scholarly journals Efficacy of anti-TNF dosing interval lengthening in adolescents and young adults with inflammatory bowel disease in sustained remission (FREE-study): protocol for a partially randomised patient preference trial

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e054154
Author(s):  
Marleen Bouhuys ◽  
Willem S Lexmond ◽  
Gerard Dijkstra ◽  
Triana Lobatón ◽  
Edouard Louis ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Patient Preference ◽  
Bowel Disease ◽  
Cumulative Incidence ◽  
Young Patients ◽  
Control Group ◽  
Sustained Remission ◽  
Dosing Interval ◽  
Inflammatory Bowel ◽  
Preference Trial

IntroductionAnti-tumour necrosis factor (TNF) therapy has greatly improved treatment outcomes in patients with inflammatory bowel disease (IBD), but long-term use is associated with cutaneous reactions, susceptibility to infections and frequent injections or hospital visits. Several non-controlled studies have demonstrated that dose reduction is feasible for a subset of patients, provided that early detection of a disease flare is possible. Here, we aim to compare the effectiveness of interval lengthening with standard dosing in maintaining remission in young patients with IBD.Methods and analysisIn this international, prospective, non-inferiority, partially randomised patient preference trial, we aim to recruit 148 patients aged 12–25 years with luminal Crohn’s disease or ulcerative colitis in sustained remission (ie, three consecutive in-range faecal calprotectin (FC) results or recently confirmed endoscopic remission). In the interventional arm, the dosing interval will be lengthened from 8 to 12 weeks for infliximab users and from 2 to 3 weeks for adalimumab users. In the control group, standard dosing will be continued. Rapid tests will be performed for FC every 4 weeks and for anti-TNF trough levels every 12 weeks. The primary outcome is the cumulative incidence of out-of-range FC results at 48-week follow-up. Secondary endpoints include time to get out-of-range FC results, cumulative incidence of adverse effects, proportion of patients progressing to loss of response and identification of predictors of successful interval lengthening.Ethics and disseminationThe protocol has been approved by the Medical Ethics Review Committee of the University Medical Centre Groningen and is pending at the other participating centres. Results will be disseminated in peer-reviewed journals and presented at scientific meetings.Trial registration numberEudraCT number: 2020-001811-26; ClinicalTrials.gov Identifier: NCT04646187. Protocol version 4, date 17 September 2021.

Immunosuppression following liver transplantation and the course of inflammatory bowel disease – a case control study

2017 ◽  
Vol 56 (02) ◽  
pp. 117-127 ◽  
Author(s):  
Martina Mogl ◽  
Daniel Baumgart ◽  
Andreas Fischer ◽  
Johann Pratschke ◽  
Andreas Pascher
Keyword(s):  
Inflammatory Bowel Disease ◽  
Liver Transplantation ◽  
Mycophenolate Mofetil ◽  
Bowel Disease ◽  
Control Group ◽  
Sustained Remission ◽  
Short Term ◽  
Surgical Interventions ◽  
Inflammatory Bowel

Abstract Aim The aim of this study was to investigate the influence of immunosuppression following orthotopic liver transplantation (OLT) on course of inflammatory bowel disease (IBD) including disease activity and complications. Methods Out of 1168 patients undergoing liver transplantation between 1988 and 2000 at our center, we identified those with IBD (n = 67). In a comparative cohort study, IBD patients after OLT were compared to controls without OLT. All drugs including immunosuppressive and anti-inflammatory medication and complications during follow-up were recorded in 6-month intervals. Also, surgical interventions before and after OLT as well as endoscopic interventions with macroscopic and microscopic findings were collected and analyzed. Additionally, development of malignant neoplasias was recorded. Results Of the 67 individuals with IBD and OLT, 41 were available for analyses and compared with 42 controls. The mean follow-up was 7.4 (range: 3 – 15) years. Short-term therapy with calcineurin inhibitors or mycophenolate mofetil led to short-term remission, yet sustained remission could only be achieved in patients receiving mycophenolate mofetil. At 14.5 years, clinical remission was reached by significantly more patients in the transplant group (54 %) than in the control group (33 %, p = 0.0295). Patients in the control group required nearly 2 times as many surgical interventions related to IBD than patients in the transplant group. Neoplasias were more common in the OLT (n = 8) compared with 4 solid organ cancers in the control group, respectively. Conclusions Our data demonstrate an overall positive impact of immunosuppression following OLT on the course of IBD, especially with mycophenolate mofetil, but an increased rate of malignancies.

