Tu1113 Fecal Microbial Composition of Inflammatory Bowel Disease (IBD) Patients With Changing Disease Activity Over Time

2013 ◽  
Vol 144 (5) ◽  
pp. S-765-S-766
Author(s):  
Edgar Wills ◽  
Daisy Jonkers ◽  
Paul Savelkoul ◽  
Marie J. Pierik ◽  
Ad Masclee ◽  
...  
2016 ◽  
Vol 52 (3) ◽  
pp. 344-350 ◽  
Author(s):  
Karin Amcoff ◽  
Mats Stridsberg ◽  
Maria Lampinen ◽  
Anders Magnuson ◽  
Marie Carlson ◽  
...  

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S314-S315
Author(s):  
N Deprez ◽  
T De Somer ◽  
D Baert ◽  
M Deceuninck ◽  
I Huys ◽  
...  

Abstract Background SB5 is approved as a biosimilar to the adalimumab (ADA) originator. Bio- and efficacy equivalence, as well as comparable safety and immunogenicity have been demonstrated in Phase I and III randomised clinical trials. In this study we want to describe the trough levels and effectiveness of switch to a biosimilar in a real-life Inflammatory Bowel Disease (IBD) population. Methods In 2 Belgian IBD centres, patients in clinical remission or stable response and treated with ADA originator were offered to enter a phase IV, interventional trial of switch to biosimilar SB5. Assessments were done at baseline, at 8 weeks, 6 and 12 months post-switch. Therapy type and dosing regimen remained unchanged the first 8 weeks; after week 8, dose adjustments could be made based on trough level and/or at the discretion of the treating physician. Trough serum ADA concentrations were measured by enzyme-linked immunosorbent assay (ELISA). The primary outcome measurement was the description of ADA trough level over time after the switch. The secondary outcome measurements were secondary loss of response (SLOR) (defined at physician’s discretion), disease activity scores and biochemical assessments (faecal calprotectin (fCal), leukocyte count (LC) and C-reactive protein (CRP)). Results In the study, 110 patients were enrolled from whom 84 had Crohn’s disease and 26 had ulcerative colitis. By 12 months, SB5 was stopped in 5 patients because of high ADA antidrug antibodies at both baseline and at week 8. Nine patients presented with SLOR of whom 3 discontinued treatment with SB5, the remaining 6 patients received treatment optimisation. Table 1 displays the core results concerning the ADA trough levels over time. Table 2a and 2b display disease activity scores and biochemical parameters at the different time points. Conclusion In this pragmatic, interventional phase IV trial, ADA trough levels remain within the therapeutic range after switch from originator to SB5. The proportion of patients in our study with SLOR is in line with what is described in literature. In patients persisting on SB5, no change in disease activity over time is observed, based on both disease activity scores and biochemical parameters.


Author(s):  
Birte Klusmann ◽  
Joke Fleer ◽  
K Annika Tovote ◽  
Rinse K Weersma ◽  
Hendrik M van Dullemen ◽  
...  

Abstract Background Fatigue is one of the most frequently reported symptoms by patients with inflammatory bowel disease (IBD), both during active disease phases as well as during clinical remission. This study addressed whether different trajectories of fatigue over time can be identified among patients with IBD. Subsequently, we compared the demographic and clinical characteristics between trajectories. Methods The current study included 849 patients with IBD diagnosed with either Crohn disease (CD; n = 511) or ulcerative colitis (UC; n = 338) who visited the University Medical Center in Groningen (the Netherlands) at least 3 times during a 9-year follow-up. We conducted latent class growth analyses to identify distinct trajectories. Results In all patients with IBD (and in the subgroup with CD), we found 5 trajectories for fatigue. In the UC subgroup, we found 4 fatigue trajectories. One trajectory present in both patients with CD (11.45%) and patients with UC (4.75%) was characterized by chronic elevated levels of fatigue across time. Women and parents were more prevalent in trajectories with higher fatigue severity. We also found significant associations among the fatigue trajectories with disease activity and psychological well-being. Conclusions The results clearly showed the existence of distinct fatigue paths over time in patients with IBD. Those reporting more chronic elevated levels of fatigue also reported greater disease activity and reduced well-being. Therefore, reducing disease activity may be important for the treatment of fatigue. In addition, given the significant association with well-being, it is possible that reducing fatigue may improve self-reported well-being.


1988 ◽  
Vol 27 (03) ◽  
pp. 83-86 ◽  
Author(s):  
B. Briele ◽  
F. Wolf ◽  
H. J. Biersack ◽  
F. F. Knapp ◽  
A. Hotze

A prospective study was initiated to compare the clinically proven results concerning localization/extent and activity of inflammatory bowel diseases with those of 111ln-oxine leukocyte imaging. All patients studied were completely examined with barium enema x-ray, clinical and laboratory investigations, and endoscopy with histopathology. A total of 31 leukocyte scans were performed in 15 patients (12 with Crohn’s disease, 3 with ulcerative colitis). The scans were graded by comparing the cell uptake of a lesion (when present) and a bone marrow area providing a count ratio (CR). The inflammatory lesions were correctly localized on 26 leukocyte scans, and in 21 scans the scintigraphically estimated extent of disease was identical to endoscopy. In 5 cases the disease extent was underestimated, 4 scans in patients with relapse of Crohn’s disease were falsely negative, and in one patient with remission truly negative. The scintigraphically assessed disease activity was also in a good agreement with clinical disease activity based on histopathology in all cases. We conclude that leukocyte imaging provides valuable information about localization and activity of inflammatory bowel disease.


