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INTRODUCTION: Ultrasound (US) is associated with severe visualization limitations (US Liver Imaging Reporting and Data System visualization score C) in one-third of patients with nonalcoholic fatty liver disease (NAFLD) cirrhosis undergoing hepatocellular carcinoma (HCC) screening. Data suggest abbreviated MRI (aMRI) may improve HCC screening efficacy. This study analyzed the cost-effectiveness of HCC screening strategies, including an US visualization score-based approach with aMRI, in patients with NAFLD cirrhosis. METHODS: We constructed a Markov model simulating adults with compensated NAFLD cirrhosis in the United States undergoing HCC screening, comparing strategies of US plus visualization score, US alone, or no surveillance. We modeled aMRI in patients with visualization score C and negative US, while patients with scores A/B did US alone. We performed a sensitivity analysis comparing US plus visualization score with US plus alpha fetoprotein or no surveillance. The primary outcome was the incremental cost-effectiveness ratio (ICER), with a willingness-to-pay threshold of $100,000 per quality-adjusted life-year. Sensitivity analyses were performed for all variables. RESULTS: US plus visualization score was the most cost-effective strategy, with an ICER of $59,005 relative to no surveillance. The ICER for US alone to US plus visualization score was $822,500. On sensitivity analysis, screening using US plus visualization score remained preferred across several parameters. Even with alpha fetoprotein added to US, the US plus visualization score strategy remained cost-effective, with an ICER of $62,799 compared with no surveillance. DISCUSSION: HCC surveillance using US visualization score-based approach, using aMRI for visualization score C, seems to be the most cost-effective strategy in patients with NAFLD cirrhosis.
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Carcinoma Hepatocelular , Análise Custo-Benefício , Cirrose Hepática , Neoplasias Hepáticas , Imageamento por Ressonância Magnética , Cadeias de Markov , Hepatopatia Gordurosa não Alcoólica , Ultrassonografia , Humanos , Carcinoma Hepatocelular/diagnóstico por imagem , Carcinoma Hepatocelular/economia , Hepatopatia Gordurosa não Alcoólica/diagnóstico por imagem , Hepatopatia Gordurosa não Alcoólica/complicações , Hepatopatia Gordurosa não Alcoólica/economia , Neoplasias Hepáticas/diagnóstico por imagem , Neoplasias Hepáticas/economia , Imageamento por Ressonância Magnética/economia , Imageamento por Ressonância Magnética/métodos , Ultrassonografia/economia , Cirrose Hepática/complicações , Cirrose Hepática/diagnóstico por imagem , Cirrose Hepática/economia , Feminino , Pessoa de Meia-Idade , Masculino , Detecção Precoce de Câncer/economia , Detecção Precoce de Câncer/métodos , Anos de Vida Ajustados por Qualidade de Vida , Estados Unidos , Análise de Custo-EfetividadeRESUMO
PURPOSE OF REVIEW: Diet and nutrition have emerged as key factors in the development and course of inflammatory bowel disease (IBD), including the approach to therapy. We present an overview of evidence-based recommendations and recent research in dietary therapy and nutrition management for patients with IBD. RECENT FINDINGS: Patients with IBD should undergo a comprehensive nutrition assessment with the assistance of a registered dietitian (RD), including screening for micronutrient deficiencies. Multiple specialized whole foods and liquid formula diets have been evaluated as part of induction and maintenance therapy for IBD. Nutritional status should ideally be optimized in the perioperative setting as well. Nutritional issues are prevalent among IBD patients and should be addressed by a multidisciplinary team, tailored to each patient's disease type, severity and course, including response to medical therapy and need for surgical management, as well as relevant psychosocial considerations.