scholarly journals Dental and periodontal disease in patients with inflammatory bowel disease

2021 ◽  
Author(s):  
Christopher X. W. Tan ◽  
Henk S. Brand ◽  
Bilgin Kalender ◽  
Nanne K. H. De Boer ◽  
Tymour Forouzanfar ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Periodontal Disease ◽  
Bowel Disease ◽  
Health Problems ◽  
Control Group ◽  
Age And Gender ◽  
Preventive Dental Care ◽  
Dmft Index ◽  
Inflammatory Bowel ◽  
And Gender

Abstract Objectives Although bowel symptoms are often predominant, inflammatory bowel disease (IBD) patients can have several oral manifestations. The aim of this study was to investigate the prevalence of dental caries and periodontal disease in patients with Crohn’s disease (CD) and ulcerative colitis (UC) compared to an age and gender-matched control group of patients without IBD. Material and methods The DMFT (Decayed, Missing, Filled Teeth) scores and the DPSI (Dutch Periodontal Screening Index) of 229 IBD patients were retrieved from the electronic health record patient database axiUm at the Academic Centre for Dentistry Amsterdam (ACTA) and were compared to the DMFT scores and DPSI from age and gender-matched non-IBD patients from the same database. Results The total DMFT index was significantly higher in the IBD group compared to the control group. When CD and UC were analyzed separately, a statistically significant increased DMFT index was observed in CD patients but not in UC patients. The DPSI did not differ significantly between the IBD and non-IBD groups for each of the sextants. However, in every sextant, IBD patients were more frequently edentulous compared to the control patients. Conclusion CD patients have significantly more dental health problems compared to a control group. Periodontal disease did not differ significantly between IBD and non-IBD groups as determined by the DPSI. Clinical relevance It is important that IBD patients and physicians are instructed about the correlation between their disease and oral health problems. Strict oral hygiene and preventive dental care such as more frequent checkups should be emphasized by dental clinicians.

Kannabiszszármazékok használatának gyakorisága gyulladásos bélbetegségben

2021 ◽  
Vol 162 (12) ◽  
pp. 443-448
Author(s):  
Gábor Xantus ◽  
V. Anna Gyarmathy
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
English Language ◽  
Pain Perception ◽  
The United States ◽  
Epidemiological Studies ◽  
Cannabis Use ◽  
Control Group ◽  
Cross Sectional ◽  
Inflammatory Bowel

