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Guselkumab

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Guselkumab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetIL23
Clinical data
Trade namesTremfya
AHFS/Drugs.comMonograph
MedlinePlusa617036
License data
Pregnancy
category
  • AU: B1
Routes of
administration		Subcutaneous
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
FormulaC6402H9864N1676O1994S42
Molar mass143561.59 g·mol−1

Guselkumab, sold under the brand name Tremfya, is a monoclonal antibody against interleukin-23 used for the treatment of plaque psoriasis, psoriatic arthritis, and ulcerative colitis.[5][7][8][9]

Medical uses

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Guselkumab is indicated to treat plaque psoriasis, psoriatic arthritis, and ulcerative colitis.[5]

Adverse effects

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Guselkumab lowers the release of immune system signalling molecules, increasing the risk of infections from bacteria, viruses, and fungi.[7]

The most common side effects for guselkumab are upper respiratory tract infections, headache, injection site reactions,[10] joint pain, diarrhea, gastroenteritis, fungal skin infections and herpes simplex infections.[11]

Pharmacology

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Mechanism of action

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Guselkumab targets the IL-23 subunit alpha (p19 subunit)[12] preventing it from binding to cell receptors that would otherwise be activated by its presence.[13]

Pharmacokinetics

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  • Cmax 8.09 μg/mL
  • tmax 5.5 days
  • volume of distribution 13.5 L
  • apparent clearance 0.516 L/day[13]

History

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Guselkumab was developed by Janssen Pharmaceuticals.[14] In November 2016, Janssen submitted a Biologics License Application (BLA) to the FDA seeking approval of guselkumab.[15]

Society and culture

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In July 2017, the US Food and Drug Administration (FDA) approved guselkumab for the treatment of plaque psoriasis.[16]

In November 2017, Health Canada approved guselkumab for the treatment of plaque psoriasis.[17] In September 2020, the approval was expanded to include the treatment of adults with psoriatic arthritis.[18]

In April 2018, guselkumab was approved in Japan for the treatment of psoriatic arthritis.[19]

In July 2020, the FDA approved guselkumab as the first IL-23 inhibitor to treat active psoriatic arthritis (PsA).[20][21]

In September 2024, the FDA approved guselkumab for the treatment of moderately to severely active ulcerative colitis in adults.[9]

Economics

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

Names

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During development, guselkumab was referred to as CNTO-1959.[13]

Research

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Guselkumab has undergone phase 3 clinical trials comparing it with adalimumab (Humira) and ustekinumab (Stelara).[14]

The safety and efficacy of guselkumab was compared to a placebo and to adalimumab in the "VOYAGE 1" and "VOYAGE 2" phase 3 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.[13]

References

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  1. ^ "Tremfya (Guselkumab) Australian Product Information". Department of Health, Therapeutic Goods Administration. The Australian Government.
  2. ^ "Product information". health-products.canada.ca. 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. ^ a b c "Tremfya- guselkumab injection". DailyMed. Retrieved 22 January 2021.
  6. ^ "European Medicines Agency". European Medicines Agency {EMA). 17 September 2018. Retrieved 12 June 2021.
  7. ^ a b "Guselkumab Injection". MedlinePlus Drug Information.
  8. ^ "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.
  9. ^ a b "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.
  10. ^ 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.
  11. ^ "TREMFYA". Drug Approvals and Databases > Drug Trials Snapshots. U.S. Food and Drug Administration. 3 August 2017.
  12. ^ 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)
  13. ^ a b c d Markham A (September 2017). "Guselkumab: First Global Approval". Drugs. 77 (13): 1487–1492. doi:10.1007/s40265-017-0800-7. PMID 28819723. S2CID 35810454.
  14. ^ a b "Janssen Wins FDA Approval for Plaque Psoriasis Treatment Tremfya". Genetic Engineering & Biotechnology News. 14 July 2017.
  15. ^ "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.
  16. ^ "Novel Drug Approvals for 2017". U.S. Food and Drug Administration (FDA). 25 January 2021.
  17. ^ "Regulatory Decision Summary for Tremfya". Drug and Health Products Portal. 10 November 2017. Retrieved 18 March 2024.
  18. ^ "Regulatory Decision Summary for Tremfya". Drug and Health Products Portal. 4 September 2020. Retrieved 18 March 2024.
  19. ^ "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.
  20. ^ "FDA approves Tremfya (guselkumab) for psoriatic arthritis". www.mdedge.com. Retrieved 15 July 2020.
  21. ^ "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.
  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. ^ a b 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)
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