Experts leading on the PROFILE trial say that following a blaze of publicity about their ground-breaking research, clinicians across the globe are making changes in the way they provide care to patients newly diagnosed with Crohn’s disease.
Crohn’s disease is a life-long condition characterised by inflammation of the digestive tract and affects around one in 350 people in the UK. Moderate and severe presentations of Crohn’s disease can impact greatly on quality of life with symptoms like stomach pain, diarrhoea, weight loss and fatigue.
PROFILE was the earliest “early treatment” clinical trial ever conducted for patients with a new diagnosis of Crohn’s disease and was led by chief investigator, Professor Miles Parkes, of the National Institute for Health and Care Research Cambridge Biomedical Research Centre at Addenbrooke’s.
First author, Dr Nuru Noor, from the Department of Medicine at the University of Cambridge, said:
“Following the preliminary findings of this study we’ve had a huge amount of media interest. With the data building on signals from previous studies, PROFILE showed that early monoclonal antibody therapy was highly effective and also a safer treatment strategy for patients than the current standard of care.
“We have also been contacted by many IBD colleagues around the world saying they feel the PROFILE findings are game-changing and provide the definitive data they have needed to change clinical practice and receive reimbursement for effective therapies straight after diagnosis.
“Now the big job is making sure we help clinicians and patients implement this change all around the world and support access to effective therapies for patients globally. A major step in this direction has come from adoption of the PROFILE trial findings in the latest guideline for Crohn’s disease management from the European Crohn’s and Colitis Organisation.”
The PROFILE trial was sponsored by Cambridge University Hospitals (CUH) NHS Foundation Trust, which runs Addenbrooke’s and the Rosie hospitals, and the University of Cambridge.
It recruited from 40 hospitals across the UK and was supported by the National Institute for Health and Care Research (NIHR) Clinical Research Network.
PROFILE involved 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, and patients were followed up over the course of a year.
The first group was treated using infliximab - a monoclonal antibody therapy used to treat a number of 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.
80 per cent in the first group had both symptoms and inflammatory markers controlled throughout the course of the entire year compared to only 15 per cent of those in the “conventional” treatment group.
In the early effective therapy group, 67 per cent 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, lower number of serious infections and lower number of hospitalisations.
Just 0.5 per cent in the first group required urgent abdominal surgery compared to five per cent in the second group.
Dr Noor said: “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’. But our findings redefine what should be considered early treatment.
“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."
Prof Parkes added: “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.”
Image: (left to right) Dr Nuru Noor and Professor Miles Parkes