Összefoglaló. Gyulladásos bélbetegségben (IBD) a fájdalomérzés komplex szomatikus és pszichés jelenség. Ez utóbbi komponens pontosabb megértése segíthet a megfelelő kezelési stratégia megállapításában. A szorongásos hangulati zavarok és egyes maladaptív viselkedési minták (dohányzás és alkoholfogyasztás) előfordulási gyakorisága jól dokumentált IBD-ben, a kannabiszhasználat hatása ugyanakkor kevésbé ismert. A szerzők szisztematikus áttekintést végeztek annak megértéséhez, hogy vajon magasabb-e a marihuánahasználat gyakorisága felnőtt IBD-s betegek között egészséges kontrollpopulációhoz viszonyítva, és ha igen, akkor melyek a szerhasználat legfontosabb jellemzői. A kutatási periódust szándékosan az elmúlt 7 évre korlátoztuk, ugyanis 2013-tól jelentős változások álltak be a kannabinoidok jogi és orvosi megítélésében az USA-ban. Öt elsődleges és több másodlagos adatbázisban kutattunk előre meghatározott kulcsszavak segítségével 2013 óta teljes szöveggel megjelent, angol nyelvű felnőtt IBD-s populációt vizsgáló epidemiológiai tanulmányok vonatkozásában. 143 rekord közül 7 cikk felelt meg a beválogatási kritériumoknak. Eredményeink szerint a kannabiszhasználat gyakorisága IBD-ben szenvedő felnőtt betegek körében valószínűleg magasabb, mint a kontrollpopulációban: a „valaha, bármikor” használók aránya 54–70% között változott (szemben a 46–60% gyakorisággal a kontrollcsoportban), míg az „aktív használók” esetén a gyakoriság 6,8–25% között változott (vs. a kontrollcsoportban tapasztalt 8,6–14%-kal). A prevalenciaadatok széles variabilitása arra utal, hogy a beválogatott epidemiológiai tanulmányok valószínűleg vagy nem voltak megfelelően tervezve, vagy jelentős heterogenitással bírtak. A pszichés tényezők ellentmondásos mintája azt sugallja, hogy a kannabinoidok egyes esetekben ronthatták, más esetben valószínűleg javították bizonyos prominens tünetek megélését. Javasoljuk ezért, hogy a valós prevalencia megállapítása érdekében a keresztmetszeti vizsgálatok mellé ismételt pszichometriai vizsgálatokon alapuló vizsgálatok is bekerüljenek a további kutatásba. Orv Hetil. 2021; 162(12): 443–448. Summary. Pain perception in inflammatory bowel disease (IBD) is beyond a purely somatic process. In-depth understanding of psychologic elements might enable more effective management in this patient group. Anxiety disorders and certain maladaptive coping strategies like smoking and alcohol consumption are well-documented in IBD, unlike the scarcely researched cannabis use. The authors designed a systematic review, to investigate if the prevalence of cannabis use is higher in IBD that in unselected controls. The research window was intentionally set to cover for the past 7 years, as in 2013 major legislative changes took place in the cannabis decriminalisation process in the United States. 5 primary and several secondary databases were researched with a pre-formulated algorithm registered at PROSPERO for full text epidemiological studies published in English language involving adult IBD patients. Out of 143 records, 7 articles met the in/exclusion criteria. Our results suggest that cannabis use among adult patients with IBD is likely to be higher than in the unselected control population. The proportion of “ever” users varied from 54% to 70% (vs. 46–60% in the control group); and for ‘active users’, the prevalence ranged between 6.8% to 25% (vs. 8.6–14% in the control group). The wide variability in prevalence data suggests that the selected epidemiological studies were either inappropriately designed or were too heterogeneous (or both). The contradictory pattern of psychological factors suggests that cannabinoids might improve or worsen IBD depending on case by case basis. We therefore opine that in addition to cross-sectional papers, studies based on repeated psychometric analysis are needed to establish the real prevalence and inform cannabinoid prescription and holistic management in inflammatory bowel disease. Orv Hetil. 2021; 162(12): 443–448.

scholarly journals P509 Vedolizumab levels in breast milk: Results from a prospective, postmarketing, milk-only lactation study in nursing mothers with inflammatory bowel disease

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S442-S442 ◽  
Author(s):  
W Sun ◽  
B Fennimore ◽  
D B Beaulieu ◽  
R Arsenescu ◽  
A Stein ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Breast Milk ◽  
Serum Concentration ◽  
Bowel Disease ◽  
Geometric Mean ◽  
Dosing Interval ◽  
Milk Samples ◽  
Inflammatory Bowel ◽  
Tract Infections ◽  
The Impact

