Guselkumab approved for treatment of Crohn’s and ulcerative colitis
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Guselkumab has been approved by the MHRA to treat Crohn’s disease and ulcerative colitis.
Guselkumab (Tremfya, Janssen-Cilag) is already approved to treat plaque psoriasis and psoriatic arthritis. However, clinical studies have shown that it is also efficacious in treating adults with moderately to severely active Crohn’s disease and UC who have not responded well to other treatments.
Using guselkumab in Crohn’s disease can benefit patients by reducing the signs and symptoms of the disease, which can include diarrhoea and abdominal pain. In UC it helps to reduce abdominal pain and inflammation of the intestinal lining.
In Crohn’s disease, three major studies involving around 1,400 patients found that up to 56 per cent of those treated with guselkumab achieved clinical remission after 12 weeks, compared to 15–22 per cent with placebo. Endoscopic response, indicating reduced inflammation in the intestines, was seen in up to 41 per cent of guselkumab-treated patients, compared to 11–21 per cent receiving placebo.
In a clinical study for UC, 23 per cent of patients receiving guselkumab achieved clinical remission after 12 weeks of induction treatment, compared to 8 per cent on placebo. Continued maintenance treatment led to remission in up to 50 per cent of patients after 44 weeks, versus 19 per cent with placebo.
Guselkumab can be administered either by intravenous infusion or injection for the initial treatment of Crohn’s disease. For UC, initial treatment is via an intravenous infusion.