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Background: There is a need for published data on real-world use of SB5, an adalimumab (ADL) biosimilar approved in Europe in 2017, on the basis of evidence from pre-clinical and analytic data as well as phase I and III clinical studies demonstrating equivalent efficacy and comparable pharmacokinetics, safety and immunogenicity profiles as the reference ADL., Objectives: The purpose of this study was to estimate patient persistence on SB5 at 12 months post-initiation using clinical and healthcare claims data from the French Système National des Données de Santé (national healthcare claims database, SNDS) in addressing data gaps., Methods: PERFUSE is a 12-month, observational, multi-centre cohort study of patients with rheumatic or gastrointestinal immune-mediated inflammatory diseases (IMIDs) who initiated routine SB5 treatment between October 2018 and October 2020, either as their first ADL (naïve) or transitioning from another ADL (switched). Clinical data, including disease activity scores, C-reactive protein levels, and dosing information, were collected as available from patient records captured during routine visits to specialist physicians. Persistence data were supplemented with data from the French national healthcare claims database (SNDS). Analyses of clinical data were descriptive, while persistence was assessed using a Kaplan-Meier survival analysis., Results: Overall, 911 patients were included: 507 from rheumatology centres [116 with rheumatoid arthritis (RA), 78 psoriatic arthritis (PsA), and 313 ankylosing spondylitis (AS)] and 404 from gastroenterology centres [316 with Crohn's disease (CD) and 88 ulcerative colitis (UC)]. Among naïve patients, 12-month remission/low activity rates were 58% for RA, 66% for PsA, 59% for AS, 94% for CD, and 85% for UC, increasing significantly from baseline for all indications (p < 0.05). Switched patients' remission rates remained stable between baseline and month 12 (M12) for all indications (p > 0.05). Persistence (95% CI) at M12 among naïve patients was 59% (46.5, 68.8) for RA, 65% (49.7, 77.1) for PsA, 56% (48.3, 62.6) for AS, 70% (63.0, 75.7) for CD, and 42% (30.7, 53.1) for UC, compared to 60% (42.7, 73.7) for RA, 57% (37.3, 72.1) for PsA, 55% (45.8, 64.0) for AS, 63% (53.4, 71.7) for CD, and 56% (27.2, 77.6) for UC among switched patients. No significant differences were observed between naïve and switched patients (p > 0.05). SNDS pairing provided information on 68 of the 132 patients (52%) who were lost to follow-up in the clinical database, of whom 57 (84%) were confirmed persistent at M12 and 11 (16%) non-persistent. Primary treatment failure (naïve patients) and patient decision (switched patients) were the most common reasons stated for treatment discontinuation., Conclusions: SB5 provides clinically effective treatment of both gastrointestinal and rheumatic IMIDs for naïve and switched patients, with no loss of control observed when switching. Persistence was comparable between naïve and switched populations, though the reasons for non-persistence differed., Trial Registry: Trial registration number: Clinical Trials identifier NCT03662919. Trial registration date: 10 September 2018., Competing Interests: Declarations. Funding: This study was sponsored by Biogen Int GmbH (Baar, Switzerland). Funding was provided by Biogen. Open access fees were sponsored by Biogen Int GmbH (Baar, Switzerland). Conflict of interest: Bruno Fautrel: received speaker/consulting fees from AbbVie, Biogen, Boehringer Ingelheim, BMS, Celgene, Janssen, Lilly, Medac, MSD, NORDIC Pharma, Novartis, Pfizer, Roche, Sobi and UCB, and grant/research support from AbbVie, MSD and Pfizer. Yoram Bouhnik: received consultancy and/or speaker fees from AbbVie, Biogaran, Biogen, Boehringer Ingelheim, CTMA, Ferring, Gilead, Hospira, ICON, Inception IBD, Janssen, Lilly, Mayoly Spindler, Merck, Merck Sharp & Dohme, Norgine, Pfizer, Robarts Clinical Trials, Roche, Sanofi, Shire, Takeda, UCB and Vifor Pharma. Carine Salliot: received consultancy and/or speaker fees from Novartis, Roche-Chugai, Pfizer and Galapagos, and grant/research support from Roche-Chugai and Novartis. Frank Carbonnel: received speaker fees from Abbvie, Astra, Biocodex, Biogen, Ferring, Janssen, MSD, Pfizer, Pileje, Takeda, Tillotts; and is a member of advisory boards for Amgen, Arena, BMS, Celltrion, Enterome, Ferring, Janssen, Medtronic, Pfizer, Pharmacosmos, Roche and Tillotts. Mathurin Fumery: received consultancy and/or speaker fees from AbbVie, Biogen, Boehringer Ingelheim, CTMA, Ferring, Gilead, Hospira, Janssen, Lilly, Merck Sharp & Dohme, Pfizer, Takeda, Tillots and Celgene. Chirstophe Bernardeau: nothing to disclose with respect to their contributions to this work. Yves Maugars: nothing to disclose with respect to their contributions to this work. Mathurin Flamant: received consultancy and/or speaker fees from AbbVie, Amgen, Biogen, Ferring, Janssen, Mayoly Spindler, Merck Sharp & Dohme, Pfizer, Takeda, Tillots and Pharma. Fabienne Coury: received speaker/consulting fees from Abbvie, Amgen, BMS, Janssen, Lilly, MSD, Novartis, Pfizer, Roche-Chugai, Sanofi and UCB, and grant/research support from Abbvie, Biogen, Celgene, Chugai, Novartis, Pfizer and UCB. Ben Braithwaite: no conflicts of interest to disclose. Salima Hateb: is an employee of and may hold stock in Biogen. Janet Addison: is an employee of and may hold stock in Biogen. Availability of data and material: The datasets generated and analysed during the current study are not publicly available as data for this study contain potentially identifying information. Ethics approval: All necessary ethical considerations and measures were taken to ensure the protection of all participants: patients were eligible for the study only if they were able to understand and sign a consent form. This study is listed on clinicaltrials.gov under the identifier NCT03662919 and was approved by the appropriate bodies in terms of quality of methodology, data security and scientific merit. The final amendment to the protocol for this study was approved by an independent ethics committee (Comité de Protection des Personnes, CPP) in France on 25 April 2019, in accordance with French regulations (CPP SUD-EST II; study ref. 2018-06; internal ref. 19.03.29.73319). Furthermore, this study conformed to all regulations concerning the use of personal data. All procedures were carried out in accordance with the ethical rules and the principles of the Declaration of Helsinki and its later amendments. Consent to participate: Informed consent was obtained from all individual participants included in the study in the form of a non-opposition form signed and archived by the physician in accordance with French regulations. Code availability: The code used to perform data management and run the analyses uses proprietary modules owned by eXYSTAT. Thus, the code cannot be made publicly available. Author contributions: Bruno Fautrel: as the coordinating investigator for rheumatology, made substantial contributions to the conception and design of the work, the acquisition and interpretation of data for the work and reviewed all draft versions of the manuscript for important intellectual content. Yoram Bouhnik: as the coordinating investigator for gastroenterology, made substantial contributions to the conception and design of the work, the acquisition and interpretation of data for the work and reviewed all draft versions of the manuscript for important intellectual content. Carine Salliot: as an investigator, made substantial contributions to the acquisition and interpretation of data for the work and reviewed all draft versions of the manuscript for important intellectual content. Mathurin Fumery: as an investigator, made substantial contributions to the acquisition and interpretation of data for the work and reviewed all draft versions of the manuscript for important intellectual content. Chirstophe Bernardeau: as an investigator, made substantial contributions to the acquisition and interpretation of data for the work and reviewed all draft versions of the manuscript for important intellectual content. Mathurin Flamant: as an investigator, made substantial contributions to the acquisition and interpretation of data for the work and reviewed all draft versions of the manuscript for important intellectual content. Fabienne Coury: as an investigator, made substantial contributions to the acquisition and interpretation of data for the work and reviewed all draft versions of the manuscript for important intellectual content. Ben Braithwaite: as the lead writer and biostatistics coordinator for this work, made substantial contributions to the design of the work, acquisition, analysis and interpretation of data for the work and produced all draft versions of the manuscript. Salima Hateb: as a study coordinator for the sponsor, made substantial contributions to the conception and design of the work, the acquisition and interpretation of data for the work and reviewed all draft versions of the manuscript for important intellectual content. Janet Addison: as the sponsor’s lead scientist for this work, made substantial contributions to the conception and design of the work, the analysis and interpretation of data for the work and critically reviewed, commented upon and edited all draft versions of the manuscript. The first draft of the manuscript was written by Ben Braithwaite and all authors commented on previous versions of the manuscript. All authors read, provided input and approved the final manuscript. All authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved., (© 2024. The Author(s).)