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Doenças Inflamatórias Intestinais , Estado Nutricional , Humanos , Doenças Inflamatórias Intestinais/terapiaRESUMO
BACKGROUND & AIMS: Patients with solid tumors who undergo chemotherapy have an increased risk of hepatitis B virus (HBV) reactivation, but a low proportion of these patients are screened for HBV infection and guidelines make conflicting recommendations. Further, the cost-effectiveness of newer treatments for HBV prophylaxis has not been examined for this population. We aimed to analyze the cost-effectiveness of HBV screening before chemotherapy for patients with solid tumors. METHODS: We compared 3 HBV screening strategies (screen all, screen only high-risk patients, or screen none) using a Markov model of a population of adults in the United States who initiated chemotherapy for a solid tumor. We modeled use of entecavir prophylaxis for HB surface antigen (HBsAg)-positive patients and surveillance for HBsAg-negative patients who are positive for HBV core antibody. The Markov cycle length was 1 year, with model simulation for up to 5 years. RESULTS: The screen all strategy was the most cost effective, with an incremental cost-effectiveness ratio of $42,761 compared to screening only high-risk patients. The screen none strategy was less effective and less costly than screening all patients or only high-risk patients. The screen-all strategy was the most cost effective for all estimates of prevalence of HBsAg-positive patients and estimates of HBV reactivation in HBsAg-positive patients. Screening only high-risk patients was the most cost-effective strategy when more than 25% of high-risk patients were screened for HBV infection. CONCLUSIONS: In a Markov model analysis, we found screening all patients with solid tumors for HBV infection before chemotherapy to be the most cost-effective strategy. Guidelines should consider recommending HBV tests for patients initiating chemotherapy.
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Hepatite B , Neoplasias , Adulto , Análise Custo-Benefício , Hepatite B/diagnóstico , Antígenos de Superfície da Hepatite B , Vírus da Hepatite B , Humanos , Ativação ViralRESUMO
BACKGROUND: Patients with ulcerative colitis (UC) are at an increased risk of Clostridium difficile infection (CDI) compared with the general population. Recent data suggest that obesity also increases the risk of CDI. AIMS: To examine whether obesity influences the risk of CDI among patients with UC. STUDY: We conducted a retrospective cross-sectional study of UC patients seen in gastroenterology clinic between January 1, 2014, and December 31, 2015. Records were reviewed for patients with the diagnosis of UC prior to 2014, and the first diagnosis of CDI between January 1, 2014, and December 31, 2015. Using body mass index (BMI), patients were classified into underweight (BMI < 18.5), normal weight (18.5 ≤ BMI < 25), overweight (25 ≤ BMI < 30), and obese (BMI ≥ 30). Age-adjusted and multivariate logistic regression was performed including gender, tobacco use, UC disease duration, medication exposure, and vitamin D deficiency. RESULTS: Of the 636 patients with UC, 114 (18%) were obese, 232 (36%) overweight, 274 (43%) normal weight, and 16 (2.5%) underweight. Nineteen patients (3.0%) developed CDI during the study period. CDI risk was not associated with BMI (OR 0.90, 95% CI 0.79-1.02). Compared to normal weight patients, risk of CDI was not influenced by being obese (multivariate OR 0.63, 95% CI 0.15-2.58), overweight (multivariate OR 0.33, 95% CI 0.08-1.30), or underweight (multivariate OR 2.98, 95% CI 0.45-19.83). CDI was associated with ever use of TNF therapy (multivariate OR 6.09, 95% CI 2.07-17.93) but not vedolizumab (multivariate OR 0.76, 95% CI 0.08-7.36). CONCLUSIONS: Obesity does not appear to be associated with the risk of C. difficile infection among patients with UC.
