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Efficacy of vedolizumab as maintenance therapy in a patient with ulcerative colitis receiving haemodialysis in end-stage kidney failure: A case report.

ABSTRACT: This report describes vedolizumab's clinical efficacy and safety in a patient with severe ulcerative colitis on haemodialysis for an end-stage kidney failure. The patient was a 75-year-old man on long-standing chronic diffusive three times per week haemodialytic treatment due to vascular nephropathy. At the presentation, the patient had severe bloody diarrhoea treated with a steroid cycle with temporary benefits and then developed steroid dependence. Upon remission, the patient started vedolizumab (Entivyo^®) as maintenance therapy. After 6 weeks of induction, patient started the maintenance therapy with an infusion every 8 weeks. After the sixth infusion, the interval was prolonged to 9 weeks because of the good and fast response. Vedolizumab treatment proceeded without adverse events. However, no changes in renal function were noted during the same period, no complications were reported, and the patient regularly continued haemodialysis. At the second induction infusion (week 2) and the second maintenance infusion (week 22), we measured vedolizumab serum level before and after haemodialysis, observing no significant changes. Our case is the first report about using vedolizumab in a patient under haemodialysis, showing that vedolizumab can be safe, well tolerated, and effective in patients undergoing haemodialysis. However, more extensive trials are needed to prove its use in these patients.

SUBMITTER: Albertini Petroni G

PROVIDER: S-EPMC10103238 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

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Efficacy of vedolizumab as maintenance therapy in a patient with ulcerative colitis receiving haemodialysis in end-stage kidney failure: A case report.

Albertini Petroni Guglielmo G Pisani Laura Francesca LF Borsotti Edoardo E Doria Maria M Annunziata Maria Laura ML

SAGE open medical case reports 20230410

This report describes vedolizumab's clinical efficacy and safety in a patient with severe ulcerative colitis on haemodialysis for an end-stage kidney failure. The patient was a 75-year-old man on long-standing chronic diffusive three times per week haemodialytic treatment due to vascular nephropathy. At the presentation, the patient had severe bloody diarrhoea treated with a steroid cycle with temporary benefits and then developed steroid dependence. Upon remission, the patient started vedolizum ...[more]

PMID: 37063436

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Project description:Background and objectivesUlcerative colitis is highly prevalent in Canada and cost-effective ulcerative colitis therapies are warranted. Vedolizumab subcutaneous (SC) formulation was recently approved for ulcerative colitis maintenance therapy. We assessed vedolizumab SC cost effectiveness vs conventional and advanced therapeutics in patients with moderately to severely active ulcerative colitis from a Canadian public healthcare payer perspective.MethodsA hybrid decision tree/Markov model was developed to evaluate vedolizumab SC costs, quality-adjusted life-years, and cost effectiveness vs conventional therapy, adalimumab SC, infliximab intravenous, golimumab SC, tofacitinib, ustekinumab SC, and vedolizumab intravenous. This model predicts the number of patients achieving clinical response and remission after treatment induction, and sustained benefit during maintenance treatment. To account for statistical uncertainties, the base-case analysis was conducted in a probabilistic manner. Scenario analyses examined the impact of previous treatment with anti-tumor necrosis factor agents, dose escalation, loss of efficacy, and treatment adherence.ResultsIn the base-case analysis, conventional therapy was the most cost-effective therapeutic option in the overall population. Vedolizumab SC was cost effective and dominant compared with other advanced therapies (adalimumab, golimumab, infliximab, tofacitinib 5 mg, ustekinumab, and vedolizumab intravenous). The annual vedolizumab SC cost per patient was reduced vs ustekinumab SC, tofacitinib 5 mg, vedolizumab intravenous, and golimumab SC by $47,024, $3251, $2120, and $2004 (Canadian dollars), respectively, and exceeded that of infliximab, adalimumab, and conventional therapy by $582, $3293, and $41,024, respectively. Among the treatments, vedolizumab SC generated the highest quality-adjusted life-years overall (14.21), which translated into the best incremental cost per quality-adjusted life-years gained over conventional therapy in the overall population ($109,374) and in anti-tumor necrosis factor-naïve and anti-tumor necrosis factor-experienced patients ($41,658/$114,287).ConclusionsConventional therapy offered the most cost-effective therapeutic option followed by vedolizumab SC. Based on a $50,000/quality-adjusted life-year threshold, vedolizumab was cost effective in anti-tumor necrosis factor-naïve patients but not the overall population also when compared to conventional therapy.

