scholarly journals Determining Health Utilities for Immunosuppression in Pediatric Inflammatory Bowel Disease

2018 ◽  
Vol 1 (1) ◽  
Author(s):  
Lauren Schmidt, BA ◽  
William E. Bennett, Jr., MD, MS

Background and Hypothesis: Inflammatory Bowel Disease is a significant cause of gastrointestinal pathology in children and adolescents, with increasing incidence. The medications used to control this disease have an overall low risk of detrimental side effects, but when they occur can be serious or life-threatening. The most important side effects of immunosuppression in IBD are infection and malignancy, but little is known about how these risks affect patients’ and their families’ decisions about medication use.  Clinical utilities are a standard methodology used to assign risk to various hypothetical health states. We hypothesized that lower health utility scores would be assigned to scenarios related to cancer than to infection, even if the risks or severity were similar.   Experimental Design or Project Methods: This study determines the clinical utility of immunosuppression and cancer / infection risk in children with inflammatory bowel disease using the standard gamble technique.  The standard gamble technique measures individual preferences for many different therapeutic modalities, under uncertain results. The study will look at the health utilities of at least 50 families at Riley hospital for Children and IU North, with at least 25 patients with ulcerative colitis and 25 patients with Crohn’s disease. In addition to the perfect health and death, we propose to utilize six different hypothetical health states during this study: (1) untreated IBD, (2) on a medication with no side effects, (3) on a medication with risk of a treatable infection, (4) on a medication with risk of an untreatable infection, (5) on a medication with risk of a treatable cancer, (6) and on a medication with risk of an untreatable cancer. We will also gather subject demographics, family education, family income, and perform an assessment of numeracy. These variables will then be used in a regression model to assess the effect of these confounders.   Results: We have not yet enrolled subjects, but now that the tool and Standard Gamble design are complete, we expect to rapidly accrue enrollment over the next two weeks and will update results at that time.  Conclusion and Potential Impact: Health utility data in pediatric IBD are quite scarce, with room for further research. It is crucial to understand the health utilities in individuals with inflammatory bowel disease (IBD), specifically in pediatric patients. This allows for cost-utility analysis to play a role in determining effectiveness for a wide variety of treatment modalities. It is also important when discussing treatment options with families when the risk of infection or cancer are present.  Knowledge gained from this study may help us design interventions that focus on educating families about the nature and magnitude of these important risks in immunosuppressive therapy. 

Children ◽  
2021 ◽  
Vol 8 (5) ◽  
pp. 343
Author(s):  
Naazish S. Bashir ◽  
Thomas D. Walters ◽  
Anne M. Griffiths ◽  
Wendy J. Ungar

Health utilities relevant to children are lacking, compromising health funding and policy decisions for children. The Child Health Utility 9D (CHU9D) is a recently developed preference-based health utility instrument designed for use in children. The objective was to examine the validity of the CHU9D in a cohort of 285 Canadian children aged 6.5 to 18 years of age with Crohn’s disease (CD) and ulcerative colitis (UC), (collectively inflammatory bowel disease (IBD)). The correlation and agreement between paired CHU9D and Health Utility Index (HUI) assessments were determined with Spearman coefficients and Bland–Altman levels of agreement. Total and domain utilities were calculated for the CHU9D using Australian adult and youth tariffs. Algorithms for HUI2 and HUI3 were used. Domain correlations were determined between domains with expected overlap between instruments. In CD and in UC, correlations between CHU9D, HUI2, and HUI3 utilities ranged between 0.62 to 0.67 and 0.67 to 0.69, respectively (p < 0.05). CHU9D utilities were lower using youth tariffs compared to adult tariffs. A large range in health utilities suggested a heterogeneous quality of life. The CHU9D is a good option for preference-based utility measurement in pediatric IBD. Additional research is required to derive pediatric tariffs to conduct economic evaluation in children.


