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Christopher B Nahm,1–3 Saxon J Connor,4 Jaswinder S Samra,1,2,5 Anubhav Mittal1,2,5 1Upper Gastrointestinal Surgical Unit, Royal North Shore Hospital, Sydney, Australia; 2Northern Clinical School, Sydney Medical School, The University of Sydney, Sydney, Australia; 3Bill Walsh Translational Cancer Research Laboratory, Kolling Institute, The University of Sydney, Sydney, Australia; 4Department of Surgery, Christchurch Hospital, Christchurch, New Zealand; 5Australian Pancreatic Centre, Sydney, Australia Abstract: Postoperative pancreatic fistula (POPF) remains the major cause of morbidity after pancreatic resection, affecting up to 41% of cases. With the recent development of a consensus definition of POPF, there has been a large number of reports examining various risk factors, prediction models, and mitigation strategies for this costly complication. Despite these strategies, the rates of POPF have not significantly diminished. Here, we review the literature and evidence regarding both traditional and emerging concepts in POPF prediction, prevention, and management. In particular, we review the evidence for the association between postoperative pancreatitis and POPF, and present a novel proposed mechanism for the development of POPF. Keywords: postoperative pancreatic fistula, postoperative pancreatitis, distal pancreatectomy, pancreaticoduodenectomy

Background: Emulsifiers are implicated in the pathogenesis of inflammatory bowel disease (IBD). Few studies have examined emulsifier intake in people with existing IBD. We aimed to describe the frequency of exposure to 6 selected emulsifiers in a contemporary cohort of people with IBD and compare intake with healthy controls (HCs)., Methods: Baseline food records from participants in an Australian prospective cohort study examining the microbiome of IBD patients and HCs were analyzed. Exposure to inflammatory emulsifiers polysorbate-80 (P80); carboxymethylcellulose (CMC); carrageenan; xanthan gum (XG); lecithin (soy and sunflower) and mono- and diglycerides of fatty acids (MDGs) were determined by examining ingredient lists. Frequency of emulsifier exposure between groups (IBD vs HC, Crohn's disease [CD] vs ulcerative colitis [UC], IBD children vs adults, active disease vs remission) was examined after controlling for confounders., Results: Records from 367 participants were analyzed (n = 176 IBD, of which there were 101 CD, 75 UC, and 191 HC patients). In total, 5022 unique food items were examined, with 18% containing 1 or more emulsifier of interest. Inflammatory bowel disease participants had significantly higher total daily emulsifier exposure compared with HCs (2.7 ± 1.8 vs 2.3 ± 1.6, P = .02). In IBD participants, emulsifiers with the highest daily exposure were MDGs (1.2 ± 0.93), lecithin (0.85 ± 0.93), and XG (0.38 ± 0.42). There were no recorded exposures to P80., Conclusions: Inflammatory bowel disease participants were exposed to more emulsifiers than HCs. Intake of inflammatory emulsifiers were low or nonexistent, suggesting their presence in the food supply are not as common as frequently stated., (© The Author(s) 2024. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Introduction: A substantial proportion of patients with inflammatory bowel disease (IBD) on intravenous infliximab require dose intensification. Accessing additional intravenous infliximab is labour-intensive and expensive, depending on insurance and pharmaceutical reimbursement. Observational data suggest that subcutaneous infliximab may offer a convenient and safe alternative to maintain disease remission in patients requiring dose-intensified infliximab. A prospective, controlled trial is required to confirm that subcutaneous infliximab is as effective as dose-intensified intravenous infliximab, to identify predictors of disease flare and to establish the role of subcutaneous infliximab therapeutic drug monitoring., Methods and Analysis: The DISCUS-IBD trial is an investigator-initiated, prospective, multicentre, randomised, open-label non-inferiority study comparing the rate of disease flares in participants randomised to continue dose-intensified intravenous infliximab to those switched to subcutaneous infliximab after 48 weeks. Participants are adult patients with IBD in sustained corticosteroid-free remission on any regimen of dose-intensified infliximab up to a maximum of 10 mg/kg 4-weekly intravenously. Participants allocated to intravenous infliximab will continue infliximab at the same dose-intensified regimen they were receiving at study enrolment. Subcutaneous infliximab dosing will be stratified by prior intravenous infliximab dosing. Clinical (Harvey-Bradshaw Index, partial Mayo score), biochemical (C reactive protein, faecal calprotectin), pharmacokinetic (drug-level±antidrug antibodies) and qualitative data are collected 12-weekly until study conclusion at week 48. 13 sites across Australia will participate in recruitment to reach a calculated sample size of 120 participants., Ethics and Dissemination: Multisite ethics approval was obtained from the Health District Human Research Ethics Committee (HREC) at The Alfred Hospital under a National Mutual Acceptance (NMA) agreement (HREC/90559/Alfred-2022; Local Reference: Project 618/22, version 1.6, 2 March 2023). Findings will be reported at national and international gastroenterology meetings and published in peer-reviewed journals. DISCUS-IBD was prospectively registered with the Australian and New Zealand Clinical Trials Registry (ANZCTR) prior to commencing recruitment., Trial Registration Number: ACTRN12622001458729., Competing Interests: Competing interests: RDL has received conference fees from Janssen and Celltrion Healthcare. AS has received speaker fees from Sandoz and received research support and advisory fees from AbbVie, Pfizer, and Arrow Pharmaceuticals. GJW has served as a speaker, a consultant or an advisory board member for Janssen, Galapagos, AbbVie, Ferring, Dr Falk Pharma, Nova Labs and Sandoz. GTM has received educational grants or research support from GESA, The Gutsy Group, NHMRC, MRFF, AbbVie, Janssen, Pfizer, Shire and Takeda; speaker fees from AbbVie, Ferring, Janssen, Orphan, Pfizer, Roche, Sandoz, Shire and Takeda and has serve on advisory boards for AbbVie, Emerge, Eli-Lilly, Gilead, Hospira, Janssen, Orphan, MSD, Pfizer, Shire and Takeda. KL declares speaker fees, advisory Board fees and/or conference travel/registration support from AbbVie, Bristol Myers Squibb, Chiesi, Dr Falk, Ferring, Gilead, Guidepoint, Intercept Pharmaceuticals, Janssen-Cilag, MSD, Norgine, Pfizer, Sandoz, Takeda and the RAH Research Fund. JA has served as a speaker, a consultant and an advisory board member for, and has received research funding from, Abbott, AbbVie, Allergan, Anatara, AstraZeneca, Bayer, Celgene, Falk, Ferring, Gilead, Hospira, Immunic, ImmunsanT, Janssen, MSD, Nestle, Progenity, Pfizer, Sandoz, Shire, Takeda, Vifor, RAH Research Fund, The Hospital Research Fund with all monies received by her department for research support. YKA reports grants from Janssen, during the conduct of the study; has received speaking and consulting fees from AbbVie, Bristol Myers Squibb, Celltrion, Chiesi, Dr Falk, Ferring, Janssen, Pfizer, Sandoz, Shire and Takeda; served on advisory boards for AbbVie, Bristol Myers Squibb, Chiesi, Janssen, NPS Medicine wise, Microba and received research and educational funding from Abbvie, Celltrion, Dr Falk, Janssen, Pfizer, Sandoz and Takeda. RVB has received grant/research support/speaker fees from AbbVie, Ferring, Janssen, Shire, Takeda, Bristol Myer Squibb and Emerge Health; and is a shareholder in Biomebank. SC declares advisory board participation, speaker fees, educational support and/or research support for Liverpool Hospital, South Western Sydney Local Health District (SWSLHD) Academic Unit or Crohn’s Colitis Cure from: AbbVie, Amgen, BMS, Celltrion, Chiesi, Eli-Lilly, Dr Falk, Ferring, Fresenius Kabi, Gilead, GSK, Janssen, MSD, Novartis, Organon, Pfizer, Sandoz, Takeda and non-pharmacological research support from Agency for Clinical Innovation, Gastroenterological Society of Australia, The Leona M and Harry B Helmsley Charitable Trust, Medical Research Future Fund, SWSLHD, Sydney Partnership for Health, Research and Enterprise (SPHERE). MG has served on the advisory board of Pfizer and has received speaker fees, research or travel grants from AbbVie, Celltrion, Dr Falk, Janssen, Pfizer, Pharmacosmos, Takeda. EKW declares speaker and consulting fees from AbbVie, BMS, Celltrion, Falk, Ferring, Janssen, Pfizer and research funding/support from AbbVie, Ferring, Janssen. JPS has received conference fees from Janssen, BMS, Takeda, educational grants from Pfizer, speaker fees from AbbVie, Takeda and Pfizer and an unrestricted grant from Tillots. PDC has served as a consultant, an advisory board member or a speaker for AbbVie, Baxter, Ferring, Janssen, Celltrion, Emerge Health, Shire and Takeda and received research support from Ferring, Shire, Janssen, AbbVie, and Takeda. MGW has received educational grants and speakers fees from AbbVie, Takeda and Ferring; travel grants from Pfizer; and has served on advisory boards for AbbVie. MPS has received educational grants or research support from Ferring, Orphan and Gilead; speakers fees from Janssen, AbbVie, Ferring, Takeda, Pfizer and Shire; and has served on advisory boards for Janssen, Takeda, Pfizer, Celgene, AbbVie, MSD, Emerge Health, Gilead and BMS. JM, PH, RBG, DC, MS, EC, LT, GH and AB declare no relevant competing interests., (© 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.)