Project description:BackgroundPatients with end-stage kidney disease, receiving haemodialysis rely increasingly on informal carers to help manage their debilitating chronic disease. Informal carers may experience a negative impact on their quality of life exacting a toll on their physical, social and emotional well-being. Informal carers of patients with end-stage kidney disease receiving haemodialysis have significant unmet needs which may include physical and psychological issues, financial disadvantage and social isolation. Poor experiences of informal carers may also impact the experience of the patients for whom they care. The needs of this group of informal caregivers have been largely neglected, with little emphasis placed on supportive interventions that might assist and support them in their caring role. The aim of this study is therefore to explore the experiences and unmet needs of informal carers of people with end-stage kidney disease receiving haemodialysis and develop a psychosocial intervention to support them in their caring role.MethodsThis qualitative study will include a systematic review, semi-structured interviews with 30 informal carers and focus groups with renal health care professionals. Perceptions of care provision, caregiving experiences as well as contextual factors impacting the design and delivery of a psychosocial intervention for informal carers of patients with end-stage kidney disease, will be explored and will inform the development of a supportive intervention.DiscussionThe needs of informal carers of patients with end-stage kidney disease have been neglected with little emphasis placed on supportive interventions that might assist and support this group in their care giving role. This is in contrast to other chronic disease groups such as stroke, cancer and dementia. In these conditions well developed supportive interventions have significantly improved outcomes in regard to informal caregivers' preparedness, competence, positive emotions and psychological well-being in terms of informal care provision. Support interventions could potentially improve the quality of life of those informal carers who provide care to patients with end-stage kidney disease receiving haemodialysis.

Project description:BackgroundEnd-stage kidney disease is a life-changing illness. Many patients require haemodialysis, a treatment that impacts profoundly on quality of life and mental health. Arts-based interventions have been used in other healthcare settings to improve mental health and quality of life; therefore, they may help address the impact of haemodialysis by improving these outcomes. However, there is a lack of evidence assessing their effectiveness in this population and few randomised controlled trials (RCTs) evaluating the effectiveness of complex arts-based interventions.MethodsThe aims of this study are to establish the feasibility of a cluster RCT of an arts-based intervention for patients with end-stage kidney disease whilst receiving haemodialysis through a cluster randomised pilot study, explore the acceptability of the intervention with a process evaluation and explore the feasibility of an economic evaluation. The study will have three phases. The first phase consists of a cluster randomised pilot study to establish recruitment, participation and retention rates. This will involve the recruitment of 30 participants who will be randomly allocated through cluster randomisation according to shift pattern to experimental and control group. The second phase will be a qualitative process evaluation to establish the acceptability of the intervention within a clinical setting. This will involve semi-structured interviews with 13 patients and three focus groups with healthcare professionals. The third phase will be a feasibility economic evaluation to establish the best methods for data collection within a future cluster RCT.DiscussionArts-based interventions have been shown to improve quality of life in healthcare settings, but there is a lack of evidence evaluating arts-based interventions for patients receiving haemodialysis. This study aims to assess the feasibility of a future cluster RCT assessing the impact of an arts-based intervention on the wellbeing and mental health of patients receiving haemodialysis and identify the key factors leading to successful implementation. The hope is this study will inform a trial that can influence future healthcare policy by providing robust evidence for arts-based interventions within the haemodialysis setting.Trial registrationThe trial was prospectively registered on clinicaltrials.gov on 14/8/2018, registration number NCT03629496.

Project description:BackgroundIn ulcerative colitis (UC), the molecular mechanisms that drive disease development and patient response to therapy are not well understood. A significant proportion of patients with UC fail to respond adequately to biologic therapy. Therefore, there is an unmet need for biomarkers that can predict patients' responsiveness to the available UC therapies as well as ascertain the most effective individualised therapy. Our study focused on identifying predictive signalling pathways that predict anti-integrin therapy response in patients with UC.MethodsWe retrieved and pre-processed two publicly accessible gene expression datasets (GSE73661 and GSE72819) of UC patients treated with anti-integrin therapies: (1) 12 non-IBD controls and 41 UC patients treated with Vedolizumab therapy, and (2) 70 samples with 58 non-responder and 12 responder UC patient samples treated with Etrolizumab therapy without non-IBD controls. We used a diffusion-based signalling model which is mainly focused on the T-cell receptor signalling network. The diffusion model uses network connectivity between receptors and transcription factors.ResultsThe network diffusion scores were able to separate VDZ responder and non-responder patients before treatment better than the original gene expression. On both anti-integrin treatment datasets, the diffusion model demonstrated high predictive performance for discriminating responders from non-responders in comparison with 'nnet'. We have found 48 receptor-TF pairs identified as the best predictors for VDZ therapy response with AUC ≥ 0.76. Among these receptor-TF predictors pairs, FFAR2-NRF1, FFAR2-RELB, FFAR2-EGR1, and FFAR2-NFKB1 are the top best predictors. For Etrolizumab, we have identified 40 best receptor-TF pairs and CD40-NFKB2 as the best predictor receptor-TF pair (AUC = 0.72). We also identified subnetworks that highlight the network interactions, connecting receptors and transcription factors involved in cytokine and fatty acid signalling. The findings suggest that anti-integrin therapy responses in cytokine and fatty acid signalling can stratify UC patient subgroups.ConclusionsWe identified signalling pathways that may predict the efficacy of anti-integrin therapy in UC patients and personalised therapy alternatives. Our results may lead to the advancement of a promising clinical decision-making tool for the stratification of UC patients.

Dataset Information

Efficacy of vedolizumab as maintenance therapy in a patient with ulcerative colitis receiving haemodialysis in end-stage kidney failure: A case report.

Publications

Efficacy of vedolizumab as maintenance therapy in a patient with ulcerative colitis receiving haemodialysis in end-stage kidney failure: A case report.

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