Over half of patients saw an improvement after being treated with biological therapies for inflammatory bowel disease (IBD). Data from the first national report of biological therapies shows that 62% of adult patients and 73% of paediatric patients saw the severity of their disease decrease after 12 weeks of treatment with biological therapy.
IBD affects approximately 240,000 people in the UK and patients with Ulcerative Colitis (UC) and Crohn’s Disease (CD) will often require surgery during their lifetime.
‘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 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.
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.
The UK IBD audit aims to improve the quality and safety of care for all IBD patients (both adult and paediatric) in UK hospitals by auditing patient care, IBD service resources, and reporting on inpatient experience. The audit is funded by the Healthcare Quality Improvement Partnership (HQIP) and managed by the IBD programme in the Clinical Effectiveness and Evaluation Unit (CEEU) at the Royal College of Physicians (RCP).
The report published today shows that after at least 12 weeks of treatment with biological therapy, both adult and paediatric patients saw a decrease in the severity of their IBD disease. Patients’ disease activity was scored before commencing with biologics and then again at least 12 weeks after receiving treatment. The median scores after 12 weeks for disease activity were lower than at the outset. The scores were calculated using Harvey-Bradshaw Index (HBI) in adult patients and Paediatric Crohn’s Disease Activity Index (PCDAI) in paediatric patients, which indicates disease activity. Figures for adult surgical activity in the six months post biological therapy treatment also saw a small decline, suggesting that treatment with biologics can help to reduce the need for surgery in CD and UC adult patients.
Dr Ian Arnott, Clinical Lead, UK Inflammatory Bowel Disease Audit said, ‘The data presented in this report show that infliximab and adalimumab are used to very good effect in hospitals across the UK. There is convincing data that these drugs reduce disease activity, improve quality of life with a relatively low frequency of adverse events. Continuing the biologics audit will deliver a greater understanding of long-term outcomes in patients treated with these medicines.’
Dr Richard Russell, Consultant paediatric gastroenterologist, Yorkhill Hospital, Edinburgh said, ‘Children and young people with IBD are the group of patients who potentially stand to benefit most from biological therapy yet at the same time they are the patient group in whom the risks of therapy have to also be carefully weighed up. The audit has demonstrated that most children who are treated gain significant benefit from these treatments. There were no worrying safety issues raised by patients who were enrolled in the audit but there needs to be more patients and a longer period of data collection to be sure that this is the case.’
Dr Kevin Stewart, Clinical director of the CEEU at the RCP said, ‘Once again we have seen how national clinical audit brings real benefit to patients and improves outcomes, with this new audit of biological therapy for patients with IBD. Its success has depended on the dedication of the front-line staff who support data collection and the leadership and expertise of senior clinical leaders and the audit team at the RCP, who are to be commended for what they have achieved. We look forward to developing this audit with our partners over coming years, as part of a wider programme of quality improvement activities for patients with IBD.’
Notes to Editors
For further information or to arrange an interview with expert spokespeople for both adult and paediatric IBD please contact Hannah Bristow, RCP Clinical Standards Communications officer, Hannah.Bristow@rcplondon.ac.uk 020 3075 1447 or 07584 303 784
The report will be available on the RCP website from Thursday 29 August 2013
Data was submitted, via audit web tool, between 12 September 2011 and 28 February 2013. Data collection took place in ‘real time’ during the clinical appointment with the patient.
The data contained within the report has been taken from only completed submissions within the biological therapy audit web tool (https://www.ibdbiologicsaudit.org). Participation in the biological therapies audit provides local IBD teams with the means to meet Standard A6 of the IBD Standards; specifically the regular review of patient outcomes auditing of biological therapy. Participation in the audit also provides the opportunity to review treatment against NICE recommendations (TA187).
157 adult Trusts/Health Boards are registered for Round 4 of the UK IBD audit, of these 122 (78%) are participating in the biological therapies element. There are an additional five adult Trusts/Health Boards that participate in the biological therapies audit, but these are sites that are not currently registered for Round 4 of the UK IBD audit. There are a total of 127 sites taking part in the biological therapies aspect.
- – Infliximab (IFX)
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.
- – Adalimumab (ADA)
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.
The Healthcare Quality Improvement Partnership (HQIP) is led by a consortium of the Academy of Medical Royal Colleges (AMoRC), the Royal College of Nursing (RCN) 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 hosts the contract to manage and develop the National Clinical Audit and Patient Outcomes Programme (NCAPOP). Their purpose is to engage clinicians across England and Wales in systematic evaluation of their clinical practice against standards and to support and encourage improvement in the quality of treatment and care. The programme comprises more than 30 clinical audits that cover care provided to people with a wide range of medical, surgical and mental health conditions.