The National Institute for Health and Care Excellence (NICE) has issued final guidance recommending Johnson & Johnson’s Tremfya (guselkumab) for the treatment of adults with moderately to severely active Crohn’s disease and ulcerative colitis.

The IL-23 inhibitor is the first therapy of its kind to offer a fully subcutaneous induction and maintenance regimen for both conditions, enabling patients to receive treatment at home or in hospital depending on clinical suitability.

Over 500,000 people in the UK live with inflammatory bowel disease (IBD), including around 115,000 with Crohn’s disease and 296,000 with ulcerative colitis. For patients who have not responded to, or cannot tolerate, conventional or biological therapies — or in ulcerative colitis, a Janus kinase (JAK) inhibitor — Tremfya provides a new treatment option.

The recommendation is based on data from multiple phase 3 trials, including the GALAXI and GRAVITI studies in Crohn’s disease and the QUASAR programme in ulcerative colitis, which showed statistically significant improvements in clinical remission and endoscopic response. Safety outcomes were consistent with Tremfya’s established profile in other indications.

Professor James Lindsay, professor of inflammatory bowel disease at Queen Mary University of London, said the decision represents “an important milestone in broadening the clinical community’s options to manage this challenging condition.”

Marianne Radcliffe, CEO of Crohn’s & Colitis UK, welcomed the expanded access, highlighting that people with IBD want treatments that help them live their lives outside of hospital.

Amanda Cunnington, senior director of patient access at Johnson & Johnson Innovative Medicine UK, added that the recommendation reflects “meaningful progress for people affected by chronic conditions like Crohn’s disease and ulcerative colitis.”

The NICE decision follows the Medicines and Healthcare products Regulatory Agency’s (MHRA) marketing authorisation of Tremfya for Crohn’s disease and ulcerative colitis earlier this year.