|Chemical and physical data|
|Molar mass||143.6 kg/mol|
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).
Because guselkumab lowers the release of immune system signalling molecules, patients have a higher risk of getting infections from bacteria, viruses, and fungi. For this reason, patients must be screened for tuberculosis infection prior to treatment with guselkumab.
The most common side effects for guselkumab are upper respiratory tract infections, headache, injection site reactions, joint pain, diarrhea, stomach flu, fungal skin infections and herpes simplex infections. It is noteworthy that during the studies where side effects were tracked, patients who received a placebo experienced these side effects at rates just slightly lower than the patients who received guselkumab, suggesting guselkumab only marginally increases the risk of having an adverse effect. As guselkumab is a new medicine, the long term effects are not fully understood.
Mechanism of action
Cmax 8.09 µg/mL tmax 5.5 days volume of distribution 13.5 L apparent clearance 0.516 L/day
Guselkumab was developed by Janssen Global Services, LLC. In November 2016, Janssen submitted a Biologics License Application (BLA) to the FDA seeking approval of guselkumab. In July 2017 Janssen gained US FDA approval to market guselkumab for treatment of plaque psoriasis. Usage for psoriatic arthritis has also been approved in Japan as of April 2018. Guselkumab is manufactured by Janssen Sciences Ireland UC in Cork, Ireland. 
The list price of each 100 mg dose (to be given once every two months) is about $10,000.
Research and development
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) While these trials are still ongoing, preliminary results indicate 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 had a PASI score of 90 vs 49.7% of those taking adalimumab; additionally, 91.2% of patients taking guselkumab had a PASI score of 75, vs 73.1% of those taking adalimumab.
The phase 3 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 stuck to ustekinumab.
- Ustekinumab, a monoclonal antibody targeting both IL-12 and IL-23 and used to treat plaque psoriasis, launched in the United States under the brand name Stelara
- Tildrakizumab, another experimental, IL-23-specific monoclonal antibody
- Guselkumab Injection: MedlinePlus Drug Information
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- Janssen Wins FDA Approval for Plaque Psoriasis Treatment Tremfya. July 2017
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- Novel Drug Approvals for 2017
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- Guselkumab BLA Approval Letter
- Johnson & Johnson's Tremfya gets its go-ahead to fight Novartis, Lilly in psoriasis. Can it stand out?