Background and Aims: Management of inflammatory bowel disease is constantly evolving, increasing the importance for gastroenterologists to keep up to date with guidelines. Traditional implementation strategies have had only small positive impacts on clinical practice. eHealth strategies such as the European Crohn's and Colitis Organisation e-guide may be beneficial for clinician decision making in keeping with guidelines. The aim of this study was to evaluate the feasibility and acceptability of the e-guide., Methods: A mixed methods approach was used to evaluate feasibility and acceptability. Cognitive (think-aloud) interviews were conducted with Australian gastroenterologists while using the e-guide. Two clinical scenarios were developed to allow evaluation of various aspects of the e-guide. Content analysis was applied to the qualitative interview data and descriptive analysis to the quantitative and observational data., Results: Seventeen participants completed the study. Data saturation were reached. The ECCO e-guide was largely feasible and acceptable, as demonstrated by most clinical questions answered correctly, 87% reaching the answer within 3 min, and most feeling it was useful, would be beneficial to their practice and would use it again. Issues raised included difficulties with website navigation, layout of the e-guide and difficulties with access (network firewalls, paid subscription required)., Conclusions: The ECCO e-guide is largely acceptable and feasible for gastroenterologists to use. Aspects of the e-guide could be modified to improve user experience. This study highlights the importance of engaging end-users in the development and evaluation of clinician educational tools., (© 2024. The Author(s).)

Background & Aims: The impact of thiopurine de-escalation while on vedolizumab versus continuing thiopurine therapy in ulcerative colitis (UC) is unclear. We aimed to determine the effect of thiopurine withdrawal for patients with UC in remission on vedolizumab., Methods: This multicenter randomized controlled trial recruited UC patients on vedolizumab 300 mg intravenously every 8 weeks and a thiopurine. Patients in steroid-free clinical remission for ≥6 months and endoscopic remission/improvement (Mayo endoscopic subscore ≤1) were randomized 2:1 to withdraw or continue thiopurine. Primary outcome was comparing week 48 vedolizumab trough concentrations. Secondary outcomes were clinical relapse (partial Mayo score ≥3 and fecal calprotectin >150 μg/g or increase in Mayo endoscopic subscore ≥1 from baseline), fecal calprotectin remission (<150 μg/g), C-reactive protein remission (<5 mg/L), centrally read endoscopic remission (Mayo endoscopic subscore = 0), histologic remission (Nancy index = 0), histo-endoscopic remission, and adverse events., Results: In total, 62 patients were randomized to continue (n = 20) or withdraw (n = 42) thiopurine. At week 48, vedolizumab trough concentrations were not significantly different between continue and withdrawal groups (14.7 μg/mL, interquartile rate [IQR], 12.3-18.5 μg/mL versus 15.9 μg/mL, IQR, 10.1-22.7 μg/mL, respectively, P = 0.36). The continue group had significantly higher fecal calprotectin remission (95.0%, 19/20 versus 71.4%, 30/42; P = .03), histologic remission (80.0%, 16/20 versus 48.6%, 18/37; P = .02), and histo-endoscopic remission (75.0%, 15/20 versus 32.4%, 12/37; P = .002) than the withdrawal group. Histologic activity (hazard ratio [HR], 15.5; 95% confidence interval [CI], 1.6-146.5; P = .02) and prior anti-tumor necrosis factor exposure (HR, 6.5; 95% CI, 1.3-33.8; P = .03) predicted clinical relapse after thiopurine withdrawal., Conclusions: Thiopurine withdrawal did not affect vedolizumab trough concentrations. However, it may increase fecal calprotectin, histologic, and histo-endoscopic activity. Histologic activity and prior anti-tumor necrosis factor exposure may predict disease relapse on thiopurine withdrawal for patients using vedolizumab for UC. Australian and New Zealand Trial Registry, number ACTRN12618000812291., (Crown Copyright © 2024. Published by Elsevier Inc. All rights reserved.)

