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Background and Objectives: The subcutaneous (SC) formulation of vedolizumab has proven to be effective for the maintenance of remission after intravenous induction. Little is known about the efficacy of switching from intravenous maintenance treatment to SC. We aimed to assess the real-world efficacy of switching to SC treatment and to assess the impact of a baseline treatment regimen. Materials and Methods: In this observational cohort study, adult patients with inflammatory bowel disease who were switched to SC vedolizumab maintenance treatment were enrolled. Patients after intravenous induction and patients who switched from intravenous maintenance treatment (every 8 weeks or every 4 weeks) were included. The SC vedolizumab dosing was 108 mg every 2 weeks, regardless of the previous regimen. The clinical, biochemical, and endoscopic disease activity parameters and vedolizumab serum concentrations at the time of the switch and at the follow-up were assessed. Results: In total, 135 patients (38% Crohn's disease, 62% ulcerative colitis) were switched to SC vedolizumab treatment. The median time to the first follow-up (FU) was 14.5 weeks (IQR 12–26), and the median time to the second FU was 40 weeks (IQR 36–52). Nine patients (7%) discontinued SC vedolizumab treatment, with two-thirds of them discontinuing due to active disease. In all dosing regimens, there were no significant changes in the clinical scores and CRP at the baseline and first and second FUs. Clinical and biochemical remission appeared to be maintained irrespective of the previous dosing regimen. Conclusions: The results of this real-world study suggest that the maintenance of clinical and biomarker remission can be achieved in patients who switched from intravenous to SC vedolizumab. The baseline vedolizumab dosing regimen (every 4 weeks versus every 8 weeks) did not have an impact on outcomes. [ABSTRACT FROM AUTHOR]

Background and Objectives: Up to one-third of patients with acute biliary pancreatitis also present with choledocholithiasis. Guidelines from the European Society of Gastrointestinal Endoscopy (ESGE) and the American Society for Gastrointestinal Endoscopy (ASGE) for investigating suspected choledocholithiasis suggest endoscopic retrograde cholangiopancreatography in patients with high-likelihood (ESGE)/high-probability (ASGE) predictors and endoscopic ultrasound in those with intermediate-likelihood (ESGE)/intermediate-probability (ASGE) predictors. Although both guidelines are similar, they are not identical. Furthermore, these algorithms were mainly developed from cohorts of patients without pancreatitis and are therefore poorly validated in a subset of patients with acute pancreatitis. We aimed to assess the performance of the ESGE and ASGE algorithms for the prediction of choledocholithiasis in patients with acute biliary pancreatitis. Materials and Methods: This was a retrospective analysis of 86 consecutive patients admitted to a tertiary referral centre in the year 2020 due to acute biliary pancreatitis. Results: Choledocholithiasis was confirmed in 29/86 (33.7%) of patients (13 with endoscopic retrograde cholangiopancreatography and 16 with endoscopic ultrasound). All 10/10 (100%) ESGE high-likelihood and 14/19 (73.7%) ASGE high-probability patients had choledocholithiasis. Only 19/71 (26.8%) patients with ESGE intermediate likelihood and 15/67 (22.4%) with ASGE intermediate probability had choledocholithiasis. Only 8/13 (61.5%) patients with the ASGE high-probability predictor of dilated common bile duct plus bilirubin > 68.4 µmol/mL had choledocholithiasis. Since this predictor is not considered high likelihood by ESGE, this resulted in a superior specificity of the European compared to the