IBD audit transition to IBD Registry
At the BSG annual meeting in Liverpool last week outgoing president Ian Forgacs praised the leaders of IBD Registry and called for all IBD teams in the UK to participate in the new programme for data capture and quality improvement using the IBD Registry.
This new programme is still on the quality accounts list and the national clinical audit and patient outcomes programme (NCAPOP) in England. The aim for the transition year is to report on 6 quality indicators for patients newly started on a biological therapy. This focus will enable the UK IBD clinical community to build the largest biologics registry in the world.
What to do next
If you haven't already done so, please register to be part of the programme using the form at http://ibdregistry.org.uk/wp-content/uploads/2016/05/Registration-Form-for-participating-in-the-IBD-Registry2.pdf.
You can participate using the data entry system that best meets your local needs and arrangements are slightly different in different parts of the UK. If you opt to use the web tool you'll be sent a starter pack once we've received your registration form.
|Northern Ireland, Scotland and Wales||Web Tool||We are awaiting permission for data to flow across NHS England's N3 secure network. Once this is confirmed the IBD programme team will issue registered sites with web tool starter packs|
July data submission
Invitation to apply to MSD "IBD Academy" 2016
This programme, which has been running for 8 years, allows trainees with a particular interest in IBD to undergo training in important professional skills at a weekend course, and subsequent full sponsorship to attend the 12th annual European Crohn’s and Colitis Organisation (ECCO) congress, which is from February 15th to 18th 2017 in Barcelona.
The weekend course will be held in London on November 19th/20th 2016, and has the overall objective of improving the quality of care provided to patients. It will cover subjects such as workforce planning, NHS structure, service development, setting up clinical research, the consultant’s role in the new NHS and the challenges of being a new consultant.
- Download invitation and agenda [ 1.09 kb ]
Application Deadline: July 24th 2016.
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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