Background: Crohn's Colitis Care is an adult inflammatory bowel disease eHealth system. Crohn's Colitis Care required additional pediatric functionality to enable life-long records and mitigate transition inadequacies., Aim: This study describes and evaluates a consensus method developed to ensure consumer needs were met., Methods: Pediatric-specific functionality and associated resources considered important for inclusion were developed by a clinician consensus group. This group was divided into thematic subgroups and underwent two voting rounds. The content validity index was used to determine items reaching consensus. Children with inflammatory bowel disease and their parents were later shown a descriptive list of non-clinical inclusion topics proposed by the consensus group, and asked to vote on whether topic-related functionality and resources should be included., Results: The consensus process consulted 189 people in total (38 clinicians, 32 children with inflammatory bowel disease and 119 parents). There was agreement across all groups to incorporate functionality and resources pertaining to quality of life, mental health, self-management, and transition readiness; however, divergence was seen for general inflammatory bowel disease facts, your inflammatory bowel disease history, and satisfaction. Cost saw the greatest disparity, being less supported by consumers compared to clinicians. Over 75% of consumers agreed it would be okay for appointments to take longer for survey completion, and > 90% thought Crohn's Colitis Care should allow consumers to ask their treating team questions., Conclusions: Widespread consumer co-design and consultation were important in unveiling differing perspectives to ensure Crohn's Colitis Care was built to support both consumer and clinician perspectives. Consumers collaborate to create a list of functionality and resources to be included in software (left), influencing the final product build (right)., (© 2023. The Author(s).)

Objectives: This study explored the variation in emerging adults' communication with gastroenterologists around the management of inflammatory bowel disease (IBD)., Methods: Nineteen emerging adults with IBD aged 18-25 and seven gastroenterologists participated in the study. Outpatient specialist consultations of consenting participants were audio-recorded and transcribed. Transcribed consultations were analysed in terms of the linguistic structure of the consultations and the gastroenterologist-patient role relationship., Results: Variations in the emerging adults' communication with their gastroenterologists stem partly from variation in their ability, opportunity, or need to contribute to the different phases of the consultation and partly from variations in the gastroenterologists' style of communication. Gastroenterologists differed in the construction of their role relationship with the patient, resulting in variations in employing empowering strategies including eliciting, exploring, and clarifying the patient's concerns, sharing clinical reasoning, and validating the patient experience. Variations were also observed in the length of appointments and the gastroenterologists' assessment and addressing of adherence issues. Techniques used by the gastroenterologist varied (1) from simply confirming adherence, to a comprehensive assessment of the patient's understanding of their management plan and their feedback, and (2) from use of persuasion to values calibration., Conclusions: Evidence-based consumer interventions and communication guidelines for clinicians are needed to address the identified variations in providing care to emerging adults living with chronic conditions., (© 2023 Walter de Gruyter GmbH, Berlin/Boston.)

Background: In the absence of targeted empirical evidence on effective clinical communication in inflammatory bowel disease (IBD), a broad overview of existing evidence on effective communication in healthcare and available recommendations for communication in telehealth is provided and mapped onto IBD research and practice., Methods: A narrative literature review was conducted using Pubmed and Scopus databases and snowballing literature search., Results: Evidence-based relationship building strategies include communicating emotions, acknowledging and addressing patients' hesitancy, and ensuring continued support. A particular recommendation regarding telehealth interaction is to avoid long stretches of talk. Effective informational strategies include facilitating and supporting information exchange and considering patients' preferences in decision-making. In teleconsultations, clinicians should ask direct questions about patients' emotional state, clarify their understanding of patients' concerns and check patients' understanding, address at least one patient-reported outcome when discussing the recommended treatment, and shorten the consultation where possible. Strategies for maximizing effective clinical communication in the spoken communicative mode include using infographics and simple language, and assessing adherence at the beginning of the consultation. For teleconsultations, clinicians are advised to allow patients to explain the reason for their call at the beginning of the teleconsultation, probe additional concerns early and before ending the teleconsultation, and be mindful of technical issues such as voice delays., Conclusions: Use of question prompt lists, decision aids, micro-lessons, and communication training interventions for clinicians could be beneficial in IBD care. Further research into the implementation of such interventions as well as clinical communication concerns specific to IBD is warranted., Competing Interests: Neda Karimi has received grant support from Janssen and conference attendance support from Ferring, and Pfizer. Alison R. Moore and Annabelle Lukin received grant support from Janssen. Susan J. Connor has received honoraria for Advisory Board participation, speaker fees, educational support, and/or research support from AbbVie, Amgen, BMS, Celltrion, Chiesi, DrFalk, Eli-Lilly, Ferring, Fresenius Kabi, Gilead, GSK, Janssen, MSD, Novartis, Organon, Pfizer, Sandoz, Takeda, Agency for Clinical Innovation, Gastroenterological Society of Australia, Medical Research Future Fund, and The Leona M and Harry B Helmsley Charitable Trust., (© The Author(s) 2023. Published by Oxford University Press on behalf of Crohn's & Colitis Foundation.)

