Search

Background: There is limited comparative data on patients with inflammatory bowel disease (IBD) switched from intravenous to subcutaneous infliximab and those continuing intravenously. This study aimed to compare the persistence and tolerance of subcutaneous and intravenous infliximab and the outcomes of patients resuming intravenous infliximab., Methods: We conducted a retrospective single-centre cohort study involving IBD patients treated with maintenance intravenous infliximab. The switch to subcutaneous infliximab was offered to patients in clinical remission receiving an intravenous dose ≤ 10 mg kg -1 every ≥ 6 weeks. The switch group was compared to controls remaining on intravenous infliximab due to refusal of the switch., Results: With a median follow-up of 59 (46-67) weeks, subcutaneous infliximab was discontinued in 28/282 (10 %) patients and intravenous infliximab in 1/78 (1 %) patient (p = 0.01); after propensity score-matching of the two cohorts, persistence rates at 52 weeks were respectively 91 % (95 % CI 84-98) and 100 % (95 % CI 100-100, p = 0.01). Among the 28 who discontinued subcutaneous infliximab, 27 resumed intravenous infliximab, with 4 (1 % of the switch group) who permanently stopped infliximab., Conclusion: Switching from intravenous to subcutaneous infliximab led to a lower treatment persistance. In cases of poor tolerance or relapse under subcutaneous infliximab, resuming intravenous infliximab is effective., (Copyright © 2024 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Introduction: The COVID-19 pandemic generated overflow of healthcare systems in several countries. As the ethical debates focused on prioritisation for access to care with scarce medical resources, numerous recommendations were created. Late 2021, the emergence of the Omicron variant whose transmissibility was identified but whose vaccine sensitivity was still unknown, reactivated debates. Fears of the need to prioritise patients arose, particularly in France. Especially, a debate began about the role of vaccination status in the prioritisation strategy., Material and Methods: The Ethics Committee (EC) of the University Hospital of Bordeaux (UHB), France, identified prioritisation criteria in the literature (some recommended, such as being a healthcare worker (HCW) or having consented to research, while others were discouraged, such as age with a threshold effect or vaccination status). A survey was sent within the institution in January 2022 to explore frontline physicians' adherence to these prioritisation criteria. The decision making conditions were also surveyed., Results: In 15 days, 78/165 (47.3%) frontline physicians responded, and more widely 1286/12946 (9.9%) professionals. A majority of frontline physicians were opposed to prioritising HCWs (54/75, 72%) and even more opposed to participating in research (69/76, 89.6%). Conversely, the results were very balanced for non-recommended criteria (respectively 39/77, 50.7% and 34/69 49.3% in favour for age with a threshold effect and for vaccination status). Decisions were considered to be multi-professional and multi-disciplinary for 65/76, 85.5% and 53/77, 68.8% of frontline physicians. Responders expressed opposition to extending decision-making to representatives of patients, civil society or HCWs not involved in care., Discussion: Prioritisation recommendations in case of scarce medical resources were not necessarily approved by the frontline physicians, or by the other HCWs. This questions the way ethical recommendations should be communicated and discussed at a local scale, but it also questions these recommendations themselves. The article also reports the experience of seeking HCWs opinions on a sensitive ethical debate in a period of crisis., Competing Interests: Declarations Ethics approval and consent to participate Participants were informed through an introductive paragraph before the questionnaire. Completion of the questionnaires was considered as a acceptance of participation (inversely, the absence of response was considered as an opposition). According French Regulation, this study is not considered as a biomedical research implying human person. This study in bioethics belongs to the field of Medical Humanities, so that it does not need the approval of an ethics committee (Articles L. 1121–1 et R. 1121–1 du Code de la Santé Publique). Likewise, informed consent is not required according to French regulations. Data were anonymised and protected according the current recommendations in France. This study was performed according to the Declaration of Helsinki. Consent for publication Non Applicable. Competing interests The authors declare no competing interests., (© 2024. The Author(s).)

Background & Aims: Breast cancer is the most common malignancy observed in patients with inflammatory bowel diseases (IBD). The aim of our study was to evaluate incident cancer rate (recurrence or new-onset cancer) in a cohort of patients with IBD with a history of breast cancer according to the subsequent IBD treatment provided., Methods: A multicenter retrospective study included consecutive patients with IBD with prior breast cancer. The inclusion date corresponded to the diagnosis of index malignancy. Follow-up lasted from cancer diagnosis until the occurrence of incident cancer., Results: Among 207 patients included (median disease duration, 13 years [interquartile range, 6-21]), first-line treatment (median interval of 28 months [interquartile range, 7-64]) was a conventional immunosuppressant in 19.3% of patients, anti-tumor necrosis factor in 19.8%, vedolizumab in 7.2%, and ustekinumab in 1.9%. After a median follow-up of 71 months (interquartile range, 34-148), 42 (20%) incident cancers were observed (34 breast cancer recurrences). Adjusted incidence rates per 1000 person-years were 10.2 (95% confidence interval, 6.0-16.4) for the untreated arm and 28.9 (95% confidence interval, 11.6-59.6) for exposed patients (P = .0519). There was no significant difference between treated patients and control subjects regarding incident cancer-free survival rates (P = .4796). In multivariable analysis, factors associated with incident cancer were stage T4d (P = .036), triple negative tumor (P = .016), and follow-up of less than 71 months (P = .005)., Conclusions: We did not find a statistically significant increase in incident breast cancer related to IBD treatment beyond the already known poor prognostic factors of breast cancer., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Immune checkpoint inhibitors (ICIs) present clinicians with the challenge of managing immune-related adverse events (irAEs), which can range from mild to severe due to immune system activation 1 . While guidelines recommend discontinuing ICIs for grade 3 partial and all grade 4 irAEs, there is growing interest in rechallenging patients based on oncological outcomes, particularly for cardiovascular and neurological irAEs where data remains scarce 1,2 . We retrospectively evaluated the safety of ICI rechallenge following grade 3-4 irAEs, specifically focusing on cardiovascular and neurological events, in patients discussed at our multidisciplinary immunotoxicity assessment board between 2019 and 2021. Fifteen patients were included, with a median time to severe irAE onset of 49 days. Among them, five patients experienced neurological adverse events (NAEs): aseptic meningitis (3), inflammatory polyradiculoneuropathy (1), and ophthalmoplegia (1), while one patient presented with myocarditis. Of the 15 patients retreated with ICIs after initial severe irAEs, 11 (73%) remained free of subsequent irAEs, two (13%) experienced recurrence of the initial irAE, and two (13%) developed new irAEs distinct from the initial event. The median time to event recurrence was 69 days, occurring no earlier than the initial severe irAE. In the subset analysis focusing on severe cardiovascular and neurological irAEs, rechallenge with ICIs was generally well tolerated. However, one patient treated with anti-PD1 experienced a relapse of grade 2 aseptic meningitis. Overall, our findings suggest that rechallenging with ICIs after severe irAEs, including those affecting the cardiovascular and neurological systems, may be safe, particularly after irAE regression and corticosteroid withdrawal., Competing Interests: EG: congress fees and investigator for BMS and MSD. RV: speakers’ bureau for BMS. SM-P: consultant on boards for BMS. AP-L: congress fees for BMS. CDu: Clinical investigation in trials, congress fees and member of boards for BMS, MSD. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Eldani, Kostine, Faure, Lazaro, Rigothier, Hiriart, Teulières, Poullenot, Haissaguerre, Zysman, Veillon, Vergnenegre, Issa, Domblides, Mary-Prey, Beylot-Barry, Pham-Ledard, Dutriaux, Sole, Duval and Gerard.)