Background & Aims: The aim of this study was to assess the long-term effectiveness and safety of risankizumab maintenance treatment in a large real-world cohort of patients with Crohn's Disease (CD)., Methods: From May 2021 to August 2023, all consecutive patients with CD treated with risankizumab in 25 GETAID centers have been retrospectively included. The primary endpoint was steroid-free clinical remission (Harvey Bradshaw Index [HBI] <5) at 52 weeks., Results: Of the 174 patients included, 99%, 93%, and 96% had been previously exposed to anti-TNF, vedolizumab, and ustekinumab, respectively. All patients had received ≥3 biologics, and 108 (62%) had previous intestinal resection. Median follow-up was 13.7 months (interquartile range, 10.0-18.1 months). The rates of steroid-free clinical remission and clinical remission at week 26 were 47% (72/152) and 52% (79/152), and 46% (58/125), and 48% (60/125) at week 52, respectively. Risankizumab persistence rates were 94%, 89%, and 79% at weeks 12, 26, and 52, respectively. At the end of follow-up, 45 (45/174; 26%) patients had discontinued risankizumab (loss of response, 42%; primary failure, 37%; intolerance, 13%). Thirty-six patients (36/174; 20.9%) were hospitalized, and 22 (22/174; 12.6%) required intestinal resection. Fifty-one patients (29%) had an adverse event, including 26 (15%) serious adverse events (CD flare, n = 17). One death (myocardial infarction) and one cancer (papillary thyroid carcinoma) were observed., Conclusion: This is the first real-life study to report long-term outcomes in patients with refractory CD treated with risankizumab. One-half of the patients achieved steroid-free clinical remission after 1 year, and the safety profile was consistent with the literature., (Copyright © 2024 AGA Institute. Published by Elsevier Inc. All rights reserved.)

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.)

Background: Mucosal healing (MH) is an established treatment goal in inflammatory bowel disease (IBD). However, various definitions of MH exist. We aimed to identify how MH is defined in randomized controlled trials (RCTs) in ulcerative colitis (UC) and Crohn's disease (CD)., Methods: We searched MEDLINE, EMBASE, and the Cochrane library from inception to December 2023 for phase 2 and 3 RCTs of advanced therapies in IBD., Results: One hundred forty-four studies were included, 72 in UC and 72 in CD, published between 1997 and 2023. In UC, 64% (46/72) RCTs reported MH as an endpoint. 12 definitions of MH were found, from endoscopic assessment alone (35/46; 76%) to the more recent combination of histology and endoscopy (10/46; 22%). 96% (44/46) of studies used the Mayo Endoscopic Subscore. In CD, reporting of MH lagged behind UC, with only 12% (9/72) of trials specifically defining MH as an endpoint, 7 as "absence of ulceration," 2 as Simplified Endoscopic Score for CD score ≤2 or 0. Histological assessment was performed in 3 RCTs of CD. Centralized reading of endoscopy was used in 48% (35/72) of RCTs of UC and 22% (16/72) of CD. Only 1 RCT included transmural healing as an endpoint., Conclusions: A standard definition of MH in IBD is lacking. Definitions have evolved particularly in UC, which now includes the addition of histological evaluation. Transmural healing holds promise as a future target in CD. We support a greater standardization of definitions as we expect endpoints to become increasingly stringent and multimodal with computers automating the assessment., (© 2024 The Author(s). United European Gastroenterology Journal published by Wiley Periodicals LLC on behalf of United European Gastroenterology.)

