scholarly journals 3334 Insurance Generosity and Inflammatory Bowel Disease: Does Higher Patient Cost-Sharing Result in Suboptimal Medication Habits and Inferior Clinical Outcomes?

2019 ◽  
Vol 3 (s1) ◽  
pp. 148-148
Author(s):  
Lindsay Anne Sceats ◽  
Cindy Kin ◽  
Amber Trickey ◽  
Maria Polyakova ◽  
M. Kate Bundorf
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Abdominal Surgery ◽  
Bowel Disease ◽  
Cost Sharing ◽  
Biologic Therapy ◽  
Corticosteroid Treatment ◽  
Patient Cost ◽  
Inflammatory Bowel ◽  
Out Of Pocket Costs

OBJECTIVES/SPECIFIC AIMS: Our primary objectives were to examine the impact of biologic cost sharing on 1) adherence to biologics and 2) persistence on biologics in inflammatory bowel disease (IBD) patients. Our secondary objective was to assess the effect of biologic cost sharing on clinical IBD outcomes, including rates of hospitalization, abdominal surgery, and corticosteroid treatment. METHODS/STUDY POPULATION: This retrospective cohort analysis used a national insurance claims database (Optum Clinformatics DataMart) to assess adult IBD patients enrolled in medium or large private insurance plans from 2007-2016. Patients were followed for one year of continuous enrollment after their index biologic claim. We assessed adherence to biologic medications (medication possession ratio >0.8) dependent on patient cost sharing, as measured by an employer-plan’s average out-of-pocket biologic medication cost. We also examined the effects of patient cost sharing for biologics on need for hospitalization, abdominal surgery, or corticosteroid treatment. We used multivariate logistic regression models adjusting for clinical and demographic characteristics. We estimated the effect of cost sharing on biologic therapy persistence using repeated measures proportional hazard survival models. RESULTS/ANTICIPATED RESULTS: We identified 2,193 adult IBD patients who initiated biologic therapy and met study criteria (Crohn’s disease 66.1% vs. ulcerative colitis 24.9%, mean age 40.8 years, mean Charlson index 0.50). Median [IQR] out-of-pocket cost per 30-day biologic prescription was $62 [$34 - $157]. 66.9% of patients were adherent to biologic therapy. Higher out-of-pocket costs for biologics were associated with increased odds of nonadherence; patients with ulcerative colitis were more price-responsive than patients with Crohn’s disease or indeterminate colitis (Figure 1). However, higher out-of-pocket biologic costs were not associated with increased odds of all-cause or IBD-related hospitalization, IBD-related surgery, or corticosteroid prescriptions for IBD flares. Patients whose out-of-pocket costs were less than $10 per 30-day biologic prescription persisted on biologic therapy for significantly longer than patients who paid >$10 (Figure 2). DISCUSSION/SIGNIFICANCE OF IMPACT: Nonadherence to biologics increases when IBD patients face higher out-of-pocket costs, particularly for ulcerative colitis patients. However, this is not associated with worse clinical outcomes. Patients with cost-sharing<$10 persisted on biologics longer than patients whose cost sharing exceeded $10.

Biosimilar adalimumab FKB-327 in the treatment of inflammatory bowel disease

2020 ◽  
Vol 74 (6) ◽  
pp. 553-557
Author(s):  
Milan Lukáš ◽  
Martin Vašátko ◽  
Martin Lukáš ◽  
Martin Kolář ◽  
Dana Ďuricová ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Side Effects ◽  
Therapeutic Effect ◽  
Drug Administration ◽  
Bowel Disease ◽  
Biologic Therapy ◽  
Positive Therapeutic Effect ◽  
Inflammatory Bowel

In 2018 year, the patent of original adalimumab expired and a new biosimilar version of adalimumab have been introduced on the Czech market. FKB-327 is one of the new biosimilar adalimumab versions and was approved for all indication of the original drug. This is the first experience with biosimilar adalimumab FKB-327 in IBD patients. Patients cohort comprised from 51 patients included 40 (82%) ones with Crohn´s disease and 9 (18%) ones with ulcerative colitis. Most of the patients (78%) have been naive for biologic therapy. A positive therapeutic effect during the median follow up time (37 weeks) was described in 47 (92%) patients. This drug was tolerated very well and none of the treated patients had to stop prematurely the drug administration due to significant side effects.

Prebiotics and Probiotics in Inflammatory Bowel Disease: Where are we now and where are we going?