Background: Recent data regarding the impact of biologics and new surgical techniques on the indications and outcomes of colectomy for ulcerative colitis (UC) are limited., Aims: The present study aimed at determining the trend of colectomy in UC by comparing colectomy indications and outcomes between 2000 and 2010 and 2011-2020., Methods: This observational retrospective study was conducted in two tertiary hospitals, including consecutive patients who underwent colectomy between 2000 and 2020. All data concerning UC history, treatment and surgeries were collected., Results: Among the 286 patients included, 87 underwent colectomy in 2001-2010 and 199 in 2011-2020. Patients' characteristics were similar between groups, except for prior biologic exposure (50.6 % vs. 74.9%; p<0.001). The indications of colectomy significantly decreased for refractory UC (50.6 % vs. 37.7%; p = 0.042), but were similar for acute severe UC (36.8 % vs. 42.2%; p = 0.390) and (pre)neoplastic lesions (12.6 % vs. 20.1%; p = 0.130). A widespread use of laparoscopy (47.7 % vs. 81.4%; p<0.001) was associated with fewer early complications (12.6 % vs. 5.5%; p = 0.038)., Conclusion: Over the last two decades, the proportion of surgery for refractory UC significantly decreased compared to other surgical indications while surgical outcomes improved despite larger exposure to biologics., (Copyright © 2023 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Background: Increased C-reactive protein (CRP) is used to diagnose and predict response to treatment in acute severe ulcerative colitis (UC)., Aims: To investigate the connection between CRP elevation and deep ulcers in UC., Methods: Patients with active UC were enrolled in a multicenter prospective cohort and a retrospective cohort of consecutive patients undergoing colectomy from 2012 to 2019., Results: Forty-one (9 (22%) with deep ulcers) patients were included in the prospective cohort: 4/5 (80%) patients with CRP > 100 mg/L, 2/10 (20%) patients with CRP between 30 and 100 mg/L and 3/26 (12%) patients with CRP < 30 mg/L had deep ulcers (p = 0.006). In the retrospective cohort [46 patients (31 (67%) with deep ulcers)], 14/14 (100%) patients with CRP > 100 mg/L, 11/17 (65%) patients with CRP between 30 and 100 mg/l and 6/15 (40%) patients with CRP < 30 mg/L had deep ulcers (p = 0.001). Positive predictive value of CRP > 100 mg/l for presence of deep ulcers was 80% and 100% in both cohorts, respectively., Conclusions: CRP elevation is a robust surrogate marker for presence of deep ulcers in UC. Elevated CRP or presence of deep ulcers could influence the choice of medical therapy in acute severe UC., Competing Interests: Conflict of interest PR declares consultancy fees from Abbvie, Amgen and Janssen. FP declares consultancy fees, bords or transports from Abbvie, MSD, Takeda, Ferring, Janssen, Pfizer FZ is a speaker for Janssen. DL declares counseling, boards, transports or fees from Abbvie, Biogaran, Biogen, Ferring, HAC-pharma, Janssen, MSD, Novartis, Pfizer, Prometheus, Roche, Takeda, Theradiag, Tillots. ES, ALC, AR, MM, BL, BF, BC and AB have no conflict of interest. XT declares counseling, boards, transports or fees from Abbvie, Janssen, MSD, Pfizer, Galapagos, Takeda, Tillots, Celltrion, Sandoz and participations in Thabor Therapeutics. MU declares counseling, boards, transports or fees from Abbvie, Celltrion, Fresenus Kabi, Galapagos, Janssen, Takeda. TB has received consulting fees from AbbVie, Alimentiv, Bristol Myers Squibb, Ferring, Janssen, Pfizer, Roche, Sandoz, Takeda; speaker's fees from AbbVie, Amgen, Bristol Myers Squibb, Ferring, Fresenius Kabi, Gilead, Janssen, Organon, Pendopharm, Pfizer, Sandoz, Takeda, and Viatris; research support from Janssen and Pentax., (Copyright © 2023. Published by Elsevier Ltd.)

Background: Real-life data on the efficacy of ustekinumab as first-line therapy for the treatment of luminal Crohn's disease (CD) compared with anti-tumor necrosis factor (anti-TNF) agents are lacking. We compared the clinical response rates at 3 months in 2 cohorts of biologic-naïve patients treated by ustekinumab and anti-TNF agents., Methods: Biologic-naïve patients starting either ustekinumab or an anti-TNF agent for luminal CD between 2016 and 2019 in 2 tertiary centers were retrospectively included. The primary endpoint was clinical response at 3 months, defined as a Harvey-Bradshaw Index <4 or a 3-point drop in the score without steroids, need for CD-related surgery, or treatment discontinuation owing to failure or intolerance. Patients treated with ustekinumab were matched to patients receiving anti-TNF agents by a propensity score algorithm., Results: We included 156 patients starting anti-TNF agents (95 adalimumab and 61 infliximab) and 50 ustekinumab. After matching, clinical response rates at 3 months were 64% and 86% in the ustekinumab and anti-TNF groups, respectively (P = .01). At 12 months, in multivariate analysis adjusted for disease duration, location, concomitant immunosuppressant and steroids, and symptoms, clinical remission was independently associated with the biological therapy received (odds ratio, 2.6 for anti-TNF agent vs ustekinumab; P = .02). With a median follow-up duration of 40 (interquartile range, 23-52) months, no difference was observed in terms of time to drug withdrawal (P = .29) or safety., Conclusions: This retrospective real-world data suggest that an anti-TNF agent as a first-line biological therapy is associated with higher rates of response at 3 months than ustekinumab in patients with CD., (© The Author(s) 2022. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Anti-TNFα are recommended for preventing Crohn's disease (CD) postoperative recurrence (POR) in patients with risk factors. However, few data exploring anti-TNFα efficacy in patients with preoperative anti-TNFα failure are available so far., Aims: The aim of the present study was to compare the efficacy of anti-TNFα with other biologics and immunosuppressants to prevent POR in this setting., Methods: Consecutive CD patients who underwent bowel resection between January 2010 and December 2019 after failure of at least one anti-TNFα were retrospectively included among three tertiary centers if they started a postoperative medical prophylaxis within the three months after index surgery. The main outcome was to compare rates of objective recurrence (endoscopic or radiological recurrence in absence of colonoscopy) between patients treated with an anti-TNFα agent or another treatment as prevention of POR., Results: Among the 119 patients included, 71 patients received an anti-TNFα (26 infliximab, 45 adalimumab) and 48 another treatment (18 ustekinumab, 7 vedolizumab, 20 azathioprine and 3 methotrexate) to prevent POR. Rates of objective recurrence at two years were 23.9% in patients treated with anti-TNFα and 44.9% in the others (p = 0.011)., Conclusion: Anti-TNFα remained an effective option to prevent POR for patients operated upon with previous anti-TNFα failure., (Copyright © 2022 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Background and Aims: To investigate the incidence and the severity of COVID-19 infection in patients enrolled in the database for home parenteral nutrition (HPN) for chronic intestinal failure (CIF) of the European Society for Clinical Nutrition and Metabolism (ESPEN)., Methods: Period of observation: March 1st, 2020 March 1st, 2021., Inclusion Criteria: patients included in the database since 2015 and still receiving HPN on March 1st, 2020 as well as new patients included in the database during the period of observation. Data related to the previous 12 months and recorded on March 1st 2021: 1) occurrence of COVID-19 infection since the beginning of the pandemic (yes, no, unknown); 2) infection severity (asymptomatic; mild, no-hospitalization; moderate, hospitalization no-ICU; severe, hospitalization in ICU); 3) vaccinated against COVID-19 (yes, no, unknown); 4) patient outcome on March 1st 2021: still on HPN, weaned off HPN, deceased, lost to follow up., Results: Sixty-eight centres from 23 countries included 4680 patients. Data on COVID-19 were available for 55.1% of patients. The cumulative incidence of infection was 9.6% in the total group and ranged from 0% to 21.9% in the cohorts of individual countries. Infection severity was reported as: asymptomatic 26.7%, mild 32.0%, moderate 36.0%, severe 5.3%. Vaccination status was unknown in 62.0% of patients, non-vaccinated 25.2%, vaccinated 12.8%. Patient outcome was reported as: still on HPN 78.6%, weaned off HPN 10.6%, deceased 9.7%, lost to follow up 1.1%. A higher incidence of infection (p = 0.04), greater severity of infection (p < 0.001) and a lower vaccination percentage (p = 0.01) were observed in deceased patients. In COVID-19 infected patients, deaths due to infection accounted for 42.8% of total deaths., Conclusions: In patients on HPN for CIF, the incidence of COVID-19 infection differed greatly among countries. Although the majority of cases were reported to be asymptomatic or have mild symptoms only, COVID-19 was reported to be fatal in a significant proportion of infected patients. Lack of vaccination was associated with a higher risk of death., Competing Interests: Conflict of interest statements LP: Participation on a Data Safety Monitoring Board or Advisory Board for Takeda, Consulting fees for Takeda, Northsea, NAPO. SL: Participation on a Data Safety Monitoring Board or Advisory Board for Baxter, Takeda, NorthSea, VectivBio; Grants or contracts from any entity for Baxter, Takeda; Consulting fees for VectivBio, Takeda, Northsea; Support for attending meetings and/or travel for Takeda; Payment or honoraria for lectures for Takeda, Fresenius. PG: none. LS: none. PO: none. NW: none. RT: Royalties or licenses for Royalties for designing the Simple Evaluation of Food Intake® (SEFI®) (Knoë, le Kremlin Bicêtre, France); Consulting fees for Nestlé Health Science; Payment or honoraria for lectures for Baxter, BBraun, Fresenius-Kabi, Nutricia; Support for attending meetings for Nutricia, NHC. PS: none. LE: none. PO: none. L D’A: none. AT: none. ND: Leadership of Pediatric Nutrition Association of Thailand Society of Parenteral Enteral Nutrition of Thailand. ASZ: Payment or honoraria for lectures for Siegfried; Consulting for Takeda; Support for attending meetings for Abbott and Nestlè. MF: Payment or honoraria for lectures for Fresenius Kabi, B Braun, Baxter. GV: none. MIS: none. MT: none. ERB: none. NVC: Payment or honoraria for lectures for Takeda, Nutricia; Payment for expert testimony, Support for attending meetings and Participation on a Data Safety Monitoring Board for Takeda. AL: Consulting fees, Support for attending meetings, Participation on a Data Safety Monitoring Board or Advisory Board for Nestlè; Participation on a Data Safety Monitoring Board or Advisory Board for Takeda; Payment or honoraria for lectures for baxter. LC: none. MA: none. EO: none. AGM: none. AVG: none. VP: honoraria for lectures for Thai Otsuka Pharmaceutical Co., Ltd., Abbott Laboratories Ltd., Nestle (Thai) Ltd., Fresenius Medical Care (Thailand) Ltd., Baxter Healthcare (Thailand) Co., Ltd., Mega Lifesciences PTY Ltd., Novo Nordisk Thailand. MSM: Grants or contracts from any entity for Fresenius Kabi, Nestle, Realfood Blends, VectivBio, Rockfield, Zealand; Consulting fees, Northsea; Participation on a Data Safety Monitoring Board for EndoBarrier. M D-S: none. TV: Grants or contracts from any entity for Vectiv Bio, Takeda; Consulting fees for Vectiv Bio, Zealand Pharma, Takeda, Baxter, Hamni, NorthSea Therapeutics; Payment or honoraria for lectures for Vectiv Bio, Takeda, Baxter; Support for attending meetings for Takeda, Vectiv Bio, Zealand Pharma, Fresenius Kabi; Receipt of equipment, materials, drugs for VectivBio. ZK: Support for attending meetings for Abbott, Fresenius, Nutricia, Nestle, Takeda; Leadership for Croatian Medical Association- The President. FP: none. LM: none. LCE: Consulting fees, Payment or honoraria for lecture and Support for attending meetings for Takeda. UA: Payment or honoraria for lectures for Takeda, Baxter; Support for attending meetings and Participation on a Data Safety Monitoring for Takeda. MK: none. MMJ: none. AC: none. DW: none. GO: none. CC: none. JS: Grants or contracts from any entity and for BBraun, FreseniusKabi, Nestle; Payment or honoraria for lectures for BBraun, OlimpLabs, FreseniusKabi, Baxter, Nestle; Support for attending meetings for FreseniusKabi. FWG: none. CS: none. MBD: none. DS: none. SL: none. SK: Payment or honoraria for lectures, for Abbott, Abela Farm, Danone/Nutricia, Fresenius, GM Pharma, Nestle, Nestle Nutrition Institute, Oktal Pharma, Shire/Takeda; Non-restricted grant delivered to the hospital from BioGaia. BC: none. GM: none. MHMdC: Grants or contracts, Consulting fees, Payment or honoraria, Support for attending meetings, Participation on a Data Safety Monitoring for lectures for Takeda Pharmaceutical Brazil. EPJ: none. FJ: none. DJ: none. GL: none. AZM: none. MT: none. DZ: none. MK: Payment or honoraria for manuscript writing and educational events for Nutricia, FreseniusKabi. ASS: none. GB: none., (Copyright © 2023 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd. All rights reserved.)