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Infecções por Clostridium/epidemiologia , Colite Ulcerativa/epidemiologia , Obesidade/epidemiologia , Adulto , Idoso , Índice de Massa Corporal , Distribuição de Qui-Quadrado , Infecções por Clostridium/diagnóstico , Infecções por Clostridium/microbiologia , Colite Ulcerativa/diagnóstico , Colite Ulcerativa/tratamento farmacológico , Colite Ulcerativa/microbiologia , Estudos Transversais , Disbiose , Feminino , Fármacos Gastrointestinais/efeitos adversos , Microbioma Gastrointestinal , Trato Gastrointestinal/microbiologia , Humanos , Modelos Lineares , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Obesidade/diagnóstico , Obesidade/microbiologia , Razão de Chances , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de TempoRESUMO
BACKGROUND & AIMS: Patients with chronic ulcerative colitis are at increased risk for colorectal neoplasia (CRN). Surveillance by white-light endoscopy (WLE) or chromoendoscopy may reduce risk of CRN, but these strategies are underused. Analysis of DNA from stool samples (sDNA) can detect CRN with high levels of sensitivity, but it is not clear if this approach is cost-effective. We simulated these strategies for CRN detection to determine which approach is most cost-effective. METHODS: We adapted a previously published Markov model to simulate the clinical course of chronic ulcerative colitis, the incidence of cancer or dysplasia, and costs and benefits of care with 4 surveillance strategies: (1) analysis of sDNA and diagnostic chromoendoscopy for patients with positive results, (2) analysis of sDNA with diagnostic WLE for patients with positive results, (3) chromoendoscopy with targeted collection of biopsies, or (4) WLE with random collection of biopsies. Costs were based on 2014 Medicare reimbursement. The primary outcome was the incremental cost-effectiveness ratio (incremental cost/incremental difference in quality-adjusted life-years) compared with no surveillance and a willingness-to-pay threshold of $50,000. RESULTS: All strategies fell below the willingness-to-pay threshold at 2-year intervals. Incremental cost-effectiveness ratios were $16,362 per quality-adjusted life-year for sDNA analysis with diagnostic chromoendoscopy; $18,643 per quality-adjusted life-year for sDNA analysis with diagnostic WLE; $23,830 per quality-adjusted life-year for chromoendoscopy alone; and $27,907 per quality-adjusted life-year for WLE alone. In sensitivity analyses, sDNA analysis with diagnostic chromoendoscopy was more cost-effective than chromoendoscopy alone, up to a cost of $1135 per sDNA test. sDNA analysis remained cost-effective at all rates of compliance; when combined with diagnostic chromoendoscopy, this approach was preferred over chromoendoscopy alone, when the specificity of the sDNA test for CRN was >65%. CONCLUSIONS: Based on a Markov model, surveillance for CRN is cost-effective for patients with chronic ulcerative colitis. Analysis of sDNA with chromoendoscopies for patients with positive results was more cost-effective than chromoendoscopy or WLE alone.
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Colite Ulcerativa/complicações , Neoplasias Colorretais/diagnóstico , Análise Custo-Benefício , DNA/análise , Detecção Precoce de Câncer/economia , Detecção Precoce de Câncer/métodos , Fezes/química , HumanosRESUMO
INTRODUCTION: Dietary fats influence intestinal inflammation and regulate mucosal immunity. Data on the association between dietary fat and risk of Crohn's disease (CD) and ulcerative colitis (UC) are limited and conflicting. METHODS: We conducted a prospective study of women enrolled in the Nurses' Health Study cohorts. Diet was prospectively ascertained every 4 years using a validated semi-quantitative food frequency questionnaire. Self-reported CD and UC were confirmed through medical record review. We examined the effect of energy-adjusted cumulative average total fat intake and specific types of fat and fatty acids on the risk of CD and UC using Cox proportional hazards models adjusting for potential confounders. RESULTS: Among 170,805 women, we confirmed 269 incident cases of CD (incidence 8/100,000 person-years) and 338 incident cases of UC (incidence 10/100,000 person-years) over 26 years and 3,317,338 person-years of follow-up. Cumulative energy-adjusted intake of total fat, saturated fats, unsaturated fats, n-6 and n-3 polyunsaturated fatty acids (PUFAs) were not associated with risk of CD or UC. However, greater intake of long-chain n-3 PUFAs was associated with a trend towards lower risk of UC (HR 0.72, 95% CI 0.51 to 1.01). In contrast, high long-term intake of trans-unsaturated fatty acids was associated with a trend towards an increased incidence of UC (HR 1.34, 95% CI 0.94 to 1.92). CONCLUSIONS: A high intake of dietary long-chain n-3 PUFAs may be associated with a reduced risk of UC. In contrast, high intake of trans-unsaturated fats may be associated with an increased risk of UC.