2020 ◽  
Vol 15 (3) ◽  
pp. 216-233 ◽  
Author(s):  
Maliha Naseer ◽  
Shiva Poola ◽  
Syed Ali ◽  
Sami Samiullah ◽  
Veysel Tahan
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Clinical Trials ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Adverse Effects ◽  
Bowel Disease ◽  
Relapse Prevention ◽  
Remission Induction ◽  
Inflammatory Bowel

The incidence, prevalence, and cost of care associated with diagnosis and management of inflammatory bowel disease are on the rise. The role of gut microbiota in the causation of Crohn's disease and ulcerative colitis has not been established yet. Nevertheless, several animal models and human studies point towards the association. Targeting intestinal dysbiosis for remission induction, maintenance, and relapse prevention is an attractive treatment approach with minimal adverse effects. However, the data is still conflicting. The purpose of this article is to provide the most comprehensive and updated review on the utility of prebiotics and probiotics in the management of active Crohn’s disease and ulcerative colitis/pouchitis and their role in the remission induction, maintenance, and relapse prevention. A thorough literature review was performed on PubMed, Ovid Medline, and EMBASE using the terms “prebiotics AND ulcerative colitis”, “probiotics AND ulcerative colitis”, “prebiotics AND Crohn's disease”, “probiotics AND Crohn's disease”, “probiotics AND acute pouchitis”, “probiotics AND chronic pouchitis” and “prebiotics AND pouchitis”. Observational studies and clinical trials conducted on humans and published in the English language were included. A total of 71 clinical trials evaluating the utility of prebiotics and probiotics in the management of inflammatory bowel disease were reviewed and the findings were summarized. Most of these studies on probiotics evaluated lactobacillus, De Simone Formulation or Escherichia coli Nissle 1917 and there is some evidence supporting these agents for induction and maintenance of remission in ulcerative colitis and prevention of pouchitis relapse with minimal adverse effects. The efficacy of prebiotics such as fructooligosaccharides and Plantago ovata seeds in ulcerative colitis are inconclusive and the data regarding the utility of prebiotics in pouchitis is limited. The results of the clinical trials for remission induction and maintenance in active Crohn's disease or post-operative relapse with probiotics and prebiotics are inadequate and not very convincing. Prebiotics and probiotics are safe, effective and have great therapeutic potential. However, better designed clinical trials in the multicenter setting with a large sample and long duration of intervention are needed to identify the specific strain or combination of probiotics and prebiotics which will be more beneficial and effective in patients with inflammatory bowel disease.

scholarly journals The Changing Prognosis of Ulcerative Colitis and Crohn’s Disease by Decades

2021 ◽  
Author(s):  
Burton I Korelitz ◽  
Judy Schneider
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Medical Therapy ◽  
Bowel Disease ◽  
Surgical Intervention ◽  
Inflammatory Bowel

Abstract We present a bird’s eye view of the prognosis for both ulcerative colitis and Crohn’s disease as contained in the database of an Inflammatory Bowel Disease gastroenterologist covering the period from 1950 until the present utilizing the variables of medical therapy, surgical intervention, complications and deaths by decades.

scholarly journals Longitudinal Trajectory of Fatigue in Patients With Inflammatory Bowel Disease: A Prospective Study

2020 ◽  
Author(s):  
Nienke Z Borren ◽  
Millie D Long ◽  
Robert S Sandler ◽  
Ashwin N Ananthakrishnan
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Chronic Illness ◽  
Prospective Study ◽  
Functional Assessment ◽  
Bowel Disease ◽  
Symptom Resolution ◽  
Chronic Illness Therapy ◽  
Inflammatory Bowel ◽  
A Prospective Study

Abstract Background Fatigue is a disabling symptom in patients with inflammatory bowel disease (IBD). Its prevalence, mechanism, and impact remain poorly understood. We determined changes in fatigue status over time and identified predictors of incident or resolving fatigue. Methods This was a prospective study nested within the IBD Partners cohort. Participants prospectively completed the Multidimensional Fatigue Inventory and the Functional Assessment of Chronic Illness Therapy-Fatigue at baseline, 6 months, and 12 months. A Functional Assessment of Chronic Illness Therapy-Fatigue score ≤43 defined significant fatigue. Multivariable regression models using baseline covariates were used to identify risk factors for incident fatigue at 6 months and to predict the resolution of fatigue. Results A total of 2429 patients (1605 with Crohn disease, 824 with ulcerative colitis) completed a baseline assessment, and 1057 completed a second assessment at 6 months. Persistent fatigue (at baseline and at 6 months) was the most common pattern, affecting two-thirds (65.8%) of patients. One-sixth (15.7%) of patients had fatigue at 1 timepoint, whereas fewer than one-fifth (18.5%) of patients never reported fatigue. Among patients not fatigued at baseline, 26% developed fatigue at 6 months. The strongest predictor of incident fatigue was sleep disturbance at baseline (odds ratio, 2.91; 95% confidence interval, 1.48–5.72). In contrast, only 12.3% of those with fatigue at baseline had symptom resolution by month 6. Resolution was more likely in patients with a diagnosis of ulcerative colitis, quiescent disease, and an absence of significant psychological comorbidity. Conclusions Fatigue is common in patients with IBD. However, only a few fatigued patients experience symptom resolution at 6 or 12 months, suggesting the need for novel interventions to ameliorate its impact.

