Lead
The National Institute for Health and Care Excellence (NICE) has approved guselkumab as a new biologic treatment option for adults with moderate to severe ulcerative colitis and active Crohn’s disease. The decision extends treatment choices for patients who have not responded adequately to existing therapies, offering clinicians another option when conventional and biological drugs have failed.
Background Context
Inflammatory bowel disease (IBD), encompassing Crohn’s disease and ulcerative colitis, is a chronic condition affecting the gastrointestinal tract, driven by dysregulated immune responses. A proportion of patients do not achieve remission with standard treatments, including corticosteroids, immunomodulators, biologics or Janus kinase (JAK) inhibitors, leaving a persistent unmet need for alternative therapeutic pathways. Guselkumab is a monoclonal antibody already used in the UK for plaque psoriasis and psoriatic arthritis. It works by targeting specific inflammatory signalling pathways implicated in chronic inflammatory conditions, and its extension into gastroenterology reflects a broader trend of repurposing immune-modulating biologics across overlapping inflammatory diseases.
Key Findings
According to reporting in the BMJ, NICE has recommended guselkumab specifically for adults with moderate to severe ulcerative colitis and for those with active Crohn’s disease who have found other treatments ineffective or intolerable, including biologics or JAK inhibitors. Clinical evidence reviewed by NICE indicated that guselkumab is an effective treatment option for this difficult-to-manage patient group. Indirect comparisons with existing biologics, including mirikizumab and vedolizumab, suggested broadly similar efficacy, positioning guselkumab as a comparable rather than superior alternative within the current treatment landscape. The approval does not replace existing first-line options but adds to the range of tools available once earlier therapies have failed. NICE’s assessment process considered both clinical effectiveness and cost-effectiveness before reaching its recommendation, a standard requirement for new treatments entering NHS use. The approval applies across England and Wales, where NICE guidance directs which treatments are routinely funded and offered within the health service.
Clinical Relevance
For clinicians managing patients with long-standing, treatment-resistant Crohn’s disease or ulcerative colitis, this approval provides an additional therapeutic pathway when other biologics or JAK inhibitors have not achieved adequate disease control. Given that a meaningful subset of IBD patients experience primary non-response or lose response over time to existing therapies, expanding the available biologic options may help more patients reach remission. The approval also reflects a wider shift in IBD care towards a broader repertoire of targeted mechanisms, allowing treatment to be tailored more closely to individual patient response rather than relying on a limited set of options.
Reference
Mahase E. NICE approves guselkumab for inflammatory bowel disease. BMJ. 2025;390:r1759. doi:10.1136/bmj.r1759
This article is a journalistic summary for informational purposes only. It does not constitute clinical advice or a recommendation to alter treatment decisions.