关键词： CT-P13   database search   IBD   infliximab biosimilar   post-marketing surveillance  

摘要： Background and Aim: CT-P13, an infliximab (IFX) biosimilar, was approved for treatment of inflammatory bowel disease. However, no comparison with the originator IFX in this indication has been conducted in Japan where endemic levels of tuberculosis and hepatitis virus infection are not low. We evaluated the safety and efficacy in real-world data of CT-P13 and compared with originator IFX data in Japan. Methods: In a prospective post-marketing surveillance (PMS) study, patients who received CT-P13 in a 28-month period from January 2015 were followed up for 2 years. By conducting Japanese administrative database search (DBS) for the same period of PMS, data of the originator IFX including treatment persistence, tuberculosis incidence, and liver injury were analyzed retrospectively and compared with the corresponding PMS data of CT-P13. Results: CT-P13 persistence in PMS (n = 640) and IFX persistence in DBS (n = 4113) were almost similar between patients who switched from the originator and patients who continued on the originator, and also between the biologics-naive patient groups. There were no differences in the incidences of tuberculosis and hepatic injury (Tuberculosis: 2 patients [0.31%] with CT-P13, 10 patients [0.24%] with the originator, P = 0.75;Hepatic injury: 18.5% with CT-P13, 15.4% with the originator, P = 0.22). Most of the patients with hepatic injury continued treatment in PMS and DBS at similar rates (80.8% vs 83.6%, P = 0.65). Conclusion: The results of long-term PMS of CT-P13 compared with external reference data from an administrative database suggested that the biosimilar and its originator were comparably useful in real-world clinical practice.

关键词： endoscopic submucosal dissection   focality   visible lesions   inflammatory bowel disease  

摘要： Aim Experience of endoscopic submucosal dissection (ESD) for colorectal lesions in the setting of inflammatory bowel disease (IBD) remains limited. The aim of this work was to determine the safety, feasibility and oncological outcomes of ESD in patients with IBD. Method A retrospective review of all adult patients (>= 18 years) with a known diagnosis of either ulcerative colitis (UC) or Crohn's disease (CD) who underwent advanced colonoscopy and ESD between 1 January 2014 and 1 October 2020. Data collected included patient demographics, disease characteristics, pathological variables and procedure-related complication rates. Results A total of 25 patients were included: 19 (76%) were male with a median age of 63 years and disease duration of more than 10 years. Sixteen had UC and nine had CD;the majority were taking corticosteroids, immunomodulators or monoclonal antibodies at the time of ESD. The median procedure time was 41 min and the majority (n = 18;72%) utilized chromoendoscopy. The median lesion size was 30 mm: eight had low-grade dysplasia, nine had high-grade dysplasia and three had adenocarcinoma and underwent oncological resection. None had surgical intervention for complication of ESD or perforation. A total of 23 (88%) had a complete R0 resection. Over a median follow-up of 19 months, three were found to have dysplasia excised in polyps and none had subsequent adenocarcinoma. Conclusion ESD in the setting of IBD is safe and effective for complete removal of large neoplastic lesions, allowing for ongoing endoscopic surveillance and organ preservation rather than surgical intervention.

关键词： Inflammatory Bowel Disease   Telemedicine   Disparities   COVID  

摘要： Background: Electronic messaging and telemedicine visits increased during the COVID pandemic. African-Americans and older patients have less frequently used electronic messaging with their physicians. This study compares the utilization of virtual health care before and during the COVID pandemic for inflammatory bowel disease (IBD) patients. Methods: A chart review of all IBD patients seen at an academic medical center from 2014-2020 was conducted to evaluate the use of telehealth options (e-messaging, e-visits) during a pre-COVID and COVID timeframe. Analysis of telehealth use from March - August 2018 and March - August 2020 was performed. Patient age, gender, race, IBD type, electronic messaging and telehealth visits were obtained. A confidential database was created. Statistical analysis was performed using Fisher Exact test with significance set at p < 0.05. The study was IRB approved. Results: 392 patients were in the pre-COVID cohort. There were 204 White, 99 African-American, 11 Asian, and 78 racially un-identified patients. 160 (40.8%) initiated E-communication with their physicians. There was a significant difference in the use of e-messaging based upon age (51.1% < 50 vs 39.7% >= 50;p = 0.0396) and race (62.3% White vs 28.2% African-American;p < 0.00001).There were no significant differences in the use of e-messaging based upon patient gender (p = 0.6840) or IBD type (p = 0.6374). There were 295 patients in the COVID cohort. There were 155 White, 83 African American patients, 24 Hispanic patients, 10 Asian patients, and 22 racially un-identified patients. 109 (36.9%) utilized a telehealth option (53 via e-messaging;56 via telemedicine visit). There was no significant difference in the use of a telehealth option based upon age (36.8% < 50 vs 37.25% >= 50 years;p = 1.00), race (42.6% White vs 35.9% African-American;p = 0.2693) or IBD type (p = 0.331). Males used telehealth more than females (46.1% vs 29.7%, respectively;p = 0.0051). Discussion: The COVID pan