American guideline (100% vs. 91.2%). Following the American instead of the European guidelines would have resulted in five unnecessary endoscopic retrograde cholangiopancreatographies and five unnecessary endoscopic ultrasound examinations. Conclusions: This retrospective analysis suggests that the European guidelines may perform better than the American guidelines at predicting choledocholithiasis in the setting of acute pancreatitis. This was because dilated common bile duct plus bilirubin > 68.4 µmol/mL was not a reliable predictor for persistent bile duct stones. [ABSTRACT FROM AUTHOR]

The use of combination therapy with a biologic agent and immunosuppressant has well-established efficacy and safety and is common practice in the management of inflammatory bowel disease (IBD). Current research has shifted focus toward the use of advanced combination treatment (ACT). This term was coined to describe combination therapy using 2 or more advanced treatments (biologic agents and/or oral small molecule drugs) with the aim of achieving optimal disease control in selected patients. An ACT approach may be particularly beneficial in patients with documented medically refractory IBD and in patients with a poor prognosis, extraintestinal manifestations, or concomitant immune-mediated inflammatory diseases. To date, the body of evidence for ACT strategies in IBD is largely comprised of uncontrolled retrospective case series and cohort studies in highly refractory patients. Recently, results from the VEGA trial have suggested that combination induction therapy with guselkumab and golimumab was more effective in ulcerative colitis than either agent alone. However, questions remain about issues such as related costs, ACT duration, and optimal combinations to adopt. Future randomized controlled trials are likely to evaluate rationally selected combinations of agents. This article summarizes the available literature on ACT, including comparisons with traditional combination therapy and the rheumatology field, and discusses practical recommendations, profiles of IBD patients who should be considered for combination approaches in clinical practice, and remaining knowledge gaps. [ABSTRACT FROM AUTHOR]

The document titled "Rare birds in Slovenia in 2020 and 2021 – Slovenian Rarities Committee's Report" provides a comprehensive report on rare bird species observed in Slovenia during the years 2020 and 2021. The report includes sightings of various bird species, such as the Brant goose, Pallas's leaf warbler, and Oriental plover. It also includes photographs of selected rare bird species. The report follows guidelines set by the Association of European Rarities Committees and provides valuable information for researchers studying bird species in Slovenia. [Extracted from the article]

Background Real life data regarding pharmacokinetics of vedolizumab in patients needing dose optimisation are scarce. We set to examine whether pre-optimisation vedolizumab levels associate with therapy outcomes and which mechanisms explain the associations. Methods A multicentre observational study assessed the outcome of dose increase in association with pre-escalation levels in vedolizumab-treated patients. SubsequentIy, α4β7 occupancy on peripheral blood [PB] and intestinal lamina propria [LP] tissues was investigated on various cellular subsets in patients undergoing lower endoscopy on infusion day. Cellular localisation of vedolizumab-bound α4β7 and effects on M1 and M2 macrophages were also explored. Results A total of 161 inflammatory bowel disease [IBD] patients were included. Among 129/161 patients intensified during maintenance [Week 14 onward], pre-intensification trough levels were comparable or higher among those subsequently attaining post-optimisation