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 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.
- Sites that prescribe and administer biological therapies to their patients with inflammatory bowel disease (IBD) should continue to participate in the national biological therapy audit. They should aim to submit complete data on all new starters. This includes data at baseline and at least 3- and 12-month follow-up. Sites that enter data to the Personalised Anti-TNF Therapy in Crohn’s disease study (PANTs) are counted as participating; these sites are reminded that data on patients not applicable for inclusion in the research study should be entered into the biological therapy audit web tool so that all new starters on biological therapies are captured.
- Disease activity should be routinely assessed and monitored, especially at baseline and again at 3- and 12-month follow-up.
- Sites should continue to encourage patients to complete patient-reported outcome measures (PROMs) at baseline, as they provide an indication of patient outcomes and the quality of care delivered to patients. It is important to ensure that PROMs are completed at follow-up.
- The audit has been extended to include patients started on biosimilar versions of infliximab and other biological treatments. Patients newly started on these treatments should now be audited.
- Sites should use the ‘Export data’ function of the web tool to check the completeness of the data entered. Exported data can also be used for any local analyses, which can support quality improvement activities.
- Sites should continue to monitor safety and efficacy over the long term and should stop biological therapies in patients who have failed to respond to treatment.
- The findings and recommendations of this report should be shared at relevant multidisciplinary team, clinical governance and audit meetings, and a local action plan for implementing change should be devised.