Background and Aims: Ulcerative colitis [UC] is a major form of inflammatory bowel disease globally. Phenotypic heterogeneity is defined by several variables including age of onset and disease extent. The genetics of disease severity remains poorly understood. To further investigate this, we performed a genome wide association [GWA] study using an extremes of phenotype strategy., Methods: We conducted GWA analyses in 311 patients with medically refractory UC [MRUC], 287 with non-medically refractory UC [non-MRUC] and 583 controls. Odds ratios [ORs] were calculated for known risk variants comparing MRUC and non-MRUC, and controls., Results: MRUC-control analysis had the greatest yield of genome-wide significant single nucleotide polymorphisms [SNPs] [2018], including lead SNP = rs111838972 [OR = 1.82, p = 6.28 × 10-9] near MMEL1 and a locus in the human leukocyte antigen [HLA] region [lead SNP = rs144717024, OR = 12.23, p = 1.7 × 10-19]. ORs for the lead SNPs were significantly higher in MRUC compared to non-MRUC [p < 9.0 × 10-6]. No SNPs reached significance in the non-MRUC-control analysis (top SNP, rs7680780 [OR 2.70, p = 5.56 × 10-8). We replicate findings for rs4151651 in the Complement Factor B [CFB] gene and demonstrate significant changes in CFB gene expression in active UC. Detailed HLA analyses support the strong associations with MHC II genes, particularly HLA-DQA1, HLA-DQB1 and HLA-DRB1 in MRUC., Conclusions: Our MRUC subgroup replicates multiple known UC risk variants in contrast to non-MRUC and demonstrates significant differences in effect sizes compared to those published. Non-MRUC cases demonstrate lower ORs similar to those published. Additional risk and prognostic loci may be identified by targeted recruitment of individuals with severe disease., (© The Author(s) 2022. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation.)

Current inflammatory bowel disease (IBD) treatments including non-biological, biological, and nutritional therapies aim to achieve remission and mucosal healing. Treatment efficacy, however, is highly variable, and there is growing evidence that the gut microbiota influences therapeutic efficacy. The aim of this study was to conduct a systematic review and meta-analysis to define changes in the gut microbiota following IBD treatment and to identify microbial predictors of treatment response. A systematic search using MEDLINE/Embase and PubMed was performed in July 2022. The review was conducted based on the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines. Studies were included if they reported longitudinal microbiota analysis (>2 weeks) using next-generation sequencing or high-throughput sequencing of faecal/mucosal samples from IBD patients commencing treatment. Meta-analysis on alpha-diversity changes following infliximab treatment was conducted. Thirty-nine studies met the inclusion criteria, and four studies were included in the meta-analysis. An increase in alpha diversity was observed following treatment with 5-aminosalicylates, corticosteroids, and biological therapies in most studies. Characteristic signatures involving the enrichment of short-chain-fatty-acid-producing bacteria including Faecalibacterium prausnitzii and a reduction of pathogenic bacteria including various Proteobacteria were demonstrated following treatment with specific signatures identified based on treatment outcome. The meta-analysis demonstrated a statistically significant increase in bacterial richness following infliximab treatment (standardised mean difference -1.16 (-1.50, -0.83), p < 0.00001). Conclusion: Distinct microbial signatures are seen following treatment and are associated with treatment response. The interrogation of large longitudinal studies is needed to establish the link between the gut microbiota and IBD therapeutic outcomes.

Psychological problems are prevalent in people with inflammatory bowel diseases but are not routinely addressed. To improve recognition, three psychological screening tools were integrated into clinical management software (Crohn Colitis Care). In the first 6 months, completion rates varied between participating sites, and approximately 23-34% of respondents scored in moderate or higher ranges for psychological distress. Evaluation of the clinical utility of the module to improve patient outcomes is recommended., (© 2023 Royal Australasian College of Physicians.)

Background and Aims: For infants exposed in utero to anti-tumour necrosis factor-α [TNF] medications, it is advised that live-attenuated vaccinations be postponed until the drug is cleared, but little is known about time to clearance. To minimize delays before live-attenuated vaccination can be given, we aimed to develop a pharmacokinetic model to predict time-to-clearance in infants exposed during pregnancy., Methods: We prospectively followed in utero infliximab/adalimumab-exposed infants of mothers with inflammatory bowel disease across four countries between 2011 and 2018. Infants with a detectable anti-TNF umbilical-cord level and at least one other blood sample during the first year of life were included., Results: Overall, 107 infants were enrolled, including 166 blood samples from 71 infliximab-exposed infants and 77 samples from 36 adalimumab-exposed infants. Anti-TNF was detectable in 23% [n = 25] of infants at 6 months. At 12 months, adalimumab was not detected but 4% [n = 3] had detectable infliximab. A Bayesian forecasting method was developed using a one-compartment pharmacokinetic model. Model validation showed that the predicted clearing time was in accordance with the measured observations. A clinician-friendly online calculator was developed for calculating full anti-TNF clearing time: https://xiaozhu.shinyapps.io/antiTNFcalculator2/., Conclusions: Almost one-quarter of infants born to mothers receiving anti-TNF during pregnancy have detectable anti-TNF at 6 months. To limit the time to live-attenuated vaccination in infants of mothers receiving anti-TNF during pregnancy, the results of a cord drug level at birth and a second sample ≥ 1 month thereafter can be used to estimate the time for full anti-TNF clearance in these children., (© The Author(s) 2022. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: Infliximab remains a mainstay for the treatment of inflammatory bowel disease (IBD), but a long infusion duration and subsequent monitoring can be burdensome to patients and healthcare providers., Aims: To assess the safety of accelerated infusions for standard and dose-intensified infliximab regimens, and the effect on patient satisfaction and potential cost savings., Methods: Patients with IBD on a stable maintenance dose of infliximab and in clinical remission received one or more accelerated infusions: over 30 min if receiving a standard dose (5 mg/kg), or over 60 min if receiving dose-intensified infliximab (up to 10 mg/kg). Outcomes included incidence of reactions (acute or delayed), patient satisfaction and potential cost savings. We also explored infliximab trough levels after one and three accelerated infusions., Results: Fifty-two patients who received 150 infusions were studied. Incidence of reactions to accelerated infusions was 3.3% (3 out of 89) with a standard dose and 0% (out of 61) with dose-intensified infliximab. Reactions were delayed, mild and self-limiting. None required drug cessation. Patient satisfaction was improved with shortened infusion time as compared with the patients' previous experiences (P = 0.00002). Mean plasma trough level of infliximab reduced from 9.3 mg/L (±4.9) to 7.9 mg/L (±4.1) (P = 0.02) with accelerated infusions, but none developed anti-infliximab antibodies. Nursing cost savings were estimated as $123.52 and $247.04 per patient per year for standard and dose-intensified infliximab respectively., Conclusion: Accelerated infliximab infusions for standard and dose-intensified regimens seem to be safe and improved patient satisfaction. Potential impact on drug trough levels requires further investigations., (© 2021 Royal Australasian College of Physicians.)