clinical, biomarker, and endoscopic remission, compared with non-remitting patients [ p  = 0.09, 0.25, 0.04, respectively]. Similar results were demonstrated for those dose-optimised during induction [Week 6, n  = 32]. In the immune sub-study [ n  = 43], free α4β7 receptors at trough were similarly low among patients with/without mucosal healing, on PB T cells [ p  = 0.15], LP T cells [ p  = 0.88], and on PB eosinophils [ p  = 0.08]. Integrin receptors on M1 and M2 macrophages were also saturated by low levels of vedolizumab and anti-inflammatory cytokine secretion was not increased. Co-localisation and dissociation experiments demonstrated membranal α4β7 receptors of two origins: non-internalised and newly generated α4β7, but re-binding was still complete at very low concentrations. Conclusions These results do not support pharmacokinetics as the mechanism responsible for loss of response to vedolizumab, nor do they support a need for higher drug concentration to enhance vedolizumab's immune effects. Higher pre-escalation levels may indicate less clearance [less severe disease] and higher likelihood of subsequent re-gained response, regardless of therapy escalation. [ABSTRACT FROM AUTHOR]

Summary: Background: Combination treatment with azathioprine for 6‐12 months is the preferred strategy for starting infliximab due to improved pharmacokinetics. However, optimised infliximab monotherapy with proactive dose escalations in case of low trough levels is a safer but under‐studied alternative. Aim: To compare the clinical success and infliximab consumption of combination vs optimised monotherapy strategies. Methods: We studied the clinical success and infliximab consumption of both strategies in 149 patients (94 Crohn's disease; 55 ulcerative colitis) starting infliximab and undergoing intensive drug monitoring assisted treatment optimisation. Results: The drug retention rates were similar for optimised monotherapy and combination treatment after induction (96% vs 97%, P = 0.73), after the first year (90% vs 83%, P = 0.23) and at the end of follow‐up (74% vs 75%, P = 0.968). Similarly, no differences were observed for steroid use at year 1 (5% vs 14%, P = 0.08) or mucosal healing at the end of follow‐up (64% vs 67%, P = 0.8). Higher infliximab consumption (7.6 mg/kg q8 weeks [interquartile range (IQR): 5.9‐10.3] vs 6.4 mg/kg q8 weeks [IQR: 5.2‐8.0], P = 0.019) combined with lower trough levels (1.7 µg/mL [IQR: 0.3‐6.6] vs 5.0 µg/mL [2.5‐8.7], P = 0.012) resulted in almost 3‐fold higher drug‐to‐trough ratio (3.9 vs 1.5) in monotherapy compared to combination strategy at year 1. At the end of follow‐up, when azathioprine had been discontinued for a median of 14 [IQR: 3‐33] months, these differences disappeared. Conclusions: In this study, optimised infliximab monotherapy was as clinically effective as combination therapy but was associated with significantly higher infliximab consumption. The infliximab‐sparing effect disappeared after azathioprine withdrawal. [ABSTRACT FROM AUTHOR]

This report by the Slovenian Rarities Committee presents records of rare bird species in Slovenia in 2017, with some addenda for previous years. The numbers in brackets refer to the number of records (first number) and individuals (second number) recorded between 1 Jan 1950 and 31 Dec 2016. Since 1 Jan 2013, submission to the Committee has been required for 37 additional species, 17 of which are regional rarities. Records of these species are not numbered, since records from previous years were not collected by the Committee. The Barnacle Goose Branta leucopsis was first recorded in Category A, in addition to previous Category D and E records. Other notable observations were the third record of Red-breasted Goose Branta ruficollis, fifth records of Lammergeier Gypaetus barbatus and Pomarine Skua Stercorarius pomarinus, and seventh records of Greater Blackbacked Gull Larus marinus and Red Phalarope Phalaropus fulicarius. The list of birds recorded in Slovenia (as of 31 Dec 2017) contains 390 species (375 in Category A, 6 in Category B, 9 exclusively in Category C; 4 species are both in Categories A and C). Category D contains 7 species, while Category E contains 39, two of which are classified into Subcategory E*. These two categories are not part of the list. [ABSTRACT FROM AUTHOR]

