Biological therapies improve inflammatory bowel disease symptoms, national audit findsBMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f5340 (Published 29 August 2013) Cite this as: BMJ 2013;347:f5340
Adults and children with inflammatory bowel disease are reporting decreases in the severity of their condition and fewer are having surgery after being treated with monoclonal antibody therapies.
Data from the first national report of biological therapies show that 62% of adult patients and 73% of paediatric patients saw the severity of their disease decrease after 12 weeks of treatment with two drugs—infliximab, a chimeric anti-TNFα monoclonal antibody, and adalimumab, a recombinant human immunoglobulin (IgG1) monoclonal antibody—known collectively as biological therapies.1
Inflammatory bowel disease affects approximately 240 000 people in the United Kingdom and patients with ulcerative colitis and Crohn’s disease will often require surgery during their lifetime. Biological therapies have been available since the 1990s and are used extensively in treating rheumatological disease and have also been used to treat patients with severe Crohn’s disease.
The National Institute for Health and Care Excellence recommends that they be used to treat patients with inflammatory bowel disease who have not responded to conventional immunosuppressive or corticosteroid treatment.
The new audit, one element of the wider UK Inflammatory Bowel Disease Audit, shows that after at least 12 weeks of treatment with biological therapy, both adults and children saw a decrease in the severity of their disease.
The audit examined a total of 1406 adults and 234 children and the patients’ disease activity was scored before they were started on biologics and then again at least 12 weeks after treatment. After 12 weeks the median scores for disease activity were lower than at the outset. The scores were calculated using the Harvey-Bradshaw Index (HBI) in adult patients and the Paediatric Crohn’s Disease Activity Index (PCDAI) in children, which indicates disease activity. Post treatment, some 62% of adults were in remission as defined by an HBI score of <4. And some 73% of children were in remission as defined by a PCDAI score of <10.
Figures for adult surgical activity in the six months post biological therapy treatment also saw a small decline. Before treatment, some 8% of adults and 7% of children studied had some form of surgical intervention. Six months after treatment the figure went down to 5% for both adults and children although there were more significant falls in some procedures such as right hemicolectomy, down from 21% to 6% in adults.
However, the report also pointed out that hospitals offering biological therapy should ensure that patients were not waiting too long for treatment. Some 43% of adults with Crohn’s disease waited more than two weeks to begin treatment on infliximab, with 33% of this delay attributed to their waiting for the next available clinic appointment.
It is also recommended that patients should be appropriately screened for opportunistic infection in keeping with current guidelines prior to initiating therapy. In addition, providing the correct loading dose of drug and avoiding unnecessary pre-treatment with corticosteroids will ensure that patients receive the most benefit from the prescribed medicine.
Ian Arnott, clinical lead for the UK Inflammatory Bowel Disease Audit, and a consultant gastroenterologist at the Western General Hospital in Edinburgh, said that the £10 000 (€11 700; $15 500) a year per patient cost of biological therapies and simple clinician unfamiliarity meant that uptake was patchy in some parts of the UK. While he said it was “fantastic” that the survey included data from three quarters of all UK hospitals using the drugs, he encouraged gastroenterologists to contribute their own and patient reported outcome data.
He told the BMJ, “Some commissioners are baulking at the cost but when you see the results from use of biological therapies, the reduction in symptoms, the improved quality of life reported, relatively low frequency of adverse reactions, and the reduction in hospital admissions and surgical interventions, the cost effectiveness speaks for itself.”
The UK Inflammatory Bowel Disease Audit aims to improve the quality and safety of care for all IBD patients by auditing patient care, IBD service resources, and reporting inpatient experience. It is funded by the Healthcare Quality Improvement Partnership (HQIP) and managed by the IBD programme in the Clinical Effectiveness and Evaluation Unit at the Royal College of Physicians.
Cite this as: BMJ 2013;347:f5340
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