Guselkumab

Last updated

Guselkumab
Monoclonal antibody
Type Whole antibody
Source Human
Target IL23
Clinical data
Pronunciation /ɡjuˈsɛlkjumæb/
gew-SEL-kew-mab
Trade names Tremfya
AHFS/Drugs.com Monograph
MedlinePlus a617036
License data
Pregnancy
category
  • AU:B1
Routes of
administration 		Subcutaneous, intravenous
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
Formula C6402H9864N1676O1994S42
Molar mass 143561.59 g·mol−1

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]

Contents

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

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]

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]

References

  1. ↑ "Tremfya (Guselkumab) Australian Product Information". Department of Health, Therapeutic Goods Administration. The Australian Government.
  2. ↑ "Product information". Health Canada . 27 November 2017. Retrieved 18 March 2024.
  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. 1 2 3 "Tremfya- guselkumab injection". DailyMed. Retrieved 22 January 2021.
  6. 1 2 3 "Tremfya EPAR". European Medicines Agency {EMA). 10 November 2017. Retrieved 12 June 2021.
  7. ↑ "Guselkumab". LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. National Institute of Diabetes and Digestive and Kidney Diseases. June 2018. PMID   31643594.
  8. 1 2 "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" (Press release). Johnson & Johnson.
  9. ↑ Kim PJ, Lansang RP, Vender R (July 2023). "A Systematic Review and Meta-Analysis of Injection Site Reactions in Randomized-Controlled Trials of Biologic Injections". Journal of Cutaneous Medicine and Surgery. 27 (4): 358–367. doi:10.1177/12034754231188444. PMC   10486173 . PMID   37533141.
  10. ↑ "Tremfya". U.S. Food and Drug Administration (FDA). 3 August 2017. Archived from the original on 2 November 2017.
  11. ↑ Oppmann B, Lesley R, Blom B, Timans JC, Xu Y, Hunte B, et al. (November 2000). "Novel p19 protein engages IL-12p40 to form a cytokine, IL-23, with biological activities similar as well as distinct from IL-12". Immunity. 13 (5): 715–725. doi: 10.1016/S1074-7613(00)00070-4 . PMID   11114383.{{cite journal}}: CS1 maint: overridden setting (link)
  12. 1 2 3 4 Markham A (September 2017). "Guselkumab: First Global Approval". Drugs. 77 (13): 1487–1492. doi:10.1007/s40265-017-0800-7. PMID   28819723. S2CID   35810454.
  13. 1 2 "Janssen Wins FDA Approval for Plaque Psoriasis Treatment Tremfya". Genetic Engineering & Biotechnology News. 14 July 2017.
  14. ↑ "Janssen Submits Application to EMA Seeking Approval of Anti-Interleukin-23 Monoclonal Antibody Guselkumab for the Treatment of Moderate-to-Severe Plaque Psoriasis" (Press release). Janssen. Archived from the original on 7 November 2017. Retrieved 1 November 2017.
  15. ↑ "Novel Drug Approvals for 2017". U.S. Food and Drug Administration (FDA). 25 January 2021. Archived from the original on 1 February 2017.
  16. ↑ "Regulatory Decision Summary for Tremfya". Drug and Health Products Portal. 10 November 2017. Retrieved 18 March 2024.
  17. ↑ "Regulatory Decision Summary for Tremfya". Drug and Health Products Portal. 4 September 2020. Retrieved 18 March 2024.
  18. ↑ "MorphoSys' licensee Janssen receives Japanese approval for Tremfya to treat moderate to severe forms of psoriasis & psoriatic arthritis". pharmabiz.com. Archived from the original on 29 April 2021. Retrieved 5 June 2018.
  19. ↑ "FDA approves Tremfya (guselkumab) for psoriatic arthritis". www.mdedge.com. Retrieved 15 July 2020.
  20. ↑ "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.
  21. ↑ "MHRA approves guselkumab for Crohn's disease and ulcerative colitis". GOV.UK. 16 May 2025. Retrieved 4 October 2025.
  22. ↑ Helfand C (13 July 2017). "Johnson & Johnson's Tremfya gets its go-ahead to fight Novartis, Lilly in psoriasis. Can it stand out?". Fierce Pharma.
  23. 1 2 Nakamura M, Lee K, Jeon C, Sekhon S, Afifi L, Yan D, et al. (September 2017). "Guselkumab for the Treatment of Psoriasis: A Review of Phase III Trials". Dermatology and Therapy. 7 (3): 281–292. doi:10.1007/s13555-017-0187-0. PMC   5574739 . PMID   28639011.{{cite journal}}: CS1 maint: overridden setting (link)
  24. ↑ Janssen Research & Development, LLC (11 August 2017). 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 (Report). clinicaltrials.gov.{{cite report}}: CS1 maint: multiple names: authors list (link)
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