Rdečenoga postovka Falco vespertinus je kot gnezdilka razširjena od vzhodne Evrope do severa osrednje Azije. Njena jesenska selitvena pot v južno Afriko poteka bolj vzhodno kot spomladanska. V Sloveniji se vrsta redno pojavlja na spomladanski selitvi, veliko redkeje pa jeseni. Občasno pride do invazij, ko je vrsta nadpovprečno številna, pojavlja pa se tudi na območjih, kjer je sicer redka. Takšna invazija se je v Sloveniji zgodila spomladi 2015. Podatke o opazovanjih smo pridobili iz spletne podatkovne baze Atlas ptic - NOAGS, s pozivi k zbiranju podatkov na novičarskih skupinah ter neposredno od opazovalcev. Opazovanih je bilo 3910-4370 osebkov te vrste, kar je 3,1-7,2 % evropske gnezdeče populacije. Višek selitve je bil med 13. in 18. 5., največje število, zabeleženo v enem dnevu, pa 1146. Največ ptic, ki so se prehranjevale in prenočevale, je bilo opaženih na Ljubljanskem barju, predvsem med Škofljico in Igom (567-883 osebkov) ter na Cerkniškem jezeru (710 osebkov). Večje seleče se jate so bile opažene tudi v Št. Juriju pri Grosuplju (500 osebkov), Veliki Pirešici pri Žalcu (406 osebkov) in na Ormoškem jezeru (206 osebkov). Nadpovprečno veliko število rdečenogih postovk so opazili tudi drugje v Evropi, od Iberskega polotoka prek južne Francije, Švice in južne Nemčije do severne Italije in južne Avstrije. Invazije te vrste v preteklosti so povezovali z večjim številom majskih hroščev Melolontha sp., s katerimi se vrsta hrani, in močnimi vzhodnimi ter jugovzhodnimi vetrovi, ki selitveno pot prestavijo proti zahodu. Noben od omenjenih vzročnih dejavnikov leta 2015 ni bil prepričljivo izražen. Invazija te vrste v Sloveniji je bila prvič podrobno dokumentirana, podatki pa potrjujejo, da sta Cerkniško jezero in Ljubljansko barje najpomembnejši lokaliteti za to vrsto. [ABSTRACT FROM AUTHOR]

This report by the Slovenian Rarities Committee presents records of rare bird species in Slovenia in 2014, with some addenda for previous years. The numbers in brackets refer to the number of records (first number) and individuals (second number) recorded between 1 Jan 1950 and 31 Dec 2013. Since 1 Jan 2013, submission to the Committee has been required for 37 additional species, 17 of which are regional rarities. Records of these species are not numbered, since records from previous years were not collected by the Committee. One new species was added to category C5: Sacred Ibis Threskiornis aethiopicus. One species, Spotted Dove Streptopelia chinensis, was added to category E. Breeding was confirmed for Muscovy Duck Cairina moschata and Northern Bobwhite Colinus virginianus; the two species were thus transferred to subcategory E*. Other notable observations were the third and fourth records of Black Vulture Aegypius monachus, fourth and fifth records of Gannet Morus bassanus, fourth record of Pomarine Skua Stercorarius pomarinus and fourth record of Richard's Pipit Anthus richardi. The flocks of four Gannets and 23 Flamingos Phoenicopterus roseus have been the largest recorded in Slovenia to date. The list of birds recorded in Slovenia (as of 31 Dec 2014) contains 385 species (369 in category A, 7 in category B, 9 exclusively in category C; 4 species are both in categories A and C). Category D contains 6 species, while category E contains 34, two of which are classified into subcategory E*. These two categories are not part of the list. [ABSTRACT FROM AUTHOR]