Abstract Background The safety of inflammatory bowel disease (IBD) medications during lactation is of significant interest and relevance to female patients of childbearing potential. Available data regarding the safety and transfer of biologic agents via breast milk are limited to case reports. Vedolizumab has a well-established, positive benefit-risk profile in adult IBD patients. Literature data show that vedolizumab is detectable in human milk. Methods A prospective, postmarketing, phase 4, open-label, milk-only lactation study was conducted to assess vedolizumab concentrations in breast milk from lactating women with IBD who were on an established vedolizumab maintenance regimen (300 mg intravenous [IV] every 8 weeks [Q8W] or an alternative dose frequency). Maternal milk samples were serially collected throughout the dosing interval on Days 1 (predose and 1 h after the end of vedolizumab infusion), 4, 8, 15, 29, and 57 to allow the estimation of drug excreted in milk relative to the maternal dosage. Maternal safety data were also collected. Results A total of 11 patients were enrolled in the study. Vedolizumab was detectable in the majority of milk samples collected on Days 1 and 57, and in all samples collected at other time points. Following receipt of vedolizumab 300 mg IV on Day 1, the vedolizumab milk concentration increased with a median time to peak concentration (Cmax) of 3–4 days, and subsequently decreased exponentially. For the 9 patients on the Q8W regimen, median Cmax was 0.213 µg/ml (range, 0.098–0.561 µg/ml); the geometric mean daily infant dosage, calculated using average concentration over 8-week dosing interval (0.13 µg/ml), was 0.02 mg/kg/day with a corresponding geometric mean percentage of maternal dosage consumed in breast milk by infants of 21%. The maternal safety profile was acceptable and similar to that observed in previous adult studies. Leveraging the mean trough serum concentration of 11.2 µg/ml from historical studies of vedolizumab, the ratio of mean milk concentration (trough, 0.05 µg/ml; peak, 0.25 µg/ml) to serum concentration was approximately 0.4%-2.2%, which is consistent with published data for vedolizumab and comparable with several other monoclonal antibody therapeutics for IBD. Published vedolizumab studies also showed no increase in general or gastrointestinal tract infections in the infants exposed to vedolizumab in breast milk, and exposed infants reached their acceptable development milestones through up to 10 months of follow-up. Conclusion Vedolizumab was found to be present in human breastmilk at a low level. The impact of vedolizumab IV administration during breastfeeding is expected to be minimal.

scholarly journals Therapeutic potential of mature adipocyte-derived dedifferentiated fat cells for inflammatory bowel disease

2020 ◽  
Vol 36 (7) ◽  
pp. 799-807
Author(s):  
Shigeki Ishioka ◽  
Takashi Hosokawa ◽  
Taro Ikeda ◽  
Noriyoshi Konuma ◽  
Hide Kaneda ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Cell Proliferation ◽  
T Cell ◽  
Cell Transplantation ◽  
Bowel Disease ◽  
T Cell Proliferation ◽  
Control Group ◽  
Mature Adipocyte ◽  
Inflammatory Bowel ◽  
Dfat Cells

Abstract Purpose Our previous studies demonstrated that mature adipocyte-derived dedifferentiated fat (DFAT) cells possess similar multipotency as mesenchymal stem cells. Here, we examined the immunoregulatory potential of DFAT cells in vitro and the therapeutic effect of DFAT cell transplantation in a mouse inflammatory bowel disease (IBD) model. Methods The effect of DFAT cell co-culture on T cell proliferation and expression of immunosuppression-related genes in DFAT cells were evaluated. To create IBD, CD4+CD45RBhigh T cells were intraperitoneally injected into SCID mice. One week later, DFAT cells (1 × 105, DFAT group) or saline (Control group) were intraperitoneally injected. Subsequently bodyweight was measured every week and IBD clinical and histological scores were evaluated at 5 weeks after T cell administration. Results The T cell proliferation was inhibited by co-cultured DFAT cells in a cell density-dependent manner. Gene expression of TRAIL, IDO1, and NOS2 in DFAT cells was upregulated by TNFα stimulation. DFAT group improved IBD-associated weight loss, IBD clinical and histological scores compared to Control group. Conclusion DFAT cells possess immunoregulatory potential and the cell transplantation promoted recovery from colon damage and improved clinical symptoms in the IBD model. DFAT cells could play an important role in the treatment of IBD.

