NICE recommends guselkumab for ulcerative colitis and Crohn’s disease

Guidance says guselkumab can be used as an option for treating moderately to severely active ulcerative colitis in adults when other treatments have not worked.

Someone undergoing an abdominal exam — The guidance clarified that patients who have started treatment with guselkumab outside these recommendations can continue until their physician considers it appropriate to stop

Patients with moderately to severely active ulcerative colitis or Crohn’s disease will now be able to access guselkumab (Tremfya; Janssen Biotech) on the NHS, when other treatments have not worked.

Final guidance published by the National Institute for Health and Care Excellence (NICE) on 28 August 2025 has recommended that guselkumab can be used as an option for treating moderately to severely active ulcerative colitis in adults when a conventional treatment, biological treatment or Janus kinase (JAK) inhibitor has not worked or cannot be tolerated, and a tumour necrosis factor (TNF)-alpha inhibitor has not worked, cannot be tolerated or is not suitable.

In ulcerative colitis, NICE recommended that guselkumab can be used as an alternative to other TNF-alpha inhibitors mirikizumab and vedolizumab. It said the lowest-cost treatment should be chosen.

In Crohn’s disease, the guidance said guselkumab can be offered to the same population as risankizumab and vedolizumab — patients for whom conventional treatments have stopped working or are unsuitable and biological treatments (including TNF-alpha inhibitors or ustekinumab) are unsuitable, do not work well enough, stop working or are not tolerated.

However, NICE added that patients who have started treatment with guselkumab outside these recommendations can continue it until they and their NHS healthcare professional consider it appropriate to stop.

Mohammed Allah-Ditta, advanced gastroenterology pharmacist at Calderdale and Huddersfield NHS Foundation Trust, commented: “From a patient perspective, guselkumab offers convenience with single SC [subcutaneous] administration, compared to mirikizumab (two injections) and risankizumab (on-body injector).

“The availability of both intravenous and SC induction routes provides flexibility, allowing trusts to tailor implementation based on infusion unit capacity and homecare pathways.

“No head-to-head trials have yet compared guselkumab with other IL-23 inhibitors [Interleukin-23 inhibitors, such as mirikizumab].

“As these agents are integrated into real-world practice, differences in efficacy, patient profiles and preferences may emerge. Until then, selection will likely be guided by factors such as cost, access, dosing intervals, patient preference and prescriber familiarity.”