The National Institute for Health and Care Excellence (NICE) has approved guselkumab for treating moderately to severely active ulcerative colitis and Crohn's disease in adults, marking a significant expansion of treatment options for patients with refractory inflammatory bowel disease.
Treatment Positioning and Patient Population
Guselkumab is positioned as a treatment option for patients who have exhausted conventional therapies and TNF-alpha inhibitors. For ulcerative colitis patients, the drug is recommended when standard treatments, JAK inhibitors, or biologic medicines have not worked or caused side effects, and TNF-alpha inhibitors have also failed or were unsuitable. For Crohn's disease, guselkumab is indicated when standard treatments or biologic medicines have been ineffective or caused adverse effects, and TNF-alpha inhibitors were similarly unsuccessful or inappropriate.
TNF-alpha inhibitors represent the most commonly used biological treatments for moderately to severely active ulcerative colitis when conventional treatments fail. When TNF-alpha inhibitors prove ineffective or intolerable, current treatment options include mirikizumab or vedolizumab, with guselkumab now joining this therapeutic arsenal for the same patient population.
Mechanism of Action and Clinical Evidence
Guselkumab is a biologic medicine produced through biological processes using living cells in laboratory settings. The drug functions by binding to interleukin-23 (IL-23), a protein produced by the immune system to combat infections but which can also trigger inflammation. By blocking IL-23 effects, guselkumab reduces gut inflammation.
Clinical trial evidence demonstrates that guselkumab is more effective than placebo. While direct head-to-head comparisons with mirikizumab or vedolizumab have not been conducted, indirect comparisons suggest guselkumab likely performs as well as these established therapies.
Dosing and Administration
The treatment protocol involves an initial induction phase with three doses administered either intravenously or subcutaneously every four weeks to achieve disease control. Following induction, patients transition to subcutaneous maintenance injections, with healthcare providers training patients for self-administration at home. Maintenance dosing occurs either every four or eight weeks, depending on the prescribed dose strength.
Cost-Effectiveness and Implementation
Cost comparison analyses indicate that guselkumab expenses are similar to or lower than those associated with mirikizumab and vedolizumab. NICE determined there is sufficient evidence demonstrating that guselkumab provides benefits and value for money, enabling routine use across the NHS for this patient population.
The guidance mandates NHS funding in England within 30 days of final publication, with Wales expected to follow within 60 days. Northern Ireland typically adopts NICE decisions, while the Scottish Medicines Consortium is currently conducting its own assessment for Scotland.
Clinical Impact
This approval addresses a critical unmet need for patients with moderate to severe inflammatory bowel disease who have limited therapeutic options after failing conventional treatments and TNF-alpha inhibitors. The addition of guselkumab to the treatment armamentarium provides clinicians with another effective biologic option, potentially improving outcomes for patients with refractory disease.
NICE has developed implementation tools and resources to support healthcare providers in adopting this guidance, ensuring consistent access to guselkumab across eligible patient populations.
