Rituximab is a safe and effective alternative treatment for patients with autoimmune hepatitis: Results from the ColHai registry.

BACKGROUND AND AIMS: Small series suggest that rituximab could be effective as treatment for autoimmune hepatitis (AIH), although data are scarce. We aimed to evaluate the efficacy and safety of rituximab in different cohorts of patients with AIH. METHODS: Multicentre retrospective analysis of the 35 patients with AIH and its variant forms treated with rituximab and included in the ColHai registry between 2015 and 2023. RESULTS: Most patients were female (83%), 10 (29%) had cirrhosis and four (11.4%) variant forms of AIH. Indication for rituximab were as follows: 14(40%) refractory AIH, 19(54%) concomitant autoimmune or haematological disorder, 2(6%) intolerance to prior treatments. In three (9%) subjects with a concomitant disorder, rituximab was the first therapy for AIH. Overall, 31 (89%) patients achieved or maintained complete biochemical response (CBR), including the three in first-line therapy. No difference in CBR was observed according to rituximab indication (refractory AIH 86% vs. concomitant disorders 90%, p = .824) or cirrhosis (80% vs. 92%, p = .319). Rituximab was associated with a significant reduction in corticosteroids (median dose: prior 20 vs. post 5 mg, p < .001) and the discontinuation of ≥1 immunosuppressant in 47% of patients. Flare-free rate at 1st, 2nd and 3rd year was 86%, 73% and 62% respectively. Flares were not associated with the development of liver failure and were successfully managed with repeated doses of rituximab and/or increased corticosteroids. Three (9%) patients experienced infusion-related adverse events (1 anaphylaxis and 2 flu-like symptoms) and five (14%) infections. CONCLUSION: Rituximab is safe and effective in patients with refractory AIH and those treated due to concomitant autoimmune or haematological disorders.

Improvement of quality of care provided to outpatients with hepatic cirrhosis after an educational intervention.

OBJECTIVE: A set of indicators has been reported to measure the quality of care for cirrhotic patients, and previously published studies report variable adherence rates to these indicators. This study aimed to assess the quality of care provided to cirrhotic outpatients before and after an educational intervention by determining its impact on adherence to quality indicators. METHODS: We conducted a quasi-experimental, cross-sectional study including 324 cirrhotic patients seen in 2017 and 2019 at a tertiary teaching hospital in Spain. Quality indicators were assessed in five domains: documentation of cirrhosis etiology, disease severity assessment, hepatocellular carcinoma (HCC) screening, variceal bleeding prophylaxis, and vaccination. After identifying areas for improvement, an educational intervention was implemented. A second evaluation was performed after the intervention to assess changes in adherence rates. RESULTS: Before the intervention, adherence rates were excellent (>90%) for indicators related to variceal bleeding prophylaxis and documentation of cirrhosis etiology, acceptable (60-80%) for HCC screening and disease severity assessment, and poor (<50%) for vaccinations. After the educational intervention, there was a statistically significant improvement in adherence rates for eight indicators related to HCC screening (70-90%), disease severity assessment (90%), variceal bleeding prophylaxis (>90%), and vaccinations (60-90%). CONCLUSION: Our study demonstrates a significant improvement in the quality of care provided to cirrhotic outpatients after an educational intervention. The findings highlight the importance of targeted educational interventions to enhance adherence to quality indicators in the management of cirrhosis.

Ulcer bleeding after band ligation of esophageal varices: Risk factors and prognosis.

BACKGROUND: Post-banding ulcer bleeding is a rare complication of endoscopic band ligation of esophageal varices with high morbidity and mortality. There exist no management guidelines for this complication. AIMS: To determine the incidence, outcome and risk factors of post-banding ulcer bleeding. METHODS: Data for cirrhotic patients with acute variceal bleeding during a six-year period were prospectively collected, and all band ligation sessions performed were retrospectively analyzed. Demographic, analytic and endoscopic data were recorded, as well as complications, outcome and management of each episode of post-banding ulcer bleeding. RESULTS: The study includes 521 band ligation sessions performed on 175 patients. There were 24 cases of post-banding ulcer bleeding in 21 patients (incidence 4.6%). Independent risk factors for post-banding ulcer bleeding were MELD score, hepatocellular carcinoma and total beta-blocker dose. Mortality during the bleeding episode was 23.8%. Active bleeding or adherent clots at the time of endoscopy was associated with treatment failure or death. CONCLUSIONS: Post-banding ulcer bleeding is an uncommon but severe complication of esophageal banding. Patients with hepatocellular carcinoma, poor liver function and a low beta-blocker dose have higher risk of post-banding ulcer bleeding. An aggressive treatment should be considered in case of active bleeding at endoscopy.

Risk factors for resistance to ceftriaxone and its impact on mortality in community, healthcare and nosocomial spontaneous bacterial peritonitis.

