Mucosal healing in the era of biologic agents in treatment of inflammatory bowel disease

2014 ◽  
Vol 50 (1) ◽  
pp. 43-52 ◽  
Author(s):  
Jon Florholmen
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Mucosal Healing ◽  
Biologic Agents ◽  
Inflammatory Bowel

scholarly journals THE SAFETY, TOLERABILITY, AND EFFECTIVENESS OF BIOLOGICS/SMALL MOLECULE THERAPY IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE AND CIRRHOSIS

2021 ◽  
Vol 27 (Supplement_1) ◽  
pp. S45-S46
Author(s):  
Muyi Li ◽  
Sameer Khan ◽  
Deborah Proctor ◽  
Jill Gaidos ◽  
Badr Al-Bawardy
Keyword(s):  
Inflammatory Bowel Disease ◽  
Adverse Events ◽  
Small Molecules ◽  
Small Molecule ◽  
Bowel Disease ◽  
Clinical Remission ◽  
Infusion Reaction ◽  
Mucosal Healing ◽  
Biologic Agents ◽  
Inflammatory Bowel

Abstract Introduction Biologic agents and small molecules have been shown to be effective and relatively safe in the treatment of inflammatory bowel disease (IBD). However, data is lacking regarding the use of these agents in patients with IBD and concomitant cirrhosis. The aim of this study is to examine the safety, tolerability and effectiveness of biologics and small molecules in patients with IBD and concomitant cirrhosis. Methods This is a retrospective study of adult patients diagnosed with both IBD and cirrhosis (by liver biopsy or Fibroscan) treated with biologic agents or small molecule agents between 2012 and 2020 within the Yale-New Haven Hospital system. We included patients on tofacitinib or any of the following biologic agents: infliximab, adalimumab, certolizumab pegol, golimumab, vedolizumab, ustekinumab. Primary outcomes were rates of adverse events (infection, infusion reaction, IBD-related hospitalization) and mortality. Secondary outcomes were clinical remission (defined by the physician global assessment) and mucosal healing (Mayo endoscopic score of 0 or 1 for ulcerative colitis (UC) and absence of erosion/ulcerations in Crohn’s disease (CD)). Results A total of 18 patients (72% CD, 28% UC) with median age of 50 (26–73) years were included (Table 1). Decompensated cirrhosis was present in 33.3% of the population prior to initiation of biologic/small molecule therapy. The most common etiology of cirrhosis was primary sclerosing cholangitis at 38.9%. IBD therapy included: infliximab/adalimumab (44.5%), vedolizumab (27.7%), and ustekinumab (22.2%) and tofacitinib (5.6%). A total of 4 patients (22.2%) were on concomitant corticosteroid therapy and 3 on combination therapy with thiopurines (Table 2). Adverse events occurred in 27.7% (n=5; 1 infusion reaction and 4 infections). The 4 patients with infections included: 2 on infliximab/adalimumab, 1 on ustekinumab, 1 on vedolizumab. Two of these patients were on concomitant thiopurines and 1 on corticosteroid. Biologic therapy was stopped in 3 patients, 2 for non-response and 1 for an infusion reaction. Mortality rate was 11% and all were liver-related. Clinical remission was achieved in 66.7% and mucosal healing was noted in 72.7% (8/11). Conclusions In this cohort of patients with IBD and cirrhosis, biologic/small molecule therapies were effective for IBD. Approximately a quarter of patients experienced adverse events that were mainly due to infections. Larger studies are needed to elucidate the relative safety of different biologic agents and small molecules in IBD patients with cirrhosis.

scholarly journals Optimal Range of Fecal Calprotectin for Predicting Mucosal Healing in Patients with Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis

2021 ◽  
pp. 1-11
Author(s):  
Bing-Jie Xiang ◽  
Min Jiang ◽  
Ming-Jun Sun ◽  
Cong Dai
Keyword(s):  
Inflammatory Bowel Disease ◽  
Diagnostic Accuracy ◽  
Likelihood Ratio ◽  
Sensitivity And Specificity ◽  
Bowel Disease ◽  
Meta Analysis ◽  
Positive Likelihood Ratio ◽  
Fecal Calprotectin ◽  
Mucosal Healing ◽  
Inflammatory Bowel

