Re-induction of intravenous ustekinumab to maintain drug persistence. A UK experience (2024)

Type of publication:
Conference abstract

*Muir J.; *Hazir Y.; *Butterworth J.

Journal of Crohn's and Colitis. Conference: 19th Congress of the European Crohn's and Colitis Organisation, ECCO 2024. Stockholm Sweden. 18(Supplement 1) (pp i1034), 2024. Date of Publication: January 2024.

Background: In this study we seek to add to the body of knowledge on the practical use of ustekinumab in patients with Crohns and Colitis. Patients commencing ustekinumab will mostly have failed, or are intolerant to, conventional biologic agents and therefore have a limited number of medical options available to manage their disease. Results from the IM-UNITI long-term extension study have shown that a proportion of patients will lose response to maintenance dose therapy, and a small number of studies have suggested that repeated induction doses of this therapy can prolong its effective use and allow patients a greater period of disease free remission. Shrewsbury and Telford hospital NHS trust is a multi-site UK hospital serving a large population in the west-midlands region which has established the routine use of usetkinumab therapy over 5 years ago and by reviewing data on our patient cohort we aimed to identify characteristics amongst patients who have required reinduction doses and how effective they have been in maintaining remission. Method(s): In this retrospective, interventional study two researchers gathered data including baseline characteristics, disease type and distribution, previous surgical and medical therapies and time from diagnosis on all patients who had received ustekinumab therapy over the past five years. We used biochemical and endoscopic data, as well as clinical records, to determine the efficacy of ustekinumab on the disease course. We identified the subgroup of patients requiring reinduction doses and noted whether this was a successful intervention and sought to describe similarities which could help identify patients at risk of failing maintenance therapy in future. Result(s): Data from 213 patients was gathered (Crohns: 150, UC: 61, IBDU: 2) and of which 87 (Crohns: 63, UC: 24) received reinduction doses. Average time to reinduction from therapy commencement was 19.5 months (Crohns) and 16.3 months (UC) respectively. Of the reinduction group 63% showed improvement in their disease control and a variety of characteristics were noted amongst the successful patients for discussion including disease location, presence of perianal disease and time from diagnosis. Conclusion(s): Ustekinumab reinduction is an important area for further research as it allows patients to prolong their successful therapy and delay the need for surgical intervention for difficult to manage disease. This study suggests characteristics which could inform further trials and establish protocols to aid clinicians when making decisions about switching biologic therapies.

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British Oncology Pharmacy Association Delphi Consensus Guidelines: co-infusion of trometamol-containing calcium folinate (Leucovorin) with Systemic Anti-Cancer Treatments (2024)

Type of publication:
Journal article

Polwart C.; Root T.; Tezcan S.; Meehan S.; Wetherill B.; Waterson C.; *Burnett B.; Chauhan R.; Al-Modaris I.; Walters-Davies R.

medRxiv. (no pagination), 2024. Date of Publication: 11 Feb 2024.

Drug stability and compatibility are critical factors influencing cost and logistics of treatment delivery, therapeutic effectiveness, and patient safety. This is particularly significant in the realm of cancer chemotherapeutics, where stability and compatibility studies play a vital role in ensuring rational and safe medicine administration. Oxaliplatin, fluorouracil, and irinotecan, commonly used in various combination for gastrointestinal cancers, are complemented by co-administration of folinic acid in certain protocols. Notably, some folinic acid preparations include trometamol as an excipient, potentially impacting the stability of the chemotherapeutic agents if infused concomitantly. This study seeks to establish guidelines for oncology multidisciplinary teams, addressing potential risks associated with the combination of trometamol-containing folinic acid and chemotherapeutics. To achieve this, a quantitative questionnaire was distributed to members of the British Oncology Pharmacy Association (BOPA) and non-BOPA members through an online survey. Nineteen healthcare professionals with oncology experience, comprising 18 pharmacists and 1 nurse, completed the questionnaires. Each participant rated the validity and clarity of statements on a 5-point scale. The Delphi process concluded after the fourth round, consolidating the findings and recommendations from the multidisciplinary team. Twelve recommendations for safe practice have been made.

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SaTH Pharmacy Improving Amendment Implementation (2023)

Type of publication:Service improvement case study

Author(s):*Angela Yeomans

Citation:SaTH Improvement Hub, 2023

Abstract:To improve the process for reviewing and implementing amendments within pharmacy supported research projects by September 2023 as evidenced by percentage performance and adherence to sponsor agreed timelines.

Link to PDF poster

Implications for sequencing of biologic therapy and choice of second anti-TNF in patients with inflammatory bowel disease: Results from the IMmunogenicity to Second Anti-TNF therapy (IMSAT) therapeutic drug monitoring study (2022)