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Colite Ulcerativa/etiologia , Doença de Crohn/etiologia , Gorduras na Dieta/efeitos adversos , Adulto , Colite Ulcerativa/epidemiologia , Doença de Crohn/epidemiologia , Inquéritos sobre Dietas , Feminino , Seguimentos , Humanos , Incidência , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Estudos Prospectivos , Fatores de Risco , Autorrelato , Estados Unidos/epidemiologiaRESUMO
BACKGROUND: Clostridium difficile infection (CDI) is an important cause of morbidity and healthcare costs, and is characterized by high rates of disease recurrence. The cost-effectiveness of newer treatments for recurrent CDI has not been examined, yet would be important to inform clinical practice. The aim of this study was to analyze the cost effectiveness of competing strategies for recurrent CDI. METHODS: We constructed a decision-analytic model comparing 4 treatment strategies for first-line treatment of recurrent CDI in a population with a median age of 65 years: metronidazole, vancomycin, fidaxomicin, and fecal microbiota transplant (FMT). We modeled up to 2 additional recurrences following the initial recurrence. We assumed FMT delivery via colonoscopy as our base case, but conducted sensitivity analyses based on different modes of delivery. Willingness-to-pay threshold was set at $50 000 per quality-adjusted life-year. RESULTS: At our base case estimates, initial treatment of recurrent CDI using FMT colonoscopy was the most cost-effective strategy, with an incremental cost-effectiveness ratio of $17 016 relative to oral vancomycin. Fidaxomicin and metronidazole were both dominated by FMT colonoscopy. On sensitivity analysis, FMT colonoscopy remained the most cost-effective strategy at cure rates >88.4% and CDI recurrence rates <14.9%. Fidaxomicin required a cost <$1359 to meet our cost-effectiveness threshold. In clinical settings where FMT is not available or applicable, the preferred strategy appears to be initial treatment with oral vancomycin. CONCLUSIONS: In this decision analysis examining treatment strategies for recurrent CDI, we demonstrate that FMT colonoscopy is the most cost-effective initial strategy for management of recurrent CDI.
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Antibacterianos/economia , Antibacterianos/uso terapêutico , Terapia Biológica/economia , Terapia Biológica/métodos , Clostridioides difficile/isolamento & purificação , Infecções por Clostridium/prevenção & controle , Infecções por Clostridium/terapia , Idoso , Idoso de 80 Anos ou mais , Infecções por Clostridium/microbiologia , Análise Custo-Benefício , Técnicas de Apoio para a Decisão , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , RecidivaRESUMO
BACKGROUND & AIMS: Sleep deprivation is associated with production of inflammatory cytokines. Disturbed sleep quality has been associated with increased risk of disease flare in patients with Crohn's disease (CD) or ulcerative colitis (UC). However, the association between sleep and risk of incident CD and UC has not been previously examined. METHODS: We conducted a prospective study of women who were enrolled in the Nurses' Health Study (NHS) I since 1976 and NHS II since 1989 and followed through detailed biennial questionnaires with >90% follow-up. We examined the association of sleep duration reported in 1986 in NHS I and 2001 in NHS II with incident CD and UC, diagnosed through 2010, in NHS I and 2009 in NHS II. Cox proportional hazards models adjusting for potential confounders were used to calculate hazard ratios and 95% confidence intervals (CIs). RESULTS: Among 151,871 women, we confirmed 191 cases of CD (incidence, 8/100,000 person-years) and 230 cases of UC (incidence, 10/100,000 person-years) over 2,292,849 person-years. Compared with women with reported usual sleep durations of 7-8 h/day (incidence, 8/100,000 person-years), women with reported sleep duration <6 h/day (11/100,000 person-years) or >9 h/day (20/100,000 person-years) had a higher incidence of UC (P < .05). The multivariate hazard ratios for UC were 1.51 (95% CI, 1.10-2.09) for sleep durations <6 h/day and 2.05 (95% CI, 1.44-2.92) for sleep durations >9 h/day, compared with sleep durations of 7-8 h/day. In contrast, sleep duration did not modify risk of CD. Duration of rotating night shift work was not associated with CD or UC. CONCLUSIONS: On the basis of data from the NHS I and II, less than 6 hours sleep/day and more than 9 hours sleep/day are each associated with an increased risk of UC. Further studies are needed to evaluate sleep as a modifiable risk factor in the pathogenesis and progression of IBD.
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Colite Ulcerativa/epidemiologia , Sono , Adulto , Estudos de Coortes , Feminino , Humanos , Incidência , Pessoa de Meia-Idade , Estudos Prospectivos , Medição de Risco , Inquéritos e Questionários , Fatores de TempoRESUMO
BACKGROUND & AIMS: Patients with inflammatory bowel diseases (IBDs) have increased risk for venous thromboembolism (VTE); those who require hospitalization have particularly high risk. Few hospitalized patients with IBD receive thromboprophylaxis. We analyzed the frequency of VTE after IBD-related hospitalization, risk factors for post-hospitalization VTE, and the efficacy of prophylaxis in preventing post-hospitalization VTE. METHODS: In a retrospective study, we analyzed data from a multi-institutional cohort of patients with Crohn's disease or ulcerative colitis and at least 1 IBD-related hospitalization. Our primary outcome was a VTE event. All patients contributed person-time from the date of the index hospitalization to development of VTE, subsequent hospitalization, or end of follow-up. Our main predictor variable was pharmacologic thromboprophylaxis. Cox proportional hazard models adjusting for potential confounders were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs). RESULTS: From a cohort of 2788 patients with at least 1 IBD-related hospitalization, 62 patients developed VTE after discharge (2%). Incidences of VTE at 30, 60, 90, and 180 days after the index hospitalization were 3.7/1000, 4.1/1000, 5.4/1000, and 9.4/1000 person-days, respectively. Pharmacologic thromboprophylaxis during the index hospital stay was associated with a significantly lower risk of post-hospitalization VTE (HR, 0.46; 95% CI, 0.22-0.97). Increased numbers of comorbidities (HR, 1.30; 95% CI, 1.16-1.47) and need for corticosteroids before hospitalization (HR, 1.71; 95% CI, 1.02-2.87) were also independently associated with risk of VTE. Length of hospitalization or surgery during index hospitalization was not associated with post-hospitalization VTE. CONCLUSIONS: Pharmacologic thromboprophylaxis during IBD-related hospitalization is associated with reduced risk of post-hospitalization VTE.
