Eli Lilly has announced the National Institute for Health and Care Excellence (NICE) have recommended mirikizumab for the treatment of adults with moderately to severely active Ulcerative Colitis (UC) in adults when conventional or biological treatment cannot be tolerated, or the condition has not responded well enough or lost response to treatment, only if:
- Tumour necrosis factor (TNF)-alpha inhibitor has not worked (that is the condition has not responded well enough or has lost response to treatment)
- (TNF)-alpha inhibitors cannot be tolerated or is not suitable
“Ulcerative colitis is a chronic, relapsing inflammatory disorder affecting the large intestine. It is characterised by symptoms of diarrhoea, bleeding and urgency, with multidimensional, and often negative effects on patients’ personal, psychological, professional and social well-being. Our understanding of the aetio-pathogenesis is improving, but our treatment options remain limited,” said Professor Jimmy Limdi, Consultant Gastroenterologist/Head of IBD Section at Northern Care Alliance NHS Foundation Trust and Professor of Gastroenterology at University of Manchester.
Our understanding of the aetio-pathogenesis is improving, but our treatment options remain limited
- Professor Jimmy Limdi, Consultant Gastroenterologist/Head of IBD Section at Northern Care Alliance NHS Foundation Trust and Professor of Gastroenterology at University of Manchester
Sarah Sleet, CEO of Crohn’s & Colitis UK, said: “Over 500,000 people in the UK are living with Crohn’s Disease and Ulcerative Colitis. They are lifelong conditions for which there is no known cure, and the symptoms are painful and debilitating. Existing medications may not work for some people, or indeed stop working for others. Expanding the treatment options for eligible people living with Colitis is a promising step forward and we welcome the NICE’s decision to recommend mirikizumab.”
The NICE recommendation was based on results from the LUCENT program, which included twoThe NICE recommendation was based on results from the LUCENT program, which included two randomised, double-blind, placebo-controlled Phase 3 clinical trials, consisting of one 12-week induction study (LUCENT-1) and one 40-week maintenance study (LUCENT-2) for 52 weeks of continuous treatment.
In the LUCENT-1 induction study, 1,162 patients were included in the primary efficacy population. Patients were randomised 3:1 to receive mirikizumab (300 mg) intravenous (IV) or placebo IV every 4 weeks for 12 weeks. After 12 weeks of treatment with mirikizumab 24.2% (n=210/868) of patients achieved the primary endpoint of clinical remission compared to 13.3% (n=39/294) of placebo.
Patients treated with mirikizumab achieved a greater reduction in rectal bleeding and stool frequency subscores as early as two weeks. The LUCENT studies also investigated endpoints such as bowel urgency remission and bowel urgency severity using the validated Urgency Numeric Rating Scale (NRS) of 0-10, with zero being no urgency and 10 being worst possible urgency.
Decreases in bowel urgency severity were observed as early as two weeks in patients treated with mirikizumab. After treatment with mirikizumab, 42.9% (n=144/336) of patients achieved bowel urgency remission at one year, compared to 25% (n=43/172) of placebo.
The Phase 3 LUCENT clinical program also evaluated the safety profile of mirikizumab. The most frequently reported adverse reactions are upper respiratory tract infections (7.9%, most frequently nasopharyngitis), headache (3.3%), rash (1.1%) and injection site reactions (8.7%, subcutaneous injection, LUCENT-2).
