HQ Team
May 19, 2025: The UK’s Medicines and Healthcare products Regulatory Agency has approved Janssen-Cilag Limited’s guselkumab (Tremfya) to treat Crohn’s disease and ulcerative colitis.
The regulator stated that using guselkumab in Crohn’s disease could benefit patients by reducing the signs and symptoms of the disease, which can include diarrhoea and abdominal pain.
In Crohn’s disease, three major studies involving around 1,400 patients found that up to 56% of those treated with guselkumab achieved clinical remission after 12 weeks, compared to 15–22% with placebo.
Endoscopic response, indicating reduced inflammation in the intestines, was seen in up to 41% of guselkumab-treated patients, compared to 11–21% receiving placebo.
Efficacy for approval
In a clinical study for ulcerative colitis, 23% of patients receiving guselkumab achieved clinical remission after 12 weeks of induction treatment, compared to 8% on placebo. Continued maintenance treatment led to remission in up to 50% of patients after 44 weeks, versus 19% with placebo.
During the late-stage study, participants were randomly assigned to different treatment groups, both doctors and patients knew which treatment was being given (open-label), and the goal was to confirm the treatment’s effectiveness and safety before potential regulatory approval.
“We’re assured that the appropriate regulatory standards of safety, quality and efficacy for the approval of this new formulation have been met,” said Julian Beach, the agency’s Interim Executive Director of Healthcare Quality and Access.
Plaque psoriasis
Guselkumab is currently approved to treat plaque psoriasis and psoriatic arthritis. Clinical studies have shown that guselkumab is also efficacious in treating adults with moderately to severely active Crohn’s disease and ulcerative colitis, who have not responded well to other treatments or experienced unacceptable side effects.
In ulcerative colitis, it helps to reduce abdominal pain and inflammation of the intestinal lining. These effects can improve a patient’s ability to do normal daily activities and reduce fatigue.
Guselkumab can be administered either by intravenous infusion or injection for the initial treatment of Crohn’s disease. For colitis, initial treatment will be administered through an intravenous infusion.