This report by the Slovenian Rarities Committee presents records of rare bird species in Slovenia in 2013, with some addenda for previous years. The numbers in brackets refer to the number of records (first number) and individuals (second number), recorded between 1 Jan 1950 and 31 Dec 2012. Since 1 Jan 2013, submission to the Committee is required for 37 additional species, 17 of which are regional rarities. Records of these species are not numbered, since records from previous years were not collected by the Committee. Four new species were recorded in category A: White-headed Duck Oxyura leucocephala, Baillon's Crake Porzana pusilla, Audouin's Gull Larus audouinii and Siberian Rubythroat Calliope calliope. Three species, Helmeted Guineafowl Numida meleagris, Chukar Alectoris chukar and Common Bulbul Pycnonotus barbatus, were added to category E. Other notable observations were the second and third records of Bewick's Swan Cygnus columbianus and fourth record of Dalmatian Pelican Pelecanus crispus. The list of birds recorded in Slovenia (as of 31 Dec 2013) contains 384 species (369 in category A, 7 in category B, 8 exclusively in category C; 4 species are both in categories A and C). Category D contains 6 species, while category E contains 33. These two categories are not part of the list [ABSTRACT FROM AUTHOR]

Ustekinumab is a monoclonal antibody used in Crohn's disease (CD). Dose optimization in case of non-response and the role of pharmacokinetic–pharmacodynamic (PK-PD) monitoring remain unresolved dilemmas in clinical practice. We aimed to develop a population PK-PD model for ustekinumab in CD and simulate efficacy of alternative dosing regimens. We included 57 patients and recorded their characteristics during 32 weeks after starting with ustekinumab therapy. Serum ustekinumab concentration was prospectively measured and fecal calprotectin (FC) concentration was used to monitor the disease activity. Ustekinumab PK-PD was described by a two-compartment target-mediated drug disposition model linked to an indirect response model. Lower fat-free mass, higher serum albumin, previous non-exposure to biologics, FCGR3A-158 V/V variant and lower C-reactive protein were associated with higher ustekinumab exposure. Model-based simulation suggested that 41.9% of patients receiving standard dosing achieve biochemical remission at week 32. In patients not achieving remission with standard dosing at week 16, transition to 4-weekly subcutaneous maintenance dosing with or without intravenous reinduction resulted in comparably higher remission rates at week 32 (51.1% vs. 49.2%, respectively). Our findings could be used to guide stratified ustekinumab treatment in CD, particularly in patients with unfavorable characteristics, who might benefit from early transition to 4-weekly maintenance dosing. [ABSTRACT FROM AUTHOR]

Intussusception is a rare cause of small bowel obstruction in adults, up to 30% of cases are caused by small bowel malignancy. Intestinal leiomyosarcoma is an extremely rare malignant mesenchymal tumour. An 80-year-old male presented with small bowel obstruction. Abdominal ultrasonography and a subsequent CT scan showed small bowel obstruction due to ileo-ileal intussusception. The patient underwent an emergency exploratory laparotomy, which confirmed prior findings on imaging. The affected segment of the ileum was resected and a primary entero-enteral anastomosis was created. Histopathological analysis revealed a 4.8 cm leiomyosarcoma. The patient remains without evidence of disease 12 months after initial presentation. Radical surgical resection remains the treatment of choice for leiomyosarcoma, with no convincing evidence supporting adjuvant treatment. Tumours smaller than 5 cm appear to have a more favourable prognosis. [ABSTRACT FROM AUTHOR]

