The U.K. National Institute for Health and Care Excellence (NICE) has recommended the use of Stelara (ustekinumab) to treat patients with moderately to severely active ulcerative colitis specifically in adults when conventional and biological therapies are ineffective or not tolerated.
Stelara’s developer, Janssen, anticipates that this recommendation may allow the treatment to be publicly available in England and Wales before the end of 2020.
Ulcerative colitis (UC) is a disorder characterized by immune system attack and inflammation of the rectum and colon. Many treatments are designed to moderate immune system activity and/or inflammation. However, for up to one-third of patients, treatments are not completely successful or lead to complications that may require surgery.
Stelara is the first approved treatment for UC that targets the IL-12/IL-23 pathways, which are involved in the inflammatory response. IL-12/IL-23 have been shown to be elevated in patients with Crohn’s disease, another form of inflammatory bowel disease.
“Ulcerative colitis can have a devastating impact on the lives of those living with this long-term condition,” James Lindsay, PhD, a consultant gastroenterologist at Barts Health NHS Trust, said in a press release. “Many patients do not respond to, or get side effects from, currently available therapies. Therefore, the recent NICE approval for ustekinumab as a novel therapy for patients that are not suited to currently available treatments is welcome.”
NICE’s recommendation indicates that Stelara should be used for UC patients who do not respond or cannot tolerate TNF-alpha inhibitors.
“The impact of uncontrolled symptoms of ulcerative colitis can be devastating and debilitating,” said Sarah Berry, health service project manager at the charity Crohn’s & Colitis UK. “Current treatments simply do not work for everyone, so having as many treatment options as possible available, and allowing doctors and other clinicians to personalise their approach, is critical.”
The recommendation follows results from the pivotal Phase 3 UNIFI clinical trial (NCT02407236) investigating Stelara as a treatment for UC. The trial showed that a greater percentage (38% to 44%) of patients achieved remission at week 44 of treatment when given Stelara delivered subcutaneously (under the skin) compared with a placebo (24%).
Stelara was also found to be well-tolerated by patients, with a similar proportion of participants reporting side effects and infections in the Stelara and placebo groups.
NICE’s recommendation for Stelara will provide the foundation for an official NICE Technology Appraisal Guidance (TAG), which allows Janssen to receive funding from the National Health Services (NHS) in both England and Wales.
Janssen expects that the TAG document will be published by NICE in June 2020, which will allow the company to have Stelara publicly available within three months of the publication.
“We are pleased with NICE’s decision to accept ustekinumab for use within NHS England and Wales for eligible patients living with ulcerative colitis when either a TNF-alpha inhibitor is not appropriate or has not been effective,” said Jennifer Lee, EMEA therapy area market access lead for immunology at Janssen.
“We have a long-standing commitment to developing innovative therapies to improve the lives of those living with immune-mediated inflammatory diseases. The decision from NICE reflects the true patient and clinical need for new treatment options for patients living with moderately to severely active ulcerative colitis,” Lee said.
Stelara was approved by the European Commission in September 2019 to treat adults with moderately to severely active UC, and in October 2019 by the U.S. Food and Drug Administration for the same indication.
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