Guselkumab, sold under the brand nameTremfya, is a medication used to treatplaque psoriasis.^[1][2] It is used for moderate to severe disease.^[1] It is given byinjection under the skin.^[1]

Common side effects includeupper respiratory tract infections.^[1] Other side effects may include infection, headache, joint pain, liver problems, and decreased effectiveness ofvaccines.^[3] Safety in pregnancy is unclear.^[3] It is amonoclonal antibody which attaches to and blocksinterleukin-23.^[1]

Guselkumab was approved for medical use in the United States and Europe in 2017.^[3][1] In the United Kingdom it costs theNHS 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 fortuberculosis 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 andherpes simplex infections.^[11] As guselkumab is a new medicine, the long term effects are not fully understood.^[12]

Pharmacology

Mechanism of action

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

Pharmacokinetics

• C_max 8.09 µg/mL
• t_max 5.5 days
• volume of distribution 13.5 L
• apparent clearance 0.516 L/day^[14]

Society and culture

Commercialization

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

In July 2017, Janssen gainedUS FDA approval to market guselkumab for treatment ofplaque psoriasis.^[17]

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

In July 2020, theFDA approved as the first IL-23 inhibitor to treatactive 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 undergonephase 3 clinical trials comparing it withadalimumab (Humira) andustekinumab (Stelara).^[15]

The safety and efficacy of guselkumab was compared to a placebo and toadalimumab 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 aPASI 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

External links

• "Guselkumab".Drug Information Portal. U.S. National Library of Medicine.Archived from the original on 2021-04-28. Retrieved2021-10-10.

• Pages using duplicate arguments in template calls
• Drugs with non-standard legal status
• Chemical articles with unknown parameter in Infobox drug
• Chemical articles without CAS registry number
• Articles without EBI source
• Chemical pages without ChemSpiderID
• Chemical pages without DrugBank identifier
• Articles without KEGG source
• Articles without InChI source
• Articles without UNII source
• Drugs missing an ATC code
• Articles containing unverified chemical infoboxes
• Drugs that are a monoclonal antibody
• Chemicals that do not have a ChemSpider ID assigned
• Monoclonal antibodies
• Johnson & Johnson brands
• RTT