scholarly journals Trends of Liver Stiffness in Inflammatory Bowel Disease with Chronic Hepatitis C

Diagnostics ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. 1037
Author(s):  
Giuseppe Losurdo ◽  
Andrea Iannone ◽  
Antonella Contaldo ◽  
Michele Barone ◽  
Enzo Ierardi ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Hepatitis C ◽  
Bowel Disease ◽  
Antiviral Treatment ◽  
Sustained Viral Response ◽  
Liver Stiffness ◽  
Control Group ◽  
Viral Response ◽  
Inflammatory Bowel ◽  
One Year

Concomitant inflammatory bowel disease (IBD) and hepatitis C virus (HCV) infection is a relevant comorbidity since IBD itself exposes to a high risk of liver damage. We aimed to evaluate liver stiffness (LS) in IBD-HCV after antiviral treatment. We enrolled IBD patients with HCV. All patients at baseline underwent LS measurement by elastography. Patients who were eligible for antiviral therapy received direct antiviral agents (DAAs) and sustained viral response was evaluated at the 12th week. A control group was selected within IBD patients without HCV. One year later, all IBD-HCV patients and controls repeated LS measurement. Twenty-four IBD-HCV patients and 24 IBD controls entered the study. Only twelve out of 24 received DAAs and all achieved sustained viral response (SVR). All IBD subjects were in remission at enrollment and maintained remission for one year. After one year, IBD patients who eradicated HCV passed from a liver stiffness of 8.5 ± 6.2 kPa to 7.1 ± 3.9, p = 0.13. IBD patients who did not eradicate HCV worsened liver stiffness: from 7.6 ± 4.4 to 8.6 ± 4.6, p = 0.01. In the IBD control group, stiffness decreased from 7.8 ± 4.4 to 6.0 ± 3.1, p < 0.001. In conclusion, HCV eradication is able to stop the evolution of liver fibrosis in IBD, while failure to treat may lead to its progression. A stable IBD remission may improve LS even in non-infected subjects.

scholarly journals P264 Analysis of nutritional status and nutrient intake in patients with inflammatory bowel disease: a prospective, case–control study

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S282-S282
Author(s):  
Y E YOON ◽  
H M Kim ◽  
J H Kim ◽  
Y H Youn ◽  
H J Park ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Nutritional Status ◽  
Energy Intake ◽  
Body Fat ◽  
Bowel Disease ◽  
Nutrient Intake ◽  
Asia Pacific ◽  
Control Group ◽  
Fat Percentage ◽  
Inflammatory Bowel

Abstract Background Anthropometric data and dietary intake pattern are poorly known in Asian inflammatory bowel disease (IBD) patients. The aim of this study was to investigate the nutritional status and nutrient intake of IBD patients compared with control population. Methods From February to June 2018, a total of 65 outpatients, including 33 ulcerative colitis (UC) and 32 Crohn’s disease (CD) were prospectively enrolled in Gangnam Severance Hospital. As a control group, age- and gender-matched 260 subjects were included among the Korean National Health and Nutrition Examination Survey (KNHANES) data. Anthropometry and body composition data were collected by bioelectrical impedance analysis(BIA); meanwhile, nutrient intake was measured based on diet diary. Results Based on Asia Pacific criteria, more than half of both UC and control group were obese or overweight, on the other hands, CD was relatively low, about 1/3. Compared with the UC group, body fat index including both fat mass index (FMI) and body fat percentage (BFP) were significantly lower in the CD group. Following nutrients intake including intake of energy, carbohydrate, niacin, sodium and potassium were significantly lower in UC than the control group. Meanwhile, intake of carbohydrate, thiamine, niacin, sodium, potassium and iron was significantly lower in CD than the control group. In addition, the ratio of energy intake through protein and fat was significantly higher in the IBD than the control group. Conclusion Similar to the control group, more than half of UC patients were overweight or obesity, meanwhile, the proportion of obese patients in CD was lower than in the control group. The ratio of energy intake through protein and fat was significantly higher in IBD than in the control group. Our results may have clinical implications for risk of IBD development in terms of dietary pattern and further direction of nutritional intervention.