Background: In industrialized countries, the incidence of inflammatory bowel disease (IBD) appears stabilized. This study examined the incidence and phenotype of IBD in Northern France over a 30-year period., Methods: Including all IBD patients recorded in the EPIMAD population-based registry from 1988 to 2017 in Northern France, we described the incidence and clinical presentation of IBD according to age, sex and time., Findings: A total of 22,879 incident IBD cases were documented (59% (n = 13,445) of Crohn's disease (CD), 38% (n = 8803) of ulcerative colitis (UC), 3% (n = 631) of IBD unclassified (IBDU)). Over the study period, incidence of IBD, CD and UC was 12.7, 7.2 and 5.1 per 10 5 person-years, respectively. The incidence of CD increased from 5.1/10 5 in 1988-1990 to 7.9/10 5 in 2015-2017 (annual percent change (APC): +1.9%, p < 0.0001). The incidence of UC increased from 4.5/10 5 to 6.1/10 5 (APC: +1.3%, p < 0.0001). The largest increase was observed in children (+4.3% in CD, p < 0.0001; +5.4% in UC, p < 0.0001) followed by young adults aged 17-39 years (+1.9% in CD, p < 0.0001; +1.5% in UC, p < 0.0001). The increase in UC incidence was significantly higher in women than in men (+1.9% in women, +0.8% in men; p = 0.006). We estimated that in our area, by 2030, nearly 0.6% of the population will have IBD., Interpretation: The persistent increase of IBD incidence among children and young adults but also in women with UC in Northern France, suggests the persistence of substantial predisposing environmental factors., Funding: Santé Publique France; INSERM; Amiens, Lille and Rouen University Hospitals., Competing Interests: Guillaume Savoye has served as speaker for MSD France, Ferring France, Abbvie France, and Vifor France. Mathurin Fumery has received lecture/consultant fees from Abbvie, Ferring, Tillots, MSD, Biogen, Amgen, Fresenius, Hospira, Pfizer, Celgene, Gilead, Boerhringer, Galapagos, Janssen and Takeda. Delphine Ley has received consultant fees from Sandoz and AbbVie. Thierry Paupard has received lecture/consultant fees from Abbvie, Amgen, Takeda, Janssen, Biogen, and Celltrion. Dominique Turck has received lecture fees from Sandoz. Nicolas Richard has received lecture/consultant fees from AbbVie and Takeda. The other authors state that they have no competing interests regarding this work to disclose., (© 2024 The Author(s).)

Introduction: It is still unclear whether Crohn's disease (CD) might be associated with diminished ovarian reserve (OvR) and factors influencing anti-Mullerian hormone (AMH) levels in CD are poorly known., Material and Methods: We conducted a comprehensive literature search of multiple electronic databases from inception to June 2022 to identify all studies reporting AMH levels or factors associated with diminished OvR in patients with CD., Results: Of the 48 studies identified in our search, eight (including 418 patients with CD) were finally included. The mean difference (95% confidence interval [CI]) in the AMH level between pooled CD patients and controls was -0.56 (-1.14 to 0.03) (p = 0.06). A history of CD-related surgery was not associated with a lower OvR (odds ratio, OR [95% CI] 1.34, [0.66-2.7]; p = 0.4). While disease activity and perianal disease seems associated with a low OvR, disease location (L2 vs. L1, OR [95% CI] = 95% CI [0.47-7.4]; p = 0.4) and L3 vs. L1 (OR [95% CI] = 1.44 [0.67-3.12]; p = 0.3), CD medication, and disease behavior were not., Conclusions: Our systematic review and meta-analysis did not identify a significantly low OvR in patients with CD. Contrary to CD-related surgery risk factor, active disease was associated lower AMH levels., (© 2024 The Authors. Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).)

Background: Several adalimumab preparations are now available for patients with inflammatory bowel disease (IBD). Comparative satisfaction and tolerability are unknown., Objectives: This study investigated IBD patient satisfaction with approved adalimumab biosimilars and their originator., Design: In this cross-sectional study, we included 941 consecutive adalimumab-treated patients with IBD across 45 centres affiliated with the Groupe d'Etude Therapeutique des Affections Inflammatoires du tube Digestif who completed a satisfaction questionnaire comprising four items each rated by a 10-point scale., Methods: The differences in responses were performed using a one-way analysis of variance followed by Tukey's honest significant difference test., Results: The most commonly used drugs at inclusion were Humira ® (436/941, 46.3%), Amgevita ® (177/941, 18.8%) and Hulio ® (105/941, 11.2%). The mean overall satisfaction rate with adalimumab was 8.5 (standard deviation 1.8). Overall satisfaction was significantly higher in patients treated with Humira (8.6 (1.5)), Hulio (8.6 (1.8)) or Amgevita (8.5 (1.4)) ( p  < 0.05). Satisfaction with the subcutaneous injection form was higher for patients treated with Yuflyma ® (9.0 (1.4)), Humira (8.9 (1.3)) and Hulio (8.9 (1.7)) ( p  < 0.05). A total of 299 patients (31.8%) described injection site reactions. In all, 223 patients (23.7%) reported being previously treated with another adalimumab of which (32/223, 14.3%) discontinued treatment due to side effects., Conclusion: In this real-world setting, patients with IBD had a high level of satisfaction with adalimumab treatment, with some differences in terms of overall satisfaction and satisfaction with the injection device., Competing Interests: B. Caron reports lecture and/or consulting fees from Abbvie, Amgen, Celltrion, Ferring, Galapagos, Janssen, Lilly and Takeda. P. Seksik received consulting fees from Takeda, Abbvie, Merck-MSD, Biocodex, Janssen, Amgen, Astellas and Pfizer and grants from Biocodex and Janssen. A. Buisson declares consulting fees from Abbvie, Amgen, Arena, Biogen, Celltrion Healthcare, CTMA, Galapagos, Janssen, MSD, Nexbiome, Pfizer, Roche, Takeda and Tillotts; lecture fees for Abbvie, Amgen, Biogen, Galapagos, Janssen, Mayoli-Spindler, MSD, Norgine, Pfizer, Roche, Takeda, Tillotts and Vifor Pharma; research grants from Abbvie, Celltrion Healthcare Janssen, Lilly, Pfizer and Takeda. P. Wils declares lecture and/or consulting fees from Abbvie, Biogen, Celltrion Ferring, Janssen, Pfizer, Lilly, Takeda and Amgen. G. Savoye reports travel from Janssen. C. Stefanescu declares lecture and/or consulting fees from Abbvie, Amgen, Biogen, Celltrion Ferring, Gilead, Janssen, Pfizer, Lilly, Takeda, Tillots. D. Laharie declares counselling, boards, transports or fees from Abbvie, Amgen, Biogen, Celltrion, Ferring, Galapagos, Janssen, Lilly, MSD, Pfizer, Prometheus, Roche, Takeda. L. Guillo declares consulting fees for Abbvie. V. Abitbol has received lecture fees from Amgen, Biogen, Mylan, Sandoz, Pfizer, Takeda, Janssen, Tillots, Gilead, Ferring. J. Bonnet reports fees from Galapagos, Celltrion Healthcare and Fresenius Kabi. R. Altwegg declares counselling, boards, transports or fees from Abbvie, Amgen, Biogen, Ferring, Janssen, MSD, Pfizer, Takeda, Tillotts. L. Vuitton declares lecture and/or consulting fees from Abbvie, Amgen, Viatris, MSD, Ferring, Celltrion, Galapagos, Takeda, Pfizer, Janssen, Lilly, Dr Falk pharma. D. Moussata reports lecture and/or consulting fees from Abbvie, Amgen, Galapagos, Janssen, Takeda, Sanofi, Fuji, Cellvizio. A. Bourreille reports lecture and/or consulting fees from AbbVie, Celltrion, Ferring, Galapagos, Janssen, Lilly, MSD, OSE Immunotherapeutics, Pfizer, Takeda, Tillots, Viatris. A. Biron reports no conflict of interest. C. Gilletta reports lecture and/or consulting fees from Abbvie, Amgen, Celltrion, Galapagos, Janssen, Pfizer and Takeda. M. Fumery has participated in advisory boards and as an educational speaker (personal fees) for AbbVie, Amgen, Biogen, Boehringer Ingelheim, Celgene, Celltrion, CTMA, Ferring, Fresenius, Galapagos, Janssen, MSD, Takeda, Tillotts, Pfizer, Sandoz and Viatris and has received research grants from Fresenius, Janssen and Pfizer. S. Nahon declares lecture and/or consulting fees from Abbvie, Amgen, Viatris, MSD, Ferring, Celltrion, Galapagos, Takeda, Pfizer, Janssen, Lilly, Ferring, Biogen. S. Nancey reports lecture and/or consulting fees from Abbvie, Amgen, Celltrion, Ferring, Galapagos, Janssen, Lilly, Takeda, Novartis and Pfizer. H. Camara declares no conflict of interest. L. Peyrin-Biroulet reports lecture and/or consulting fees from AbbVie, Adacyte, Alimentiv, Alma Bio Therapeutics, Amgen, Applied Molecular Transport, Arena, Biogen, BMS, Celltrion, CONNECT Biopharm, Cytoki Pharma, Enthera, Ferring, Fresenius Kabi, Galapagos, Genentech, Gilead, Gossamer Bio, GSK, HAC-Pharma, IAG Image Analysis, Index Pharmaceuticals, Inotrem, Janssen, Lilly, Medac, Mopac, Morphic, MSD, Norgine, Nordic Pharma, Novartis, OM Pharma, ONO Pharma, OSE Immunotherapeutics, Pandion Therapeutics, Par’Immune, Pfizer, Prometheus, Protagonist, Roche, Sanofi, Sandoz, Takeda, Theravance, Thermo Fisher, Tigenix, Tillots, Viatris, Vifor, Ysopia, Abivax, Samsung, Ventyx, Roivant and Vectivbio., (© The Author(s), 2024.)

