Guselkumab

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Guselkumab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetIL23
Names
Trade namesTremfya
Clinical data
Main usesPlaque psoriasis[1][2]
Side effectsUpper respiratory tract infections, headache, joint pain, liver problems, decreased effectiveness of vaccines[3]
Pregnancy
category
  • AU: B1
Routes of
use		Subcutaneous
External links
AHFS/Drugs.comMonograph
MedlinePlusa617036
Legal
License data
Legal status
Chemical and physical data
FormulaC6402H9864N1676O1994S42
Molar mass143561.59 g·mol−1

Guselkumab, sold under the brand name Tremfya, is a medication used to treat plaque psoriasis.[1][2] It is used for moderate to severe disease.[1] It is given by injection under the skin.[1]

Common side effects include upper respiratory tract infections.[1] Other side effects may include infection, headache, joint pain, liver problems, and decreased effectiveness of vaccines.[3] Safety in pregnancy is unclear.[3] It is a monoclonal antibody which attaches to and blocks interleukin-23.[1]

Guselkumab was approved for medical use in the United States and Europe in 2017.[3][1] In the United Kingdom it costs the NHS about £2,250 per 100 mg as of 2021.[8] This amount in the United States is about 11,600 USD.[9]

Medical uses

Guselkumab is used to treat moderate to severe plaque psoriasis, and psoriatic arthritis in adults.[7]

Dosage

Guselkumab is provided as a subcutaneous injection of 100 mg given every eight weeks (except for the second dose, which is given four weeks after the first dose).[1]

Side effects

Because guselkumab lowers the release of immune system signalling molecules, patients may have a higher risk of getting infections from bacteria, viruses, and fungi.[10] For this reason, people with psoriasis being considered for treatment with guselkumab must be screened for tuberculosis infection prior to treatment with guselkumab.[10]

The most common side effects for guselkumab are upper respiratory tract infections, headache, injection site reactions, joint pain, diarrhea, gastroenteritis, fungal skin infections and herpes simplex infections.[11] As guselkumab is a new medicine, the long term effects are not fully understood.[12]

Pharmacology

Mechanism of action

Guselkumab targets the IL-23 subunit alpha (p19 subunit)[13] preventing it from binding to cell receptors that would otherwise be activated by its presence.[14]

Pharmacokinetics

  • Cmax 8.09 µg/mL
  • tmax 5.5 days
  • volume of distribution 13.5 L
  • apparent clearance 0.516 L/day[14]

Society and culture

Commercialization

Guselkumab was developed by Janssen Global Services, LLC.[15] In November 2016, Janssen submitted a Biologics License Application (BLA) to the FDA seeking approval of guselkumab.[16]

In July 2017, Janssen gained US FDA approval to market guselkumab for treatment of plaque psoriasis.[17]

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

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

Guselkumab is manufactured by Janssen Sciences Ireland UC in Cork, Ireland.[21]

Cost

The list price of each 100 mg dose (to be given once every two months) is about $10,000.[22]

Research

During development, guselkumab was referred to as CNTO-1959.[14] Guselkumab has undergone phase 3 clinical trials comparing it with adalimumab (Humira) and ustekinumab (Stelara).[15]

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 NCT02207231).[12] 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.[12]

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.[14]

References

  1. ↑ 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 "Tremfya". Archived from the original on 22 November 2021. Retrieved 9 December 2021.
  2. ↑ 2.0 2.1 "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.
  3. ↑ 3.0 3.1 3.2 3.3 "Guselkumab Monograph for Professionals". Drugs.com. Archived from the original on 27 September 2021. Retrieved 9 December 2021.
  4. ↑ "Tremfya (Guselkumab) Australian Product Information". Department of Health, Therapeutic Goods Administration. The Australian Government. Archived from the original on 2021-06-13. Retrieved 2021-10-10.
  5. ↑ "European Medicines Agency". European Medicines Agency {EMA). Retrieved 12 June 2021.
  6. ↑ "Tremfya 100 mg solution for injection in pre-filled pen - Summary of Product Characteristics (SmPC)". (emc). 1 November 2020. Archived from the original on 13 June 2021. Retrieved 12 June 2021.
  7. ↑ 7.0 7.1 "Tremfya- guselkumab injection". DailyMed. Archived from the original on 28 January 2021. Retrieved 22 January 2021.
  8. ↑ BNF 81: March-September 2021. BMJ Group and the Pharmaceutical Press. 2021. p. 1302. ISBN 978-0857114105.
  9. ↑ "Guselkumab Prices, Coupons & Savings Tips - GoodRx". GoodRx. Retrieved 9 December 2021.
  10. ↑ 10.0 10.1 "Guselkumab Injection". MedlinePlus Drug Information. Archived from the original on 2017-12-22. Retrieved 2021-10-10.
  11. ↑ "TREMFYA". Drug Approvals and Databases > Drug Trials Snapshots. U.S. Food and Drug Administration. 3 August 2017. Archived from the original on 23 April 2019. Retrieved 10 October 2021.
  12. ↑ 12.0 12.1 12.2 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.
  13. ↑ 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): 715–25. doi:10.1016/S1074-7613(00)00070-4. PMID 11114383.
  14. ↑ 14.0 14.1 14.2 14.3 Markham A (September 2017). "Guselkumab: First Global Approval". Drugs. 77 (13): 1487–1492. doi:10.1007/s40265-017-0800-7. PMID 28819723. S2CID 35810454.
  15. ↑ 15.0 15.1 "Janssen Wins FDA Approval for Plaque Psoriasis Treatment Tremfya". Genetic Engineering & Biotechnology News. 14 July 2017. Archived from the original on 31 October 2017. Retrieved 10 October 2021.
  16. ↑ "Janssen Submits Application to EMA Seeking Approval of Anti-Interleukin-23 Monoclonal Antibody Guselkumab for the Treament of Moderate-to-Severe Plaque Psoriasis". Janssen. Archived from the original on 2017-11-07. Retrieved 2021-10-10.
  17. ↑ "Novel Drug Approvals for 2017". U.S. Food and Drug Administration. 25 January 2021. Archived from the original on 29 June 2017. Retrieved 10 October 2021.
  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 2021-04-29. Retrieved 2018-06-05.
  19. ↑ "FDA approves Tremfya (guselkumab) for psoriatic arthritis". www.mdedge.com. Archived from the original on 2020-07-15. Retrieved 2020-07-15.
  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. 2020-07-14. Archived from the original on 2021-04-29. Retrieved 2020-09-06.
  21. ↑ "Guselkumab BLA Approval Letter" (PDF). U.S. Food and Drug Administration. Archived (PDF) from the original on 2021-10-12. Retrieved 2021-10-10.
  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. Archived from the original on 17 January 2021. Retrieved 10 October 2021.

External links

  • "Guselkumab". Drug Information Portal. U.S. National Library of Medicine. Archived from the original on 2021-04-28. Retrieved 2021-10-10.
Identifiers:
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