Johnson & Johnson has announced that the National Institute for Health and Care Excellence (NICE) has recommended Tremfya® (guselkumab) in the final guidance for the treatment of adult patients with moderately to severely active Crohn’s disease and ulcerative colitis.1,2 For Crohn’s disease, guselkumab can be used as an option when a conventional or biological treatment has not worked or cannot be tolerated, and when tumour necrosis factor (TNF)-alpha inhibitor has not worked, cannot be tolerated, or is not suitable.1 For ulcerative colitis, guselkumab can be used as an option when a conventional or biological treatment, or a Janus kinase (JAK) inhibitor, has not worked or cannot be tolerated, and when a TNF-alpha inhibitor has not worked, cannot be tolerated, or is not suitable.2
Guselkumab is the first IL-23 inhibitor that could offer a fully subcutaneous induction and maintenance regimen in Crohn’s disease and ulcerative colitis recommended for use in the NHS, allowing for the treatment to be taken at home or hospital, depending on clinical suitability.1-7
Over 500,000 people in the UK live with inflammatory bowel disease (IBD). Approximately 115,000 have Crohn’s disease and nearly half have moderately to severely active Crohn’s disease. Around 296,000 people have ulcerative colitis and over half have moderately to severely active ulcerative colitis.8-11
In the UK, the most prevalent forms of IBD are Crohn’s disease and ulcerative colitis, affecting one in every 123 people.8,a
This Final Guidance follows the Medicines and Healthcare products Regulatory Agency’s (MHRA) marketing authorisation of guselkumab for moderately to severely active Crohn’s disease and ulcerative colitis in May this year.14 MHRA marketing authorisation for guselkumab subcutaneous induction for moderately to severely active ulcerative colitis was received on 19 August 2025, based on data from the Phase 3 ASTRO trial.
References supplied.