Introduction: Inflammatory bowel diseases (IBD) are frequently diagnosed between the ages of 20 and 40, i.e. the most fertile period for women. The potential impact of IBD on pregnancy is therefore a frequent issue., Study Objective: To determine the impact of disease activity during pregnancy on the obstetric prognosis of women with IBD., Methods: Gastroenterological and obstetric data were collected for patients for all consecutive patients with IBD and pregnancy followed up at Amiens University Hospital (Amiens, France) between 2007 and 2021. Obstetrics outcome of patients with and without active disease were compared., Results: One hundred patients were included (81 with Crohn's Disease for 198 pregnancies, 19 with Ulcerative Colitis for 37 pregnancies). Patients with active IBD (21 patients, 24 pregnancies) were more likely to be admitted to hospital during pregnancy (66.6, vs. 5.2% in the inactive IBD group; p < 0.001), to give birth prematurely (mean term: 36.77 weeks of amenorrhoea (WA) vs. 38.7 WA, respectively; p = 0.02) and to experience very premature delivery (before 32 WA: 12.5 vs. 1.4%, respectively; p = 0.02). Patients with active disease had a shorter term at birth (38.4 WA, vs. 39.8 WA in the inactive disease group; p < 0.0001), a lower birth weight (2707 g vs. 3129 g, respectively; p = 0.01) and higher caesarean section rate (54.2 vs. 16.9%, respectively; p = 0.03)., Conclusion: Women with IBD patients are at risk of pregnancy related complications, especially when IBD is active. Controlling disease activity at conception and close monitoring of the pregnancy is essential to improve both gastroenterological and obstetric outcome., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background and Aims: While the occurrence of colonic stricture in Crohn's disease (CD) always raises concerns about the risk of cancer, the neoplastic risk associated with its stricture remains poorly known., Methods: All consecutive patients with colorectal stricture complicating CD in 3 academic centers between 1993 and 2022 were included in a retrospective cohort. We collected clinical, endoscopic, surgical, and pathology data and information on outcomes. Factors associated with neoplastic stricture were investigated by logistic regression., Results: A total of 88 patients (median age, 25 [interquartile range {IQR}, 19-37] years and median disease duration 12 [4-19] years) with 96 colorectal strictures were included. Strictures were nonpassable by the scope in 61.4% (n = 54) of cases, 70.5% (n = 62) were ulcerated, and 62.5% (n = 55) were symptomatic. Colonic resection and endoscopic balloon dilatation were needed in 47.7% (n = 42) and 28.6% (n = 12) of patients, respectively. After a median follow-up of 21.5 months (IQR [5.5-46.5]), 7 (8%) patients were diagnosed with neoplasia at the colonic stricture site (colonic adenocarcinoma, n = 5; neuroendocrine carcinoma, n = 1; and B-cell lymphoproliferative neoplasia, n = 1), with a median stricture duration at colorectal neoplasia diagnosis of 0 month (IQR [0.0-5.5]). While neoplastic strictures were diagnosed in older patients (58 vs 39 years), with longer disease duration (18 vs 11 years) and frequent obstructive symptoms (57.1% vs 11.1%), no patient-related or stricture-related factor was associated with neoplastic stricture in multivariate analysis., Conclusion: Eight percent of patients with colonic stricture complicating CD developed colorectal cancer. Colorectal cancer and stricture were often diagnosed at the same time and we did not report malignant stricture after 1 year of follow-up., (© 2024 The Authors.)

