Crohn’s treatment by Cambridge researchers sets global standard

Changes in the way clinicians care for Crohn’s disease patients are now being made across the world, thanks to a “game-changing” trial.

The PROFILE trial results published by Cambridge researchers earlier this year have helped set a new global standard for the treatment of the life-long condition, doctors said.

It showed early monoclonal antibody therapy, a type of targeted drug therapy, was highly effective and a safer treatment for newly diagnosed patients than the current standard of care.

Trial author Dr Nuru Noor said inflammatory bowel disease colleagues around the world had said they felt the findings were “game-changing” and provided the definitive data they needed to change clinical practice.

Crohn’s disease is characterised by inflammation of the digestive tract and can impact a person’s quality of life with symptoms that include stomach pain, diarrhoea, weight loss and fatigue.

Dr Noor from the Department of Medicine at the University of Cambridge said the findings redefined what should be considered early treatment of the disease.

“Historically, treatment with an advanced therapy like infliximab within two years of diagnosis has been considered ‘early’ and an ‘accelerated step-up’ approach, therefore ‘good enough’,” he explained.

“As soon as a patient is diagnosed with Crohn’s disease, the clock is ticking – and has likely been ticking for some time – in terms of damage happening to the bowel, so there’s a need to start on an effective therapy as soon as possible.”

The trial was led by chief investigator, Professor Miles Parkes, of the National Institute for Health and Care Research Cambridge Biomedical Research Centre at Addenbrooke’s.

He said: “If you take a holistic view of safety, including the need for hospitalisations and urgent surgery, then the safest thing from a patient point of view is to offer ‘top-down’ therapy straight after diagnosis rather than having to wait and use ‘step-up’ treatment.”

The trial, which also involved patients at Addenbrooke’s Hospital, was sponsored by Cambridge University Hospitals NHS Foundation Trust.

PROFILE included 386 newly diagnosed patients from 40 hospitals who were assigned at random to one of two treatment groups.

Each group was given a different treatment strategy.

The first group was treated using infliximab, a monoclonal antibody therapy used to treat several autoimmune diseases, as soon as possible after their diagnosis.

The second group was treated using the conventional method of only starting patients on infliximab if their disease was progressing and not responding to other simpler treatments.

In the first group, 80% had both symptoms and inflammatory markers controlled throughout the course of the entire year compared to 15% of those in the “conventional” treatment group.

In the early effective therapy group, 67% had no ulcers on their end of the trial colonoscopy camera test.

Patients receiving early effective therapy also had higher quality of life scores, less use of steroid medication, a lower number of serious infections, and a lower number of hospitalisations.

Just 0.5% in the first group required urgent abdominal surgery compared to 5% in the second group.