‘Top-down’ treatment strategy dramatically improves outcomes for Crohn’s patients

Approximately 80% of patients taking Remicade from diagnosis had symptoms controlled

Researchers from the University of Cambridge have revealed a ‘top-down’ treatment strategy involving Janssen’s Remicade (infliximab) straight after diagnosis significantly improved outcomes for patients with Crohn’s disease.

Affecting around one in 350 people in the UK, Crohn’s disease is a life-long condition caused by inflammation of the digestive tract, which can lead to flares of inflammation and progressive bowel disease damage as the condition worsens.

Sponsored by Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge, with support from the National Institute for Health and Care Research (NIHR), the PROFILE trial recruited 386 Crohn’s disease patients from 40 hospitals across the UK.

Despite the biomarker not proving useful in selecting treatments for individual patients, patients were randomly assigned to one of two treatment groups, which were given a different treatment strategy: ‘accelerated step-up’ or ‘top-down’.

The accelerated step-up group treatment approach involved patients starting Remicade if their disease was progressing and not responding to other treatments, while the top-down group was provided with Remicade as soon as possible after their diagnosis.

Remicade blocks the protein found in the body’s immune system, tumour necrosis factor-alpha, which plays a vital role in inflammation.

After being followed up over the course of the year, results showed that 80% of people receiving the top-down therapy had both symptoms and inflammatory markers controlled,
compared to only 15% in the accelerated step-up cohort.

Additionally, 67% of patients in the top-down group had no ulcers seen on their endoscopy camera test at the end of the trial, had higher quality of life scores, less use of steroid medication and 0.5% of patients required urgent abdominal surgery for their Crohn’s disease, compared to 5% of patients in the accelerated step-up group.

Professor Miles Parkes, director, NIHR Cambridge Biomedical Research Centre, said: “We now know we can prevent the majority of adverse outcomes… by providing a treatment strategy that is safe and becoming increasingly affordable.”

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