Gastroenterology Today Autumn 2023

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NEWS Inflammatory bowel disease treatments reach inflection point requiring active comparators, says GlobalData At Digestive Disease Week (DDW) 2023, a comment was made following a presentation discussing the preliminary induction findings from GlobalData, a leading data and analytics company. The attendant continued by pointing out that GUS was shown to only effect remission in less than a quarter of the treated patients (22.5%), with a moderate benefit over placebo of only approximately 12%. The commenter concluded the argument with the observation that GUS and many other inflammatory bowel disease (IBD) therapies do not meet the historical therapeutic standards, referencing a recent meta-analysis study that showed that treatments generally achieve a 20% delta over placebo. Adeleke Badejo, Senior Analyst – Immunology at GlobalData, comments: “At the crux of this line of thought is a lack of evidence to support the market narrative and messaging of high-quality current and upcoming IBD therapies, and a need for better data.” Observed from recent interviews of key opinion leaders (KOLs) within IBD conducted by GlobalData, the unmet need for more evidence to define the most efficacious therapy in the field has been echoed repeatedly. One such thought leader acknowledged the current status quo with companies being able to “get away, so to speak, in the IBD field with these placebocontrolled trials”. Adding that the sole use of placebo is not the norm with other indications. “I think you see more comparative effectiveness trials in some of the other fields, certainly in oncology… it’s always the standard of care versus the new thing”. Addressing this situation, not only improves the quality of care for the IBD patient population, but it also would benefit companies in a quickly evolving and expanding market. Badejo continues: “The significance of addressing this unmet need is of increased importance in light of recent bets within IBD and immunology through mergers and acquisitions, such as the purchase of Prometheus Biosciences by Dice Therapeutics.” In addition to the effect these strategic transactions will have on the market in the coming years, long-established agents such as Humira and Stelara are transitioning to legacy assets, providing the opportunity for the next generation of treatments to capture significant market share. The current situation would be best addressed through clinical asset evaluation through trials with active comparators, but of the eight latestage pipeline agents at the beginning of this year, only Lilly’s mirikizumab and AstraZeneca’s brazikumab were being evaluated against active comparators (ustekinumab and adalimumab respectively), with the former program ending following assessment of the competitive landscape. Badejo concludes: “The apparent risk with higher probability of failure associated with incorporating active comparators during therapy development is known, but the benefit in establishing confidence with decision makers should not be overlooked.” GASTROENTEROLOGY TODAY – AUTUMN 2023 26
COMPANY NEWS A New Portal To Ef-FITciency: Introducing The Alpha Portal (TAP) by Alpha Laboratories The Faecal Immunochemical Test (FIT) has revolutionised the colorectal cancer referral pathway with its quick and user-friendly nature, making it an easily integrated test for efficient patient triaging. However, the valuable benefits of FIT have brought forth logistical challenges, primarily concerning sample collection kit distribution to healthcare providers and patients. The increasing demand for this essential test is rapidly outpacing the current capacity. To tackle these challenges head-on, Alpha Laboratories has collaborated with FIT users to introduce the Alpha Portal (TAP), marking the next phase in FIT evolution. TAP is a cutting-edge solution designed to streamline and manage the logistics associated with the Faecal Immunochemical Test, providing a scalable and efficient system to meet the surging demand. Already proving its effectiveness, Southmead Hospital in Bristol has experienced significant improvements in its FIT service following the implementation of TAP. Key features of the Alpha Portal include: FIT-KIT Stock Management: Offering a snapshot of FIT-KIT stock levels, lot and expiry dates, and real-time tracking to ensure a continuous and seamless supply. Print-Ready Documents: Providing healthcare providers with easily accessible and print-ready documents detailing kit components and product descriptions. Traceable Ordering System: Implementing a sophisticated ordering system to deliver FIT-KITs to any location in the UK, ensuring prompt and reliable distribution. Order Reports: Generating comprehensive order reports that highlight demand at each site and ordering frequency, allowing for better inventory management. The Alpha Portal has been met with enthusiasm and praise from various healthcare facilities across the UK, significantly reducing unnecessary workload and enhancing the scalability of the FIT service. As Alpha Laboratories remains committed to delivering