Crohn's disease (CD) is associated with an increased risk of small bowel neoplasia (SBN). We aimed to assess preoperative predictors of SBN in CD patients. We conducted a retrospective case-control study including CD patients who underwent surgery: cases were diagnosed with SBN on histopathological analysis and controls had no neoplasia. Preoperative cross-sectional imaging was reviewed by a panel of blinded expert radiologists. Fifty cases were matched to one hundred and fifty consecutive controls. In multivariable analysis, predictors of SBN were age ≥ 50 years (OR = 28, 95% CI = 5.05-206), median CD duration ≥ 17.5 years (OR = 4.25, 95% CI = 1.33-14.3), and surgery for stricture (OR = 5.84, 95% CI = 1.27-35.4). The predictors of small bowel adenocarcinoma were age ≥ 50 years (OR = 5.14, 95% CI = 2.12-12.7), CD duration ≥ 15 years (OR = 5.65, 95% CI = 2.33-14.3), and digestive wall thickening > 8 mm (OR = 3.79, 95% CI = 1.45-11.3). A predictive score based on the aforementioned factors was constructed. Almost 73.7% of patients with a high score had SBA. Old age, long small bowel CD duration, and stricture predicted the presence of SBN, particularly adenocarcinoma when patients have digestive wall thickening > 8 mm on preoperative imaging.

Immunomodulators, conventional immunosuppressants, and/or biologics are used more often, earlier, and longer than before in patients with inflammatory bowel disease (IBD). Along with this, the lifetime risk for cancer is estimated to be 33% in the general population in Europe. Thus, physicians face therapeutic choices in an increasing number of IBD patients with current or past malignancy. Few data are available so far for managing this IBD subpopulation and this clinical concern still remains a critical situation for four reasons: (i) risk of reactivation of dormant micrometastasis with immunomodulators is of major concern, (ii) there is a knowledge gap about the safety of the most recent molecules, (iii) current guidelines do not recommend the use of immunomodulators within 2-5 years after a diagnosis of cancer, (iv) patients with previous cancers are excluded from clinical trials. There is a lack of scientific evidence supporting the non-use of immunomodulators in IBD patients with previous cancer. Indeed, accumulative data suggest that the risk for recurrent and new cancer in patients with a history of cancer is not increased by thiopurines and anti-TNF agents. Most recently, cohort studies have found no differences in incident cancer rates in IBD patients with prior malignancy treated with vedolizumab or ustekinumab compared to those treated with anti-TNF agents. Therefore, decisions should be shared by the oncologist and the patient, considering the natural history of cancer, the time elapsed since cancer diagnosis, and IBD prognosis.