摘要： Background Fatigue is the inability to achieve or maintain an expected work output resulting from central or peripheral mechanisms. The prevalence of inflammatory bowel disease (IBD) fatigue can reach 86% in active disease, persisting in 50%-52% of patients with mild to inactive disease. Fatigue is the commonest reason for work absence in IBD, and patients often report fatigue burden to be greater than that of primary disease symptoms. Relatively few evidence-based treatment options exist, and the aetiology is poorly understood. Aim To review the available data and suggest a possible aetiology of IBD fatigue and to consider the efficacy of existing management strategies and highlight potential future interventions. Methods We reviewed fatigue-related literature in IBD using PubMed database. Results Disease related factors such as inflammation and pharmacological treatments negatively impact skeletal muscle and brain physiology, likely contributing to fatigue symptoms. Secondary factors such as malnutrition, anaemia, sleep disturbance and psychological comorbidity are potential determinants. Immune profile, faecal microbiota composition and physical fitness differ significantly between fatigued and non-fatigued patients, suggesting these may be aetiological factors. Solution-focused therapy, high-dosage thiamine supplementation and biological therapy may reduce fatigue perception in IBD. The effect of physical activity interventions is inconclusive. Conclusions A multimodal approach is likely required to treat IBD fatigue. Established reversible factors like anaemia, micronutrient deficiencies and active disease should initially be resolved. Psychosocial intervention shows potential efficacy in reducing fatigue perception in quiescent disease. Restoring physical deconditioning by exercise training intervention may further improve fatigue burden.

关键词： Candida albicans   candidosis   immunomodulatory therapy   inflammatory bowel disease   inflammatory rheumatic disease   microbiota   preterm birth   vulvovaginal infection  

摘要： Background Rheumatic diseases and vaginal infections both increase the risk of preterm birth. It is unclear whether pregnant women with rheumatic disease are more likely to experience vaginal infections, which might potentially accumulate modifiable risk factors. Objective In this study, we sought to evaluate the vaginal microbiota of pregnant women with inflammatory rheumatic and inflammatory bowel disease. Methods A total of 539 asymptomatic women with singleton pregnancy were routinely screened for an abnormal vaginal microbiota between 10 + 0 and 16 + 0 gestational weeks. Vaginal smears were Gram-stained and microscopically analysed. Those with inflammatory diseases (with or without immunomodulatory therapy) were assigned to the case group and matched in a 1:3 ratio to healthy pregnant controls. Results Overall, an abnormal vaginal microbiota occurred more frequently among women of the case group, compared with those of the control group (33.8% vs 15.6%;95% CI: 1.78-4.27, p < .001). In particular, Candida colonisation (22.3% vs 9.2%;95% CI: 1.69-4.75, p < .001), but also bacterial vaginosis (14.9% vs 7.2%;95% CI: 1.25-4.1, p = .006), occurred more often in the case than in the control group. No significant difference was found with regard to the occurrence of an abnormal vaginal microbiota between subgroups with and without immunomodulatory treatment (37.0% vs 27.1%;95% CI: 0.29-1.35, p = .232). Conclusion Pregnant women with inflammatory rheumatic and inflammatory bowel disease are at risk for bacterial vaginosis and Candida colonisation, which might pose a risk for preterm birth. Prospective studies are needed to further evaluate the influence of autoimmune conditions and immunosuppressive therapy on the vaginal microbiota.

