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Guselkumab

Monoclonal antibody From Wikipedia, the free encyclopedia

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Guselkumab, sold under the brand name Tremfya, is a human monoclonal antibody against interleukin-23 used for the treatment of plaque psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn's disease.[5][6][7][8]

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Medical uses

Guselkumab is indicated to treat plaque psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn's disease.[5][6]

Adverse effects

The most common side effects for guselkumab are upper respiratory tract infections, headache, injection site reactions,[9] joint pain, diarrhea, gastroenteritis, fungal skin infections and herpes simplex infections.[10]

Pharmacology

Mechanism of action

Guselkumab targets the IL-23 subunit alpha (p19 subunit)[11] preventing it from binding to cell receptors that would otherwise be activated by its presence.[12]

Pharmacokinetics

  • Cmax 8.09 μg/mL
  • tmax 5.5 days
  • volume of distribution 13.5 L
  • apparent clearance 0.516 L/day[12]

History

Guselkumab was developed by Janssen Pharmaceuticals.[13] In November 2016, Janssen submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) seeking approval of guselkumab.[14]

Society and culture

In July 2017, the US Food and Drug Administration (FDA) approved guselkumab for the treatment of plaque psoriasis.[15]

In November 2017, Health Canada approved guselkumab for the treatment of plaque psoriasis.[16] In September 2020, the approval was expanded to include the treatment of adults with psoriatic arthritis.[17]

In April 2018, guselkumab was approved in Japan for the treatment of psoriatic arthritis.[18]

In July 2020, the FDA approved guselkumab as the first IL-23 inhibitor to treat active psoriatic arthritis (PsA).[19][20]

In September 2024, the FDA approved guselkumab for the treatment of moderately to severely active ulcerative colitis in adults.[8]

In May 2025, the UK Medicines and Healthcare products Regulatory Agency approved guselkumab for Crohn's disease and ulcerative colitis.[21]

Economics

The list price of each 100 mg dose is about US$10,000.[22]

Names

During development, guselkumab was referred to as CNTO-1959.[12]

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Research

Guselkumab has undergone phase III clinical trials comparing it with adalimumab (Humira) and ustekinumab (Stelara).[13]

The safety and efficacy of guselkumab was compared to a placebo and to adalimumab in the "VOYAGE 1" and "VOYAGE 2" phase III clinical trials (ClinicalTrials.gov IDs: NCT02207231 and NCT02207244).[23] Preliminary results indicated that a significantly higher proportion of patients taking guselkumab had better skin clearance compared to those taking the other treatments. At week 16, 73.3% of patients taking guselkumab achieved a PASI 90 (90% reduction in PASI score from baseline), vs 49.7% of those taking adalimumab; additionally, 91.2% of patients taking guselkumab achieved a PASI 75 (75% reduction in PASI score from baseline), vs 73.1% of those taking adalimumab.[23]

The phase III clinical trial "NAVIGATE" (ClinicalTrials.gov ID: NCT02203032) included only patients who had poor responses to treatment with ustekinumab. It showed that patients who switched to guselkumab from ustekinumab did better than those who remained on ustekinumab.[12][24]

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References

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