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Guselkumab has new approved indications for treating Crohn’s disease and ulcerative colitis patients

June 20, 2025

As of 16th of May 2025 Guselkumab (Tremfya) has been approved for the treatment of Crohn’s disease & Ulcerative colitis. However, it was initially used for the treatment of plaque psoriasis and psoriatic arthritis.

Recent clinical studies showed that Guselkumab was effective in treatment of moderate to severe Crohn’s disease and UC For patients who have not achieved adequate response with other therapies or could not tolerate their side effects

Moreover, Guselkumab has shown major improvement in patients’ quality of life through reducing unfavorable symptoms such as diarrhea, abdominal pain & inflammation of the intestinal lining, which in turn has made it easier to go on with preforming daily activities.

The performed clinical trials for Crohn’s disease involved approximately 1,400 patients, up to 56% of those treated with Guselkumab achieved clinical remission at 12 weeks, compared to 15–22% with placebo. Endoscopic response—a marker of reduced intestinal inflammation—was observed in up to 41% of Guselkumab-treated patients versus 11–21% with placebo.

For ulcerative colitis, 23% of patients reached clinical remission after 12 weeks of induction therapy, compared to 8% on placebo. With continued maintenance treatment, remission rates rose to 50% at 44 weeks, versus 19% with placebo.

Details on side effects are available in the Patient Information Leaflet and SmPC on the MHRA website within seven days of approval.

Learn more: MHRA approves guselkumab for Crohn’s disease and ulcerative colitis - GOV.UK

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