Type of publication:Journal article

Author(s):Chanchlani N.; Lin S.; Auth M.K.; Lee C.L.; Robbins H.; Looi S.; Murugesan S.V.; Riley T.; Preston C.; Stephenson S.; Cardozo W.; Sonwalkar S.A.; Allah-Ditta M.; Mansfield L.; Durai D.; Baker M.; London I.; London E.; Gupta S.; Di Mambro A.; Murphy A.; Gaynor E.; Jones K.D.J.; Claridge A.; Sebastian S.; Ramachandran S.; Selinger C.P.; Borg-Bartolo S.P.; Knight P.; Sprakes M.B.; Burton J.; Kane P.; Lupton S.; Fletcher A.; Gaya D.R.; Colbert R.; Seenan J.P.; MacDonald J.; Lynch L.; McLachlan I.; Shields S.; Hansen R.; Gervais L.; Jere M.; Akhtar M.; Black K.; Henderson P.; Russell R.K.; Lees C.W.; Derikx L.A.A.P.; Lockett M.; Betteridge F.; De Silva A.; Hussenbux A.; Beckly J.; Bendall O.; Hart J.W.; Thomas A.; Hamilton B.; Gordon C.; Chee D.; McDonald T.J.; Nice R.; Parkinson M.; Gardner-Thorpe H.; *Butterworth J.R.; *Javed A.; *Al-Shakhshir S.; *Yadagiri R.; *Maher S.; Pollok R.C.G.; Ng T.; Appiahene P.; Donovan F.; Lok J.; Chandy R.; Jagdish R.; Baig D.; Mahmood Z.; Marsh L.; Moss A.; Abdulgader A.; Kitchin A.; Walker G.J.; George B.; Lim Y.-H.; Gulliver J.; Bloom S.; Theaker H.; Carlson S.; Cummings J.R.F.; Livingstone R.; Beale A.; Carter J.O.; Bell A.; Coulter A.; Snook J.; Stone H.; Kennedy N.A.; Goodhand J.R.; Ahmad T.

Citation:Alimentary Pharmacology and Therapeutics, 2022 Oct; Vol. 56 (8), pp. 1250-1263. Date of Publication: October 2022

Abstract:Background: Anti-drug antibodies are associated with treatment failure to anti-TNF agents in patients with inflammatory bowel disease (IBD). <Aim(s): To assess whether immunogenicity to a patient's first anti-TNF agent would be associated with immunogenicity to their second, irrespective of drug sequence. <br/>Method(s): We conducted a UK-wide, multicentre, retrospective cohort study to report rates of immunogenicity and treatment failure of second anti-TNF therapies in 1058 patients with IBD who underwent therapeutic drug monitoring for both infliximab and adalimumab. The primary outcome was immunogenicity to the second anti-TNF drug, defined at any timepoint as an anti-TNF antibody concentration >=9 AU/ml for infliximab and >=6 AU/ml for adalimumab. Result(s): In patients treated with infliximab and then adalimumab, those who developed antibodies to infliximab were more likely to develop antibodies to adalimumab, than patients who did not develop antibodies to infliximab (OR 1.99, 95%CI 1.27-3.20, p = 0.002). Similarly, in patients treated with adalimumab and then infliximab, immunogenicity to adalimumab was associated with subsequent immunogenicity to infliximab (OR 2.63, 95%CI 1.46-4.80, p < 0.001). For each 10-fold increase in anti-infliximab and anti-adalimumab antibody concentration, the odds of subsequently developing antibodies to adalimumab and infliximab increased by 1.73 (95% CI 1.38-2.17, p < 0.001) and 1.99 (95%CI 1.34-2.99, p < 0.001), respectively. Patients who developed immunogenicity with undetectable drug levels to infliximab were more likely to develop immunogenicity with undetectable drug levels to adalimumab (OR 2.37, 95% CI 1.39-4.19, p < 0.001). Commencing an immunomodulator at the time of switching to the second anti-TNF was associated with improved drug persistence in patients with immunogenic, but not pharmacodynamic failure. Conclusion(s): Irrespective of drug sequence, immunogenicity to the first anti-TNF agent was associated with immunogenicity to the second anti-TNF, which was mitigated by the introduction of an immunomodulator in patients with immunogenic, but not pharmacodynamic treatment failure.

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Reducing medication (TTOs) delays when patients are ready to leave hospital (2016)

Type of publication:
Post on the Academy of Fab NHS Stuff website

Nick Holding

Academy of Fab NHS Stuff (, February 2016

It’s a commonly held belief that patient discharge medication and discharge summaries are a cause of delays to patients leaving hospital.

Last year we tested to what extent this was a problem, confirm or dispel myths, and work with teams to find ways to improve turnaround times of medication.

We found that the process could be broken down into 4 key cycles of work:

1. Pharmacist generating the medication request (average 1.5hrs)

2. Prescription in queue waiting to be picked (average 1hr)

3. Prescription collection in Pharmacy Dept (average 50 mins)

4. Delivery of medication back to the patient (average 1hr)

Overall lead time to turnaround medication was therefore 4hrs 40mins. One of our roles in this was to help the teams that carry out the work, improve the work. So with this in mind we presented our findings to ward and pharmacy teams and ran a workshop to identify a number of improvement ideas which we would test and measure their effectiveness using Plan, Do, Study, Act (PDSA) cycles.

The teams came up with 3 simple ideas that they wanted to try out.

1. Pharmacist on daily ward round to improve communication and reduce delays in generating prescription

2. Separate work line in pharmacy for outpatient and inpatient activity to reduce delays in the picking queue

3. Introduce a direct delivery service to wards from pharmacy to reduce delivery times of medication

Testing the concepts and ideas Using PDSA cycles we planned a series of improvement weeks where we tested out the various concepts and measured the impact. Our aim was to develop a proof of concept which could then be explored further and introduced appropriately. By doing a number of simple steps we found that in after the first improvement week we reduced the turnaround time from 4hrs 40mins to 2hrs 30mins. By retesting, refining and introducing the other ideas in the second improvement week, the teams reduced the turnaround time further down to 1hr 30mins

Therefore, in conclusion, by truly understanding the current state, allowing the teams that carry out the work to improve the work, and giving them the space and time to test out their ideas, we showed that we can significantly reduce delays that patient experience when they are ready to leave hospital.

Link to more details or full-text: