Royal College of Physicians. National clinical audit of biological therapies: paediatric report. UK inflammatory bowel disease (IBD) audit

IBD programme steering group

Research output: Book/ReportCommissioned report

Abstract / Description of output

Biological therapies are the newest group of drugs to be used in inflammatory bowel disease (IBD). Most of these drugs work by targeting a protein in the body called tumour necrosis factor alpha (TNFα). Overproduction of this protein is thought to be partly responsible for the chronic inflammation in patients with IBD.
The purpose of this audit is to measure the efficacy, safety and appropriate use of the biological therapies infliximab and adalimumab, also known as anti-TNFα drugs, in patients with IBD in the UK. The audit also aims to capture patients’ views on their quality of life at intervals during their treatment.
This is the fourth report of the biological therapy element of the UK IBD audit; all analyses within this report include only those patients who were newly started on biological therapies between 12 September 2011 (the start of data collection) and 28 February 2015. The data contained within this report have only been taken from completed submissions within the biological therapy audit web tool (
The biological therapies audit provides IBD teams with the means to meet Standard A6 of the IBD standards;1 specifically, regular review of patient outcomes and auditing of biological therapy. Participation in the audit provides the opportunity to review compliance with National Institute for Health and Care Excellence (NICE) recommendations technology appraisal 1872 and technology appraisal 3293 and also fulfils NICE quality statement 4: monitoring drug treatment in quality standard 81.4
Key messages
Participation in the biological therapies audit has improved substantially over time. Of 25 IBD specialist paediatric sites in the UK, 23 (92%) are participating in either the audit or the Personalised Anti-TNF Therapy in Crohn’s disease study (PANTs).5 A total of 696 paediatric patients have now been included in this national analysis. This is a clear demonstration of the effectiveness of collaboration between national audit and research, which results in a reduced burden of data entry for clinicians and greater engagement.
The organisational audit in 2013 collected data on the number of paediatric patients newly started on infliximab, with 16% of sites estimating this figure. When current data are compared with this, it is encouraging that 62% of eligible new starters have been audited.
The data presented in this report demonstrate that biological therapies for IBD are effective and relatively safe treatments. Patterns of use are changing, with earlier use in patients with less severe disease. It is likely that this reflects more appropriate prescribing as physicians become more familiar with these drugs. It is also clear that only a minority of patients have their treatment stopped when effective, as recommended in the NICE guidance. Further audit will clarify this issue, identifying those patients in whom treatment can be stopped. These data are vital for local quality improvement.
Original languageEnglish
Place of PublicationLondon
PublisherHealthcare Quality Improvement Partnership 2015
Number of pages68
ISBN (Electronic)978-1-86016-574-0
ISBN (Print)978-1-86016-573-3
Publication statusPublished - Sept 2015


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