Background: With the evolving inflammatory bowel disease (IBD) management landscape, it is critical that gastroenterologists keep up to date with the clinical practice guidelines (CPGs). Several studies in IBD have documented suboptimal adherence to CPGs. We aimed to gain an in-depth understanding of guideline adherence barriers reported by gastroenterologists and determine how evidence-based education can best be delivered., Methods: Interviews were conducted with a purposive sample of gastroenterologists' representative of the current workforce. Questions focused on previously identified problematic areas and shaped by the theoretical domains framework, a theory-informed approach to understanding clinician behavior, to assess all determinants of behavior. Questions explored perceived barriers to adherence and clinicians' preferred content and modes of delivery for an educational intervention. Interviews were conducted by a single interviewer and qualitative analysis performed., Results: A total of 20 interviews were conducted before data saturation was achieved (male = 12, work in a metropolitan area = 17). Five dominant subthemes for barriers to adherence emerged: negative experiences impacting future decisions, time constraints, long guidelines are impractical, unfamiliar with guideline specifics and prescribing restrictions. Adherence enablers were identified including features that improved the usability of CPGs. Computer- or smart phone-based educational interventions were preferred., Conclusions: This study identified several barriers and enablers for IBD guideline adherence and gained insight into how gastroenterologists prefer to receive evidence-based education. These results will inform the development of a targeted intervention to improve IBD guideline adherence. Improving guideline adherence is expected to facilitate standardized IBD care, ultimately leading to improved patient outcomes., Competing Interests: R.K. has received educational support from AbbVie, Takeda, Janssen, Sandoz, and Ferring. S.J.C. has received honoraria for Advisory board participation, speaker fees, educational support and/or research support from AbbVie, BMS, Celgene, Celltrion, Chiesi, Dr Falk, Ferring, Fresenius Kabi, Gilead, GSK, Janssen, MSD, Novartis, Organon, Pfizer, Takeda, and Vifor. The remaining authors have no conflicts of interest to declare., (© The Author(s) 2022. Published by Oxford University Press on behalf of Crohn's & Colitis Foundation.)

Background & Aims: Higher anti-tumor necrosis factor-α (TNF) drug levels are associated with improved clinical healing of Crohn's perianal fistulas. It is unclear whether this leads to improved healing on radiologic assessment. We aimed to evaluate the association between anti-TNF drug levels and radiologic outcomes in perianal fistulising Crohn's disease., Methods: A cross-sectional retrospective multicenter study was undertaken. Patients with perianal fistulising Crohn's disease on maintenance infliximab or adalimumab, with drug levels within 6 months of perianal magnetic resonance imaging were included. Patients receiving dose changes or fistula surgery between drug level and imaging were excluded. Radiologic disease activity was scored using the Van Assche Index, with an inflammatory subscore calculated using indices: T2-weighted imaging hyperintensity, collections >3 mm diameter, rectal wall involvement. Primary endpoint was radiologic healing (inflammatory subscore ≤6). Secondary endpoint was radiologic remission (inflammatory subscore = 0)., Results: Of 193 patients (infliximab, n = 117; adalimumab, n = 76), patients with radiologic healing had higher median drug levels compared with those with active disease (infliximab 6.0 vs 3.9 μg/mL; adalimumab 9.1 vs 6.2 μg/mL; both P < .05). Patients with radiologic remission also had higher median drug levels compared with those with active disease (infliximab 7.4 vs 3.9 μg/mL; P < .05; adalimumab 9.8 vs 6.2 μg/mL; P = .07). There was a significant incremental reduction in median inflammatory subscores with higher anti-TNF drug level tertiles., Conclusions: Higher anti-TNF drug levels were associated with improved radiologic outcomes on magnetic resonance imaging in perianal fistulising Crohn's disease, with an incremental improvement at higher drug level tertiles for both infliximab and adalimumab., (Copyright © 2022 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Ménétrier's disease (MD) is a rare gastropathy characterised by giant rugal folds which can present with nausea, vomiting, abdominal pain and protein losing gastropathy. We report a 21-year-old woman with comorbid MD and ulcerative colitis (UC). Management was complicated by limited treatment options for MD, significant symptom burden, worsening nutrition and difficulty determining which disease was the predominant cause of symptoms. Since age 18 the patient experienced recurrent UC flares characterised by diarrhoea, persistent vomiting and corticosteroid dependence. Endoscopic assessment demonstrated concurrent MD and active UC. Octreotide and cetuximab were trialled given persistent hypoalbuminaemia and suspicion for MD associated protein-losing gastropathy. UC management comprised dose-optimised infliximab and methotrexate. Repeat endoscopic assessment demonstrated improvement in UC without corresponding improvement in symptoms or hypoalbuminaemia. Nasojejunal feeding and parenteral nutrition failed to significantly improve nutritional status and accordingly the patient proceeded to radical total gastrectomy. Postoperatively, MD-associated symptoms and hypoalbuminemia resolved completely., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: This retrospective cohort study investigated the economic impact of implementing a nurse-led inflammatory bowel disease (IBD) advice-line and virtual clinic on the Australian healthcare system. The advice line is a telephone and email service managed by IBD specialist nurses. The virtual clinic is a planned, formal communication between the gastroenterologist and the specialist IBD nurse the result of which is communicated to the patient electronically., Methods: Advice line telephone calls and virtual clinic consultations registered between 1 June 2015 and 1 June 2016 were reviewed and analyzed in terms of outcome: avoidance of general practitioner (GP) consultation, IBD outpatient consultation, emergency department (ED) presentation, or hospital admission. Cost-benefit analysis was conducted to estimate financial savings., Results: During the study period, 220 calls were received through the advice line and 1017 virtual clinic consultations occurred. The advice line resulted in the avoidance of 53 GP visits, 159 IBD outpatient department visits, six ED presentations, and one hospital admission. The virtual clinic resulted in the avoidance of four GP visits, 954 IBD outpatient department visits, and 58 ED presentations. This led to an estimated annual cost saving of AUD 169 376.80, with the annual costs incurred estimated to be $58 713. Thus, the annual net benefit of implementing the advice line and the virtual clinic was estimated to be $110 663.80., Conclusion: Specialized-IBD-nurse-led advice line and virtual clinic improves IBD patients' access to services and reduces healthcare costs. This highlights the importance of a proactive multidisciplinary approach in optimizing the care of patients with IBD., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Background and Aim: The Global Ulcerative Colitis (UC) Narrative Survey aimed to evaluate the impact of UC, perceptions of UC burden, and management approaches. Here, we present data from patients and physicians in Australia., Methods: Surveys, fielded by The Harris Poll, were completed by 215 patients with UC and 90 physicians, between August 2017 and February 2018. Surveys included questions on disease characteristics, impact on life, communication with physicians, and patient knowledge of UC. Results are presented descriptively from all respondents (with no imputation for missing data)., Results: Based on medication history, 84% of patients had moderate to severe UC. Diagnostic delay was on average 1.9 (SD 5.0) years and 48% of patients had waited ≥1 year for diagnosis. Nearly two-thirds (65%) of patients considered themselves to be in remission, with 97% also reporting a flare in the past year. The majority (92%) of patients were satisfied with their UC medication and, if their treatment made them feel "good enough," many (75%) would not consider an alternative. Most (90%) patients were satisfied with communication with their physician; however, only 48% felt comfortable raising emotional concerns. Both patients and physicians desired more time during routine appointments. Patients had gaps in their knowledge of UC, which physicians mostly recognized., Conclusions: The Australian survey results highlighted the diagnostic delay and burden of UC patients' experience, gaps in patients' knowledge of UC, and challenges in patient-physician communication. Compared with the overall Global UC Narrative Survey, patients in Australia reported a high burden of disease., (© 2021 The Authors. JGH Open published by Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.)