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Anticoagulantes/uso terapêutico , Hospitalização/estatística & dados numéricos , Doenças Inflamatórias Intestinais/complicações , Tromboembolia/epidemiologia , Tromboembolia/prevenção & controle , Adulto , Idoso , Estudos de Coortes , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Estudos RetrospectivosRESUMO
BACKGROUND & AIMS: Increased intake of dietary fiber has been proposed to reduce the risk of inflammatory bowel disease (Crohn's disease [CD] and ulcerative colitis [UC]). However, few prospective studies have examined associations between long-term intake of dietary fiber and risk of incident CD or UC. METHODS: We collected and analyzed data from 170,776 women, followed up over 26 years, who participated in the Nurses' Health Study, followed up for 3,317,425 person-years. Dietary information was prospectively ascertained via administration of a validated semiquantitative food frequency questionnaire every 4 years. Self-reported CD and UC were confirmed through review of medical records. Cox proportional hazards models, adjusting for potential confounders, were used to calculate hazard ratios (HRs). RESULTS: We confirmed 269 incident cases of CD (incidence, 8/100,000 person-years) and 338 cases of UC (incidence, 10/100,000 person-years). Compared with the lowest quintile of energy-adjusted cumulative average intake of dietary fiber, intake of the highest quintile (median of 24.3 g/day) was associated with a 40% reduction in risk of CD (multivariate HR for CD, 0.59; 95% confidence interval, 0.39-0.90). This apparent reduction appeared to be greatest for fiber derived from fruits; fiber from cereals, whole grains, or legumes did not modify risk. In contrast, neither total intake of dietary fiber (multivariate HR, 0.82; 95% confidence interval, 0.58-1.17) nor intake of fiber from specific sources appeared to be significantly associated with risk of UC. CONCLUSIONS: Based on data from the Nurses' Health Study, long-term intake of dietary fiber, particularly from fruit, is associated with lower risk of CD but not UC. Further studies are needed to determine the mechanisms that mediate this association.
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Colite Ulcerativa/epidemiologia , Doença de Crohn/epidemiologia , Fibras na Dieta/administração & dosagem , Fibras na Dieta/uso terapêutico , Adulto , Colite Ulcerativa/prevenção & controle , Doença de Crohn/prevenção & controle , Ingestão de Alimentos , Feminino , Seguimentos , Humanos , Incidência , Estudos Longitudinais , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Estudos Prospectivos , Fatores de Risco , AutorrelatoRESUMO
BACKGROUND: Recent studies report that the risk of colorectal cancer (CRC) among patients with ulcerative colitis (UC) may be lower than previously estimated. Although white-light endoscopy (WLE) with random biopsies is recommended for dysplasia detection in patients with UC, several studies reported increased detection of dysplasia by chromoendoscopy. OBJECTIVE: To analyze the cost effectiveness of chromoendoscopy relative to WLE or no endoscopy for CRC surveillance in patients with UC. DESIGN: Decision-analytic state-transition (Markov) model with Monte Carlo simulation. SETTING: To simulate the clinical course of chronic UC, we estimated dysplasia and CRC incidence and progression, endoscopic test characteristics, stage-specific mortality rates, and costs from published literature and Medicare reimbursement data. PATIENTS: Patients from a population-based age distribution with ulcerative colitis for ≥8 years. INTERVENTION: We compared 3 different strategies at various surveillance intervals: chromoendoscopy with targeted biopsies, WLE with random biopsies, and no surveillance. The robustness of the model was assessed by using probabilistic sensitivity analysis. One-way sensitivity analyses were performed to evaluate individual variables, and 3-dimensional analysis was used to examine the effects of varying screening intervals. MAIN OUTCOME MEASUREMENTS: Incremental cost-effectiveness ratio (ICER). RESULTS: Chromoendoscopy was found to be more effective and less costly than WLE at all surveillance intervals. However, compared with no surveillance, chromoendoscopy was cost effective only at surveillance intervals of at least 7 years, with an ICER of $77,176. Chromoendoscopy was the most cost effective strategy at sensitivity levels >0.23 for dysplasia detection and cost <$2200, regardless of the level of sensitivity of WLE for dysplasia detection. The estimated population lifetime risk of developing CRC ranged from 2.5% (annual chromoendoscopy) to 5.9% (chromoendoscopy every 10 years). LIMITATIONS: Estimates used for the model are based on best available data in the literature. CONCLUSION: Chromoendoscopy is both more effective and less costly than WLE and becomes cost effective relative to no surveillance when performed at intervals of ≥7 years.
