The National Institute for Health and Care Excellence (NICE) has recommended mirikizumab for adults with moderately to severely active Crohn’s disease who have already received previous treatment.

The decision means mirikizumab will be available on the NHS in England within 30 days, and in Wales within 60 days, following marketing authorisation from the Medicines and Healthcare products Regulatory Agency earlier this year.

According to NICE’s final guidance, mirikizumab should be offered if the disease has not responded adequately to another biological treatment, if a previous therapy was not tolerated, or if tumour necrosis factor (TNF) inhibitors are not suitable.

Clinical evidence

The recommendation is based on data from the Phase 3 VIVID-1 trial, which studied adults with Crohn’s disease who had an inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators and/or biologics.

The trial met its co-primary endpoints. At one year, 45% of patients treated with mirikizumab achieved clinical remission compared with 20% of those who received placebo. In addition, 38% of patients on mirikizumab showed visible healing of the intestinal lining at one year, compared with 9% on placebo.

Mirikizumab’s safety profile in Crohn’s disease was broadly consistent with that seen in ulcerative colitis. The most common adverse reactions reported included COVID-19, joint pain, headache, and upper respiratory tract infections.

Expert and patient perspectives

James Lindsay, professor of inflammatory bowel disease at Barts and the London School of Medicine and Dentistry, and consultant gastroenterologist at Barts Health NHS Trust, said: “Many patients with Crohn’s disease have explored several of the currently available therapies but are still seeking a treatment option that effectively helps manage their symptoms and reduces the long-term inflammatory burden of the condition. The recent authorisation of mirikizumab is positive news for those living with Crohn’s disease as well as the gastroenterologists and specialists who care for them.”

Marianne Radcliffe, CEO of Crohn’s & Colitis UK, added: “Crohn’s disease is a lifelong condition affecting more than 200,000 people in the UK. There is no cure and existing treatments may not work for some, or may stop working over time. Expanding the treatment options for eligible people living with Crohn’s – with drugs like mirikizumab – can only be a good thing.”

James Neville, associate vice president of specialty care at Lilly UK and Ireland, said: “With mirikizumab now authorised in both Crohn’s disease and ulcerative colitis, more patients will have access to a treatment option that may provide long-term disease control and address key symptoms that matter most to them.”