Introduction: Symptoms, endoscopy and histology have been proposed as therapeutic targets in ulcerative colitis (UC). Observational studies suggest that the achievement of histologic remission may be associated with a lower risk of complications, compared with the achievement of endoscopic remission alone. The actiVE ulcerative colitis, a RanDomIsed Controlled Trial (VERDICT) aims to determine the optimal treatment target in patients with UC., Methods and Analysis: In this multicentre, prospective randomised study, 660 patients with moderate to severe UC (Mayo rectal bleeding subscore [RBS] ≥1; Mayo endoscopic score [MES] ≥2) are randomly assigned to three treatment targets: corticosteroid-free symptomatic remission (Mayo RBS=0) (group 1); corticosteroid-free endoscopic remission (MES ≤1) and symptomatic remission (group 2); or corticosteroid-free histologic remission (Geboes score <2B.0), endoscopic remission and symptomatic remission (group 3). Treatment is escalated using vedolizumab according to a treatment algorithm that is dependent on the patient's baseline UC therapy until the target is achieved at weeks 16, 32 or 48. The primary outcome, the time from target achievement to a UC-related complication, will be compared between groups 1 and 3 using a Cox proportional hazards model., Ethics and Dissemination: The study was approved by ethics committees at the country level or at individual sites as per individual country requirements. A full list of ethics committees is available on request. Study results will be disseminated in peer-reviewed journals and at scientific meetings., Trial Registration Number: EudraCT: 2019-002485-12; NCT04259138., Competing Interests: Competing interests: VJ has received consulting/advisory board fees from AbbVie, Alimentiv Inc (formerly Robarts Clinical Trials), Arena Pharmaceuticals, Asieris, Bristol Myers Squibb, Celltrion, Eli Lilly, Ferring, Fresenius Kabi, Galapagos, GlaxoSmithKline, Genentech, Gilead, Janssen, Merck, Mylan, Pandion, Pendopharm, Pfizer, Reistone Biopharma, Roche, Sandoz, Takeda and Topivert; and speaker’s fees from Abbvie, Ferring, Janssen, Pfizer, Shire and Takeda. GZ has received consulting fees from Alimentiv Inc. ZW is an employee of Alimentiv Inc. SA is an employee of Takeda Pharmaceuticals. JFC reports receiving research grants from AbbVie, Janssen Pharmaceuticals and Takeda; payment for lectures from AbbVie, Amgen, Allergan. Ferring Pharmaceuticals, Shire and Takeda; consulting fees from AbbVie, Amgen, Arena Pharmaceuticals, Boehringer Ingelheim, BMS, Celgene Corporation, Eli Lilly, Ferring Pharmaceuticals, Galmed Research, Genentech, Glaxo Smith Kline, Janssen Pharmaceuticals, Kaleido Biosciences, Imedex, Immunic, Iterative Scopes, Merck, Microbia, Novartis, PBM Capital, Pfizer, Protagonist Therapeutics, Sanofi, Takeda, TiGenix, Vifor; and holds stock options in Intestinal Biotech Development. GRD has served as a consultant and/or received speaker fees from Abbvie, Alimentiv, AstraZeneca, Biora (Progenity), Boehringer Ingelheim, Bristol Myers Squibb, Celltrion Healthcare, Cytoki Pharma, Eli Lilly, Ferring, Galapagos, GlaxoSmithKline, Gossamer Bio, Immunic, InDex Pharmaceuticals, Janssen, Johnson & Johnson, Kaleido, Pfizer, Prometheus Biosciences, Prometheus Laboratories, Protagonist Therapeutics, Takeda, Tillotts and Ventyx Biosciences. MF is an employee of Takeda Pharmaceuticals. GWM is a consultant for Alimentiv and in receipt of research funding from AstraZeneca and Johnson and Johnson. LPB has received personal fees from AbbVie, Adacyte, Alimentiv, Alma Bio Therapeutics, Amgen, Applied Molecular