The UK inflammatory bowel disease (IBD) clinical audit report reveals today that the majority of patients (80% adult and 77% paediatric) with Crohn’s disease saw an improvement following biological therapies.
The results clearly demonstrate biological therapies for IBD are effective and safe treatments. Patterns of prescribing are also changing with earlier use in patients with less severe disease which suggests doctors have become more familiar with the treatment.
The audit is commissioned by the Healthcare Quality Improvement Partnership (HQIP),*as part of the National Clinical Audit Programme (NCA). The UK IBD audit is carried out by the Royal College of Physicians on behalf of the IBD programme steering group.
‘Biological therapies’ is the collective term for two particular drugs – Infliximab (IFX) and Adalimumab (ADA). These are strong anti-inflammatory drugs that are used to treat patients with severe Crohn’s disease (CD). The National Institute of Health and Care Excellence (NICE) recommend that these drugs are used for treatment of patients who have not responded to conventional therapy, such as immunosuppressive or corticosteroid treatment.
Participation in the biological therapies audit has been excellent with 152 out of 159 (96%) adult trusts and health boards, and 23 out of the 25 (92%) specialist paediatric sites providing data. However, a minority of cases are being entered at some adult sites and follow up data remains incomplete for both adult and paediatric sites. Further improvement is needed to ensure that complete data is entered on all eligible patients.
Dr Ian Arnott, associate clinical director, UK IBD audit said: This audit demonstrates that biological therapies continue to be safe and effective treatments for IBD. It is interesting to see that patterns of use have changed over the course of this audit suggesting more appropriate prescribing. It is important that further audits continue to address the issue of long term safety and also collect data on biosimilars* and newer biological treatments.
Dr Richard Russell, consultant paediatric gastroenterologist, The Royal Hospital for Sick Children, Glasgow said: It is very encouraging to see more than half of all children that are receiving these therapies in the UK are participating in this audit, so we can be confident that the results produced are likely to apply to all children across the UK. With the imminent introduction of a wider range of these medicines this will allow us to closely monitor any changes in their effectiveness or safety profile.
Ulcerative colitis and Crohn’s disease are the two main forms of IBD and they are lifelong, chronic conditions. It is estimated that over 300,000 people are likely to be affected in the UK. IBD is a debilitating condition for both adults and children. It causes bouts of watery and bloody diarrhoea but also stomach pain, weight loss and lethargy and severely affects the way these people live their lives. Left untreated it can be a life-threatening disease.
Biological therapies have been available since the 1990s. This audit is one element of the wider UK IBD audit and strives to provide a much better understanding of the role of biological therapies in the overall treatment of IBD as currently undertaken in the UK.
*About HQIP, the National Clinical Audit Programme and how it is funded
The Healthcare Quality Improvement Partnership (HQIP) is led by a consortium of the Academy of Medical Royal Colleges, the Royal College of Nursing and National Voices. Its aim is to promote quality improvement, and in particular to increase the impact that clinical audit has on healthcare quality in England and Wales. HQIP holds the contract to manage and develop the National Clinical Audit Programme, comprising more than 30 clinical audits that cover care provided to people with a wide range of medical, surgical and mental health conditions. The programme is funded by NHS England, the Welsh Government and, with some individual audits, also funded by the Health Department of the Scottish Government, DHSSPS Northern Ireland and the Channel Islands. www.hqip.org.uk
IFX (Remicade) is a chimeric anti-TNFα monoclonal antibody with potent anti-inflammatory effects, possibly dependent on apoptosis of inflammatory cells. Controlled trials have demonstrated efficacy in both active and fistulating CD. Typically IFX is administered via an intravenous infusion during an outpatient clinic appointment at an infusion centre by a suitably qualified health professional.
ADA (Humira™) is a recombinant human immunoglobulin (IgG1) monoclonal antibody containing only human peptide sequences. Typically ADA is provided via a self-administered injection. Patients are provided with a home supply of the medication and following close monitoring are able to manage their own treatment with regular medical follow up.
A similar biological or ‘biosimilar’ medicine is a biological medicine that is similar to another biological medicine that has already been authorised for use.
1 Molodecky NA, Soon IS, Rabi DM et al. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology2012;142:46-54