British Society of Gastroenterology guidance for management of inflammatory bowel disease during the COVID-19 pandemic.

The COVID-19 pandemic is putting unprecedented pressures on healthcare systems globally. Early insights have been made possible by rapid sharing of data from China and Italy. In the UK, we have rapidly mobilised inflammatory bowel disease (IBD) centres in order that preparations can be made to protect our patients and the clinical services they rely on. This is a novel coronavirus; much is unknown as to how it will affect people with IBD. We also lack information about the impact of different immunosuppressive medications. To address this uncertainty, the British Society of Gastroenterology (BSG) COVID-19 IBD Working Group has used the best available data and expert opinion to generate a risk grid that groups patients into highest, moderate and lowest risk categories. This grid allows patients to be instructed to follow the UK government's advice for shielding, stringent and standard advice regarding social distancing, respectively. Further considerations are given to service provision, medical and surgical therapy, endoscopy, imaging and clinical trials.

Systematic review: advice lines for patients with inflammatory bowel disease.

OBJECTIVE: Advice lines for patients with inflammatory bowel diseases (IBD) have been introduced internationally. However, only a few publications have described the advice line service and evaluated the efficiency of it with many results presented as conference posters. A systematic synthesis of evidence is needed and the aim of this article was to systematically review the evidence of IBD advice lines. MATERIALS AND METHODS: A broad systematic literature search was performed to identify relevant studies addressing the effect of advice lines. The process of selection of the retrieved studies was undertaken in two phases. In phase one, all abstracts were review by two independent reviewers. In phase two, the full text of all included studies were independently reviewed by two reviewers. The included studies underwent quality assessment and data synthesis. RESULTS: Ten published studies and 10 congress abstracts were included in the review. The studies were heterogeneous both in scientific quality and in the focus of the study. No rigorous evidence was found to support that advice lines improve disease activity in IBD and correspondingly no studies reported worsening in disease activity. Advice lines were found to be health economically beneficial with clear indications of the positive impact of advice lines from the patient perspective. CONCLUSION: The levels of evidence of the effect of advice lines in IBD are low. However, the use of advice lines was found to be safe, and cost-effective. Where investigated, patients with IBD overwhelmingly welcome an advice line with high levels of patient satisfaction reported.

Exploring the role of the inflammatory bowel disease nurse specialist.

The number of inflammatory bowel disease (IBD) nurses and the amount of biological therapies being used in IBD has proliferated over the past ten years. Coordinating and managing a biologics service requires highly skilled specialist nursing knowledge and awareness of the support, assessment, administration and monitoring required in supporting the patient through this pathway. This article explores the role of the nurse and clinical issues in managing patients receiving biological therapies.

Barriers to international travel in inflammatory bowel disease patients.

BACKGROUND: Inflammatory bowel disease poses substantial challenges to travel. We aimed to investigate inflammatory bowel diseases (IBD)-associated challenges to travel, information-seeking behaviour and associated factors. METHODS: We collected data on patients' demographics, disease characteristics, travel barriers, information-seeking behaviour and travel outcomes in UK, Australia, New Zealand and Israel (2016-2018). Summary statistics were used to describe the sample, whereas multivariate binary and nominal logistic regression were used to model the outcome variables. RESULTS: Almost 75.4% (1878/2491) participants' data were analysed with 71.14%, 15.4%, 11.2% and 2.1% from UK, Australia, NZ and Israel, respectively (76.3% females, 48.2% 30-49 years old 58.8% Crohn's disease). About 7.7% of study participants sought medical advice/were hospitalised while overseas. About 43.8% cancelled/changed their plans due to IBD. The most common barriers were worry about toilet facilities (76.3%), cleanliness/sanitation (50.9%) and availability of medical care (41.1%). Only 60.5% sought travel advice; the most popular information source was IBD doctor/nurse (32.6%). Almost 32.6% of study participants did not get travel insurance that covered their IBD. Those who did not receive advice or found obtaining travel insurance difficult, were less likely to obtain travel insurance (P < 0.001). Participants who travelled for work were more likely to be hospitalised/seek medical advice overseas and not obtain travel insurance. CONCLUSIONS: We report a detailed investigation on the IBD-associated barriers while travelling abroad, common information-seeking behaviours and factors associated with worse outcomes. Importantly, patients from all the surveyed countries provided similar travel barrier and preparation habits, highlighting the consistent nature of the challenge.

