Guselkumab: First Global Approval

@article{Markham2017GuselkumabFG,
  title={Guselkumab: First Global Approval},
  author={Anthony Markham},
  journal={Drugs},
  year={2017},
  volume={77},
  pages={1487-1492}
}
Guselkumab (Tremfya™) is a human monoclonal IgG1λ antibody being developed by Janssen Biotech, Inc. that has been approved in the USA as a treatment for moderate-to-severe plaque psoriasis. Guselkumab inhibits the binding of interleukin 23 (IL-23) to its cell surface receptor, disrupting the type 17 helper T cell/IL-17 pathway. This article summarizes the milestones in the development of guselkumab leading to this first approval for the treatment of adults with moderate-to-severe plaque… 
Guselkumab: an anti-IL-23 antibody for the treatment of moderate-to-severe plaque psoriasis
TLDR
In the overall management of patients with plaque psoriasis, guselkumab is a robust treatment option with durable maintenance of response over time and has a consistently favourable safety profile and is well tolerated over the long-term.
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TLDR
The results of the head-to-head trial ECLIPSE were recently released and contribute to the increasing confidence in guselkumab, demonstrating great potential for long-term treatment of psoriasis.
A safety evaluation of guselkumab for the treatment of psoriasis
TLDR
Targeting IL-23, may be responsible for the high efficacy and durable responses of guselkumab, avoiding some adverse effects of IL-17A blockade, like mucocutaneous candida infections or triggering/worsening of inflammatory bowel disease.
Guselkumab for the Treatment of Psoriasis
TLDR
In terms of efficacy, guselkumab showed promising results in the treatment of psoriasis and psoriatic arthritis, although it did not show significant clinical improvement in rheumatoid arthritis.
The safety of ixekizumab in psoriasis drug therapy
  • L. Puig
  • Medicine, Biology
    Expert opinion on drug safety
  • 2019
TLDR
These studies show that ixekizumab demonstrates a favorable safety profile, and the occasional de novo appearance or exacerbation of preexistent inflammatory bowel disease remains a cause of concern, and requires close monitoring of patients at risk.
A real‐life experience as a proof of Guselkumab effectiveness and safety in patients with moderate to severe psoriasis
TLDR
A single‐center retrospective cohort study in a population consisting of 46 patients followed from December 2018 to April 2021 confirms that Guselkumab is an excellent choice in terms of security, long‐term efficacy, and overall tolerance.
Spotlight on risankizumab and its potential in the treatment of plaque psoriasis: evidence to date
TLDR
Risankizumab showed an excellent efficacy when compared to placebo and ustekinumab, with higher Psoriasis Area Severity Index (PASI) 75, PASI 90, and PASi 100 rates, along with a convenient every 12-week maintenance dosing regimen.
Interleukin-23 Blockers: Born to be First-line Biologic Agents in Inflammatory Bowel Disease?
TLDR
More selective anti-IL23 agents (anti-p19) have shown efficacy and are being further developed, in contrast to agents inhibiting IL-17 downstream, which have failed in IBD clinical trials despite their clear efficacy in psoriasis.
Guselkumab is efficacious and safe in psoriasis patients who failed anti-IL17: a 52-week real-life study.
TLDR
The authors' real-life study confirmed the efficacy and safety of guselkumab in daily clinical practice suggesting it as a valuable weapon also in psoriasis patients who previously failed anti-IL17 treatments.
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Risankizumab showed an excellent efficacy when compared to placebo and ustekinumab, with higher Psoriasis Area Severity Index (PASI) 75, PASI 90, and PASi 100 rates, along with a convenient every 12-week maintenance dosing regimen.
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FDA approval of TREMFYA(T) (guselkumab) for the treatment of moderate to severe plaque psoriasis
  • [media release]
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