Introduction Vedolizumab is a gut-selective immunosuppressive biologic used to treat moderate to severe Crohn’s disease and ulcerative colitis. Vedolizumab is not licensed for use in children under 18 years of age. However, there is experience of using Vedolizumab in paediatric1 patients in practice. Vedolizumab incurs a significant cost to the NHS, as a result identification of patient response to treatment is fundamental.
Aim To ensure Vedolizumab is prescribed in adherence to guidance documented in the clinical guideline ‘Vedolizumab treatment for inflammatory bowel disease patients’ at an NHS trust.
100% of patients on Vedolizumab have been diagnosed with moderate to severe ulcerative colitis or Crohn’s disease
100% of patients on Vedolizumab have had and inadequate response with, lost response to, or are intolerant to either conventional therapy or anti-TNF treatment
100% of patients were assessed for risk of TB prior to starting treatment
100% of patient’s immunisation status was reviewed prior to starting therapy
100% of patients were prescribed doses recommended in the guideline
100% of patients had Vedolizumab checklist completed:
Prior to infusion
100% of patients had outcome of disease reviewed at 3 months
Method A retrospective study was undertaken to investigate the prescribing of Vedolizumab in CD and UC patients since the implementation of the clinical guideline in June 2018. Ethics approval was not required. List of patients prescribed Vedolizumab was obtained from pharmacy dispensing system. Infusion details were obtained from patient notes. Qualitative data was obtained and analysed.
Results Four patients were prescribed Vedolizumab at the NHS trust between June 2018 and June 2019. One patient had to be excluded from the audit as they had already commenced Vedolizumab prior to the implementation of the clinical guideline. 6 out of the 7 standards were met with a result of 100% except standard 6 which was met with a result of 33% (1 out of the 3 patients).
Discussion and Conclusion 6 out of the 7 standards were completely met; highlighting a robust system in place. The publication of the guideline has ensured that vedolizumab prescribing is appropriate, as inefficient prescribing could result in treatment failure, drug wastage and safety concerns. The only standard not completely met was standard 6, due to the use of surgical booklets on the outpatient wards, the standardised Vedolizumab checklists were not complete.
Recommendations Ensure Vedolizumab checklist is printed out from the clinical guideline and attached in the patient notes. Medical pharmacist to re-audit data yearly to ensure the clinical guideline is being adhered to.
Entyvio, Vedolizumab. Summary of Product Characteristics, Accessed via http://emc.medicines.org.uk Last updated 20.08.2015 [accessed 07/06/19]
Vedolizumab (review) for the treating moderately to severely active ulcerative colitis. June 2015, NICE Technology Appraisal Guidance 342.
O Ledder, A Assa, A Levine, et al. Vedolizumab in Paediatric Inflammatory Bowel Disease: A Retrospective Multi-Centre Experience From the Paediatric IBD Porto Group of ESPGHAN. Journal of Crohn’s and Colitis. 2017:11;1230–1237.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.