Transport, Arena, Biogen, BMS, Celltrion, CONNECT Biopharm, Cytoki Pharma, Enthera, Ferring, Fresenius Kabi, Galapagos, Genentech, Gilead, Gossamer Bio, GSK, HAC-Pharma, IAG Image Analysis, Index Pharmaceuticals, Inotrem, Janssen, Lilly, Medac, Mopac, Morphic, MSD, Norgine, Nordic Pharma, Novartis, OM Pharma, ONO Pharma, OSE Immunotherapeutics, Pandion Therapeutics, Par’Immune, Pfizer, Prometheus, Protagonist, Roche, Sanofi, Sandoz, Takeda, Theravance, Thermo Fisher, Tigenix, Tillots, Viatris, Vifor, Ysopia, Abivax, Samsung, Ventyx, Roivant and Vectivbio. WJS reports receiving consulting fees from Abbvie, Abivax, Alfasigma, Alimentiv, Beigene, Biora (Progenity), Celltrion, Forbion, Genentech, Gossamer Biosciences, Index Pharmaceuticals, Prometheus Biosciences, Protagonist Therapeutics, Shoreline Biosciences, Vedanta Biosciences, Ventyx Biosciences, Zealand Pharma; and stock or stock options from BeiGene, Gossamer Bio, Biora (Progenity), Prometheus Biosciences, Prometheus Laboratories, Shoreline Biosciences, Ventyx Biosciences, Vimalan Biosciences, Vivreon Gastrosciences; he is an employee at Shoreline Biosciences and Ventyx Biosciences. Spouse: Iveric Bio—consultant, stock options; Biora (Progenity)—stock; Prometheus Biosciences—employee, stock, stock options; Prometheus Laboratories—stock, stock options; Ventyx Biosciences—stock, stock options; Vimalan Biosciences—stock, stock options. SS reports research grants from Takeda, Pfizer, Tillotts Pharma, Abbvie and Biogen; and personal fees for speaker role and advisory board meetings from Janssen, Amgen, Tillotts Pharma, Abbvie, Takeda, Celgene, Roche, Pharmacosmos, and Falk Pharma outside the submitted work. ST has received grants/research support from AbbVie, Buhlmann, Celgene, ECCO, Helmsley Trust, IOIBD, Janssen, Lilly, Pfizer, Takeda, UCB, UKIERI, Vifor and Norman Collisson Foundation; consulting fees from Abacus, AbbVie, Actial, ai4gi, Alcimed, Allergan, Amgen, Apexian, Aptel, Arena, Asahi, Aspen, Astellas, Atlantic, AstraZeneca, Barco, Biocare, Biogen, BLPharma, Boehringer Ingelheim, BMS, Buhlmann, Calcico, Celgene, Cellerix, Cerimon, ChemoCentryx, Chiesi, CisBio, ComCast, Coronado, Cosmo, Ducentis, Dynavax, Elan, Enterome, EQrX, Equillium, Falk, Ferring, FPRT Bio, Galapagos, Genentech/Roche, Genzyme, Gilead, Glenmark, Grunenthal, GSK, GW Pharmaceuticals, Immunocore, Immunometabolism, Indigo, Janssen, Lexicon, Lilly, Medarex, Medtrix, Merck, Merrimack, Mestag, Millenium, Neovacs, Novartis, Novo Nordisk, NPS-Nycomed, Ocera, Optima, Origin, Otsuka, Palau, Pentax, Pfizer, Pharmaventure, Phesi, Phillips, P&G, Pronota, Protagonist, Proximagen, Resolute, Robarts, Sandoz, Sanofi, Santarus, Satisfai, Sensyne Health, Shire, SigmoidPharma, Sorriso, Souffinez, Syndermix, Synthon, Takeda, Theravance, Tigenix, Tillotts, Topivert, Trino Therapeutics with Wellcome Trust, TxCell, UCB Pharma, Vertex, VHsquared, Vifor, Warner Chilcott and Zeria; speaker fees from AbbVie, Amgen, Biogen, BMS, Falk, Ferring, Janssen, Lilly, Pfizer, Shire, Takeda and UCB. He has no stocks or share options. SV has received grants from AbbVie, J&J, Pfizer, Takeda and Galapagos; consulting and/or speaking fees from AbbVie, AbolerIS Pharma, AgomAb, Alimentiv, Arena Pharmaceuticals, AstraZeneca, Avaxia, BMS, Boehringer Ingelheim, Celgene, CVasThera, Cytoki Pharma, Dr Falk Pharma, Ferring, Galapagos, Genentech-Roche, Gilead, GSK, Hospira, Imidomics, Janssen, J&J, Lilly, Materia Prima, MiroBio, Morphic, MrMHealth, Mundipharma, MSD, Pentax, Pfizer, Prodigest, Progenity, Prometheus, Robarts Clinical Trials, Second Genome, Shire, Surrozen, Takeda, Theravance, Tillots Pharma AG and Zealand Pharma. GR is an employee of Alimentiv Inc. JS is an employee of Alimentiv Inc. JH has received consulting fees from Alimentiv Inc.; and speaker’s