Guselkumab is indicated to treat moderate to severe plaque psoriasis, and psoriatic arthritis in adults.[5]
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).[9]
Because guselkumab lowers the release of immune system signalling molecules, patients may have a higher risk of getting infections from bacteria, viruses, and fungi.[7] For this reason, people with psoriasis being considered for treatment with guselkumab must be screened for tuberculosis infection prior to treatment with guselkumab.[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] Because guselkumab is a new medicine, the long-term effects are not fully understood.[12]
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]
In July 2017, Janssen gained US FDA approval to market guselkumab for treatment of plaque psoriasis.[17]
In November 2017 Health Canada approved guselkumab to be marketed for the treatment of plaque psoriasis in Canada. [18] In September 2020 approval was expanded to include the treatment of adults with psoriatic arthritis. [19]
In April 2018, guselkumab was approved in Japan for the treatment psoriatic arthritis.[20]
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).[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]
^"Guselkumab". LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. National Institute of Diabetes and Digestive and Kidney Diseases. June 2018. PMID31643594.