IBD Regsitry Update: Join us at the BSG in June!
Join Stuart Bloom, Ian Arnott, Pearl Avery, Keith Bodger and Fraser Cummings at the BSG meeting in Liverpool next month. Delivering Quality with the IBD Registry will give you a chance to find out more about IBD Audit and IBD Registry plans as the Registry takes over from the Audit as the vehicle for ongoing data collection. The session is on Thursday 23rd June 8:45-10:15 and will include group work and discussions to give you a chance to help shape the project.
If you can't make the Thursday session, the IBD Audit Programme and IBD Registry teams will be sharing a stand in the charities section of the exhibition throughout the conference. Do come and see us to find out more about plans for the future.
April data submission
Web tool update
Crohn's & Colitis UK Registry Research Project
As part of Crohn's and Colitis UK funded registry research, the team at University of Liverpool (led by Keith Bodger) has generated reports of IBD-related activity for English hospitals based on anonymous HES data. Pilot local reports have been sent to selected hospital IBD teams in a first round of consultation. The next phase of the project will share reports more widely with Registry sites. Feedback from local teams will help to shape the content of reports and explore better ways to analyse the administrative data. The Registry is working to gain permission to extend reporting to similar administrative datasets in other parts of the UK. Future linkage to Registry data will aim to maximise the value of both sources of data to support service delivery and quality improvement.
The first patients' data has been entered on the anaemia service evaluation pages of the web tool, demonstrating the ability to use the system for specific research or audit projects involving selected IBD Teams.
IBD Registry News - March 2016
Latest data submission
We now have information from 11 hospitals on 12,246 IBD patients (up from 8 hospitals and 8,037 IBD patients last quarter). 3 additional teams have registered with HSCIC, so are ready to contribute their data next time.
We're making steady progress with participation and importantly, we have now successfully uploaded data not only from sites using the IBD Registry Patient Management System (PMS) but also sites using the Emis system, 2 web tool sites and one hospital using an in-house database, demonstrating the infrastructure for all the different data capture options. That infrastructure will also allow us to deliver other projects.
The Registry is currently recruiting a Data Manager who will enable us to begin providing a standard report back to sites when we receive their data. Meanwhile, Keith Bodger and his team at Aintree are busy analysing the Hospital Episode Statistics (HES) for IBD as part of a Crohn's and Colitis UK research project. We will begin to see some of the results of this analysis soon; later in the year we will extract the HES data for all patients in the Registry database and be able to analyse the demographics, clinical and HES history for that group.
Regional meetings update
We've almost completed our initial series of regional meetings and have now met and developed action plans with over 170 members of IBD clinical teams across the country. Slides from the meetings are at http://ibdregistry.org.uk/workshops/
The Scottish regional meeting will take place in Glasgow on Wednesday 20th April and will be chaired by Dr Ian Arnott. We'd really encourage you to come along, and to bring your team if you can. There is no charge to attend, thanks to support from Tillotts, Takeda, Janssen and Shire. For more information and to register please go to http://ibdregistry.org.uk/
IBD Audit news
As you may know, there is an exciting future ahead for IBD services in the UK. The UK IBD Audit as you know it is moving towards an improved system for data capture and quality improvement, using the IBD Registry. This new programme of work remains on both the quality accounts list and the national clinical audit and patient outcomes programme (NCAPOP) in England. Your ongoing participation is very important, and you'll be hearing from the IBD Audit team at the RCP very soon, with a registration form for you to sign up to join this new initiative.
BSG Guidance on the Use of Biosimilar Infliximab CT-P13 in IBD
Introduction: Dr AB Hawthorne, Chair BSG IBD Section Committee
The infliximab biosimilar CT-P13 (Remsima or Inflectra) received marketing authorisation in June 2013.The drug is now widely used in the treatment of inflammatory bowel disease. There is sufficient data from observational studies to show that safety and clinical efficacy of CT-P13 are comparable to the originator drug, with similar immunogenicity.
- Infliximab must be prescribed by brand name (ie Remicade, Remsima or Inflectra) and not by International Non-proprietary Name (INN).
- For patients starting infliximab: Remicade, Remsima or Inflectra can be prescribed, taking into account the evidence showing similar clinical effectiveness. There is evidence that monitoring of patients, including measurement of drug and anti-drug antibody levels, is no different for the biosimilar drugs compared to Remicade. The choice of preparation should take into account the cost of the drug and its administration.
- There is sufficient evidence to recommend that patients who are in a stable clinical response or remission on Remicade therapy can be switched to Remsima or Inflectra at the same dose and dose interval. This should be done after discussion with individual patients, with explanation of the reason for switching (which is usually on the grounds of benefit to the overall service by reduction in costs of the drug and its administration).
- Automatic substitution, (dispensing one medicine instead of another equivalent and interchangeable medicine at the pharmacy level without consulting the prescriber), is not appropriate.
- Pharmacovigilance is essential for any new biological medicine, and patients prescribed Remsima or Inflectra should be followed for safety, in a registry such as the UK National IBD Registry.
This document replaces the previous BSG guidance on Biosimilar drugs - IBD Section Statement on Biosimilar drugs (2014) (View here)
- Download guidance [ 330 kb ]
Fourth report of the biological therapy element of the UK IBD audit
Latest UK IBD audit report shows further improvement for patients following treatment with biological therapies
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
This is the fourth report of the biological therapy element of the UK IBD audit. 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.
The data presented in the reports 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.
National and executive summary versions of both adult and paediatric reports are available on the Royal College of Physicians' website:
Biosimilar Medicines: all you need to know
Professor Chris Probert, Chair BSG IBD Committee
The announcement by NICE that anti-TNFs may be used, within licence, for patients with ulcerative colitis has coincided with the launch of two biosimilar infliximabs in the UK.
We (BSG) are arranging an educational meeting in conjunction with representatives from the Association of the British Pharmaceutical Industry Biological Medicines Access Group (ABPI BMAG), Hospira and Napp. Our goal is to deliver an educational event with talks from all interested parties as well as from MHRA and NICE. The meetings are on 9th (London) and 16th (Manchester) June and commence at 14:00.
- Download the agenda [ 619 kb ]
- Download the invitation letter [ 619 kb ]
- Download the reply form [ 619 kb ]
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