fees from Abbvie, Janssen and Takeda. CM has received consulting fees from AbbVie, Alimentiv, Amgen, AVIR Pharma, Bristol Myers Squibb, Ferring, Fresenius Kabi, Janssen, McKesson, Mylan, Takeda, Pfizer and Roche; speaker's fees from AbbVie, Amgen, AVIR Pharma, Alimentiv, Ferring, Janssen, Takeda and Pfizer; and research support from Pfizer. RS is an employee of Alimentiv Inc. SCM is an employee of Alimentiv Inc. NA reports no conflicts of interest. MB has received honoraria from Shire, Allergan, Pfizer, and Takeda; advisory board fees from AbbVie, Takeda, Janssen, Lupin, Gilead, Pfizer, and Novo Nordisk; clinical trials: AbbVie, Novo Nordisk, Gilead, Takeda, Boehringer Ingelheim, Janssen, Pfizer, AstraZeneca and Intercept; research publications: AbbVie (2021–letter signed). PB reports receiving research grants from Abbvie, Amgen, Celltrion, Mylan, Pfizer and Takeda; lecture fees from AbbVie, Celltrion, Janssen, Lilly, and Takeda; and consulting fees Abbvie, Arena Pharmaceuticals, BMS, Celltrion, Dr Falk, Galapagos, Janssen, Lilly, Pentax, PSI-CRO, Roche, Takeda, and Tetrameros. DG has received advisory board fees from Takeda, Abbvie, Janssen, Pfizer, Merck, and Freseni Kabi. WH reports no conflicts of interest. MH reports no conflicts of interest. MK has received personal fees from Shire, a Takeda company, during the conduct of the study; personal fees and non-financial support from Takeda; personal fees and non-financial support from Janssen; personal fees and non-financial support from Ferring, outside the submitted work. RP has received consulting/advisory board fees from AbbVie, Janssen, Pfizer and Allergan. MSS has received consulting, speaker and advisory board fees from Abbvie, Janssen, Pfizer, and Takeda. LW reports no conflicts of interest. BGF is a scientific advisory board member for AbbVie, Allergan, Amgen, AstraZeneca, Avaxia Biologics, Boehringer-Ingelheim, Bristol-Myers Squibb, Celgene, Elan, Biogen, Ferring, Genentech–Roche, Janssen–Johnson & Johnson, Merck, Millennium, Nestlé, Novo Nordisk, Novartis, Pfizer, Prometheus, Protagonist, Receptos, Salix, Sigmoid Pharma, Takeda, Teva, TiGenix, Tillotts Pharma and UCB Pharma; consulting fees from AbbVie, Actogenix, Akros, Albireo Pharma, Allergan, Amgen, AstraZeneca, Avaxia Biologics, Avir Pharma, Axcan, Baxter Healthcare, Biogen Idec, Boehringer Ingelheim, Bristol-Myers Squibb, Calypso Biotech, Celgene, Elan–Biogen, EnGene, Ferring, Genentech–Roche, GiCare Pharma, Gilead Sciences, Given Imaging, GlaxoSmithKline, Ironwood, Janssen Biotech–Centocor, Janssen–Johnson & Johnson, Kyowa Hakko Kirin, Eli Lilly, Merck, Mesoblast Pharma, Millennium, Nestlé, Novo Nordisk, Novartis, Pfizer, Prometheus, Protagonist, Receptos Salix, Sanofi, Shire, Sigmoid Pharma, Synergy Pharma, Takeda, Teva, TiGenix, Tillotts Pharma, UCB Pharma, Vertex, VHsquared, Wyeth, Zealand and Zygenia; lecture fees from AbbVie, Janssen–Johnson & Johnson, Takeda, and UCB Pharma, and grant support from AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Janssen Biotech–Centocor, Janssen–Johnson & Johnson, Pfizer, Receptos, Sanofi, and Takeda and is the Senior Scientific Officer of Alimentiv Inc. Alimentiv Inc is an academic gastrointestinal contract research organisation (CRO), operating under the Alimentiv Health Trust. Alimentiv Inc. provides comprehensive clinical trial services, precision medicine offerings, and centralised imaging solutions for endoscopy, histopathology and other imaging modalities. The beneficiaries of the Alimentiv Health Trust are the employees of the enterprises it holds. BGF, GRD, GZ, VJ and WJS are consultants to Alimentiv Inc. and have a primary academic appointment; they do not hold equity positions or shares in Alimentiv Inc., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)