Background and Aim: There is an increasing prevalence of chronic disease worldwide, resulting in multiple management challenges. Inflammatory bowel disease (IBD) is an exemplar chronic disease requiring coordinated longitudinal care. We propose that Crohn's Colitis Care (CCCare), a novel IBD-specific, structured electronic medical record is effective at improving data capture and is acceptable to patients., Methods: A comparison was made between IBD-data completeness in usual records and CCCare. CCCare's acceptability to patients was assessed in two independent IBD patient cohorts and included:• Overall ratings of acceptability.• Factors associated with pre-exposure acceptability ratings.• Whether exposure and security concerns influenced acceptability ratings.• Direct patient feedback through CCCare's patient portal., Results: In all cases reviewed, there was data gain using structured CCCare fields compared with IBD documentation in usual medical records. The overall acceptability in the combined cohort ( n  = 310) was very high. More than three-quarters of patients rated acceptability as >7 of 10. Self-reported information technology (IT) literacy positively associated with acceptability. Exposure had a small positive affect on acceptability, whereas security concerns had little impact on acceptability. Patient portal feedback revealed that most patients are very likely to recommend CCCare to others (8.56 ± 2.2 [out of 10])., Conclusion: CCCare is effective in supporting more complete IBD-specific data capture compared with usual medical records. It is highly acceptable to patients, especially those with reasonable IT literacy. Patient concerns about privacy and security of electronic medical records (EMRs) did not significantly affect acceptability., (© 2021 The Authors. JGH Open published by Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.)

Background: The current COVID-19 pandemic, caused by Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2), has drastically impacted societies worldwide. Vaccination against SARS-CoV-2 is expected to play a key role in the management of this pandemic. Inflammatory conditions such as inflammatory bowel disease (IBD) often require chronic immunosuppression, which can influence vaccination decisions., Aim: This review article aims to describe the most commonly available SARS-CoV-2 vaccination vectors globally, assess the potential benefits and concerns of vaccination in the setting of immunosuppression and provide medical practitioners with guidance regarding SARS-CoV-2 vaccination in patients with IBD., Methods: All published Phase 1/2 and/or Phase 3 and 4 studies of SARS-CoV-2 vaccinations were reviewed. IBD international society position papers, safety registry data and media releases from pharmaceutical companies as well as administrative and medicines regulatory bodies were included. General vaccine evidence and recommendations in immunosuppressed patients were reviewed for context. Society position papers regarding special populations, including immunosuppressed, pregnant and breast-feeding individuals were also evaluated. Literature was critically analysed and summarised., Results: Vaccination against SARS-CoV-2 is supported in all adult, non-pregnant individuals with IBD without contraindication. There is the potential that vaccine efficacy may be reduced in those who are immunosuppressed; however, medical therapies should not be withheld in order to undertake vaccination. SARS-CoV-2 vaccines are safe, but data specific to immunosuppressed patients remain limited., Conclusions: SARS-CoV-2 vaccination is essential from both an individual patient and community perspective and should be encouraged in patients with IBD. Recommendations must be continually updated as real-world and trial-based evidence emerges., (© 2021 John Wiley & Sons Ltd.)

Background: The Ottawa subarachnoid haemorrhage (SAH) rule and the Emerald SAH rule are clinical decision tools to aid in the decision for computed tomography (CT) of the head in patients attending an emergency department (ED) with acute non-traumatic headache. The objective of this study was to analyse the performance of these rules in a contemporary UK cohort., Methods: We performed a retrospective external validation study. Patients undergoing CT of the head for the evaluation and treatment of non-traumatic headaches over a 6-month period in the ED at two tertiary centres were assessed. Each patient's Ottawa rule and Emerald rule were calculated and compared with their final diagnosis., Results: The cohort consisted of 366 patients and there were 16 cases of SAH (based on CT findings or the presence of xanthochromia in cerebrospinal fluid). The Ottawa rule identified 288 patients requiring CT of the head. The sensitivity of the Ottawa rule was 100% (95% confidence interval (CI) 71-100%) and the specificity was 22% (95% CI 18-27%). The Emerald rule identified 267 patients who required CT, and achieved a sensitivity of 81% (95% CI 54-96%) and a specificity of 27% (95% CI 23-32%)., Conclusions: The Ottawa SAH rule correctly identified all patients with SAH in this contemporary cohort. The Emerald rule did not perform as well in this cohort and is unsuitable for clinical use. The Ottawa rule is a useful tool to aid in the decision for CT of the head in patients presenting with acute non-traumatic headache to the ED., (© Royal College of Physicians 2021. All rights reserved.)