Correction to: The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases.

The affiliation of the corresponding author Silvio Danese, which currently reads.

The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases.

Biologics have transformed the treatment of immune-mediated inflammatory diseases such as rheumatoid arthritis (RA) and inflammatory bowel disease (IBD). Biosimilars-biologic medicines with no clinically meaningful differences in safety or efficacy from licensed originators-can stimulate market competition and have the potential to expand patient access to biologics within the parameters of treatment recommendations. However, maximizing the benefits of biosimilars requires cooperation between multiple stakeholders. Regulators and developers should collaborate to ensure biosimilars reach patients rapidly without compromising stringent quality, safety, or efficacy standards. Pharmacoeconomic evaluations and payer policies should be updated following biosimilar market entry, minimizing the risk of imposing nonmedical barriers to biologic treatment. In RA, disparities between treatment guidelines and national reimbursement criteria could be addressed to ensure more uniform patient access to biologics and enable rheumatologists to effectively implement treat-to-target strategies. In IBD, the cost-effectiveness of biologic treatment earlier in the disease course is likely to improve when biosimilars are incorporated into pharmacoeconomic analyses. Patient understanding of biosimilars is crucial for treatment success and avoiding nocebo effects. Full understanding of biosimilars by physicians and carefully considered communication strategies can help support patients initiating or switching to biosimilars. Developers must operate efficiently to be sustainable, without undermining product quality, the reliability of the supply chain, or pharmacovigilance. Developers should also facilitate information sharing to meet the needs of other stakeholders. Such collaboration will help to ensure a sustainable future for both the biosimilar market and healthcare systems, supporting the availability of effective treatments for patients.

Can ELISpot replace the tuberculin skin test for latent tuberculosis?

BACKGROUND: Screening and treatment of latent tuberculosis infection (LTBI) prior to anti-tumour necrosis factor alpha (anti-TNF-alpha) therapy has been shown to decrease the incidence of active tuberculosis (TB) by more than 80%, and is recommended by the British Thoracic Society. In the absence of a gold standard test for LTBI, conventional screening currently involves taking a clinical history of risk factors, a chest X-ray and a tuberculin skin test (TST) which can be difficult to interpret in immunosuppressed patients. Alternative cellular immune-based screening tests have been developed to detect Mycobacterium tuberculosis. AIM: To examine, evaluate and summarize the quality of evidence on the use of interferon gamma release assay (the ELISpot test) in the diagnosis of latent tuberculosis prior to initiation of anti-TNF-alpha and examine the agreement with the tuberculin skin test. METHODS: Ovid Medline, Embase and the Cochrane library were searched using search terms that included tuberculosis, each of the current anti-TNF-alpha biological agents, TST and interferon-gamma release assay. Terms were searched using MeSH (medical subject headings) terms and/or free text where relevant. RESULTS: Discordance between tuberculin skin test and ELISpot is greater in individuals who have had the bacillus Calmette-Guérin (BCG) vaccination and are taking corticosteroids. ELISpot technique using CFP-10 and ESAT-6 antigens is more sensitive than TST in detecting M. tuberculosis infection in patients taking corticosteroids. ELISpot avoids cross-reaction with BCG, making it a more specific test in this group of patients. Agreement between the tests was found to be fair (72.8% kappa value=0.38). CONCLUSION: Tuberculosis resulting from reactivation of latent tuberculosis following treatment with anti-TNF is a continuing problem. Screening reduces the risk but does not eliminate it. Further studies are needed into the cost-effectiveness and sensitivity of ELISpot and the tuberculin skin test in routine clinical practice.

