Product Code Database
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.
In November 2017, Health Canada approved guselkumab for the treatment of plaque psoriasis. In September 2020, the approval was expanded to include the treatment of adults with psoriatic arthritis.
In April 2018, guselkumab was approved in Japan for the treatment of psoriatic arthritis.
In July 2020, the FDA approved guselkumab as the first IL-23 inhibitor to treat active psoriatic arthritis (PsA).
In September 2024, the FDA approved guselkumab for the treatment of moderately to severely active ulcerative colitis in adults.
In May 2025, the UK Medicines and Healthcare products Regulatory Agency approved guselkumab for Crohn's disease and ulcerative colitis.
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). 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.
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.
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