UK’s NICE Publishes Briefing Supporting PredictImmune Tool for Estimating IBD Flare-up Likelihood

UK’s NICE Publishes Briefing Supporting PredictImmune Tool for Estimating IBD Flare-up Likelihood

The National Institute for Health and Care Excellence (NICE) supports the use of PredictImmune‘s newly launched prognostic tool, PredictSURE IBD, for estimating the likelihoood of disease flare-ups in patients with inflammatory bowel disease (IBD), according to a published Medtech Innovation Briefing (MIB).

PredictSURE IBD is a prognostic tool that estimates the chances of disease flare-ups in patients recently diagnosed with Crohn’s disease or ulcerative colitis. It also will help physicians decide the best course of treatment for these patients.

The tool was launched April 2 through Cambridge University Hospitals NHS Foundation Trust, and will be available to IBD patients in the United Kingdom and Ireland, according to a press release from PredictImmune. “It enables both clinicians and patients to understand, at the point of diagnosis, the likely course of disease — differentiating between an aggressive or milder form of the disease — and opens up the possibility of better treatment choices from the outset,” the release states.

PredictSURE IBD works by looking for specific genetic signatures using a technique called quantitative real-time polymerase chain reaction (qPCR).

Clinical findings, summarized in the MIB report, demonstrate that PredictSURE IBD can accurately estimate the probability that a patient with IBD will experience a severe relapse episode.

Results also indicate that starting treatment with tumor necrosis factor (TNF) inhibitors, such as Remicade (infliximab) or Humira (adalimumab) shortly after patients are diagnosed may improve the disease outcomes.

TNF is a pro-inflammatory cytokine — a molecule that mediates and regulates immune and inflammatory response — that is often found at abnormally high levels in patients with IBD.

In addition, the MIB findings suggest the resource impact associated with using PredictSURE IBD could be much lower compared to current care standards, in cases where treatment with TNF inhibitors is started early on, preventing further disease flare-ups.

However, it is important to note that TNF inhibitors are not currently recommended by NICE as a first-line treatment for patients with Crohn’s disease.

“We are very pleased to have received such a positive MIB. Given that these briefings are referenced not only across the UK, but also further afield, it is an important milestone and further validation for us as we continue to develop personalized approaches to treatment for patients with severe, debilitating diseases,” Paul Kinnon, CEO of PredictImmune, said in a press release.

“We strongly believe that helping to inform clinical decision making in the very early stages of diagnosis could vastly improve patient outcomes and quality of life. The evidence suggests that PredictSURE IBD™ enables us to do that for those suffering from Crohn’s disease and ulcerative colitis, which could have a major impact on treatment pathways in the future,” Kinnon added.

MIBs are part of NICE’s advice programs, which are designed to aid the U.K.’s National Health Insurance (NHS), social care commissioners, and other staff in deciding if a new medical device or diagnostic technology should be implemented. MIBs are commissioned to NICE by the NHS to support patients’ access to new treatments and technologies that may bring benefits over standard therapies.

Each MIB contains information on how the medical device or new technology works, how it should be used, and how much it would cost to implement. It also includes a review of all clinical findings that have been described in the literature up until that point.