Background: Shared decision making (SDM) is becoming an important part of ulcerative colitis (UC) management because of the increasing complexity of available treatment choices and their trade-offs. The use of decision aids (DA) may be effective in increasing patients' participation in UC management but their uptake has been limited due to high attrition rates and lack of a participatory approach to their design and implementation., Objective: The primary aim of this study is to explore the perspectives of Australian patients and their clinicians regarding the feasibility and acceptability of myAID, a web-based DA, in informing treatment decisions in UC. The secondary aim is to use the findings of this pilot study to inform the design of a cluster randomized clinical trial (CRCT) to assess the efficacy of the DA compared with usual care., Methods: myAID, a DA was designed and developed using a participatory approach by a multidisciplinary team of clinicians, patients, and nonmedical volunteers. A qualitative pilot study to evaluate the DA, involving patients with UC facing new treatment decisions and inflammatory bowel disease clinicians, was undertaken., Results: A total of 11 patients with UC and 15 clinicians provided feedback on myAID. Themes explored included the following: Acceptability and usability of myAID-myAID was found to be acceptable by the majority of clinicians as a tool to facilitate SDM, uptake was thought to vary depending on clinicians' approaches to patient education and practice, potential to overcome time restrictions associated with outpatient clinics was identified, presentation of unbiased information enabling patients to digest information at their own pace was noted, and potential to provoke anxiety among patients with a new diagnosis or mild disease was raised; Perceived role and usefulness of myAID-discordance was observed between patients who prioritized voicing preferences and clinicians who prioritized treatment adherence, and myAID facilitated early discussion of medical versus surgical treatment options; Target population and timing of use-greatest benefit was perceived at the time of initiating or changing treatment and following commencement of immunosuppressive therapy; and Potential concerns and areas for improvement-some perceived that use of myAID may precipitate anxiety by increasing decisional conflict and impact the therapeutic relationship between patient and the clinician and may increase resource requirements., Conclusions: These preliminary findings suggest that patients and clinicians consider myAID as a feasible and acceptable tool to facilitate SDM for UC management. These pilot data have informed a participatory approach to the design of a CRCT, which will evaluate the clinical efficacy of myAID compared with usual care., Trial Registration: Australian New Zealand Clinical Trial Registry ACTRN12617001246370; http://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12617001246370., (©Andrew H Kim, Afaf Girgis, Peter De Cruz, Corey A Siegel, Neda Karimi, Sasha O Ruban, Alexandra J Sechi, Wa Sang Watson Ng, Jane M Andrews, Susan J Connor. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 25.02.2021.)

Background: Therapeutic drug monitoring of tumor necrosis factor inhibitors, such as adalimumab (ADM), is increasingly being performed for the management of autoimmune diseases. However, there can be significant variation in drug and antibody concentrations obtained by different assay methods. The aim of this study was to compare the performance of 4 enzyme-linked immunosorbent assay (ELISA) kits for measuring ADM and anti-ADM antibodies., Method: Dilutions of ADM or anti-ADM spiked sera were assessed for recovery rate and precision using the following 4 kits: LISA-Tracker (Theradiag, Croissy-Beaubourg, France), Promonitor (Grifols, Barcelona, Spain), Ridascreen (R-Biopharm, Darmstadt, Germany), and Shikari (Matriks Biotek, Gölbaşi/Ankara Turkey). Interference samples were also assessed., Results: At the therapeutic concentration, ADM detection was comparable among the 4 ELISA kits. Lisa-Tracker and Shikari kits produced low-range false positive results in normal sera. Infliximab and etanercept caused false positives in Lisa-Tracker and Shikari kits. Anti-ADM antibody ELISA kits performed differently with spiked samples because of different measuring units and ranges. Ridascreen and Shikari kits were dose responsive across the entire standard curve and correlated well with each other (r = 0.997). Cross reactivity was observed in rheumatoid factor positive sera tested on the Promonitor anti-ADM kit., Conclusions: All ADM kits tested were dose responsive within the therapeutic range and correlated well. The significance of observed low-range false positives and cross reactivity with infliximab in LISA-Tracker and Shikari kits is dependent on the indications received for testing in the laboratory. Anti-ADM ELISA kits produced varied results for spiked sera; however, they showed good precision. Inter-kit variability suggested that anti-ADM levels should be compared only when using the same method.

Background: Hospice is the key provider of end-of-life care to patients. As the number of U.S. hospice agencies has rapidly increased, the performance has been scrutinized more deeply., Purpose: To foster understanding of how hospice performance is measured and what factors are associated with performance, we conducted a systematic review of empirical research on hospice performance in the United States., Methods: Both structure-process-outcome and structure-conduct-performance frameworks were applied to categorize and summarize the hospice performance literature. A total of 36 studies were included in the systematic review., Results: Hospice agencies adopted different strategies (e.g., service provision strategy and staffing strategy) to improve performance. Two strategic approaches (innovation and volunteer usage) were associated with better outcomes. Hospice organizational factors, market environment, and patient characteristics were related to hospice strategic conduct and performance. Majority of hospice performance studies have examined the relationship between hospice structure and strategic conduct/process, with fewer studies focusing on structure performance and even fewer concentrating on strategy performance., Practice Implications: Patient, organizational, and market factors are associated with hospice strategic conduct and performance. The majority of the literature considered the impact of hospice organizational characteristics, whereas only a few studies included patient and market factors. The summarization of factors that may influence hospice performance provides insight to different stakeholders.

Background: Patients with ulcerative colitis (UC) often face complex treatment decisions. Although shared decision making (SDM) is considered important, tools to facilitate this are currently lacking for UC. A recent pilot study of a novel Web-based decision aid (DA), my Actively Informed Decision (myAID), has suggested its acceptability and feasibility for informing treatment decisions and facilitating SDM in clinical practice., Objective: This paper describes the study protocol of the myAID study to assess the clinical impact of systematic implementation of myAID in routine UC management., Methods: The myAID study is a multicenter, cluster randomized controlled trial (CRCT) involving 22 Australian sites that will assess the clinical efficacy of routine use of myAID (intervention) against usual care without access to myAID (control) for UC patients. Participating sites (clusters) will be randomly allocated in a 1:1 ratio between the 2 arms. Patients making a new treatment decision beyond 5-aminosalicylate agents will be eligible to participate. Patients allocated to the intervention arm will view myAID at the time of recruitment and have free access to it throughout the study period. The effect of the myAID intervention will be assessed using the results of serial Web-based questionnaires and fecal calprotectin at baseline, 2 months, 6 months, and 12 months. A Web-based questionnaire within 2-4 weeks of referral will determine early change in quality of decision making and anxiety (both arms) and intervention acceptability (intervention arm only)., Results: Study recruitment and funding began in October 2016, and recruitment will continue through 2020, for a minimum of 300 study participants at baseline at the current projection. The primary outcome will be health-related quality of life (Assessment of Quality of Life-8D), and secondary outcomes will include patient empowerment, quality of decision making, anxiety, work productivity and activity impairment, and disease activity. In addition, we aim to determine the predictors of UC treatment decisions and outcomes and the cost-effectiveness of implementing myAID in routine practice. Feedback obtained about myAID will be used to determine areas for improvement and barriers to its implementation. Completion of data collection and publication of study results are anticipated in 2021., Conclusions: myAID is a novel Web-based DA designed to facilitate SDM in UC management. The results of this CRCT will contribute new evidence to the literature in comparing outcomes between patients who routinely access such decision support intervention versus those who do not, across multiple large inflammatory bowel disease centers as well as community-based private practices in Australia., Trial Registration: Australian New Zealand Clinical Trial Registry ACTRN12617001246370 http://anzctr.org.au/Trial/ Registration/TrialReview.aspx?ACTRN=12617001246370., International Registered Report Identifier (irrid): DERR1-10.2196/15994., (©Andrew H Kim, Afaf Girgis, Neda Karimi, Alexandra J Sechi, Joseph Descallar, Jane M Andrews, Corey A Siegel, Susan J Connor. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 10.07.2020.)