<b><i>Objective:</i></b> Fecal calprotectin (FC) is a promising marker for assessment of inflammatory bowel disease (IBD) activity. However, the utility of FC for predicting mucosal healing (MH) of IBD patients has yet to be clearly demonstrated. The objective of our study was to perform a meta-analysis evaluating the diagnostic accuracy of FC in predicting MH of IBD patients. <b><i>Methods:</i></b> We systematically searched the databases for studies from inception to April 2020 that evaluated MH in IBD. The methodological quality of each study was assessed according to the Quality Assessment of Diagnostic Accuracy Studies checklist. The extracted data were pooled using a summary receiver operating characteristic curve model. Random-effects model was used to summarize the diagnostic odds ratio, sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio. <b><i>Results:</i></b> Sixteen studies comprising 1,682 ulcerative colitis (UC) patients and 4 studies comprising 221 Crohn’s disease (CD) patients were included. The best performance of FC for predicting MH in UC was at cut-off range of 60–75 μg/g with area under the curve (AUC) of 0.88 and pooled sensitivity and specificity of 0.87 and 0.79, respectively. The pooled sensitivity and specificity values of cutoff range 180–250 μg/g for predicting MH in CD were 0.67 and 0.76, respectively. The AUC of 0.79 also revealed improved discrimination for identifying MH in CD with FC concentration. <b><i>Conclusion:</i></b> Our meta-analysis has found that FC is a simple, reliable noninvasive marker for predicting MH in IBD patients. FC cutoff range 60–75 μg/g appears to have the best overall accuracy in UC patients.

scholarly journals Revisiting Inflammatory Bowel Disease: Pathology, Treatments, Challenges and Emerging Therapeutics Including Drug Leads from Natural Products

2020 ◽  
Vol 9 (5) ◽  
pp. 1273 ◽  
Author(s):  
Karma Yeshi ◽  
Roland Ruscher ◽  
Luke Hunter ◽  
Norelle L. Daly ◽  
Alex Loukas ◽  
...  
Keyword(s):  
Health Care ◽  
Inflammatory Bowel Disease ◽  
Natural Products ◽  
Bowel Disease ◽  
Inflammatory Diseases ◽  
Treatment Options ◽  
Mucosal Healing ◽  
Main Challenge ◽  
Long Term Treatment ◽  
Inflammatory Bowel

Inflammatory bowel disease (IBD) is a chronic and life-long disease characterized by gastrointestinal tract inflammation. It is caused by the interplay of the host’s genetic predisposition and immune responses, and various environmental factors. Despite many treatment options, there is no cure for IBD. The increasing incidence and prevalence of IBD and lack of effective long-term treatment options have resulted in a substantial economic burden to the healthcare system worldwide. Biologics targeting inflammatory cytokines initiated a shift from symptomatic control towards objective treatment goals such as mucosal healing. There are seven monoclonal antibody therapies excluding their biosimilars approved by the US Food and Drug Administration for induction and maintenance of clinical remission in IBD. Adverse side effects associated with almost all currently available drugs, especially biologics, is the main challenge in IBD management. Natural products have significant potential as therapeutic agents with an increasing role in health care. Given that natural products display great structural diversity and are relatively easy to modify chemically, they represent ideal scaffolds upon which to generate novel therapeutics. This review focuses on the pathology, currently available treatment options for IBD and associated challenges, and the roles played by natural products in health care. It discusses these natural products within the current biodiscovery research agenda, including the applications of drug discovery techniques and the search for next-generation drugs to treat a plethora of inflammatory diseases, with a major focus on IBD.

scholarly journals P378 Mucosal healing is achieved in most of the inflammatory bowel disease patients in clinical remission with vedolizumab: a real-life single-centre experience

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S355-S355
Author(s):  
M I Calvo Moya ◽  
I Omella Usieto ◽  
M I Vera Mendoza ◽  
V Matallana Royo ◽  
I Gonzalez Partida ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Clinical Practice ◽  
Bowel Disease ◽  
Clinical Remission ◽  
Real Life ◽  
Mucosal Healing ◽  
Surveillance Colonoscopy ◽  
Previously Treated ◽  
Inflammatory Bowel

