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)
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Endoscopy in patients on antiplatelet or anticoagulant therapy, including direct oral anticoagulants
Monday, 15 February 2016 10:45
New BSG/ESGE guideline...
The risk of endoscopy in patients on antithrombotics depends on the risks of procedural haemorrhage versus thrombosis due to discontinuation of therapy.
P2Y12 receptor antagonists (clopidogrel, prasugrel, ticagrelor) For low-risk endoscopic procedures we recommend continuing P2Y12 receptor antagonists as single or dual antiplatelet therapy (low quality evidence, strong recommendation); For high-risk endoscopic procedures in patients at low thrombotic risk, we recommend discontinuing P2Y12 receptor antagonists five days before the procedure (moderate quality evidence, strong recommendation). In patients on dual antiplatelet therapy, we suggest continuing aspirin (low quality evidence, weak recommendation). For highrisk endoscopic procedures in patients at high thrombotic risk, we recommend continuing aspirin and liaising with a cardiologist about the risk/benefit of discontinuation of P2Y12 receptor antagonists (high quality evidence, strong recommendation).
Warfarin The advice for warfarin is fundamentally unchanged from British Society of Gastroenterology (BSG) 2008 guidance.
Direct Oral Anticoagulants (DOAC) For low-risk endoscopic procedures we suggest omitting the morning dose of DOAC on the day of the procedure (very low quality evidence, weak recommendation); For high-risk endoscopic procedures, we recommend that the last dose of DOAC be taken ≥48 h before the procedure (very low quality evidence, strong recommendation). For patients on dabigatran with CrCl (or estimated glomerular filtration rate, eGFR) of 30–50 mL/min we recommend that the last dose of DOAC be taken 72 h before the procedure (very low quality evidence, strong recommendation). In any patient with rapidly deteriorating renal function a haematologist should be consulted (low quality evidence, strong recommendation).
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NICE Quality Standard: Irritable bowel syndrome in adults
Monday, 15 February 2016 13:50
This quality standard covers the diagnosis and management of irritable bowel syndrome in adults. It does not cover other gastrointestinal disorders such as non-ulcer dyspepsia, coeliac disease and inflammatory bowel disease. For more information see the irritable bowel syndrome topic overview.
UK NSC recommendation on Bowel Cancer screening in adults
Tuesday, 19 January 2016 14:45
Following evaluation and consultation, that BSG fed in to, the UK National Screening Committee (NSC) has recommended a change to the test used in the Bowel Cancer Screening Programmes. UK NSC has announced that the use of Faecal Immunochemical Test as the primary test for bowel cancer should replace guaiac Faecal Occult Blood Test. UK NSC has also indicated that as colonoscopy capacity grows or screening uptake increases, the programmes should review and recommend alteration of the cut offs to increase the number of cancers detected.
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