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Adenoma/diagnóstico , Colonoscopia/normas , Neoplasias Colorretais/diagnóstico , Detecção Precoce de Câncer/normas , Vigilância da População , Indicadores de Qualidade em Assistência à Saúde , Idoso , Benchmarking , Feminino , Hospitais Universitários , Humanos , Indiana , Masculino , Pessoa de Meia-Idade , Estudos RetrospectivosRESUMO
Diet is an environmental exposure implicated in the development of inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC). Dietary therapy is also a tool for management of these conditions. Nutrition therapy for IBD has been shown to reduce intestinal inflammation, promote healing, and alleviate symptoms, as well as improve patients' nutrition status. Although the mechanisms of action of most nutrition therapies for IBD are not well understood, the diets are theorized to eliminate triggers for gut dysbiosis and mucosal immune dysfunction associated with the typical Western diet. Exclusive enteral nutrition and the Crohn's disease exclusion diet are increasingly being used as the primary treatment modality for the induction of remission and/or maintenance therapy in children, and in some adults, with CD. Several other diets, such as the Mediterranean diet, anti-inflammatory diet for IBD, and diets excluding gluten, FODMAPs (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols), lactose, or other compounds, may be helpful in symptom management in both CD and UC, though evidence for biochemical efficacy is limited. In this review, we discuss the role of diet components in IBD pathogenesis and examine diets currently used in the management of children and adults with IBD. We also address practical, psychosocial, and cultural considerations for dietary therapy across diverse populations.
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Doença de Crohn , Doenças Inflamatórias Intestinais , Humanos , Criança , Adulto , Doenças Inflamatórias Intestinais/dietoterapia , Doenças Inflamatórias Intestinais/terapia , Doença de Crohn/terapia , Doença de Crohn/dietoterapia , Nutrição Enteral/métodos , Dieta Mediterrânea , Colite Ulcerativa/terapia , Colite Ulcerativa/dietoterapia , Dieta/métodosRESUMO
INTRODUCTION: We previously reported the results of tofacitinib induction therapy in the prospective multisite US real-world Tofacitinib Response in Ulcerative Colitis registry. We now assessed patient-reported outcomes (PROs) and predictors of success during tofacitinib maintenance therapy. METHODS: Tofacitinib Response in Ulcerative Colitis included 103 patients with refractory ulcerative colitis (UC); 67% had failed ≥ 2 biologics. Patients reported the Simple Clinical Colitis Activity Index (SCCAI), Patient-Reported Outcome Measurement Information System measures for anxiety, depression, social satisfaction, and adverse events between weeks 8 and 52 using a web-based system. Paired t test and P for trend were used to compare changes in PRO measures over time. Bivariate analyses and logistic regression models were used to determine factors associated with response (SCCAI <5) or remission (SCCAI <2) at week 52. RESULTS: Of 103 patients, 82.5% entered the maintenance phase and 43.7% remained on tofacitinib at week 52. Tofacitinib de-escalation to 5 mg BID occurred in 15% of patients. At week 52, 42.7% and 31.1% of all patients reported an SCCAI <5 and SCCAI ≤2, respectively. Normalization of bowel frequency, rectal bleeding, and urgency occurred in 79%, 61%, and 48% of patients remaining on maintenance therapy. Social satisfaction improved significantly ( P < 0.001), while anxiety and depression scores only numerically improved. No consistent predictors for tofacitinib long-term treatment efficacy were identified, and safety findings were consistent with the known safety profile of tofacitinib. DISCUSSION: Tofacitinib is an effective maintenance therapy in patients with refractory UC. Dose reductions infrequently occurred during maintenance. Unmet needs in UC maintenance include improvement of urgency and psychosocial factors (NCT03772145).