Abstract Background Current therapeutic goals in inflammatory bowel disease (IBD) include not only the mere absence of symptoms but also the resolution of endoscopic lesions, so-called mucosal healing (MH), which has been related to better outcomes. Data regarding the achievement of MH with vedolizumab (VDZ) in real-life clinical practice is still scarce. Methods Retrospective cohort study was carried out in a tertiary hospital between January 2015 and April 2019 including patients with a basal colonoscopy showing activity and who achieved clinical remission under treatment with VDZ, defined by partial Mayo score &lt;2 for ulcerative colitis (UC) and Harvey–Bradshaw Index score (HBI) &lt;4 for Crohn’s disease (CD). Surveillance colonoscopy was performed along with the follow-up according to clinical practice. In UC patients, MH was defined as Mayo Endoscopic Subscore (MES) = 0; the endoscopic response was defined by a decrease in MES ≥1 point. In CD, MH was defined by achievement SES-CD = 0–3 or Rutgeerts index i0; the endoscopic response was defined by a decrease of SES-CD of 50% or Rutgeerts index &lt;i2 with at least 1 point of decease compared with baseline. Results In total, 118 patients treated with VDZ were analysed, but only 45 met inclusion criteria with a median follow-up of 21 (IQR: 14–19) months. Surveillance colonoscopy was performed after a median time of 12 months (IQR:9–17) of treatment. MH achieved in 33/45 patients (73%): 17/23 CD patients (74%) and 16/22 UC patients (73%). The endoscopic response was achieved in 9 of the remaining 12 patients: 3/6 CD patients and 6/6 UC patients. Only 3 (7%) of patients included showed no endoscopic benefit at the time of surveillance endoscopy. In multivariate analysis, probability of not achieving MH was 75% in patients previously treated with immunosuppressants (ISS) (HR 0.25, 0.11–0.55 IC95; p = 0.001) and 60% in patients previously treated with anti-TNFα (HR 0.40, 0.18–0.90 95% CI; p = 0.026). Type of IBD, concomitant ISS, corticosteroid use at induction, baseline endoscopy score or duration of disease before VDZ treatment were not associated with the achievement of MH. Conclusion In our experience, most of the patients who achieve clinical remission with VDZ also achieve MH. Refractory patients were less likely to achieve MH despite having achieved clinical remission.

scholarly journals Development of Machine Learning Model to Predict the 5-Year Risk of Starting Biologic Agents in Patients with Inflammatory Bowel Disease (IBD): K-CDM Network Study

2020 ◽  
Vol 9 (11) ◽  
pp. 3427 ◽  
Author(s):  
Youn I Choi ◽  
Sung Jin Park ◽  
Jun-Won Chung ◽  
Kyoung Oh Kim ◽  
Jae Hee Cho ◽  
...  
Keyword(s):  
Machine Learning ◽  
Inflammatory Bowel Disease ◽  
Validation Study ◽  
Bowel Disease ◽  
Medical Center ◽  
External Validation ◽  
Biologic Agents ◽  
Risk Level ◽  
Common Data Model ◽  
Inflammatory Bowel

Background: The incidence and global burden of inflammatory bowel disease (IBD) have steadily increased in the past few decades. Improved methods to stratify risk and predict disease-related outcomes are required for IBD. Aim: The aim of this study was to develop and validate a machine learning (ML) model to predict the 5-year risk of starting biologic agents in IBD patients. Method: We applied an ML method to the database of the Korean common data model (K-CDM) network, a data sharing consortium of tertiary centers in Korea, to develop a model to predict the 5-year risk of starting biologic agents in IBD patients. The records analyzed were those of patients diagnosed with IBD between January 2006 and June 2017 at Gil Medical Center (GMC; n = 1299) or present in the K-CDM network (n = 3286). The ML algorithm was developed to predict 5- year risk of starting biologic agents in IBD patients using data from GMC and externally validated with the K-CDM network database. Result: The ML model for prediction of IBD-related outcomes at 5 years after diagnosis yielded an area under the curve (AUC) of 0.86 (95% CI: 0.82–0.92), in an internal validation study carried out at GMC. The model performed consistently across a range of other datasets, including that of the K-CDM network (AUC = 0.81; 95% CI: 0.80–0.85), in an external validation study. Conclusion: The ML-based prediction model can be used to identify IBD-related outcomes in patients at risk, enabling physicians to perform close follow-up based on the patient’s risk level, estimated through the ML algorithm.