2013 ◽  
Vol 19 (5) ◽  
pp. 1086-1098 ◽  
Author(s):  
Joana Torres ◽  
Sébastien Buche ◽  
Emmanuel Delaporte ◽  
Jean-Frédéric Colombel

Author(s):  
M. Sandhya Bhavani ◽  
S. Kavitha ◽  
B. Gowri ◽  
Abid Ali Bhat

Background: Inflammatory bowel disease (IBD) is the common cause of chronic gastrointestinal signs in dogs. The treatment possesses numerous difficulties due to the idiopathic nature of the disease. Conventional steroid therapy usually produces side effects on long term usage. Thus, there is a need for alternative therapies. When compared to human medicine, there is no published data on the use of budesonide and probiotic in the treatment of canine IBD in India. The present study was proposed to compare oral prednisolone, budesonide and probiotics in the management of canine inflammatory bowel disease. Methods: Thirty dogs with idiopathic IBD were selected and randomly grouped. They were subjected to therapy involving prednisolone, budesonide or probiotics. Clinical assessment was performed by calculation of the post treatment Clinical Inflammatory Bowel Disease Activity Index (CIBDAI) score, faecal score and endoscopy. Biochemical analysis of alkaline phosphatase and alanine transaminase were done to record side effects of steroid administration. Result: It was observed from the present study that both prednisolone and budesonide are equally effective in the management of IBD in dogs. Probiotics were found to be less effective when compared to prednisolone and budesonide in the treatment of IBD.


2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S549-S550
Author(s):  
K Bąk-Drabik ◽  
J Duda-Wrońska ◽  
D Dąbrowska-Piechota ◽  
P Adamczyk

Abstract Background Azathioprine (AZA) is an immunosuppressive drug, which is metabolised in the liver and kidneys into 6-thioguanine- the form responsible for the therapeutic effect. Despite its anti-inflammatory, antibacterial and immunomodulating properties, azathioprine has also dose-related side effects, such as bone marrow suppression, liver damage and pancreatitis. The purpose of this study was to assess the usefulness of monitoring the concentration of azathioprine metabolites: 6-tioguanine (6-TG) and 6-methylmercaptopurine (6-MMP) in the group of paediatric patients with inflammatory bowel disease (IBD) and autoimmune hepatitis (AIH). Methods The clinical data of 46 paediatric patients (24 girls) with IBD and AIH, aged 8–17 years, hospitalised in the Department of Gastroenterology, who had undergone a blood examination for AZA metabolites concentration, were analysed. Results Initial mean dose of azathioprine was 1.23 mg/kg/day in IBD and 1.16 mg/kg/day in AIH. In 30% of patients, the concentrations of 6-TG and 6-MMP were within the normal range. Forty-eight per cent of patients required a dose change due to: elevated 6-TG concentration (32.6%) or underdosage (15.4%). After modification the mean dose was 1.16 mg/kg/day in IBD and 0.85 mg/kg/day in AIH. In 10.7 % of patients, the concentrations of 6-TG and 6 MMP were below the proper range, in the same percentage of patients metabolites were undetectable. Conclusion In a significant number of cases monitoring the concentration of AZA metabolites indicated the necessity to reduce the dose of AZA allowing to achieve the therapeutic optimum and prevent serious side effects. Receiving undetectable concentration of metabolites is a sign of non-compliance. The final doses of AZA were found to be lower than the recommended doses. Therapeutic drug monitoring (TDM), which involves measurement of drug or active metabolite levels is a good strategy that can be used to optimise IBD and AIH therapeutics.


1990 ◽  
Vol 4 (7) ◽  
pp. 417-419 ◽  
Author(s):  
Marta Carpani de Kaski ◽  
Humphery JF Hodgson

Although effective for both acute and often long term treatment of inflammatory bowel disease, systemically absorbed corticosteroids have a high incidence of side effects. This article briefly reviews the pharmacokinetics of corticosteroids and the strategics available for reducing systemic side effects. In particular, fluitcasone propionate is a fluorinated glucocorticoid, in which systemic side effects are absent or minimal due to its relatively low absorption and rapid first pass metabolism In an open trial in 12 patients with mild and moderately active Crohn's disease, administration of 20 mg fluitcasone propionate orally was associated with a significant fall in the Crohn's disease activity index and improvement in other parameters of inflammation, without change in either plasma cortisol levels or responsiveness to adrenocorticotropic hormone, suggesting that this drug is a promising therapy for Crohn's disease meriting evaluation against conventional corticosteroids.