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Colite Ulcerativa , Pirimidinas , Humanos , Colite Ulcerativa/diagnóstico , Colite Ulcerativa/tratamento farmacológico , Estudos Prospectivos , Piperidinas/efeitos adversos , Sistema de RegistrosAssuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Doença de Crohn/tratamento farmacológico , Esofagite Eosinofílica/tratamento farmacológico , Fármacos Gastrointestinais/uso terapêutico , Integrinas/antagonistas & inibidores , Adulto , Anticorpos Monoclonais Humanizados/administração & dosagem , Doença de Crohn/complicações , Esofagite Eosinofílica/complicações , Fármacos Gastrointestinais/administração & dosagem , Humanos , Infliximab/administração & dosagem , Infliximab/uso terapêutico , MasculinoRESUMO
BACKGROUND: Tofacitinib is an oral, small-molecule JAK inhibitor for the treatment of ulcerative colitis (UC). Using a novel electronic reporting tool, we aimed to prospectively describe the onset of tofacitinib efficacy during induction therapy in a real-world study. METHODS: Patient-reported outcome data (PROs) including the simple clinical colitis activity index (SCCAI), PRO Measurement Identification Systems (PROMIS) measures, and adverse events were collected daily for the first 14 days and at day 28 and 56. Paired t tests and P for trend were utilized to compare changes in SCCAI over time. Bivariate analyses and logistic regression models were performed to describe response (SCCAI <5) and remission (SCCAI ≤2) by clinical factors. RESULTS: Of all included patients (n = 96), 67% had failed ≥2 biologics, and 61.5% were on concomitant steroids. Starting at day 3, PROs showed significant and persistent decline of the mean SCCAI (-1.1, P < 000.1) including significantly lower SCCAI subscores for stool frequency (-0.3; P < .003), bleeding (-0.3; P < .0002) and urgency (-0.2; P < .001). Steroid-free remission at day 14, 28, and 56 was achieved in 25%, 30.2%, and 29.2% of patients, respectively. Neither prior biologics nor endoscopic severity were independently predictive of response or remission in multivariate models. Numeric improvements in all PROMIS measures (anxiety, depression, social satisfaction) were seen through day 56. Rates of discontinuation due to adverse events were low. CONCLUSIONS: In this prospective real-world study, tofacitinib resulted in a rapid and persistent improvement in UC disease activity PROs. The safety findings were consistent with the established safety profile of tofacitinib.
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Produtos Biológicos , Colite Ulcerativa , Colite , Humanos , Colite Ulcerativa/tratamento farmacológico , Estudos Prospectivos , Fatores Biológicos/uso terapêutico , Produtos Biológicos/uso terapêuticoAssuntos
2-Piridinilmetilsulfinilbenzimidazóis/efeitos adversos , Colite Microscópica/induzido quimicamente , Diarreia/etiologia , Inibidores da Bomba de Prótons , 2-Piridinilmetilsulfinilbenzimidazóis/uso terapêutico , Idoso de 80 Anos ou mais , Biópsia por Agulha , Doença Crônica , Colite Microscópica/complicações , Colite Microscópica/patologia , Diarreia/diagnóstico , Seguimentos , Humanos , Imuno-Histoquímica , Mucosa Intestinal/efeitos dos fármacos , Mucosa Intestinal/patologia , Lansoprazol , Masculino , Bombas de Próton/efeitos adversos , Medição de RiscoRESUMO
Human cytomegalovirus (CMV) is a ubiquitous Herpesviridae virus with a wide spectrum of pathology in humans. Host immunity is a major determinant of the clinical manifestation of CMV and can vary widely in the gastroenterology and hepatology practice setting. Immunocompetent patients generally develop a benign, self-limited mononucleosis-like syndrome whereas gastrointestinal tissue-invasive disease is more frequently seen in immunocompromised and inflammatory bowel disease patients. Additionally, liver allograft dysfunction is a significant consequence of CMV infection in liver transplant patients. While polymerase chain reaction and immunohistochemistry techniques allow for the reliable and accurate detection of CMV in the human host, the diagnostic value of different serologic, endoscopic, and histologic tests depends on a variety of factors. Similarly, latent CMV, CMV infection, and CMV disease carry different significance depending on the patient population, and the decision to initiate antiviral therapy can be complex and patient-specific. This review will focus on the pathophysiology, diagnosis, and management of CMV in patient populations relevant to the practice of gastroenterology and hepatology-liver transplant recipients, inflammatory bowel disease patients, and otherwise immunocompetent patients.