关键词： Prebiotics   Crohn's disease   Microbiota   Pre-disease   First-degree relative   Prevention  

摘要： Background & aims: Siblings of people with Crohn's disease (CD) share aspects of the disease phenotype (raised faecal calprotectin, altered microbiota), which are markers of risk for their own development of CD. The aim was to determine whether supplementation with prebiotic oligofructose/inulin induces a prebiotic response and impacts the risk phenotype in CD patients and siblings. Methods: Patients with inactive CD (n = 19, CD activity index <150) and 12 of their unaffected siblings (with calprotectin >50 mg/g) ingested oligofructose/inulin (15 g/day) for three weeks. Faecal microbiota (qPCR), intestinal permeability (lactulose-rhamnose test), blood T cells (flow-cytometry) and calprotectin (ELISA) were measured at baseline and follow-up. Results: Following oligofructose/inulin, calprotectin did not significantly change in patients (baseline mean 537 SD 535 mg/g;follow-up mean 974 SD 1318 mg/g, p = 0.08) or siblings (baseline mean 73 SD 90 mg/g: follow up mean 58 SD 72 mg/g, p = 0.62). Faecal Bifidobacteria and Bifidobacterium longum increased in patients and siblings;Bifidobacterium adolescentis and Roseburia spp. increased only in siblings. Compared with patients, siblings had a greater magnitude change in Bifidobacteria (+14.6% vs +0.4%, p = 0.028), B. adolescentis (+1.1% vs 0.0% p = 0.006) and Roseburia spp. (+1.5% vs -0.1% p = 0.004). Intestinal permeability decreased significantly in patients after oligofructose/inulin to a level that was similar to siblings. Blood T cell abundance reduced in siblings but not patients following oligofructose/inulin. Conclusions: Oligofructose/inulin supplementation did not significantly impact calprotectin, but the prebiotic effect was more marked in healthy siblings compared with patients with inactive CD and was associated with alterations in other CD risk markers. Future research should focus on dietary intervention, including with prebiotics, in the primary prevention of CD. (c) 2021 Elsevier Ltd and European Society for

摘要： Background Data about thiopurines or anti-TNF use during pregnancy in women with inflammatory bowel diseases (IBD) are reassuring. However, many studies are based upon small sample sizes. Aims To assess IBD medication safety during pregnancy. Methods Using the French national health database, which covers more than 99% of the French population, around 65 000 000 people, we identified pregnancies ending with a birth in IBD patients in France between 2010 and 2018. Pregnancy outcomes (vital status at birth, birth term, and weight for gestational age) were compared according to treatment exposure during pregnancy using propensity score-weighted marginal logistic regression models. Results 27 729 pregnancies were included: 3554 were exposed to thiopurines monotherapy, 3525 to anti-TNF monotherapy, 839 to combination therapy, and 19 811 unexposed. Pregnancies exposed to thiopurines monotherapy compared to unexposed pregnancies more frequently resulted in stillbirths (1.0% vs 0.5%, aOR 2.04;95%CI: 1.18-3.55), preterm birth (12.3% vs 7.1%, aOR 1.76;95%CI: 1.55-2.00), large for gestational age (10.6% vs 8.4%, aOR 1.32;95%CI: 1.13-1.53) and less frequently in small for gestational age (9.6% vs 11.1%, aOR 0.79;95%CI: 0.67-0.92). By contrast, pregnancies exposed to anti-TNF monotherapy were not different from unexposed pregnancies as regards to these outcomes. Compared to unexposed pregnancies, those exposed to combination therapy more frequently resulted in preterm births (aOR 1.55;95%CI: 1.15-2.11) and larger for gestational age (aOR 1.61;95%CI: 1.13-2.29) but did not differ as regards to stillbirths. Conclusions Pregnancies exposed to thiopurines more frequently resulted in stillbirths, preterm births and large for gestational age compared to pregnancies exposed to anti-TNF or unexposed pregnancies. By contrast, pregnancies exposed to anti-TNF monotherapy were not associated with these outcomes.