Nurses are Critical in Aiding Patients Transitioning to Biosimilars in Inflammatory Bowel Disease: Education and Communication Strategies.

The increasing prevalence of inflammatory bowel disease and the high costs associated with biologic therapies suggest that biologics with lower costs, but no compromise on efficacy and safety, should be considered when developing a treatment plan for inflammatory bowel disease. Biosimilars offer a more cost-effective alternative, and although the European Medicines Agency has approved the use of biosimilars for many indications, including inflammatory bowel disease, patients may be concerned about the safety and efficacy of these agents. The updated Nurses-European Crohn's and Colitis Organisation statements, published in March 2018, recommend that inflammatory bowel disease nurses facilitate patient choice of biologic or biosimilar therapy. Nurses are pivotal in managing the challenges associated with patients transitioning to biosimilars. However, there is limited information available on how inflammatory bowel disease nurses can communicate the concept of biosimilars to patients and also on how best to support them before and during the switch from originators. This review article will focus on patients' concerns regarding biosimilars and describe considerations for nurses when supporting patients transitioning from originators to biosimilars. Through nurse-led patient education and the use of structured communication strategies, as well as investment in managed switching programmes, patients will become more confident and adherent to their biosimilar therapy, and this may lead to overall reductions in health-care expenditure for inflammatory bowel disease.

Anti-TNF biosimilars in Crohn's Disease: a patient-centric interdisciplinary approach.

Introduction: The purpose of this review is to highlight the role of biosimilars in early treatment in IBD and introduce ways to facilitate a patient-centric switching process through multidisciplinary approach. Areas covered: We summarize existing scientific literature related to the role of biosimilars in inflammatory bowel disease in terms of early treatment and cost-saving and implementing switching process. Expert opinion: Use of anti-TNF biosimilars in patients has the potential for large drug-acquisition cost-saving, which can be reinvested into early treatment. Managed switched programs for adalimumab can add further benefits in the future.

A Global Survey of Gastroenterologists' Travel Advice to Patients with Inflammatory Bowel Disease on Immunosuppressive Agents and Management of Those Visiting Tuberculosis-Endemic Areas.

BACKGROUND: With increasing use of biological therapies and immunosuppressive agents, patients with inflammatory bowel disease[IBD] have improved clinical outcome and international travel in this group is becoming common. Adequate pre-travel advice is important. We aim to determine the proportion of gastroenterologists who provided pre-travel advice, and to assess their management strategies for patients on biological therapies visiting tuberculosis[TB]-endemic areas. METHODS: A 57-question survey was distributed to IBD physicians in 23 countries. We collected physicians' demographics, and using a standardized Likert scale, assessed physicians' agreement with stated treatment choices. RESULTS: A total of 305 gastroenterologists met inclusion criteria. Overall, 52% would discuss travel-related issues: travellers' diarrhoea [TD], travel-specific vaccines, medical care and health insurance abroad, and TB. They were more likely to advise patients not to travel to TB-endemic area if on both anti-tumour necrosis factor [TNF] and azathioprine, than if on vedolizumab and azathioprine [47% vs 17.6%, p < 0.01]. More IBD physicians agreed with vedolizumab monotherapy vs anti-TNF monotherapy [29.9% vs 23%, p < 0.01]. Two-thirds would continue all IBD treatments and not cease any medications. Chest X-ray and interferon-gamma-release assay were the preferred methods to assess for active and latent TB infection. Knowledge on vaccines among IBD physicians was inadequate (survey mean [SD] scores 10.76 [±6.8]). However, they were more familiar with the societal guidelines on management of venous thromboembolism and TD (mean scores 14.9 [±5.3] and 11.9 [±3.9] respectively). CONCLUSION: Half of IBD specialists would provide pre-travel advice to IBD patients and two-thirds would advise continuing all IBD medications even when travelling to TB-endemic areas. More education on vaccinations would be particularly helpful for IBD physicians.

Travel health and pretravel preparation in the patient with inflammatory bowel disease.