scholarly journals Predicting disease course in ulcerative colitis using stool proteins identified through an aptamer-based screen

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Sanam Soomro ◽  
Suresh Venkateswaran ◽  
Kamala Vanarsa ◽  
Marwa Kharboutli ◽  
Malavika Nidhi ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Fecal Calprotectin ◽  
Disease Monitoring ◽  
Disease Course ◽  
Lipocalin 2 ◽  
Time Points ◽  
Inflammatory Bowel ◽  
Stool Samples

AbstractIn the search for improved stool biomarkers for inflammatory bowel disease (IBD), an aptamer-based screen of 1129 stool proteins was conducted using stool samples from an IBD cohort. Here we report that of the 20 proteins subsequently validated by ELISA, stool Ferritin, Fibrinogen, Haptoglobin, Hemoglobin, Lipocalin-2, MMP-12, MMP-9, Myeloperoxidase, PGRP-S, Properdin, Resistin, Serpin A4, and TIMP-1 are significantly elevated in both ulcerative colitis (UC) and Crohn’s disease (CD) compared to controls. When tested in a longitudinal cohort of 50 UC patients at 4 time-points, fecal Fibrinogen, MMP-8, PGRP-S, and TIMP-2 show the strongest positive correlation with concurrent PUCAI and PGA scores and are superior to fecal calprotectin. Unlike fecal calprotectin, baseline stool Fibrinogen, MMP-12, PGRP-S, TIMP-1, and TIMP-2 can predict clinical remission at Week-4. Here we show that stool proteins identified using the comprehensive aptamer-based screen are superior to fecal calprotectin alone in disease monitoring and prediction in IBD.

scholarly journals Crohn’s disease and ulcerative colitis patient-reported outcomes signs and symptoms for the remote management of inflammatory bowel disease during the COVID-19 pandemic

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Sergio Pinto ◽  
Erica Loddo ◽  
Salvatore Paba ◽  
Agnese Favale ◽  
Fabio Chicco ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Crohn’S Disease ◽  
Bowel Disease ◽  
Patient Reported Outcomes ◽  
Signs And Symptoms ◽  
Patient Reported ◽  
Inflammatory Bowel ◽  
Active Patients ◽  
Active Disease

Abstract Background and aims The COVID-19 pandemic has led to a deep reorganization of hospital services including inflammatory bowel disease (IBD) units. In this situation, conversion of in-person routine follow-up visits into phone consultations might be necessary. Here we explored the feasibility of using the validated Crohn’s Disease (CD) or Ulcerative Colitis (UC) Patient-Reported Outcomes Signs and Symptoms (CD- and UC-PRO/SS) to collect data about abdominal symptoms (abdominal/S) and bowel signs and symptoms (bowel/SS) remotely. Methods CD- and UC-PRO/SS were collected during phone consultations and compared among patients with active and inactive disease. The effectiveness of therapeutic intervention in patients with active disease was assessed by PRO/SS variation. Results Twenty-one CD and 56 UC patients were evaluated by phone. Six (28.6%) CD and 15 (26.8%) UC patients were considered to have active disease. In CD the bowel/SS but not the abdominal/S module was significantly higher in active patients (mean bowel/SS 2.50 [SE ± 0.44] active vs 0.76 [SE ± 0.18] remission, p = 0.008, AUC 0.87; mean abdominal/S 1.11 [SE ± 0.38] active vs 0.24 [SE ± 0.13] remission, p = 0.066). UC-PRO/SS measures were significantly higher in active patients as compared to patients in remission (median bowel/SS 1.63 [SE ± 0.24] active vs 0.33 [SE ± 0.04] remission; p < 0.0001, AUC 0.91; mean abdominal/S 1.03 [SE ± 0.24] vs 0.37 [SE ± 0.12]; p = 0.009, AUC 0.71). Therapy was escalated in 12 patients (3 CD and 9 UC) due to disease relapse. Therapy escalation resulted in the reduction of PRO/SS as evaluated at the subsequent phone consultation. Conclusions PRO/SS might represent a feasible tool to evaluate disease activity and therapy outcome in IBD patients during periods of limited access to outpatient clinics.

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