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Guselkumab

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]

Medical uses

Guselkumab is indicated to treat plaque psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn's disease.[7][5]

Adverse effects

The most common side effects for guselkumab are upper respiratory tract infections, headache, injection site reactions,[8] joint pain, diarrhea, gastroenteritis, fungal skin infections and herpes simplex infections.[9]

Pharmacology

Mechanism of action

Guselkumab targets the IL-23 subunit alpha (p19 subunit)[10] preventing it from binding to cell receptors that would otherwise be activated by its presence.

Pharmacokinetics

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

History

Guselkumab was developed by Janssen Pharmaceuticals.[11] In November 2016, Janssen submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) seeking approval of guselkumab.[12]

Society and culture

Legal status

In July 2017, the US Food and Drug Administration (FDA) approved guselkumab for the treatment of plaque psoriasis.[13]

In November 2017, Health Canada approved guselkumab for the treatment of plaque psoriasis.[14] In September 2020, the approval was expanded to include the treatment of adults with psoriatic arthritis.[15]

In April 2018, guselkumab was approved in Japan for the treatment of psoriatic arthritis.[16]

In July 2020, the FDA approved guselkumab as the first IL-23 inhibitor to treat active psoriatic arthritis (PsA).[17][18]

In September 2024, the FDA approved guselkumab for the treatment of moderately to severely active ulcerative colitis in adults.[19]

In May 2025, the UK Medicines and Healthcare products Regulatory Agency approved guselkumab for Crohn's disease and ulcerative colitis.[20]

Economics

The list price of each 100 mg dose is about US$10,000.[21]

Names

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

Research

Guselkumab has undergone phase III clinical trials comparing it with adalimumab (Humira) and ustekinumab (Stelara).[11]

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).[22] 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.[22]

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.[23][24]

References

  1. Tremfya (Guselkumab) Australian Product Information Department of Health, Therapeutic Goods Administration, The Australian Government^
  2. Product information Health Canada, 2017-11-27, retrieved 2024-03-18^
  3. Skin health Health Canada, 9 May 2018, retrieved 13 April 2024^
  4. Tremfya 100 mg solution for injection in pre-filled pen - Summary of Product Characteristics (SmPC) (emc), 1 November 2020, retrieved 12 June 2021^
  5. {{cite web | title=Tremfya EPAR | website=European Medicines Agency {EMA) | date=10 November 2017 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/tremfya | access-date=12 June 2021}}^
  6. Guselkumab LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]., National Institute of Diabetes and Digestive and Kidney Diseases, June 2018^
  7. Tremfya- guselkumab injection DailyMed, retrieved 22 January 2021^
  8. A Systematic Review and Meta-Analysis of Injection Site Reactions in Randomized-Controlled Trials of Biologic Injections Journal of Cutaneous Medicine and Surgery, July 2023^
  9. Tremfya U.S. Food and Drug Administration (FDA), 3 August 2017^
  10. Novel p19 protein engages IL-12p40 to form a cytokine, IL-23, with biological activities similar as well as distinct from IL-12 Immunity, November 2000^
  11. Janssen Wins FDA Approval for Plaque Psoriasis Treatment Tremfya Genetic Engineering & Biotechnology News, 14 July 2017^
  12. Janssen Submits Application to EMA Seeking Approval of Anti-Interleukin-23 Monoclonal Antibody Guselkumab for the Treatment of Moderate-to-Severe Plaque Psoriasis Janssen, retrieved 1 November 2017^
  13. Novel Drug Approvals for 2017 U.S. Food and Drug Administration (FDA), 25 January 2021^
  14. Regulatory Decision Summary for Tremfya Drug and Health Products Portal, 2017-11-10, retrieved 2024-03-18^
  15. Regulatory Decision Summary for Tremfya Drug and Health Products Portal, 2020-09-04, retrieved 2024-03-18^
  16. MorphoSys' licensee Janssen receives Japanese approval for Tremfya to treat moderate to severe forms of psoriasis & psoriatic arthritis pharmabiz.com, retrieved 5 June 2018^
  17. FDA approves Tremfya (guselkumab) for psoriatic arthritis www.mdedge.com, retrieved 15 July 2020^
  18. DGAP-News: MororphoSys's Licensee Janssen Announces Approval of Tremfya (Guselkumab) by U.S. FDA for Treatment of Adults with Active Psoriatic Arthritis Bloomberg.com, 14 July 2020, retrieved 6 September 2020^
  19. Tremfya (guselkumab) receives U.S. FDA approval for adults with moderately to severely active ulcerative colitis, strengthening Johnson & Johnson's leadership in inflammatory bowel disease Johnson & Johnson^
  20. MHRA approves guselkumab for Crohn's disease and ulcerative colitis GOV.UK, 16 May 2025, retrieved 4 October 2025^
  21. Johnson & Johnson's Tremfya gets its go-ahead to fight Novartis, Lilly in psoriasis. Can it stand out? Fierce Pharma, 13 July 2017^
  22. Guselkumab for the Treatment of Psoriasis: A Review of Phase III Trials Dermatology and Therapy, September 2017^
  23. Guselkumab: First Global Approval Drugs, September 2017^
  24. Janssen Research & Development, LLC. A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab clinicaltrials.gov, 2017-08-11^