The REMSWITCH study recently demonstrated that switching from intravenous (IV) to subcutaneous (SC) infliximab (IFX) is feasible and well-accepted leading to a low risk of relapse in patients with inflammatory bowel disease (IBD). 1 Because the doses of IV IFX depend on patients' weight contrary to SC IFX, whether the switch is also feasible in patients with IBD suffering from obesity remains questionable., (Copyright © 2024 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Background: The long-term risk of relapse after switching from intravenous (IV) to subcutaneous (SC) infliximab remains unknown in inflammatory bowel disease (IBD)., Aims: To assess the long-term effectiveness and acceptability of switching from IV to SC infliximab in patients with IBD treated with or without an intensified IV regimen., Methods: We extended the follow-up of the REMSWITCH study including patients with IBD in clinical remission who were switched from IV to SC infliximab (120 mg/2 weeks). Relapse was defined as clinical relapse or faecal calprotectin increase ≥150 μg/g compared to baseline., Results: After median follow-up of 18 [15-20] months, among 128 patients, rates of relapse were 13.8% (8/58), 18.4% (7/38), 35.3% (6/17) and 86.7% (13/15) at last follow-up (p < 0.001), in those receiving 5 mg/kg/8 weeks, 10 mg/kg/8 weeks, 10 mg/kg/6 weeks and 10 mg/kg/4 weeks at baseline, respectively. Among relapsing patients, dose escalation led to clinical remission in 82.1% (23/28). In multivariable analyses, factors associated with higher risk of relapse were IV infliximab 10 mg/kg/4 weeks (OR = 61.0 [6.1-607.0], p < 0.001) or 10 mg/kg/6 weeks (OR = 4.7 [1.1-20.2], p = 0.017), and decreased (OR = 5.6 [1.5-20.3], p = 0.004) or stable (OR = 5.0 [1.6-15.0], p = 0.009) serum levels of infliximab between baseline and first post-switch visit. Acceptability was improved at 6 months and did not decrease over time (6.9 ± 1.6 before the switch vs. 8.8 ± 1.3 at 6 months and 8.8 ± 1.3 at last follow-up; p < 0.001). No severe adverse events were reported., Conclusions: Switching from IV to SC infliximab 120 mg every other week is safe and well accepted leading to low long-term risk of relapse. Tight monitoring and dose escalation should be recommended for patients receiving 10 mg/kg/6 weeks and 4 weeks, respectively., (© 2023 John Wiley & Sons Ltd.)

Cardiovascular and thromboembolic risks are increasing in the population as a whole and therefore also in inflammatory bowel disease (IBD) patients. Obesity is a worldwide challenge also affecting the IBD population, and a causal association with Crohn's disease may exist. IBD itself, particularly when active, is also associated with a significant risk of thromboembolic and cardiovascular events such as myocardial infarction and stroke. Cardiovascular risk is also a significant consideration when using Janus kinase (JAK) inhibitors and sphingosine 1 phosphate (S1P) receptor modulators to treat IBD. JAK inhibitors - such as tofacitinib - are associated with several cardiovascular and venous thromboembolic risks, including hypertension and alterations in lipid profiles - specifically, increased LDL cholesterol and triglycerides - which may contribute to atherosclerosis and cardiovascular disease. S1P receptor modulators pose a slightly different set of cardiovascular risks. Initially, these drugs can cause transient bradycardia and atrioventricular (AV) block, leading to bradycardia. Moreover, they may induce QT interval prolongation, which increases the risk of life-threatening arrhythmias such as torsades de pointes. Some patients may also experience hypertension as a side effect. In this context, IBD healthcare providers need to be alert to the assessment of cardiovascular risk - particularly as cardiovascular events appear to be confined to specific patient groups with pre-existing risk factors. In addition, the potential for S1P modulator drug interactions requires a higher level of vigilance in patients with polypharmacy compared to biologics. Cardiovascular risk is not static, and updated assessment will need to become part of the routine in many IBD units., (© 2023 The Authors. Journal of Internal Medicine published by John Wiley & Sons Ltd on behalf of Association for Publication of The Journal of Internal Medicine.)