Introduction: Knowledge about the cancer risk when initiating a biologic in inflammatory bowel disease [IBD] patients with prior malignancy remains scarce, especially for vedolizumab. Our aim was to evaluate the rate of incident cancer in a cohort of IBD patients with prior non-digestive malignancy, according to the subsequent treatment given., Methods: A multicentre retrospective study included consecutive IBD patients with prior non-digestive malignancy. Inclusion date corresponded to the diagnosis of index malignancy. Patients were categorized into different cohorts according to the first treatment [none, conventional immunosuppressant, anti-TNF, or vedolizumab] to which they were exposed after inclusion and before incident cancer [recurrent or new cancer]., Results: Among the 538 patients {58% female; mean (standard deviation [SD]) age inclusion: 52 [15] years} analyzed, the most frequent malignancy was breast cancer [25%]. The first immunomodulator given after inclusion was a conventional immunosuppressant in 27% of patients, anti-TNF in 21%, or vedolizumab in 9%. With a median (interquartile range [IQR]) follow-up duration of 55 [23-100] months, 100 incident cancers were observed. Crude cancer incidence rates per 1000 person-years were 47.0 for patients receiving no immunomodulator, 36.6 in the anti-TNF cohort, and 33.6 in the vedolizumab cohort [p = 0.23]. Incident-cancer free survival rates were not different between patients receiving anti-TNF and those receiving vedolizumab [p = 0.56]. After adjustment, incidence rates were not different between patients receiving no immunomodulator, anti-TNF, or vedolizumab., Conclusions: In this large multicentre cohort study, there was no difference of cancer incidence in those IBD patients with prior non-digestive malignancy, treated with vedolizumab or anti-TNF., (© 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: Home parenteral nutrition (HPN) is the recommended treatment in patients with chronic intestinal failure (CIF). HPN is associated with a worsening of patients' quality of life and has a dramatic impact on personal and familial daily life. Little is known about the informal caregiver burden of patients receiving HPN., Aim: To assess informal caregiver burden and the factors associated with moderate-to-severe caregiver burden in patients treated with HPN., Methods: Informal caregivers of consecutive patients treated with HPN in a French nutrition referral center were invited to participate in a survey between January 2021 and June 2021. They had to fill out an anonymous standardized self-questionnaire evaluating burden by the Zarit Burden Interview (ZBI) and depression and anxiety symptoms by the Hospital Anxiety and Depression Scale (HADS) score since HPN introduction., Results: Among the 87 HPN patients having informal caregivers, 53 (61%) completed the questionnaire. Thirty (57%) informal caregivers were women. The caregiver's median age was 62 years (IQR, 21.0). Twelve (22%) expressed moderate to severe burden (ZBI score, 41-88). In a multivariate analysis, the caregiver's male gender (odds ratio [OR], 16.45; 95% CI, 2.30-238.75; P = 0.014) and the number of simultaneous infusions per day >1 (OR, 9.92; 95% CI, 1.35-121.60; P = 0.0038) were associated with a moderate to severe burden. Twenty caregivers reported anxious and depressive symptoms with an elevated HADS score., Conclusion: In this prospective survey, a minority of informal caregivers of patients with CIF being treated with HPN expressed moderate to severe burden. The caregiver's male gender was associated with a higher burden in patients with CIF., (© 2022 American Society for Parenteral and Enteral Nutrition.)

Background and Aims: There is no consensus on the management of immune checkpoint inhibitor (ICI) for treating cancer in patients with pre-existing inflammatory bowel disease (IBD). The Groupe d'Étude Thérapeutique des Affections Inflammatoires du tube Digestif (GETAID) aimed to provide recommendations on this topic., Methods: A dedicated working group performed a comprehensive expert-based review of the literature, generated clinical key question and shaped recommendations that were further voted for approval by the educational and scientific committees of the GETAID. Using consensus methods, treatment modalities were defined by vote., Results: Majority of patients with IBD in clinical remission can be treated with ICI after cancer diagnosis. The rate of relapse or immune-related diarrhoea or colitis upon ICI treatment is up to 39.8% and is maximal with ICI combination therapy compared to monotherapies. When starting ICI in a patient with IBD, it is recommended to assess disease activity and pursue ongoing maintenance therapy. In case of relapse or immune-related diarrhoea or colitis upon ICI treatment, treatment depends on grading of diarrhoea or colitis and may include corticosteroid therapy, infliximab and/or vedolizumab., Conclusions: In the present publication, we provided recommendations, which may assist gastroenterologists, haematologists, and oncologists for a better management of patients with pre-existing IBD before and during cancer treatment with ICI., Competing Interests: Conflict of interest Aurelien Amiot has received consulting fees from Abbvie, Hospira, Takeda, Gilead and Biocodex as well as lecture fees and travel accommodations from Abbvie, Janssen, Biocodex, Hospira, Ferring, Takeda and MSD. This author has also received advisory board fees from Gilead, Takeda and Abbvie. David Laharie declares counselling, boards, transports, or personal fees from Abbvie, Biogaran, Biogen, Celgene, Celltrion, Ferring, Galapagos, HAC-pharma, Janssen, MSD, Novartis, Pfizer, Prometheus, Roche, Takeda, Theradiag, Tillots. Georgia Malamut declares consulting fees from Calypso, lecture fees from Janssen and Mayoli Spindler and congress registration fees from Janssen and Amgen Melanie Serrero has received lecture or consulting fees from Abbvie, Ferring, Amgen, Celltrion, Janssen, Ferring, Takeda and Tillotts. Florian Poullenot declares counselling, boards, transports, or personal fees from Abbvie, Biogen, Ferring, Janssen, MSD, Pfizer, Takeda. No conflicts of interest are claimed by the remaining authors., (Copyright © 2022 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Although central venous catheter (CVC)-related thrombosis (CRT) is a severe complication of home parenteral nutrition (HPN), the amount and quality of data in the diagnosis and management of CRT remain low. We aimed to describe current practices regarding CVC management in French adult and pediatric HPN centers, with a focus on CVC obstruction and CRT. Current practices regarding CVC management in patients on HPN were collected by an online-based cross-sectional survey sent to expert physicians of French HPN centers. We compared these practices to published guidelines and searched for differences between pediatric and adult HPN centers' practices. Finally, we examined the heterogeneity of practices in both pediatric and adult HPN centers. The survey was completed by 34 centers, including 21 pediatric and 13 adult centers. We found a considerable heterogeneity, especially in the responses of pediatric centers. On some points, the centers' responses differed from the current guidelines. We also found significant differences between practices in adult and pediatric centers. We conclude that the management of CVC and CRT in patients on HPN is a serious and complex situation for which there is significant heterogeneity between HPN centers. These findings highlight the need for more well-designed clinical trials in this field.

Introduction: Patients treated with biologics for inflammatory bowel disease (IBD) have an increased risk of severe infections. Real-life vaccination coverage in this population remains low despite international vaccination guidelines. The aim of this study was to evaluate the impact of a dedicated vaccination visit on vaccination coverage., Methods: A dedicated vaccination visit was offered to all patients admitted for an infusion of a biologic in a tertiary IBD center during a 4-week period. At baseline, vaccination status was collected. Patients received specific information on recommended vaccinations. Perceived utility of both vaccination and the dedicated visit were assessed by visual analogue scale (VAS). Vaccination coverage was reassessed 6 months later by phone call., Results: Among the 207 patients analyzed (1 patient declined), rates of vaccination at baseline and 6 months later against diphtheria were 52.7% and 68.6% ( p  < 0.001), tetanus 55.1% and 70% ( p  < 0.001), poliomyelitis 51.7% and 68.6% ( p  < 0.001), pertussis 33.3% and 51.2% ( p  < 0.001), hepatitis B virus (HBV) 61.4% and 66.7% ( p  < 0.01), pneumococcus 15.5% and 42.0% ( p  < 0.001), influenza 29.5% and 36.2% ( p  < 0.01), and meningococcus C 11.6% and 13.0% ( p  = 0.083), respectively. A quarter of the patients declined at least one recommended vaccination after the visit. The main reason for this refusal was distrust toward one or more vaccines., Conclusion: A single visit dedicated to vaccination significantly increases rates of vaccination in patients with IBD treated with biologics., Competing Interests: Conflict of interest statement: The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: G.L.C. and L.G. have no conflict of interest. P.R. declares consultancy fees from Amgen and Janssen. A.B. has no conflict of interest. F.Z. speaker for Janssen. D.L. declares counseling, boards or transport fees from AbbVie, Biogaran, Biogen, Celltrion, Ferring, Fresenius-Kabi, Janssen, MSD, Novartis, Pfizer, Roche, Sandoz, Takeda, Theradiag, and Tillots-Pharma. F.P. declares fees from AbbVie, MSD, Takeda, Ferring, Janssen, and Pfizer., (© The Author(s), 2022.)

The quality of life (QOL) of patients with celiac disease (CD) can be altered by both symptoms of the disease and by the restrictions of the gluten-free diet (GFD). The objective was to determine the factors associated with better QOL in a large cohort of CD patients. A link to an online survey was sent to the members of the French Association of Gluten Intolerant People (AFDIAG). The French-Celiac Disease Questionnaire (F-CDQ), scoring from 0 to 100, was used to measure the QOL. Other data collected were sociodemographic characteristics, information on CD, purchasing and consumption habits of gluten-free products, and a self-assessment scale (ranging from 0 to 10) to determine the compliance with the GFD. Among the 907 CD patients who returned the questionnaire, 787 were analyzed (638 women (81%); median age: 49 years; 71% with self-assessed GFD compliance > 8). Their median F-CDQ was 73 (range: 59−82). In multivariate analysis, the main factors associated with a better quality of life were the long duration of the GFD, good compliance with the GFD, and the number of follow-up visits. Compliance with and duration of the GFD are associated with a better quality of life in patients with CD. Taking this into consideration would offset its restrictive aspect and improve its adherence.