Cells ◽  
2019 ◽  
Vol 8 (5) ◽  
pp. 397 ◽  
Author(s):  
Paolo Giuffrida ◽  
Sara Cococcia ◽  
Mariangela Delliponti ◽  
Marco Vincenzo Lenti ◽  
Antonio Di Sabatino

Inflammatory bowel disease (IBD) is caused by a dysregulated immune response against normal components of the intestinal microflora combined with defective functioning of anti-inflammatory pathways. Currently, all therapies approved for IBD manipulate the immune system by inhibiting pro-inflammatory mechanisms, such as tumor necrosis factor-α, gut-homing α4β7 integrin, interleukin-12/interleukin-23, and Janus kinases. However, some IBD patients are non-responders to these drugs, which are also associated with serious side effects. Thus, it has been hypothesized that therapies aimed at restoring anti-inflammatory signals, by exploiting the tolerogenic potential of cytokines (interleukin-10, transforming growth factor-β, granulocyte macrophage colony-stimulating factor), immune cells (regulatory T cells, tolerogenic dendritic cells), or mesenchymal stem cells, might offer promising results in terms of clinical efficacy with fewer side effects. In this review, we provide new insights into putative novel treatments aimed at restoring anti-inflammatory signaling pathways in IBD.


2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S505-S505
Author(s):  
C Cassieri ◽  
R Pica ◽  
E V Avallone ◽  
G Brandimarte ◽  
M Zippi ◽  
...  

Abstract Background Azathioprine (AZA) and thiopurine are widely used for induction and maintenance of remission in steroid-dependent patients with inflammatory bowel disease (IBD). The aim of this study has been to investigate its efficacy and safety in maintaining steroid-free remission in steroid-dependent IBD patients eight years after the institution of treatment. Methods Data from consecutive IBD outpatients referred in our Institution, between 1985–2017, were reviewed and all patients treated with AZA were included in this retrospective study. AZA was administered at the recommended dose of 2–2.5 mg/kg. Results Out of 2992 consecutive IBD outpatients visited in the index period, AZA was prescribed to 446 patients, 245 (54.9%) were affected by Crohn’s disease (CD) and 201 (45.1%) by ulcerative colitis (UC). One hundred and ninety-six patients with a follow-up &lt; 96 months were excluded from the study. Two hundred and fifty patients were evaluated, 140 (56%) with CD and 110 (44%) with UC. One hundred and thirty-eight (55.2%) were male and 112 (44.8%) female (average age of 35.48 ± 14.26 SD years, range 14–74 years). Eight year after the institution of treatment, 123 (49.2%) patients still were in steroid-free remission (82 CD vs. 41 UC, 58.6% and 37.3%, respectively, p = 0.0009), 71 (28.4%) had a relapse requiring retreatment with steroids (29 CD vs. 42 UC, 20.7% and 38.2%, respectively, p = 0.0030), 56 (22.4%) discontinued the treatment due to side effects (29 CD vs. 27 UC, 20.7% and 24.5%, respectively). The loss of response from first to eighth year of follow-up was low, about 21%. Conclusion Eight years after the onset of treatment about 50% of patients did not require further steroid courses. After the first-year loss of response was low in seven subsequent years. In the present series, the maintenance of steroid-free remission was significantly higher in CD than in UC patients. The occurrence of side effects leading to the withdrawal of AZA treatment has been low.


Author(s):  
Satish Keshav ◽  
Alexandra Kent

This chapter discusses psychiatric conditions with gastrointestinal (GI) consequences (including eating disorders, depression, and side effects of psychiatric medications), and GI diseases with psychiatric symptoms (including hepatic encephalopathy, coeliac disease, Wilson’s disease, acute intermittent porphyria, functional GI disease, and inflammatory bowel disease).


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