关键词： ACIP   anti-TNF   BCG   CAG   CDC   CoE   GRADE   HZ   IBD   MMR   NACI   VZV   VPD   WHO  

摘要： Background & Aims: Patients with inflammatory bowel disease (IBD) may be at increased risk of some vaccine-preventable diseases. The effectiveness and safety of vaccinations may be altered by immunosuppressive therapies or IBD itself. These recommendations developed by the Canadian Association of Gastroenterology and endorsed by the American Gastroenterological Association, aim to provide guidance on immunizations in adult and pediatric patients with IBD. This publication focused on live vaccines. Methods: Systematic reviews evaluating the efficacy, effectiveness, and safety of vaccines in patients with IBD, other immune-mediated inflammatory diseases, and the general population were performed. Critical outcomes included mortality, vaccine-preventable diseases, and serious adverse events. Immunogenicity was considered a surrogate outcome for vaccine efficacy. Certainty of evidence and strength of recommendations were rated according to the GRADE (Grading of Recommendation Assessment, Development, and Evaluation) approach. Key questions were developed through an iterative process and voted on by a multidisciplinary panel. Recommendations were formulated using the Evidence-to-Decision framework. Strong recommendation means that most patients should receive the recommended course of action, whereas a conditional recommendation means that different choices will be appropriate for different patients. Results: Three good practice statements included reviewing a patient's vaccination status at diagnosis and at regular intervals, giving appropriate vaccinations as soon as possible, and not delaying urgently needed immunosuppressive therapy to provide vaccinations. There are 4 recommendations on the use of live vaccines. Measles, mumps, rubella vaccine is recommended for both adult and pediatric patients with IBD not on immunosuppressive therapy, but not for those using immunosuppressive medications (conditional). Varicella vaccine is recommended for pediatric patients with

关键词： psoriasis   ulcerative colitis   Crohn’   s disease   biologic drugs  

摘要： Psoriasis and inflammatory bowel disease (IBD) are immune-mediated diseases occurring in barrier organs whose main task is to protect the organism from attack. These disorders are highly prevalent especially in northern Europe where psoriasis has a prevalence of around 3-4% and IBD around 0.3%. The prevalence of IBD in North America has been estimated at around 0.4%. The total incidence rates in northern Europe have been estimated at around 6 for Crohn's disease and 11 for ulcerative colitis per 100 000 person-years, compared with an incidence rate of around 280 per 100 000 person-years for psoriasis. Both diseases are less common in countries with a lower index of development. The rise in IBD appears to occur as populations adopt a westernized lifestyle, whereas psoriasis seems more stable and prevalence differences may derive more from variation in genetic susceptibility. The gut microbiota is clearly an important driver of IBD pathogenesis;in psoriasis, changes in gut and skin microbiota have been reported, but it is less clear whether and how these changes contribute to the pathogenesis. Large studies show that most identified genes are involved in the immune system. However, psoriasis and IBD are highly heterogeneous diseases and there is a need for more precise and deeper phenotyping to identify specific subgroups and their genetic, epigenetic and molecular signatures. Epigenetic modifications of DNA such as histone modifications, noncoding RNA effects on transcription and translation and DNA methylation are increasingly recognized as the mechanism underpinning much of the gene-environment interaction in the pathogenesis of both IBD and psoriasis. Our understanding of underlying pathogenetic mechanisms has deepened fundamentally over the past decades developing hand in hand with novel therapies targeting pathways and proinflammatory cytokines incriminated in disease. There is not only substantial overlap between psoriasis and IBD, but also there are difference

关键词： IBD   CD   UC   Inflammation   Diet ingredients  

摘要： Purpose Non-specific inflammatory bowel diseases (IBD) include Crohn's disease and ulcerative colitis. More and more often attention is paid to the possibility of dietary support for inflammatory bowel diseases. Methods The following review article considers the role of dietary components in the treatment of IBD as: pteridines, probiotics, bovine immunoglobulin, vitamin D, omega-3, flavonoids, polyphenols, curcumin and phosphatidylcholine. The article also discusses plant raw materials of arjuna, soy protein and nettles, trying to summarize their effect on quenching the inflammatory process within the intestines. This review focuses on the possibilities of dietary components and supplementation use to improve the pharmacotherapy response as well as the general clinical patients' condition. Results The mechanism of action of supportive therapy is based on reduction in oxidative stress, maintaining the adequate balance between Th1 and Th2 lymphocytes by affecting cytokines, increasing riboflavin supply for macrophages, increasing expression of vitamin D receptor, regulation by decreasing the expression of NF-kappa B in liver cells and ability to inhibit the COX2 entrance and inactivate prostaglandins that are involved in the inflammatory process and 12-lipoxygenase pathway inhibition. Conclusion Considering clinical researches, it seems that the use of the above-mentioned ingredients in the diet of patients suffering IBD may positively influence the treatment process and maintenance of remission.