Immunotherapy with immune checkpoint inhibitors (ICIs) has improved the prognosis of many cancers; a combination of nivolumab (anti-programmed cell death protein 1) and ipilimumab (anti-cytotoxic T-lymphocyte-associated protein 4) is approved as first-line therapy for advanced melanoma, with objective responses obtained in more than half of patients. However, this combination is associated with a high rate of immune-related adverse events, which are often severe and multiple. Neurological immune-related adverse events are rare but feared because they can be life-threatening, their diagnosis and management are challenging, and patients can have irreversible sequelae. We reported a case of a young patient treated by nivolumab and ipilimumab combination for metastatic melanoma. Severe dysphagia with regurgitations, major weight loss, uveitis, and vitiligo occurred after 3 infusions of nivolumab and ipilimumab. Magnetic resonance imaging and positron emission tomography scan showed complete remission of melanoma. The endoscopic examination did not find any digestive toxicity. Esophageal manometry revealed achalasia. This was associated with mydriasis, pathologic deep breath test, and alteration of the cutaneous sympathetic response on electromyogram, which was consistent with autonomic neuropathy. This rare etiology of atypical vomiting under ICI should be known by prescribers, as ICI prescription is widening in many new cancers., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Background and Aims: The case-mix of patients with intestinal failure due to short bowel syndrome (SBS-IF) can differ among centres and may also be affected by the timeframe of data collection. Therefore, the ESPEN international multicenter cross-sectional survey was analyzed to compare the characteristics of SBS-IF cohorts collected within the same timeframe in different countries., Methods: The study included 1880 adult SBS-IF patients collected in 2015 by 65 centres from 22 countries. The demographic, nutritional, SBS type (end jejunostomy, SBS-J; jejuno-colic anastomosis, SBS-JC; jejunoileal anastomosis with an intact colon and ileocecal valve, SBS-JIC), underlying disease and intravenous supplementation (IVS) characteristics were analyzed. IVS was classified as fluid and electrolyte alone (FE) or parenteral nutrition admixture (PN). The mean daily IVS volume, calculated on a weekly basis, was categorized as <1, 1-2, 2-3 and >3 L/day., Results: In the entire group: 60.7% were females and SBS-J comprised 60% of cases, while mesenteric ischaemia (MI) and Crohn' disease (CD) were the main underlying diseases. IVS dependency was longer than 3 years in around 50% of cases; IVS was infused ≥5 days/week in 75% and FE in 10% of cases. Within the SBS-IF cohort: CD was twice and thrice more frequent in SBS-J than SBS-JC and SBS-JIC, respectively, while MI was more frequent in SBS-JC and SBS-JIC. Within countries: SBS-J represented 75% or more of patients in UK and Denmark and 50-60% in the other countries, except Poland where SBS-JC prevailed. CD was the main underlying disease in UK, USA, Denmark and The Netherlands, while MI prevailed in France, Italy and Poland., Conclusions: SBS-IF type is primarily determined by the underlying disease, with significant variation between countries. These novel data will be useful for planning and managing both clinical activity and research studies on SBS., Competing Interests: Declaration of competing interest None declared., (Copyright © 2021 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd. All rights reserved.)

Introduction: While endoscopic balloon dilation (EBD) is widely used to manage ileal strictures, EBD of colorectal strictures remains poorly investigated in Crohn's disease (CD)., Methods: We performed a retrospective study that included all consecutive CD patients who underwent EBD for native or anastomotic colorectal strictures in 9 tertiary centers between 1999 and 2018. Factors associated with EBD failure were also investigated by logistic regression., Results: Fifty-seven patients (25 women, median age: 36 years (InterQuartile Range, 31-48) were included. Among the 60 strictures, 52 (87%) were native, 39 (65%) measured < 5 cm and the most frequent location was the left colon (27%). Fifty-seven (95%) were non-passable by the scope and 35 (58%) were ulcerated. Among the 161 EBDs performed (median number of dilations per stricture: 2, IQR 1-3), technical and clinical success were achieved for 79% (n = 116/147) and 77% (n = 88/115), respectively. One perforation occurred (0.6% per EDB and 2% per patient). After a median follow-up of 4.3 years (IQR 2.0-8.4), 24 patients (42%) underwent colonic resection and 24 (42%) were asymptomatic without surgery. One colon lymphoma and one colorectal cancer were diagnosed (3.5% of patients) from endoscopic biopsies and at the time of surgery, respectively. No factor was associated with technical or clinical success., Conclusion: EDB of CD-associated colorectal strictures is feasible, efficient and safe, with more than 40% becoming asymptomatic without surgery., (Copyright © 2020. Published by Elsevier Masson SAS.)

Immune checkpoint inhibitors have been approved as adjuvant therapy. Adverse immune events occurred during the administration of treatment, and delayed immune-related events have low incidence. A 66-year-old man was treated for hypopharynx cancer in 2012. In 2019, he was treated for a new oropharynx cancer. After undergoing surgery and complete response, the patient received nivolumab as adjuvant treatment. 5 months after the last dose of nivolumab, he presented with grade III diarrhea and abdominal pain for 3 weeks. Rectoscopy showed infiltration of mucous by lymphocytes. Corticosteroid was started resulting in a rapid decrease in symptom severity. With the increasing immune checkpoint inhibitors in adjuvant therapy, strict surveillance and education of patient in remission is necessary.

Background and Aim: No marker to categorise the severity of chronic intestinal failure (CIF) has been developed. A 1-year international survey was carried out to investigate whether the European Society for Clinical Nutrition and Metabolism clinical classification of CIF, based on the type and volume of the intravenous supplementation (IVS), could be an indicator of CIF severity., Methods: At baseline, participating home parenteral nutrition (HPN) centres enrolled all adults with ongoing CIF due to non-malignant disease; demographic data, body mass index, CIF mechanism, underlying disease, HPN duration and IVS category were recorded for each patient. The type of IVS was classified as fluid and electrolyte alone (FE) or parenteral nutrition admixture (PN). The mean daily IVS volume, calculated on a weekly basis, was categorised as <1, 1-2, 2-3 and >3 L/day. The severity of CIF was determined by patient outcome (still on HPN, weaned from HPN, deceased) and the occurrence of major HPN/CIF-related complications: intestinal failure-associated liver disease (IFALD), catheter-related venous thrombosis and catheter-related bloodstream infection (CRBSI)., Results: Fifty-one HPN centres included 2194 patients. The analysis showed that both IVS type and volume were independently associated with the odds of weaning from HPN (significantly higher for PN <1 L/day than for FE and all PN >1 L/day), patients' death (lower for FE, p=0.079), presence of IFALD cholestasis/liver failure and occurrence of CRBSI (significantly higher for PN 2-3 and PN >3 L/day)., Conclusions: The type and volume of IVS required by patients with CIF could be indicators to categorise the severity of CIF in both clinical practice and research protocols., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: The approved maintenance regimens for ustekinumab in Crohn's disease (CD) are 90 mg every 8 or 12 weeks. Some patients will partially respond to ustekinumab or will experience a secondary loss of response. It remains poorly known if these patients may benefit from shortening the interval between injections., Methods: All patients with active CD, as defined by Harvey-Bradshaw score ≥ 4 and one objective sign of inflammation (CRP > 5 mg/L and/or fecal calprotectin > 250 µg/g and/or radiologic and/or endoscopic evidence of disease activity) who required ustekinumab dose escalation to 90mg every 4 weeks for loss of response or incomplete response to ustekinumab 90mg every 8 weeks were included in this retrospective multicenter cohort study., Results: One hundred patients, with a median age of 35 years (Interquartile Range (IQR), 28 - 49) and median disease duration of 12 (7 - 20) years were included. Dose intensification was performed after a median of 5.0 (2.8 - 9.0) months of ustekinumab treatment and was associated with corticosteroids and immunosuppressants in respectively 29% and 27% of cases. Short-term clinical response and clinical remission were observed in respectively 61% and 31% after a median of 2.4 (1.3 - 3.0) months. After a median follow-up of 8.2 (5.6-12.4) months, 61% of patients were still treated with ustekinumab, and 26% in steroid-free clinical remission. Among the 39 patients with colonoscopy during follow-up, 14 achieved endoscopic remission (no ulcers). At the end of follow-up, 27% of patients were hospitalized, and 19% underwent intestinal resection surgery. Adverse events were reported in 12% of patients, including five serious adverse events., Conclusion: In this multicenter study, two-thirds of patients recaptured response following treatment intensification with ustekinumab 90 mg every 4 weeks., (© The Author(s) 2020. 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 & Aims: Teduglutide, a GLP-2-analog, has proven effective in two placebo-controlled studies in reducing parenteral support (PS) in patients with short bowel syndrome-associated intestinal failure (SBS-IF) after 24 weeks. The aim of this study was to describe in a real-life situation the effects of teduglutide treatment and their predictive factors., Methods: We included 54 consecutive SBS-IF patients treated with teduglutide in France for at least 6 months from 10 expert centers. Small bowel length was 62 ± 6 cm and 65% had colon in continuity. PS was 4.4 ±0 .2 infusions per week, started 9.8 ± 1.2 years before. Response (PS reduction ≥ 20%) and PS discontinuation rates were assessed at week 24. Adjusted p values of factors associated with response and weaning were calculated using a multivariate logistic regression model., Results: At week 24, 85% of patients were responders and 24% had been weaned off PS, with a 51% reduction of PS needs and 1.5 ± 0.2 days off PS per week. Response to teduglutide was influenced by a higher baseline oral intake (p = 0.02). Weaning off PS was influenced by the presence of colon (p = 0.04), a lower PS volume (p = 0.03) and a higher oral intake (p = 0.01). There were no differences based on age, bowel length or SBS-IF causes., Conclusions: Our study confirms the effectiveness of teduglutide in reducing PS needs in SBS-IF patients. We associated reduced parenteral support volume with baseline parenteral volume support, bowel anatomy, and oral intake. These findings underline the role of nutritional optimization when starting the treatment., (Copyright © 2019 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.)