BACKGROUND AND AIMS: Foreign travel for people with inflammatory bowel disease (IBD) carries an increased risk of travel-related morbidity. There is limited research looking specifically at travel-associated health risks and travel preparation in patients with IBD. The aims of this study are to explore the experience of travel, pretravel preparation undertaken by the patient with IBD and examine IBD healthcare professionals' (HCP) confidence at providing travel advice and the content of that advice. METHODS: A survey of patients with IBD attending an outpatient clinic with a separate online survey sent to IBD HCPs recruited using regional and international network databases. RESULTS: A total of 132 patients with IBD, Crohn's disease (67/132, 51%), male (60/132, 45%) and 128 HCPs (IBD nurse specialist 113, 88%; IBD physician 15, 12%) completed the questionnaires. IBD affected travel to some extent in 62% (82/132) of patients, and 64% (84/132) had experienced an IBD flare, of whom 64% still travelled overseas during this time. Only 23% (31/132) travellers sought pretravel medical advice and 40% (53/132) obtained travel insurance. Forty-eight per cent of respondents on immunomodulator therapy were unaware of the need to avoid live vaccines. Twenty-seven per cent (34/128) of IBD HCPs are not confident at providing pretravel advice; vaccination advice (54%), obtaining travel insurance (61%) and healthcare abroad (78%) are the areas of most uncertainty. CONCLUSIONS: Patients do not seek adequate pretravel advice and consultations for those who do are often deficient. The majority of IBD professionals are not confident to provide comprehensive travel advice. Greater IBD-specific travel education and awareness is needed for both patients with IBD and professionals.

Yield and cost effectiveness of mycobacterial infection detection using a simple IGRA-based protocol in UK subjects with inflammatory bowel disease suitable for anti-TNFα therapy.

BACKGROUND AND AIMS: Testing for LTBI is recommended prior to anti-TNFα agents. This includes an assessment of TB risk factors, chest radiograph, and interferon-gamma release assay alone or with concurrent Tuberculin skin testing. Here we review our experience and cost-effectiveness of using T-SPOT.TB IGRA to detect mycobacterial infection in patients with IBD suitable for anti-TNFα therapy. METHODS: This was a single-centre, retrospective review and economic evaluation (compared to British Thoracic Society guidance) of 125 adult IBD patients (90 anti-TNFα naïve, 35 established on anti-TNFα) tested for LTBI using T-SPOT.TB IGRA. RESULTS: All subjects had normal chest radiographs and no clinical evidence for TB. 109 (87%) were BCG vaccinated. 27 (22%) of all patients tested were not using immunomodulation at the time of testing. 66 (53%) were taking thiopurines, 22 (18%)corticosteroids, and 35 (28%) anti-TNFα agents. One hundred twenty two (98%) had a negative IGRA result, two (2%) had positive results, and one (1%) had an indeterminate IGRA. A strategy using IGRA to guide TB preventative treatment produced cost savings of £10.79 per person compared to the BTS guidance. Eighty eight percent of the anti-TNFα naïve group have subsequently received treatment with either infliximab or adalimumab (median follow-up of 24 months, IQR 18-30) with no cases of TB disease occurring. CONCLUSIONS: The use of a simple screening protocol for LTBI incorporating T-SPOT.TB IGRA in place of TST in a largely BCG vaccinated population, many using immunomodulatory agents, appears to work well and is a cost-effective strategy in our IBD service.

Interferon γ-release assays for detecting latent tuberculosis infection in patients scheduled for anti-TNFα therapy.

Screening for, and treatment of, latent tuberculosis infection (LTBI) before anti- tumour necrosis factor α therapy has been shown to decrease the incidence of active tuberculosis by more than 80% and is recommended before initiation of treatment. In the absence of a 'gold standard' test for LTBI, current screening involves taking a clinical history of risk factors, chest radiograph and tuberculin skin test. Alternative cellular immune-based screening tests have been developed to detect Mycobacterium tuberculosis infection. This paper summarises the current position and advances in the use of newer screening strategies for LTBI.