Background & Aims: The management of intra-abdominal abscesses complicating Crohn's disease (CD) is challenging, and surgery with delayed intestinal resection is often recommended. The aims of this study were to estimate the success rate of adalimumab (ADA) in patients with CD with an intra-abdominal abscess resolved without surgery, and to identify predictive factors for success., Methods: A multicenter, prospective study was conducted in biologic-naïve patients with CD with resolved intra-abdominal abscess treated with ADA with a 2-year follow-up. The primary endpoint was ADA failure at week (W) 24 defined as a need for steroids after W12, intestinal resection, abscess recurrence, and clinical relapse. Secondary post-hoc endpoint was the long-term success defined as the survival without abscess relapse or intestinal resection at W104. The factors associated with ADA failure at W24 and W104 were identified using a logistic and a Cox regression, respectively., Results: From April 2013 to December 2017, 190 patients from 27 GETAID centers were screened, and 117 were included in the analysis. Fifty-eight patients (50%) were male, and the median age at baseline was 28 years. At W24, 87 patients (74%; 95% confidence interval [CI], 65.5%-82.0%; n = 117) achieved ADA success. Among the 30 patients with ADA failure, 15 underwent surgery. At W104, the survival rate without abscess recurrence or surgery was 72.9% (95% CI, 62.1%-79.8%; n = 109). Abscess drainage was significantly associated with ADA failure at W24 (odds ratio, 4.18; 95% CI, 1.06-16.5; P =0 .043). Disease duration (hazard ratio [HR], 1.32; 95% CI, 1.09-1.59; P = .008), abscess drainage (HR, 5.59; 95% CI, 2.21-14.15; P = .001), and inflammatory changes in mesenteric fat (HR, 0.4; 95% CI, 0.17-0.94; P = .046) were significantly associated with ADA failure at W104., Conclusion: Provided that the abscess was carefully managed before initiating medical treatment, this study showed the high efficacy of ADA in the short and long term in biologic-naïve patients with CD complicated by an intra-abdominal abscess., Clinicaltrials: gov, Number: NCT02856763., (Copyright © 2023 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of the study was to provide an overview of the practices of French general dentists (GDs) and specialists (SDs) concerning the management of patients with inflammatory bowel diseases (IBDs), rheumatic inflammatory diseases (IRDs), and vasculitis on biologic disease-modifying antirheumatic drugs (bDMARDs), conventional DMARDs, or immunosuppressants (ISs)., Materials and Methods: An online national cross-sectional survey with 53 questions was developed by a multidisciplinary team including rheumatologists, gastroenterologists and dentists based on their clinical experience. It was refined following a test with nine dentists in private practice and in hospital before being disseminated to the members of French scientific societies and colleges of dentistry teachers over 3 months. Responses of general dentists versus specialists were compared with respect to their experience in managing patients with IRDs or IBDs, knowledge/training, type of invasive procedure performed, management of medical treatment, perioperative oral-care protocols, and frequency of postoperative complications after invasive dental care procedures., Result: In total, 105 practitioners fully completed the survey (participation rate 11.1%). SDs more frequently performed invasive surgical procedures and were more aware of the recommendations of learned societies than GDs. They encountered more post-operative complications for patients on bDMARDs. For both SDs and GDs, most patients were managed without stopping treatment and pre- and postoperative antibiotics were prescribed to more than 75% of patients. When medical treatment was stopped, the decision was made by the prescribing physician., Conclusion: Complications were reported more frequently by SDs when highly invasive procedures were performed on patients under active drug therapy. Certain common procedures, such as scaling and root planing, appear to be safe, regardless of treatment management. However, adapted guidelines for the practice of dentistry are needed to standardize the management of patients on bDMARDS, conventional DMARDs, or ISs., Clinical Relevance: French dentists perform a wide range of oral procedures on patients on bDMARDS, conventional DMARDs, or ISs under antibiotic coverage and antiseptic mouthwashes. SDs reported more postoperative complications after extensive invasive procedures for patients under active drug therapy, despite their greater knowledge of recommendations on how to manage such patients., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Background and Aims: We assessed the effectiveness of switching from intravenous to subcutaneous infliximab in patients with inflammatory bowel diseases (IBDs) treated with or without intensified intravenous regimen., Methods: In this multicenter observational study, IBD patients in clinical remission (partial Mayo score ≤2 or Harvey-Bradshaw index ≤4) were switched to a unique dose of subcutaneous infliximab (120 mg every other week). Pharmacological and biological data were collected at baseline, visit 1 (4-8 weeks postswitch), visit 2 (8-16 weeks postswitch), and visit 3 (16-24 weeks postswitch). Relapse was defined as clinical relapse or fecal calprotectin increase ≥150 μg/g compared with baseline., Results: Among 184 eligible patients, 72.3% (n = 133 of 184) agreed to switch to subcutaneous infliximab. At visit 3, a relapse occurred in 10.2% (n = 6 of 59), 7.3% (n = 3 of 38), 16.7% (n = 3 of 18), and 66.7% (n = 10 of 15) (P < .001) of patients receiving 5 mg/kg every 8 weeks, 10 mg/kg every 8 weeks, 10 mg/kg every 6 weeks, and 10 mg/kg every 4 weeks, respectively. Dose escalation to 240 mg every other week led to recapture clinical remission in 93.3% (n = 14 of 15). Infliximab serum levels increased after the switch (P < .0001) except for patients receiving 10 mg/kg every 4 weeks. In multivariable analysis, 10 mg/kg every 4 weeks regimen (odds ratio, 12.4; 95% confidence interval, 1.6-98.4; P = .017) and fecal calprotectin >250 μg/g at baseline (odds ratio, 5.4; 95% confidence interval, 1.1-27.6; P = .042) had a higher risk of relapse as well as reduced (41.7%) or stable (36.8%) infliximab serum levels between baseline and visit 1 compared with increased serum levels (12.7%) (P = .020 and P = .019, respectively). Patients' acceptability (10-point scale) was improved by the switch (6.9 ± 1.6 vs 8.6 ± 1.4; P < .0001). No severe adverse event was reported., Conclusions: Switching from intravenous to subcutaneous infliximab 120 mg every other week is safe and well accepted, leading to a low risk of relapse in IBD patients except for those receiving 10 mg/kg every 4 weeks requiring 240 mg every other week., (Copyright © 2023 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Introduction: Loss of response to golimumab occurs in nearly 40% of patients with ulcerative colitis (UC). Unlike others anti-TNF, no study has reported a correlation between serum golimumab level and response to drug intensification. The objective of this study was to evaluate the effectiveness and safety of golimumab intensification and to identify the best threshold of serum golimumab before drug intensification predictive of response., Patients and Methods: We included all consecutive patients with active UC with loss of response to golimumab in a prospective multicentric cohort study. Patients with loss of response at 50 mg q4 weeks (W) and 100 mg q4W underwent therapeutic intensification at 100 mg q4W and 100 mg q2W, respectively. Effectiveness and safety were assessed between Weeks 2 and 4 (visit 2) and between Weeks 4 and 8 (visit 3) after intensification. Serum level and anti-golimumab antibodies were evaluated at each medical visit (Lisa Tracker, Theradiag France)., Results: A total of 47 UC patients (Female, 50%; median age, 39 years (IQR, 27-52)) treated with golimumab for a median of 20.4 weeks (IQR, 10.7-38.3) were included. The median partial Mayo score was 6 (IQR, 5-7), and the median endoscopic Mayo score was 3 (IQR, 2-3). The median golimumab serum level before intensification was 2.23 μg/mL (IQR, 1.02-3.96) and only one patient (2.1%) had anti-drug antibodies. At Visit 2 (Week 2-4), 40% patients experienced clinical response, 10% clinical remission, 33% endoscopic response and 23% endoscopic remission. At Visit 3 (Week 4-8), 44% of patients had clinical response, 22% of patients had clinical remission, 45% of patients had endoscopic response, and 41% of patients had endoscopic remission. The median golimumab levels before intensification do not differ between responders and non-responders (2.13 μg/ml (0.76-2.76) and 3.37 μg/ml (IQR, 1.08-4.67), respectively; p = 0.14) assessed at Visit 3. Golimumab intensification to 100 mg q4W (vs q2W) (OR 1.98, 95% CI [1.06-3.70]; p = 0.032) was significantly associated with clinical remission at Visit 3. Serum drug level at baseline or the presence of antidrug antibodies were not associated with clinical or endoscopic remission/response. Two serious adverse events (one infection and one UC flare) were reported during the 24-week follow-up., Conclusion: In this prospective multicentric study, half of patients recaptured response following golimumab intensification in UC. Therapeutic drug monitoring did not predict response after optimisation of golimumab., (© 2023 John Wiley & Sons Ltd.)

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.