Background: Despite an optimal medico-surgical management of perineal Crohn's disease (PCD), fistula relapse still occurs in 30% of patients. Our aim was to determine predictors of fistula relapse in patients in remission after treatment of a PCD lesion., Methods: Consecutive patients treated for fistulizing PCD have been included in a retrospective study when they achieved fistula remission within 3 months after the surgery. Remission was defined as the absence of any draining fistula at clinical examination. Primary outcome was the occurrence of a fistula relapse, defined as a subsequent perianal draining fistula or an abscess confirmed clinically and/or by pelvic MRI., Results: One hundred and thirty-seven patients (57% female, median age: 35 years) corresponding to 157 abscess events, including 120 (76.4%) treated by anti-TNF after drainage, achieved fistula remission after surgery. During the follow-up period (median duration: 43 months [interquartile range 26 to 64]), 34 (22%) patients experienced a fistula relapse within a median time of 1.8 years. Survival without fistula was 96.7% at 1 year, 78.4% at 3 years, and 74.4% at 5 years. Fistula relapse rates were not different in patients receiving infliximab or adalimumab (P = 0.66). In patients treated by anti-TNF at inclusion, discontinuation of anti-TNF therapy (odds ratio 3.49, P = 0.04), colonic location (OR 6.25, P = 0.01), and stricturing phenotype (odds ratio 4.39, P = 0.01) were independently associated with fistula relapse in multivariate analysis., Conclusion: In patients achieving fistula remission of PCD, relapse rates are low and are not different between infliximab and adalimumab. Discontinuation of anti-TNF therapy is associated with increased relapse rate., (© 2019 Crohn’s & Colitis Foundation. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: According to infliximab (IFX) license in Crohn's disease (CD), infusion doses are based on patient's body-weight. Dose banding providing standardized doses (SD) has been implemented in parenteral chemotherapy in order to optimize aseptic unit capacity and reduce drug expenditure, duration of hospital stay and costs without decreasing efficacy., Material and Method: The first part was a single-center retrospective analysis of consecutive CD patients receiving IFX maintenance therapy to determine standardized doses covering more than 50% of infusions. The second part was a prospective cohort study assessing the impact of SD compared to body-weight doses (BWD) on admission duration and costs., Results: Six IFX SD covering more than 90% of infusion doses were implemented for dose banding. According to the Monte-Carlo simulation, there was no significant difference between IFX SD and BWD maintenance regimens. When assessed prospectively in 116 patients (75 patients treated with SD and 41 with BWD) corresponding to 128 infusions, hospitalization duration was shortened by 70 min per patient (p < 0.001)., Conclusion: According to a pharmacokinetic model, IFX SD has a pharmacokinetic profile close to BWD and is associated with reduced length of hospitalization in a cohort of patients with CD. IFX SD implementation could optimize infusion units functioning and, save time and costs without decreasing efficacy., (Copyright © 2019 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Background & Aims: It is a challenge to manage patients with ulcerative proctitis (UP) refractory to standard therapy. We investigated the effectiveness of tumor necrosis factor (TNF) antagonists in a large cohort of patients with refractory UP., Methods: We conducted a nationwide retrospective cohort study of 104 consecutive patients with active UP refractory to conventional therapies, treated at 1 of 15 centers in France or 1 center in Belgium (the GETAID cohort). Patients received at least 1 injection of anti-TNF (infliximab, adalimumab, golimumab) from October 2006 through February 2017. Clinical response was defined as significant improvement in UC-related symptoms, and remission as complete disappearance of UC-related symptoms, each determined by treating physicians. We collected demographic, clinical, and treatment data. The median duration of follow-up was 24 months (interquartile range, 13-51 months). The primary outcome was clinical response of UP to anti-TNF treatment., Results: Overall, 80 patients (77%) had a clinical response to anti-TNF therapy and 52 patients (50%) achieved clinical remission. Extra-intestinal manifestations (odds ratio OR, 0.24; 95% CI, 0.08-0.7), ongoing treatment with topical steroids (OR, 0.14; 95% CI, 0.03-0.73), and ongoing treatment with topical 5-aminosalycilates (OR, 0.21; 95% CI, 0.07-0.62) were significantly associated with the absence of clinical remission. Sixty percent (38/63) of the patients who had endoscopic assessment during follow up had mucosal healing. Among the overall population (n = 104), the cumulative probabilities of sustained clinical remission were 87.6% ± 3.4% at 1 year and 74.7% ± 4.8% at 2 years., Conclusions: In a retrospective study of 104 patients with refractory UP, anti-TNF therapy induced clinical remission in 50% and mucosal healing in 60%. About two thirds of the patients were still receiving anti-TNF therapy at 2 years., (Copyright © 2020 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Background & Aims: The safety and effectiveness of a home parenteral nutrition (HPN) program depends both on the expertise and the management approach of the HPN center. We aimed to evaluate both the approaches of different international HPN-centers in their provision of HPN and the types of intravenous supplementation (IVS)-admixtures prescribed to patients with chronic intestinal failure (CIF)., Methods: In March 2015, 65 centers from 22 countries enrolled 3239 patients (benign disease 90.1%, malignant disease 9.9%), recording the patient, CIF and HPN characteristics in a structured database. The HPN-provider was categorized as health care system local pharmacy (LP) or independent home care company (HCC). The IVS-admixture was categorized as fluids and electrolytes alone (FE) or parenteral nutrition, either commercially premixed (PA) or customized to the individual patient (CA), alone or plus extra FE (PAFE or CAFE). Doctors of HPN centers were responsible for the IVS prescriptions., Results: HCC (66%) was the most common HPN provider, with no difference noted between benign-CIF and malignant-CIF. LP was the main modality in 11 countries; HCC prevailed in 4 European countries: Israel, USA, South America and Oceania (p < 0.001). IVS-admixture comprised: FE 10%, PA 17%, PAFE 17%, CA 38%, CAFE 18%. PA and PAFE prevailed in malignant-CIF while CA and CAFE use was greater in benign-CIF (p < 0.001). PA + PAFE prevailed in those countries where LP was the main HPN-provider and CA + CAFE prevailed where the main HPN-provider was HCC (p < 0.001)., Conclusions: This is the first study to demonstrate that HPN provision and the IVS-admixture differ greatly among countries, among HPN centers and between benign-CIF and cancer-CIF. As both HPN provider and IVS-admixture types may play a role in the safety and effectiveness of HPN therapy, criteria to homogenize HPN programs are needed so that patients can have equal access to optimal CIF care., (Copyright © 2019 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.)