top-notch solutions, it has exciting plans for additional offerings from TAP in the near future. In conclusion, the Alpha Portal (TAP) is a game-changing tool for managing the logistical challenges associated with the Faecal Immunochemical Test (FIT). It provides an efficient and reliable means of tracking, ordering, and distributing FIT-KIT components, enabling healthcare providers to meet the soaring demand for this crucial test. By adopting TAP, healthcare facilities can optimize their FIT services and focus on providing timely and effective care to patients. Please visit www.faecal-immunochemicaltest.co.uk/TAP for further information or contact Alpha Laboratories on 0800 38 77 32 or email marketing@alphalabs.co.uk Microbiome characterisation ensures success in faecal microbiota transplantation Graham Johnson, Managing Director, BIOHIT Healthcare. Faecal microbiota transplantation (FMT) is becoming a more widespread treatment for dysbiosis-associated conditions, in particular, for gastrointestinal disorders, and its use was further endorsed recently when, in 2022, the National Institute for Health and Care Excellence (NICE) approved it for treating recurrent Clostridium difficile infections.[1] However, several randomized controlled trials investigating FMT in irritable bowel syndrome (IBS) patients have revealed huge variability in treatment response. [2] These contradictory findings may be attributable to a lack of standardisation in various aspects of the trial protocol design, one of which is donor selection criteria.[3] At the same time, there has been a rising tendency to recruit ‘superdonors’ – favourable both in terms of their microbial diversity and stool composition – with the aim of ensuring positive outcomes for recipient patients. [4, 5] The gut microbiota of these donors is currently not always characterised, but some advocates of FMT are beginning to suggest that this may be more valuable than simple clinical screening when it comes to matching recipients to donors, especially with the innovative diagnostic tools that are now available.[6] Microbial profiling undoubtedly provides key information, such as the abundance and diversity of bacteria in the gut – as well as a measure of dysbiosis in patients – and applying this approach across the board as a measure of standardisation could help to refine therapeutic FMT strategies and lead to more consistent study results with favourable patient outcomes.[7] Purposeful protocol design This is certainly the strategy chosen by Magdy El-Salhy, Professor of Gastroenterology and Hepatology at the University of Bergen, whose research team recently conducted a clinical trial to determine the efficacy of FMT for IBS patients.[8] The study found that FMT is an effective therapy for IBS, with up to 89.1 % of patients responding to treatment, and around half of all patients experiencing clinical improvements in abdominal symptoms, fatigue and quality of life. However, Magdy is convinced that protocol design was key to ensuring the validity of the study results. There were five important factors: the super-donors were screened against set criteria; there was frequent faecal analysis of the donor to monitor microbiome stability; the fresh donor faeces were immediately frozen; the sample was mixed manually prior to administration; and the donor material was administered by gastroscope directly into the recipient’s duodenum. The right tool for the job On top of this, the GA-map ® Dysbiosis Test (GA-map ® Test) – a gut microbiota DNA-based platform that identifies and characterises dysbiosis – was used throughout the trial, as Magdy explained: “The GA map ® Test was fundamental to the analytical element of our trial; we used it to profile the faecal samples from the donor and to evaluate the intestinal bacterial profiles of patients following transplantation.” GA-map ® Test assigns each sample with an index that ranges from 1 for ‘normobiosis’ to any score greater than 2 to represent an increasing degree of dysbiosis. Samples are then cross-indexed with an additional value that represents the abundance of present species compared to the reference population. Indexing in this manner refines the definition of dysbiosis and multiple FMT studies have correlated the GA-map ® Test index with effectiveness of therapeutic intervention.[9-12] Standardisation for success The trial protocol included faecal analysis of the super-donor at the start of the study to ensure that they had normal gut microbiota, and then at three monthly intervals throughout the year to confirm stability of their microbiome. Christina Casèn, Senior Vice President, Clinical and Medical Affairs at GASTROENTEROLOGY TODAY – AUTUMN 2023 27
Page 1 and 2: Volume 34 No. 3 Autumn 2023 THE BES
Page 3 and 4: CONTENTS CONTENTS Gastroenterology
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Page 7 and 8: Mesalazine optimisation can increas
Page 9 and 10: FEATURE A liver ultrasound was norm
Page 11 and 12: Optimising maintenance therapy for
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Page 24 and 25: NEWS Severe bowel condition on the
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