Background: Data comparing tofacitinib and vedolizumab in ulcerative colitis (UC) are lacking., Aims: To compare the effectiveness of tofacitinib and vedolizumab in patients with UC who had prior exposure to anti-TNF therapy METHODS: In this multicentre study, we included consecutive patients with UC ≥18 years old with partial Mayo score >2 and prior anti-TNF exposure, who started tofacitinib or vedolizumab between January 2019 and June 2021. Comparisons were performed using propensity score analyses (inverse probability of treatment weighting)., Results: Overall, 126 and 178 patients received tofacitinib and vedolizumab, respectively. Intensified induction (vedolizumab infusion at week 10 or tofacitinib 10 mg b.d until week 16) was performed in 28.5% and 41.5% of patients, respectively. After propensity-score analysis, corticosteroid-free clinical remission (partial Mayo score ≤2) was achieved at week 16 in 45.1% and 40.2% of patients receiving tofacitinib and vedolizumab, respectively (aOR = 0.82 [0.35-1.91], p = 0.64). Endoscopic improvement (corticosteroid-free clinical remission and endoscopic Mayo score ≤1) (aOR = 0.23[0.08-0.65], p = 0.0032) and histological healing (endoscopic improvement + Nancy histological index ≤1) (13.4% vs 3.2%, aOR = 0.21[0.05-0.91], p = 0.023) were higher at week 16 in patients treated with tofacitinib. No factor was predictive of tofacitinib effectiveness. At least one primary failure to a biologic (OR = 0.46[0.22-0.99], p = 0.049), partial Mayo score >6 (OR = 0.39[0.17-0.90], p = 0.029) and CRP level > 30 mg/L at baseline (OR = 0.08[0.01-0.85], p = 0.036) were associated with vedolizumab failure., Conclusion: Tofacitinib and vedolizumab are effective in UC after failure of anti-TNF agents. However, tofacitinib seems more effective, especially in severe disease and primary failure to biologics., (© 2022 John Wiley & Sons Ltd.)

Cross-sectional magnetic resonance enterography (MRE) and intestinal ultrasonography (IUS) provide valuable and noninvasive information to accurately assess disease activity, severity, and extent; detect complications; and monitor the response to treatment, as well as predict the postoperative recurrence of Crohn's disease and a negative disease course. Therefore, both imaging modalities are emerging as pivotal diagnostic tools to achieve the emerging therapeutic target of transmural healing associated with better disease outcomes. Despite its numerous potential advantages over endoscopy and even MRE and its good availability, IUS is still widely underused to monitor and manage inflammatory bowel disease (IBD) patients and help in making clinical decisions in routine practice. This situation is clearly due to the absence of validated, reliable, and responsive indices, as well as the lack of trained gastroenterologists and radiologists, as IUS is a component of radiologist expertise in several countries but not yet integrated into the training program of gastroenterologists. However, there is an increasing body of evidence in the literature that IUS and MRE are both becoming essential imaging resources to help clinicians in making reliable decisions. Here, we discuss the up-to-date evidence about the usefulness and performance of cross-sectional imaging, focusing on the ability of bowel US and MRE to aid clinical decision-making for the optimal management and monitoring of IBD., Competing Interests: The authors declare that there is no conflict of interest., (© The Author(s), 2023.)

Background and Aim: Psoriatic arthritis (PsA) is a polymorphic disease associated with numerous comorbidities. The objective of this study was to describe the main clinicobiological and imaging characteristics of a population of PsA and to extract any disparities between men and women., Methods: A total of 132 patients in the rheumatology department of Amiens University Hospital with a confirmed diagnosis of PsA according to the CASPAR criteria were included over a period of 4 months. All data were collected retrospectively in this observational and single-center study., Results: The sex ratio was 1 and the average age at inclusion was 54.9 years. Peripheral PsA was the predominant clinical form. Axial PsA represented 12.1% of cases. Enthesitis was noted in 52.3% of cases while dactylitis was identified in 29.5% of cases. Moreover, 12.1% had a joint symptomatology preceding the appearance of cutaneous signs. HLA-B*27 positivity was found in 33.3% of cases. Chronic hyperuricemia accounted for 10% of our population. Sacroiliitis was observed in 41% of cases. The disparities between men and women are multiple and consistent with the literature: Polyarticular form, enthesitis, obesity, more intensive prescription of s-DMARDs, and b-DMARDs are more associated with the female population. Oligoarticular form, psoriatic nail dystrophy, radiological axial involvement, and chronic hyperuricemia are more encountered in the male population., Conclusions: Our study found a very heterogeneous disease, with marked differences between men and women. Peripheral PsA remains predominant but the search for associated axial involvement, which is probably underestimated, seems essential., Relevance for Patients: This work studied the main characteristics of patients with PsA followed in real life, in a regional university reference center. We have highlighted a very heterogeneous disease as well as some gender disparities, not well described in the literature, which should be taken into account in order to optimize therapeutic management., Competing Interests: The authors declare no competing interest on this study or its publication., (Copyright: © 2023 Author(s).)

Background: Phase III trials have demonstrated the efficacy of risankizumab in moderate-to-severe Crohn's disease (CD), but no real-world data are currently available. We aimed to assess the short-term effectiveness and safety of risankizumab in patients with CD., Methods: From May 2021 to May 2022, all patients with refractory luminal CD treated with risankizumab in 22 French GETAID centres were retrospectively included. The primary endpoint was steroid-free clinical remission at week 12 (Harvey-Bradshaw [HB] score <5). Secondary endpoints included clinical response (≥3-point decrease of HB score and/or (HB) score <5), biochemical remission (CRP ≤ 5 mg/L), need for CD-related surgery and adverse events., Results: Among the 100 patients included, all have been previously exposed to anti-TNF agents, 94 to vedolizumab, 98 to ustekinumab (all exposed to at least three biologics) and 61 had a previous intestinal resection. All but three (97%) received a 600 mg risankizumab intravenous induction at weeks 0-4-8. At week 12, steroid-free clinical remission was observed in 45.8% of patients, clinical remission in 58% and clinical response in 78.5%. In subgroup analysis restricted to patients with objective signs of inflammation at baseline (n = 79), steroid-free clinical remission at week 12 was observed in 39.2% of patients. Biochemical remission was observed in 50% of patients. Six patients discontinued risankizumab before the week 12 visit due to lack of efficacy. CD-related hospitalisation was needed in six patients, and three underwent intestinal resection. In multivariable analysis, only a history of ustekinumab loss of response (vs primary failure) (odds ratio (OR), 2.80; 95% CI: 1.07-7.82; p = 0.041) was significantly associated with clinical remission at week 12. Twenty adverse events (AE) occurred in 20 patients including 7 serious AE corresponding to 6 CD exacerbation and one severe hypertension., Conclusion: In a cohort of highly refractory patients with luminal CD and multiple prior drug failures including ustekinumab, risankizumab induction provided a clinical response in about 3 out of 4 patients and steroid-free clinical remission in about half of patients., (© 2022 John Wiley & Sons Ltd.)