Introduction: Erectile dysfunction (ED) is common in patients with chronic diseases. It is evaluated using the International Index of Erectile Function (IIEF5) questionnaire. The relationship between ED and cirrhosis is complex. The aims of our study were (1) to assess the prevalence of ED in cirrhosis and (2) to evaluate factors associated with ED, with a special focus on minimal hepatic encephalopathy (MHE)., Methods: We performed a prospective, observational study. Patients with cirrhosis were invited to complete the IIEF5 questionnaire. The exclusion criteria were clinical hepatic encephalopathy (HE) and dementia. MHE was evaluated by the psychometric hepatic encephalopathy test score (PHES) and the critical flicker frequency (CFF)., Results: Between April 2016 and April 2017, 87 patients were included (age: 55 [51-57] years, Child-Pugh score: 8 [7-9], MELD score: 13 [11-16]. Minimal HE was diagnosed in 33% of the patients according to the PHES and in 44% of the patients according to the CFF. ED was diagnosed in 74/87 patients (85%) when compared to 12.5% in healthy controls (p < 0.001). In a multivariate analysis, the independent factors associated with ED were age, Child-Pugh and MELD scores. Significant correlations were identified between the IIEF5 and each component of the PHES., Conclusion: ED should be systematically screened in cirrhotics, especially in patients with MHE., (Copyright © 2019 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Background: Proactive therapeutic drug monitoring (TDM) to titrate tumor necrosis factor (TNF) antagonists has emerged recently as a tool to routinely monitor drug concentration to achieve target levels in patients with quiescent inflammatory bowel disease (IBD)., Methods: The purpose of the present review article was to present available data exploring the concept of proactive TDM., Results: While several observational studies have identified an association between proactive TDM and better IBD outcomes, 2 randomized controlled studies did not confirm this advantage., Conclusions: Based on the evidence to date, proactive TDM cannot be recommended in daily practice. However, analysis is hampered by the low level of evidence for the cutoffs used and the need for point-of-care assays. Regarding economic issues and de-escalating strategies, proactive TDM may have several future indications in IBD. Exploratory studies on proactive TDM with newly available biologic agents in IBD are also awaited., (© 2018 Crohn’s & Colitis Foundation. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Aim: Inflammatory bowel diseases (IBD) are associated with an increased risk for colorectal cancer (CRC). However and despite significant advances in the management of IBD and CRC, the prognosis of IBD-related CRC (IBD-CRC) remains controversial. The aim of the present case-control study was to compare the prognosis of IBD-CRC to sporadic CRC., Methods: Consecutive patients operated for IBD-CRC from 2004 to 2014 were recruited and matched with sporadic CRC (ratio 3:1) from the same center. Matching was performed on gender, tumor stage, and location and period of surgery. Endpoints were postoperative morbidity (Dindo-Clavien III-V), quality of surgery, and long-term oncological outcomes., Results: Among 1498 CRC patients operated during the study period, 21 patients were identified with IBD-CRC and matched to 63 patients with sporadic CRC (S-CRC). Patients with IBD-CRC were significantly younger (p < 0.001), had multifocal lesions more frequently (p = 0.04), and undergone abdominoperineal excision and coloproctectomy more often (p = 0.001). Postoperative morbidity was not significantly different between the two groups (25 vs. 14%; p = 0.309), as well as the rate of R0 resection (86 vs. 95%; p = 0.162). Five-year disease-free and overall survival were 71 and 81% in patients with IBD-CRC and 69% (p = 0.801) and 78% (p = 0.845) in those with S-CRC, respectively., Conclusion: In a case-control study of patients operated for CRC within the last decade, the prognosis of cancer associated with IBD is similar to sporadic cancer.

Background & Aims: The aim of the study was to evaluate the applicability of the ESPEN 16-category clinical classification of chronic intestinal failure, based on patients' intravenous supplementation (IVS) requirements for energy and fluids, and to evaluate factors associated with those requirements., Methods: ESPEN members were invited to participate through ESPEN Council representatives. Participating centers enrolled adult patients requiring home parenteral nutrition for chronic intestinal failure on March 1st 2015. The following patient data were recorded though a structured database: sex, age, body weight and height, intestinal failure mechanism, underlying disease, IVS volume and energy need., Results: Sixty-five centers from 22 countries enrolled 2919 patients with benign disease. One half of the patients were distributed in 3 categories of the ESPEN clinical classification. 9% of patients required only fluid and electrolyte supplementation. IVS requirement varied considerably according to the pathophysiological mechanism of intestinal failure. Notably, IVS volume requirement represented loss of intestinal function better than IVS energy requirement. A simplified 8 category classification of chronic intestinal failure was devised, based on two types of IVS (either fluid and electrolyte alone or parenteral nutrition admixture containing energy) and four categories of volume., Conclusions: Patients' IVS requirements varied widely, supporting the need for a tool to homogenize patient categorization. This study has devised a novel, simplified eight category IVS classification for chronic intestinal failure that will prove useful in both the clinical and research setting when applied together with the underlying pathophysiological mechanism of the patient's intestinal failure., (Copyright © 2017 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.)

Background: Improvement of quality of life is a main objective in inflammatory bowel disease [IBD] management. Data on sexual dysfunction [SD] in IBD are scarce. This study compared rates of SD between IBD patients and healthy controls [HC], and searched for predictors of SD., Methods: All consecutive IBD patients seen in two tertiary centres during 2 months were invited to fill an anonymous validated questionnaire on their sexual function [Female Sexual Index Function and International Index of Erectile Function]. The same questionnaires were filled by HC and by patients with irritable bowel syndrome [IBS] enrolled as a second comparative group., Results: In all, 358 IBD patients filled the questionnaire [192 women]-including 238 with Crohn's disease and 120 with ulcerative colitis-and 110 HC [54 women] and 107 IBS patients [54 women]. In women, SD rates were 53.6% in IBD vs 28% in HC [p < 0.01] and 77.5% in IBS [p = 0.10] patients; in men, figures were 16.9% in IBD, 7.4% in HC [p = 0.64], and 26.4% in IBS [p = 0.60]. An erectile dysfunction [ED] was reported by 43% of IBD patients, 13% of HC [p < 0.01] and 55% of IBS patients [p = 0.60 vs IBD]. Predictors of SD and ED were social and emotional functioning, anxiety in women and depression in men. IBD activity was not associated with SD., Conclusions: In IBD, 54% of women have an SD and 43% of men an ED. These rates are significantly higher than in HC, mostly driven by psychological factors, and independent from disease severity., (Copyright © 2017 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com)

Background & Aims: Home parenteral nutrition (HPN) improves survival and quality of life in patients with chronic intestinal failure (IF). Few cases of pregnancy on HPN have been published. The aim of this study was to report pregnancy cases on long-term HPN in benign IF., Methods: This retrospective study included all pregnant patients on HPN from 4 HPN referral centers. Data on demographics, ongoing pathology, HPN type, maternal and newborn complications were collected., Results: From 1984 to 2014, 21 pregnancies occurred in 15 patients (short bowel syndrome (n = 11), motility disorders (n = 3), mucosal disease (n = 1)) of whom 14 occurred after 2010. Median follow-up was 12 years. Median HPN duration before pregnancy was 8 years. HPN was adapted monthly during pregnancy, with close monitoring and supplementations. Energy intake was regularly increased and median maternal weight gain was 10 kg. Median age at the first pregnancy was 27 years. In 55% of cases, the newborn was preterm. Maternal complications occurred in 67% of cases (mainly due to underlying disease or HPN complications). There were 3 post-partum hemorrhages and 6 hypotrophic newborns. Eighteen infants were healthy and 2 chronic intestinal pseudo-obstruction (CIPO) were suspected., Conclusion: Our series, the largest reported to date, shows that pregnancy is possible in HPN patients but the complication rate is high. A specific support is necessary, particularly in CIPO patients. As pregnancies have increased over the last 15 years, physicians practicing in HPN referral centers should be aware of the need for implementing a specific multidisciplinary monitoring in HPN patients considering pregnancy., (Copyright © 2016 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.)