The COVID-19 pandemic, caused by the novel coronavirus SARS-CoV-2, has emerged as a public health emergency and challenged healthcare systems globally. In a minority of patients, SARS-CoV-2 manifests with a severe acute respiratory illness and currently there is insufficient data regarding the virulence of COVID-19 in inflammatory bowel disease patients taking immunosuppressive therapy. This review aims to summarise the current literature and provide guidance on the management of inflammatory bowel disease patients in the context of the COVID-19 pandemic in the Australasian setting., (© 2020 Royal Australasian College of Physicians.)

Background: Medicinal cannabis (MC) is being used for symptomatic relief by many patients with inflammatory bowel disease (IBD), often independently of clinical guidance. Such use presents challenges for supporting clinicians. The aim of this study was to determine the current attitudes, knowledge, and experience of gastroenterologists toward patient use of MC for symptom management in IBD., Methods: Australian gastroenterologists ( n = 70) and trainees ( n = 23) completed an anonymous, 30-item questionnaire, probing their knowledge, attitudes, and experience with MC in managing IBD. Survey data were collected between April and August 2019., Results: Thirty-nine percent of survey respondents reported having patients using MC; however, only a minority supported use of MC in IBD (21%) or expressed a desire to prescribe (28%). Only 6% claimed good understanding of current patient access pathways and only 31% felt comfortable discussing MC with their patients. Some respondents (20%) cited adverse side effects as a reason for not wanting to prescribe, with driving impairment (64%) and impacts on the developing brain (56%) cited as significant concerns. Nonetheless, MC was ranked as less hazardous than corticosteroids, immunomodulators, and biologics by most respondents, and many (53%) were encouraging of patient participation in future clinical trials., Conclusions: Specialist support for the use of MC in IBD patients is relatively low, potentially reflecting the lack of experience and knowledge with MC, uncertain evidence for efficacy, and the often-unorthodox nature of current MC use in patients. This situation may change rapidly with increased familiarity, evidence development, and education around MC prescribing., (© 2020 Crohn’s & Colitis Foundation. Published by Oxford University Press on behalf of Crohn's & Colitis Foundation.)

Background: Medicinal cannabis (MC) is an increasingly utilized treatment option for various refractory diseases. While robust clinical evidence supporting MC efficacy in inflammatory bowel disease (IBD) is lacking, many IBD patients report using MC to obtain symptomatic relief. Understanding this use and associated outcomes may help inform future clinical trials., Methods: A cross-sectional anonymous online survey was conducted involving Australians with IBD. It examined attitudes and experiences with MC in relation to IBD management. The survey included validated sub-questionnaires assessing quality of life, medication adherence, IBD severity, and functional impairment., Results: A total of 838 responses were obtained. Results showed 25.3% (n = 212) of respondents were current or previous users of MC (18.1% current, 7.2% previous). Half of the current users also consumed cannabis recreationally although less frequently than for medicinal purposes. Cannabis consumption was via smoking (joints 34.2%; water pipe/bongs 14.5%) or as an oral liquid (19.7%) with products obtained from recreational dealers (44.6%), friends/family (26.1%), or self-grown (9.8%). Only 3 respondents reported using legally accessed products. Clinical ratings of IBD severity did not differ according to cannabis use although users reported more hospitalizations, less engagement with specialist services, and lower medication adherence. IBD symptoms reported as positively affected by cannabis included abdominal pain, stress, sleep, cramping, and anxiety. Most users (92.7%) endorsed cannabis as effective in symptom management. Cannabis-using ulcerative colitis patients reported better quality of life than nonusers on some measures., Conclusion: Many patients in Australia are using illicit MC to manage their IBD. Further clinical trials are required to validate, or refute, patient claims around MC efficacy for symptom control in IBD., (© 2020 Crohn’s & Colitis Foundation. Published by Oxford University Press on behalf of Crohn's & Colitis Foundation.)

Background: Active inflammatory bowel disease (IBD) adversely affects pregnancy outcomes. Little is known about the risk of relapse after stopping anti-tumor necrosis factor (anti-TNF) treatment during pregnancy. We assessed the risk of relapse before delivery in women who discontinued anti-TNF treatment before gestational week (GW) 30, predictors of reduced infant birth weight, a marker associated with long-term adverse outcomes, and rates and satisfaction with counseling., Methods: Pregnant women with IBD receiving anti-TNF treatment were prospectively invited to participate in an electronic questionnaire carried out in 22 hospitals in Denmark, Australia, and New Zealand from 2011 to 2015. Risk estimates were calculated, and birth weight was investigated using t tests and linear regression., Results: Of 175 women invited, 153 (87%) responded. In women in remission, the relapse rate did not differ significantly between those who discontinued anti-TNF before GW 30 (1/46, 2%) compared with those who continued treatment (8/74, 11%; relative risk, 0.20; 95% confidence interval [CI], 0.02 to 1.56; P = 0.08). Relapse (P = 0.001) and continuation of anti-TNF therapy after GW 30 (P = 0.007) were independently associated with reduced mean birth weight by 367 g (95% CI, 145 to 589 g; relapse) and 274 g (95% CI, 77 to 471 g; anti-TNF exposure after GW 30). Of 134 (88%) women who received counseling, 116 (87%) were satisfied with the information provided., Conclusions: To minimize fetal exposure in women in remission, discontinuation of anti-TNF before GW 30 seems safe. Relapse and continuation of anti-TNF therapy after GW 30 were each independently associated with lower birth weight, although without an increased risk for birth weight <2500 g. Most women received and were satisfied with counseling., (© 2019 Crohn’s & Colitis Foundation. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)