2021 ◽  
Vol 28 (1) ◽  
pp. e100337
Author(s):  
Vivek Ashok Rudrapatna ◽  
Benjamin Scott Glicksberg ◽  
Atul Janardhan Butte

ObjectivesElectronic health records (EHR) are receiving growing attention from regulators, biopharmaceuticals and payors as a potential source of real-world evidence. However, their suitability for the study of diseases with complex activity measures is unclear. We sought to evaluate the use of EHR data for estimating treatment effectiveness in inflammatory bowel disease (IBD), using tofacitinib as a use case.MethodsRecords from the University of California, San Francisco (6/2012 to 4/2019) were queried to identify tofacitinib-treated IBD patients. Disease activity variables at baseline and follow-up were manually abstracted according to a preregistered protocol. The proportion of patients meeting the endpoints of recent randomised trials in ulcerative colitis (UC) and Crohn’s disease (CD) was assessed.Results86 patients initiated tofacitinib. Baseline characteristics of the real-world and trial cohorts were similar, except for universal failure of tumour necrosis factor inhibitors in the former. 54% (UC) and 62% (CD) of patients had complete capture of disease activity at baseline (month −6 to 0), while only 32% (UC) and 69% (CD) of patients had complete follow-up data (month 2 to 8). Using data imputation, we estimated the proportion achieving the trial primary endpoints as being similar to the published estimates for both UC (16%, p value=0.5) and CD (38%, p-value=0.8).Discussion/ConclusionThis pilot study reproduced trial-based estimates of tofacitinib efficacy despite its use in a different cohort but revealed substantial missingness in routinely collected data. Future work is needed to strengthen EHR data and enable real-world evidence in complex diseases like IBD.


2021 ◽  
Vol 4 (Supplement_1) ◽  
pp. 77-79
Author(s):  
Y Hanna ◽  
P Tandon ◽  
V W Huang

Abstract Background Women with active inflammatory bowel disease (IBD) are at increased risk of adverse pregnancy outcomes such as preeclampsia. Though aspirin prophylaxis is prescribed in the general population (prior to 16 weeks’ gestation) for those at high-risk of preeclampsia, its use in patients with IBD has not been established. Aims To determine the frequency of and risk factors for adverse pregnancy outcomes in women with IBD, and to evaluate the risk for preeclampsia and the use of aspirin for primary prevention. Methods All pregnant women with IBD (Crohns disease (CD), ulcerative colitis (UC) and IBD-unclassified (IBDU)) seen at Mount Sinai Hospital from 2016–2020 were retrospectively identified. Demographics, reproductive history, and IBD characteristics including therapy and activity during pregnancy were recorded. Adverse pregnancy outcomes were also identified. Active disease during pregnancy was defined as a fecal calprotectin > 250 ug/g and/or using clinical disease activity scores. Categorical variables were compared using the Chi-square (x2) test and continuous variables using the Mann-Whitney test. A two-sided p-value less than 0.05 was considered statistically significant. Results 127 patients (66 with CD, 60 with UC, 1 with IBDU) were included with a median age of 32 years at conception. The majority were Caucasian (70.9%), married (82.7%), completed post-secondary education (69.3%), had no prior or current smoking (78.7%) or alcohol use history (67.7%), and had no other comorbidities (81.9%). 50.4% of women had a prior pregnancy. 3 had a history of preeclampsia and 15/127 were prescribed aspirin prophylaxis. 73.2% of women were in clinical remission at conception. Compared to women with CD, women with UC were more likely to have infants with low birth weight (LBW) (p=0.031), small for gestational age (SGA) (p=0.002) and had higher rates of active IBD during pregnancy (p=0.005). 13 women with IBD developed preeclampsia (6 with UC and 7 with CD). IBD type (p=0.844) and disease activity (p=0.308) were not associated with preeclampsia. Married women (p=0.001) while those who had a preconception consultation (50/127) (p=0.009) had lower rates of preeclampsia while those with a prior history of preeclampsia had higher rates (p=0.002). Among women who developed preeclampsia, pregnancy outcomes were comparable to those who did not. Women on aspirin prophylaxis (5/13) had a higher rate of preeclampsia (p=0.012), although they were also more likely to have a history of preeclampsia (p=0.002). Aspirin use was not associated with subsequent disease activity in pregnancy (p=0.830). Conclusions Women receiving aspirin prophylaxis had higher rates of preeclampsia, likely owing to a higher baseline risk. Preeclampsia prevention with aspirin prophylaxis does not appear to result in disease flares but larger studies are needed to confirm this finding. Funding Agencies None


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