Background: Objective control of intestinal inflammation during inflammatory bowel disease (IBD) is becoming the main driver for medical treatment. However, the monitoring tools-related burden remains poorly investigated. We aimed to evaluate their comparative acceptability and utility according to patients with IBD., Methods: After a preliminary phase, the final questionnaire encompassing self-administered and physician questionnaires was prospectively and consecutively submitted to 916 patients with IBD from 20 public and private centers. Acceptability and utility visual analog scales (VAS) were expressed as median with interquartile range., Results: Regarding the group of patients with Crohn's disease (n = 618), venipuncture (VAS = 9.3 [8.8-9.7]) and ultrasonography (VAS = 9.3 [8.7-9.7]) were the most acceptable tools (P < 0.0001, for each comparison), whereas rectosigmoidoscopy was the least acceptable tool (VAS = 4.4 [1.2-7.3]) (P < 0.0001, for each comparison). Wireless capsule endoscopy (VAS = 8.5 [5.2-9.3]), magnetic resonance enterocolonography (VAS = 8.0 [5.0-9.2]), and stools collection (VAS = 7.7 [4.6-9.3]) were more acceptable than colonoscopy (VAS = 6.7 [4.3-8.9]) (P < 0.0001, for each comparison). The acceptability was assessed in 298 patients with ulcerative colitis for venipuncture (VAS = 9.4 [8.8-9.7]), stools collection (VAS = 8.1 [5.7-9.4]), colonoscopy (VAS = 7.5 [4.7-9.2]), and rectosigmoidoscopy (VAS = 6.7 [2.8-9.1]); (P < 0.001 for each comparison). All monitoring tools were considered as highly useful by patients with IBD. Decreased acceptability was related to embarrassment for the collection/transport of stools (60.7%), bowel cleansing (76.3%) for colonoscopy, abdominal discomfort (51.3%) and rectal enema (36.6%) for rectosigmoidoscopy, bowel distension (48.3%) for magnetic resonance enterocolonography, and potential capsule retention (21.4%) for wireless capsule endoscopy., Conclusions: Among the IBD monitoring tools, endoscopy demonstrated the lowest acceptability supporting the development of alternative modalities. Patients' information and examination conditions should be improved to ensure proper monitoring adherence.

Introduction: Cyclosporine (CsA) is an effective agent for treating patients with acute steroid-refractory ulcerative colitis (UC). The aim was to assess endoscopic and histologic responses to CsA and to determine their predictive value on UC outcome., Patients and Methods: Consecutive UC patients who received intravenous CsA for an acute refractory UC were included when they had endoscopic assessments with biopsies at entry and, at CsA interruption in responders. Mucosal healing (MH) was defined by Mayo endoscopic subscore ≤1 and, histologic response (HR) by the absence of basal plasmocytosis or a Geboes score <3.1., Results: Among 21 patients who responded to CsA, MH was achieved in 81%. Survival rates without relapse at 2 years were 79% and 25% in patients with MH and without MH, respectively (p=0.04). HR was observed in 84% of patients according to basal plasmocytosis and in 68% according to Geboes score. Multivariate analysis revealed that a Mayo endoscopic subscore of 0 was the only prognostic factor associated with absence of relapse (RR=12; 95%CI: 1.05-136.79)., Conclusion: CsA provides MH and HR in most of UC patients responding to this drug. As suggested with other UC treatments, a complete MH with CsA has a good prognostic value., (Copyright © 2016 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Background: Patients with inflammatory bowel disease (IBD) and history of malignancy within the last 5 years are usually contraindicated for receiving anti-tumor necrosis factor (anti-TNF) agents. The aim of this study is to assess survival without incident cancer in a cohort of IBD patients exposed to anti-TNF while having previous malignancy within past 5 years., Methods: Data from IBD patients with previous malignancy diagnosed within the last 5 years before starting an anti-TNF agent were collected through a Groupe d'Etude Thérapeutiques des Affections Inflammatoires du tube Digestif multicenter survey. Inclusion date corresponded to the first anti-TNF administration after cancer diagnosis., Results: Twenty centers identified 79 cases of IBD patients with previous malignancy diagnosed 17 months (median; range: 1-65) before inclusion. The most frequent cancer locations were breast (n = 17) and skin (n = 15). After a median follow-up of 21 (range: 1-119) months, 15 (19%) patients developed incident cancer (8 recurrent and 7 new cancers), including 5 basal-cell carcinomas. Survival without incident cancer was 96%, 86%, and 66% at 1, 2, and 5 years, respectively. Crude incidence rate of cancer was 84.5 (95% CI, 83.1-85.8) per 1000 patient-years., Conclusions: In a population of refractory IBD patients with recent malignancy, anti-TNF could be used taking into account a mild risk of incident cancer. Pending prospective and larger studies, a case-by-case joint decision taken with the oncologist is recommended for managing these patients in daily practice.

Background and Aim: Anti-tumour necrosis factor [TNF] agents have dramatically improved the prognosis of inflammatory bowel disease [IBD]. However, despite their good safety profile, use of these agents may lead to paradoxical manifestations involving skin or joints. Pathogenesis of such side effects is poorly understood and may involve anti-TNF pharmacokinetics. The aim of the present study was to look for an association between infliximab trough levels [ITL] and cutaneous [CPM] or rheumatological [RPM] paradoxical manifestations., Methods: IBD patients receiving infliximab as maintenance therapy were included in a cross-sectional prospective monocentre study. At inclusion, patients had an ITL measurement [LISA-TRACKER®, Biomedical Diagnostics BMD] and were assessed for paradoxical manifestations: a CPM was defined by new onset or exacerbation of pre-existing psoriasis lesions during IFX therapy, and an RPM by new onset of severe poly-arthralgia during IFX therapy., Results: Among the 121 patients included [69 female; median age: 38.9 years; 92 with Crohn's disease], 7% had CPM and 8% RPM. Median ITL values were 5.87 [range: 0.52-19.53] µg/ml in patients with CPM and 1.90 [0.00-13.5] µg/ml in those with RPM, as compared respectively with 5.12 [0.00-49.12] µg/ml in patients without CPM [p = 0.56] and 5.57 [0.00-49.12] µg/ml in those without RPM [p = 0.058]. No prognostic factor was associated with CPM. The single factor associated with RPM was elevated antinuclear antibodies., Conclusion: ITL were not elevated in IBD patients developing cutaneous or rheumatological paradoxical manifestations when receiving IFX as maintenance therapy. As suggested by the high level of antinuclear antibodies, RPM could be related to an induced autoimmune disorder., (Copyright © 2015 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

During the last decade, anti-TNF agents and emergence of new therapeutic concepts have dramatically changed inflammatory bowel disease (IBD) management, especially at their early phase. Salicylates remain the therapeutic basis in ulcerative colitis while their efficacy in Crohn's disease has not been confirmed. A rapid step-up approach is considered for managing IBD at early phase providing early immunomodulators--such as immunosuppressant and anti-TNF--in case of poor disease course. Some specific situations (severe, extended or complicated forms) require the most efficient first-line therapy that is combination between anti-TNF and immunosuppressant. A close follow-up not only based on clinical symptoms, but also on objective inflammatory tools (endoscopy, cross-sectional imaging, biomarkers), is needed to adjust medical therapy rapidly in order to prevent complications and surgery.

Introduction: Gastrointestinal hemorrhage is an emergency requiring usually an admission in intensive care unit (ICU), which may prove abusive secondarily. The aim of this study was to identify predictive risk factors of organ failure in patients admitted for GH in our ICU., Design: Retrospective and observational, Methods and Measurements: Between January 2008 and December 2011, all patients admitted in our ICU for gastrointestinal hemorrhage were consecutively included. The primary endpoint was the occurrence of at least an organ failure. We realized an univariate analysis then a backward regression to identify independent risk factors associated with the occurrence of at least one organ failure during the ICU hospitalization., Results: During this period study, 441 consecutive patients with a mean age of 67±15years were included. The median ICU length of stay was of 4 (3-7) days and 116 (26% [IC95%: 22-30]) patients presented at least one organ failure. The multivariate analysis identified predictive risk factors of organ failure: history of cirrhosis (OR=3.5 [IC95%: 1.9-6.7], P<0.001) and an increase in troponin at the admission above the 99th percentile (OR=3.1 [IC95%: 1.8-5.5], P<0.001)., Conclusion: Our results confirmed that a large proportion of patients admitted in ICU for the primary diagnosis of gastrointestinal hemorrhage developed any organ failure. The history of cirrhosis and the systemic consequences of the hemorrhagic syndrome as myocardial damage represents important risk factors of morbidity and mortality and thus should be considered during the management., (Copyright © 2013 Société française d’anesthésie et de réanimation (Sfar). Published by Elsevier SAS. All rights reserved.)