scholarly journals Work Productivity Loss in Inflammatory Bowel Disease Patients in Turkey

2020 ◽  
Vol 2020 ◽  
pp. 1-6 ◽  
Author(s):  
Firdevs Topal ◽  
Hakan Camyar ◽  
Elif Saritas Yuksel ◽  
Suleyman Gunay ◽  
Fatih Topal ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Online Survey ◽  
Productivity Loss ◽  
Young Patients ◽  
Significant Difference ◽  
Inflammatory Bowel ◽  
The Impact

Background. Beyond the medical treatment in inflammatory bowel disease (IBD), there are other issues which influence the quality of life adversely. The aim of this study was to determine the impact of the IBD patients’ illness on working and education life. Method. The participants were invited to participate in the online survey from the Turkish Crohn’s and Ulcerative Colitis Patient Association network. The data was analysed and then discussed to improve the health-related quality of working and education life. Results. One hundred and fifteen patients had ulcerative colitis (UC) (57.2%), and 86 had Crohn’s disease (CD) (42.8%). There was a statistically significant difference in UC between retirement age group 1 (<40 age) and groups 2 (40-49 ages) and 4 (60-65 ages) (p<0.05). There was the same significant difference in CD. Even though the data did not have significant statistical difference, there was clustering around negative perceptions the patients have about their working and education lives. Conclusion. Our survey revealed a very strong causative relationship between work and IBD involving problems before, during, and at the end of employment. Young patients lower their career expectations, and that announces a clear need to support them and improve career guidance.

Sa1768 A MAJORITY OF YOUNG PATIENTS WITH INFLAMMATORY BOWEL DISEASE HAVE SUSTAINED IMMUNITY TO HEPATITIS B

2020 ◽  
Vol 158 (6) ◽  
pp. S-415-S-416
Author(s):  
Dana Ley ◽  
Mary S. Hayney ◽  
Sumona Saha ◽  
Ian C. Grimes ◽  
Ryan Smith ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Hepatitis B ◽  
Bowel Disease ◽  
Young Patients ◽  
Inflammatory Bowel

scholarly journals Inflammatory Bowel Disease in Children of Middle Eastern Descent

2014 ◽  
Vol 2014 ◽  
pp. 1-7 ◽  
Author(s):  
Christina Mai Ying Naidoo ◽  
Steven T. Leach ◽  
Andrew S. Day ◽  
Daniel A. Lemberg
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Middle Eastern ◽  
Control Group ◽  
Colonic Disease ◽  
Disease Course ◽  
Age And Gender ◽  
Inflammatory Bowel ◽  
And Gender ◽  
And Behavior

Increasing rates of inflammatory bowel disease (IBD) are now seen in populations where it was once uncommon. The pattern of IBD in children of Middle Eastern descent in Australia has never been reported. This study aimed to investigate the burden of IBD in children of Middle Eastern descent at the Sydney Children’s Hospital, Randwick (SCHR). The SCHR IBD database was used to identify patients of self-reported Middle Eastern ethnicity diagnosed between 1987 and 2011. Demographic, diagnosis, and management data was collected for all Middle Eastern children and an age and gender matched non-Middle Eastern IBD control group. Twenty-four patients of Middle Eastern descent were identified. Middle Eastern Crohn’s disease patients had higher disease activity at diagnosis, higher use of thiopurines, and less restricted colonic disease than controls. Although there were limitations with this dataset, we estimated a higher prevalence of IBD in Middle Eastern children and they had a different disease phenotype and behavior compared to the control group, with less disease restricted to the colon and likely a more active disease course.

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