A large-scale clinical trial of treatment strategies for Crohn's disease has shown that offering early advanced therapy to all patients straight after diagnosis can drastically improve outcomes, including by reducing the number of people requiring urgent abdominal surgery for treatment of their disease tenfold.

Crohn's disease is a life-long condition characterized by inflammation of the digestive tract. Even at its mildest, it can cause symptoms that have a major impact on quality of life including stomach pain, diarrhea, weight loss, and fatigue. It often comes stepwise with conditions like inflammatory bowel disease or ulcerative colitis.

The Cambridge-led research involved 386 patients with newly diagnosed active Crohn's disease and found that use of the drug infliximab straight after diagnosis showed dramatic results.

Infliximab works by blocking an inflammatory cytokine, the proteins that cause acute inflammatory reactions like swelling, called TNF-alpha, which is found in nearly every disease known to man.

Historical concerns about the cost and side effects of infliximab mean it's currently only offered when patients experience regular flare-ups that don't respond to less potent treatments.

To see if this drug was rightly overlooked the researchers conducted a trial in which two groups were assigned either the current UK treatment plan or immediate use of infliximab as soon as possible after diagnosis.

The results, published in The Lancet Gastroenterology and Hepatology, were dramatic with 80% of people receiving the immediate infliximab therapy having both symptoms and inflammatory markers controlled throughout the course of the entire year compared to only 15% of people receiving the usual UK treatment plan.

Two-thirds of patients in the infliximab group had no ulcers seen on their endoscopy camera test at the end of the trial, something known as endoscopic remission and associated with decreased risk of later complications in Crohn's disease.

Most previous clinical trials of therapies are considered successful if one-third or even less of patients achieve endoscopic remission.

"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 advanced therapy such as infliximab as soon as possible," said Dr. Nuru Noor, of Cambridge's Department of Medicine.

"We've shown that by treating earlier, we can achieve better outcomes for patients than have previously been reported."

As well as these findings, patients in this group also had higher quality of life scores, less use of steroid medication, and lower number of hospitalizations.

Strikingly, while around one in 20 patients in the conventional treatment arm of the trial required urgent abdominal surgery for their Crohn's disease, only one in 193 receiving the new approach required the same.

The researchers also note that there was no difference in risk of serious infection between treatment strategies, suggesting that infliximab straight after diagnosis was well tolerated, contrary to previous concerns about its safety.

These concerns, says 28-year-old Toby Moore, a paitent in the study who was diagnosed with Crohn's at age 10, were what prevented him from being given infliximab at any time other than during bad and sudden flare-ups, a decision which he says caused him years of additional suffering and complication.

In terms of financial concerns, the drug has fallen considerably from around £15,000 to around £3,000 per patient per year.

"Up until now, the view has been 'why would you use a more expensive treatment strategy and potentially over-treat people if there's a chance they might do fine anyway?'" said Professor Miles Parkes, Director of the NIHR Cambridge Biomedical Research Center.

"We now know we can prevent the majority of adverse outcomes, including the need for urgent surgery, by providing a treatment strategy that is safe and becoming increasingly affordable."

The Cambridge scientists add that while there are other anti-TNF drugs, such as adalimumab, that work in a similar manner to infliximab and are significantly cheaper, more research is required to understand if it would be as clinically effective.

The team believes that their findings are the start of a new treatment path for people suffering with Crohn's, which may help them spend less time in hospital and more time living life.

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