scholarly journals The Role of Long-Chain Fatty Acids in Inflammatory Bowel Disease

2019 ◽  
Vol 2019 ◽  
pp. 1-10 ◽  
Author(s):  
Chunxiang Ma ◽  
Reshma Vasu ◽  
Hu Zhang
Keyword(s):  
Inflammatory Bowel Disease ◽  
Fatty Acids ◽  
Bowel Disease ◽  
Mucosal Healing ◽  
Long Chain Fatty Acids ◽  
Inflammatory Bowel ◽  
Underlying Mechanisms ◽  
Long Chain ◽  
Chain Fatty Acids

Inflammatory bowel disease (IBD) is a complicated disease involving multiple pathogenic factors. The complex relationships between long-chain fatty acids (LCFAs) and the morbidity of IBD drive numerous studies to unravel the underlying mechanisms. A better understanding of the role of LCFAs in IBD will substitute or boost the current IBD therapies, thereby obtaining mucosal healing. In this review, we focused on the roles of LCFAs on the important links of inflammatory regulation in IBD, including in the pathogen recognition phase and in the inflammatory resolving phase, and the effects of LCFAs on immune cells in IBD.

scholarly journals P186 Association between anti-TNF serum levels and mucosal healing in inflammatory bowel disease

2017 ◽  
Vol 11 (suppl_1) ◽  
pp. S171-S171
Author(s):  
M. Chaparro ◽  
M. Barreiro-de Acosta ◽  
A. Echarri ◽  
R. Almendros ◽  
J. Barrio ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Serum Levels ◽  
Mucosal Healing ◽  
Inflammatory Bowel

scholarly journals Relationship between Serum Adalimumab Levels and Clinical Outcome in the Treatment of Inflammatory Bowel Disease

2019 ◽  
Vol 37 (6) ◽  
pp. 444-450 ◽  
Author(s):  
Joaquín Hinojosa ◽  
Fernando Muñoz ◽  
Gregorio Juan Martínez-Romero
Keyword(s):  
Inflammatory Bowel Disease ◽  
Clinical Outcome ◽  
Maintenance Therapy ◽  
Bowel Disease ◽  
Clinical Remission ◽  
Meta Analysis ◽  
Serum Levels ◽  
Mucosal Healing ◽  
Endoscopic Remission ◽  
Inflammatory Bowel

Background: Adalimumab (ADA) is an anti-tumor necrosis factor agent that has been shown to be effective in inducing and maintaining remission in adult patients with inflammatory bowel disease. The relationship between the ADA trough levels and clinical efficacy has been demonstrated, but there is variability in the definition of the most suitable range for its clinical applicability. Summary: A review of published studies during the last 5 years on ADA serum levels and its relationship with the clinical outcome was performed. The studies selected included 7 observational studies, a systematic review, a meta-analysis and a post hoc analysis of a clinical trial. The reported ADA levels that discriminate patients in clinical remission from those with active disease range from 4.5 to 8 µg/mL. This therapeutic range varies when considering endoscopic remission (7.5 to >13.9 µg/mL). Although the sample of patients with ulcerative colitis is small, a tendency to reach higher levels of ADA is observed in both clinical and endoscopic remission. Key Messages: The optimal therapeutic cut-off point of serum ADA levels ranges from 4.5–5 to 12 µg/mL, where ADA levels are associated with an adequate clinical monitoring of the disease during maintenance therapy. These ranges vary according to the target, suggesting levels of 4.8 µg/mL as the cut-off for clinical remission and levels ≥7.5 µg/mL for mucosal healing/endoscopic response. Controlled prospective studies are required to determine the optimal therapeutic interval of ADA serum levels both as induction and as maintenance therapy.

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