UK’s NICE Approves New Crohn’s Disease Therapy

The National Institute for Health and Care Excellence has recommended that Janssen’s Crohn’s disease drug Stelara (ustekinumab) be made available to patients in the UK through the NHS. Adult patients who have failed to show clinical improvements after taking first-line therapies for Crohn’s disease may be eligible for treatment with Stelara.

Crohn’s disease is a form of inflammatory bowel disease that affects around 132,000 people in the UK. The chronic condition has no known cure and can cause recurrent flare-ups characterized by symptoms like stomach cramps, diarrhea and weight loss.

Stelara is a human monoclonal antibody which targets interleukin (IL)-12 and IL-23 cytokines, both of which are known to be involved in the inflammatory response. The EMA originally approved the biologic in November of 2016.

“We are delighted to be able to recommend ustekinumab for routine NHS use. Crohn’s disease can have a debilitating impact on a person’s quality of life, from self-esteem through to experiencing regular relapses,” said Professor Carole Longson, director of the health technology evaluation centre at NICE. “Ustekinumab provides a convenient and viable option for patients with Crohn’s. It is a new way of treating the disease compared to conventional treatment, and can be used where other options have already been tried and stopped working.”

In three Phase III clinical trials which enrolled a total of 1,400 patients, Stelara was able to elicit a clinical response and was able to help more patients stay in a state of remission after one year of treatment, compared to a placebo. The biologic was also well tolerated in Crohn’s patients.

“We are delighted that NICE has recommended ustekinumab as a treatment option for adults with Crohn’s disease and has listened to and valued the evidence from patients through the appraisal process,” said Sarah Berry, Health Policy & Public Affairs Officer from Crohn’s and Colitis UK. “The impact of uncontrolled symptoms of Crohn’s disease can be profoundly debilitating and current treatment options simply do not work for everyone.

“This ruling gives access to a desperately needed additional treatment to those who may otherwise have been condemned to living with unmanageable disease progression with devastating impact on their quality of life,” continued Berry. “We now look forward to people being able to access this treatment option as soon as possible.”

It’s estimated that 28,000 patients living with Crohn’s disease in England and Wales could be treated with Stelera. Once the NICE draft guidance is finalized, the NHS will have three months to make sure that Stelara is available to eligible patients.

Stelara has also been recommended by NICE to treat psoriasis and psoriatic arthritis. The injectable was approved by the US FDA in September of 2016.