do not get better on a galore of drugs will just do fine on the next biologic. Risankizumab is tested in Crohn's disease, psoriasis, and psoriatic arthritis [1].

K.A. Papp and colleagues published this study [2] in the New England Journal of Medicine: “Risankizumab versus Ustekinumab for Moderate-to-Severe Plaque Psoriasis”. They could conclude: “In this phase 2 trial, selective blockade of interleukin-23 with risankizumab was associated with clinical responses superior to those associated with ustekinumab. […]”

Risankizumab appeared at the 2017 ACR Annual Meeting in San Diego with just one study in the late breaking section. P.J. Mease and colleagues presented [3]: “Efficacy and Safety Results from a Phase 2 Trial of Risankizumab, a Selective IL-23p19 Inhibitor, in Patients with Active Psoriatic Arthritis”. Patients were stratified into groups of 20-40 to look at different dosages of risankizumab (RZB). “ACR20 responses were significantly greater in pts receiving RZB (across all arms, 57.1–65.0%) compared with PBO (37.5% …)”. Conclusion: “In this Phase 2 study, RZB significantly improved joint and skin symptoms in pts with active PsA. RZB was well-tolerated with no new or unexpected safety findings.”

It doesn’t mean that we have a new drug, but in a few years we might have a new drug against psoriatic arthritis and maybe then also against ankylosing spondylitis. There have to be some phase 3 studies before getting approval by FDA and EMA, but my guess is that AbbVie is planning to go for approval of risankizumab in different indications. Let’s wait.

 

 

Links:

[1] https://www.abbvie.com/our-science/pipeline/risankizumab.html 

[2] http://www.nejm.org/doi/full/10.1056/NEJMoa1607017

[3] Mease PJ, Kellner H, Morita A, Kivitz AJ, Papp KA, Aslanyan S, Berner B, Chen K, Eldred A, Behrens F. Efficacy and Safety Results from a Phase 2 Trial of Risankizumab, a Selective IL-23p19 Inhibitor, in Patients with Active Psoriatic Arthritis [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). http://acrabstracts.org/abstract/efficacy-and-safety-results-from-a-phase-2-trial-of-risankizumab-a-selective-il-23p19-inhibitor-in-patients-with-active-psoriatic-arthritis/. Accessed March 8, 2018.

[4] https://www.ncbi.nlm.nih.gov/pubmed/26080615  

 

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