Background: No study has performed a face-to-face comparison of biologics after the failure of the first anti-TNF agent in patients with Crohn's disease (CD). The aim of the study was to compare the efficacy of biologics in this setting., Methods: Patients with CD who were refractory to a first anti-TNF agent, and treated with ustekinumab (UST), vedolizumab (VDZ), or a second anti-TNF drug as a second-line biological agent at 10 French tertiary centres from 2013 to 2019 were retrospectively included in this study., Results: Among the 203 patients included, 90 (44%) received UST, 42 (21%) received VDZ and 71 (35%) received a second anti-TNF agent. The first anti-TNF agent was discontinued due to a primary nonresponse in 42 (21%) patients. At weeks 14-24, the rates of steroid-free remission were similar between the UST, VDZ and second anti-TNF groups (29%, 38% and 44%, respectively, p = 0.15). With a mean follow-up of 118 weeks, drug survival was shorter for patients who received ustekinumab treatment (p = 0.001). In the case of trough level less than 5 µg/ml, patients treated with a second anti-TNF agent had a higher postinduction remission rate (p = 0.002), and drug survival (p = 0.0005). No other relevant factors were associated with treatment efficacy, including trough levels greater than 5 µg/ml., Conclusions: VDZ, UST and a second anti-TNF agent exhibit similar efficacy in the short term, as second-biological line treatment in patients with CD who are refractory to a first anti-TNF agent, but shorter drug maintenance is observed for patients treated with UST., (© 2022. The Author(s).)

Background: In 2020, the European Medicines Agency approved infliximab subcutaneous (SC) for the treatment of inflammatory bowel disease. This new mode of infliximab administration will reduce outpatient visits and costs of intravenous (IV) administration. This article describes a budget impact analysis of introducing infliximab SC to the Big-5 European (E5) market (Germany, France, Italy, Spain and UK) for 5 years, from the healthcare payer's perspective., Methods: A prevalence-based budget impact model was developed to examine the financial impact of infliximab SC. "World with" versus "world without" infliximab SC scenarios were compared, including the potential administration costs of IV administration., Results: Introducing infliximab SC in patients with Crohn's disease (CD) for 5 years resulted in cost savings of €42.0 million in the UK, €59.4 million in Germany, and €46.4 million in France and Italy, but increased budget expenditure in Spain by €3.8 million. For ulcerative colitis (UC), cost savings of €42.7 million in the UK, €44.9 million in Germany, €44.3 million in France, and €53.0 million in Italy occurred, but with no savings in Spain for 5 years. Cost-savings per patient was calculated by diving the net budget saving by number of treatment eligible patients. Maximum and minimum saving per patient per year ranged between €38.25 and €575.74 in CD, both from Germany, and €105.06 (France) and €647.25 (Germany) in UC., Conclusion: Healthcare payers in the UK, Germany, France, and Italy, but not in Spain, will make budget savings by using infliximab SC for the treatment of inflammatory bowel disease., (© 2022. The Author(s).)

Background & Aims: We evaluated the impact of immunosuppressants (IS) and anti-tumor necrosis factor (TNF) introduction on Crohn's disease (CD) long-term outcomes in a large population-based, pediatric-onset cohort., Methods: All patients included in the EPIMAD registry with a diagnosis of CD occurring when they were younger than age 17 years and between 1988 and 2011 were followed up retrospectively until 2013. Three diagnostic periods were defined: 1988 to 1993 (period [P]1; pre-IS era), 1994 to 2000 (P2; pre-anti-TNF era), and 2001 to 2011 (P3; anti-TNF era). Medication exposure and disease outcomes were compared between the 3 diagnostic periods., Results: A total of 1007 patients diagnosed with CD were followed up for a median duration of 8.8 years (interquartile range, 4.6-14.2 y). The IS and anti-TNF exposure rate at 5 years increased over time from 33.9% (in P1) to 76.5% (in P3) and from 0% (in P1) to 50.5% (in P3), respectively. In parallel, the risk for intestinal resection at 5 years decreased significantly over time (P1, 35%; P2, 31%; and P3, 22%; P = .0003, Ptrend &lt; .0001), and between the pre-anti-TNF era (P1 + P2, 32%) and the anti-TNF era (P3, 22%) (P = .0007). The risk for progression from inflammatory to stricturing behavior decreased significantly over time (P1, 27%; P2, 28%; and P3, 20%; P = .11, Ptrend = .041) and between the pre-anti-TNF era (P1 + P2, 28%) and the anti-TNF era (P3, 20%) (P = .040). The risk for a CD flare-related hospitalization at 5 years remained stable over time (P1, 31%; P2, 31%; and P3, 29%; P = .76, Ptrend = .53)., Conclusions: In parallel with the increased use of IS and anti-TNF, positive changes in the natural history of pediatric-onset CD were observed at the population level. A decreased risk of both intestinal resections and stricturing complications were observed during the anti-TNF era., (Copyright © 2022 AGA Institute. Published by Elsevier Inc. All rights reserved.)

The development of an individual during fetal life and childhood is characterized by rapid growth as well as gradual maturation of organs and systems. Beyond the nutritional intake in essential nutrients, food contaminants can permanently influence the way organs mature and function. These processes are called "programming" and play an essential role in the occurrence of non-communicable chronic diseases throughout the lifespan. Populations as pregnant women, fetuses and young children are vulnerable and particularly sensitive to food contaminants which can induce epigenetic modifications transmissible to future generations. Among these contaminants, pesticides are found in most food matrices exposing humans to cocktails of molecules through variable concentrations and duration of exposure. The Maillard reaction products (MRPs) represent other food contaminants resulting from heat treatment of food. Modern diet, rich in fats and sugars, is also rich in neoformed pathogenic compounds, Advanced Glycation End products (AGEs), the levels of which depend on the heat treatment of foods and eating habits and whose effects on health are controversial. In this review, we have chosen to present the current knowledge on the impacts of selected pesticides and MRPs, on the risk of developing during life non-communicable chronic diseases such as IBD, metabolic disorders or allergies. A large review of literature was performed via Pubmed, and the most appropriate studies were summarised., (Copyright © 2022 Elsevier Ltd. All rights reserved.)