Guselkumab, sold under the brand name Tremfya, is a human monoclonal antibody against interleukin-23 used for the treatment of plaque psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn's disease.[5][6]
Guselkumab is indicated to treat plaque psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn's disease.[7][5]
The most common side effects for guselkumab are upper respiratory tract infections, headache,
Guselkumab targets the IL-23 subunit alpha (p19 subunit)[10] preventing it from binding to cell receptors that would otherwise be activated by its presence.
Guselkumab was developed by Janssen Pharmaceuticals.[11] In November 2016, Janssen submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) seeking approval of guselkumab.[12]
In July 2017, the US Food and Drug Administration (FDA) approved guselkumab for the treatment of plaque psoriasis.[13]
In November 2017, Health Canada approved guselkumab for the treatment of plaque psoriasis.[14] In September 2020, the approval was expanded to include the treatment of adults with psoriatic arthritis.[15]
In April 2018, guselkumab was approved in Japan for the treatment of psoriatic arthritis.[16]
In July 2020, the FDA approved guselkumab as the first IL-23 inhibitor to treat active psoriatic arthritis (PsA).[17][18]
In September 2024, the FDA approved guselkumab for the treatment of moderately to severely active ulcerative colitis in adults.[19]
In May 2025, the UK Medicines and Healthcare products Regulatory Agency approved guselkumab for Crohn's disease and ulcerative colitis.[20]
The list price of each 100 mg dose is about US$10,000.[21]
During development, guselkumab was referred to as CNTO-1959.
Guselkumab has undergone phase III clinical trials comparing it with adalimumab (Humira) and ustekinumab (Stelara).[11]
The safety and efficacy of guselkumab was compared to a placebo and to adalimumab in the "VOYAGE 1" and "VOYAGE 2" phase III clinical trials (ClinicalTrials.gov IDs: NCT02207231 and NCT02207244).[22] 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.[22]
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.[23][24]