BACKGROUND & AIMS: The recent emergence of third-generation cephalosporin resistance in spontaneous bacterial peritonitis is of great concern, although neither the risk factors for resistance nor its real impact on mortality have been well defined. METHODS: We conducted a retrospective study of all spontaneous bacterial peritonitis episodes with positive blood and/or ascitic culture at our center (2001-2009). Episodes were classified according to the place of acquisition: community, healthcare system, or nosocomial. RESULTS: Two hundred and forty-six episodes were analyzed in 200 patients (150 males, 57.3 years): 34.6% community-acquired, 38.6% healthcare system-acquired, and 26.8% nosocomially-acquired. Third-generation cephalosporin resistance occurred in 21.5% (7.1% community-acquired, 21.1% healthcare system-acquired, 40.9% nosocomially-acquired). These resistant cases were categorized as extended-spectrum ß-lactamase-producing Gram-negative bacilli, other resistant Gram-negative bacilli, and Enterococci. Risk factors for resistance were previous use of cephalosporins, diabetes mellitus, upper gastrointestinal bleeding, nosocomial acquisition, and a low polymorphonuclear count in ascites. Regarding third-generation cephalosporin resistance, adequate empirical treatment was 80.7%. Independent predictors of mortality were nosocomial acquisition, poor hepato-renal function, immunosuppressive therapy, a marked inflammatory response during the episode and either third-generation cephalosporin-resistance or low rates of adequate empirical treatment. CONCLUSIONS: The risk of third-generation cephalosporin resistance was particularly high in nosocomially-acquired episodes of spontaneous bacterial peritonitis, but also occurred in healthcare system-acquired cases. The extent of resistance and the adequacy of empirical antibiotics had a significant effect on mortality along with the patient's hepato-renal function. These data can help determine the most suitable empirical antimicrobial treatments in these patients.

Serious drug-induced liver disease secondary to ezetimibe.

Ezetimibe is the first member of a new family of lipid-lowering drugs that inhibits uptake of dietary and biliary cholesterol. It was approved by the FDA in 2002 for hypercholesterolemia alone or in combination with statins. Its use has been spreading over the last years. Ezetimibe was considered a safe drug. We report a case of a woman who developed a serious hepatocellular drug-induced liver disease after 4 mo therapy with 10 mg daily of ezetimibe. After withdrawal of the drug, the patient recovered slowly. Ezetimibe may produce serious toxic hepatitis and prompt withdrawal is mandatory in case of a significant abnormality in liver testing after beginning or during treatment with ezetimibe.

Efficacy and safety of pegylated interferon-alpha2b plus ribavirin for the treatment of chronic hepatitis C in HIV-infected patients.

Low response rates and concerns about safety have limited the implementation of treatment for chronic hepatitis C (CHC) in patients with HIV infection. The efficacy and safety of pegylated interferon (peg-IFN) plus ribavirin in HIV-infected patients with CHC were evaluated in a prospective, open-label, multicenter study. Sixty patients with persistently high transaminases, positive HCV-RNA, CD4 count > or = 300 cells/microl, and HIVRNA <10,000 copies/ml were included. Patients were given peg-IFN 80-150 microg/week plus ribavirin 800-1200 mg/day. Treatment was scheduled for 24 weeks for genotypes 2/3 and 48 weeks for genotypes 1/4. In an intent- to-treat analysis, 16 (26.7%) patients achieved a sustained virological response (SVR). Twenty patients (33.3%) discontinued treatment prematurely, but only in 10 (16.6%) was discontinuation due to adverse events. Negative predictive values for SVR on the basis of HCV-RNA decline between baseline and week 4 were 100% for 1- and 2-log10 fall, and positive predictive values were 40% and 58.3% for 1- and 2-log10 fall, respectively. CD4 fell by a median of 216 cells during treatment, but no HIV-associated complications occurred. In conclusion, treatment with peg-IFN alpha-2b plus ribavirin is safe and clears RNA-HCV in about one-quarter of HIV-infected patients with CHC. Efforts should be focused on optimizing management of side effects and counseling to improve adherence and to keep patients on treatment. Assessment of HCV-RNA at week 4 may help guide early therapeutic decision making.

Cost-effectiveness of a 'score and scope' strategy for the management of dyspepsia.

OBJECTIVE: It is important to identify the best initial work-up in patients with uninvestigated dyspepsia because of its epidemiological and economical relevance. The objective of the study was to assess systematically the effectiveness and cost-effectiveness of invasive and non-invasive strategies for the management of dyspepsia. METHODS: A decision analysis was performed to compare prompt endoscopy, score and scope, test and scope, test and treat, and empirical antisecretory treatment. Published and local data on the prevalence of different diagnoses, rates of Helicobacter pylori infection, accuracy values of diagnostic tests, and effectiveness of drug treatments were used. The perspective of analysis was that of the public healthcare payer, and only direct costs were included, with a one-year post-therapy time horizon. The main outcome measure was cost per asymptomatic patient, valued in 2003 Euros. RESULTS: Endoscopy was found to be the most effective strategy for the management of dyspepsia (38.4% asymptomatic patients), followed by test and scope (35.5%), test and treat (35.3%), score and scope (34.7%), and empirical treatment (28.5%). Incremental cost-effectiveness ratios showed that score and scope was the most cost-effective alternative (483.17 Euros per asymptomatic patient), followed by prompt endoscopy (1396.85 Euros). Sensitivity analyses showed variations when varying the values of prevalence of duodenal ulcer, and the values of healing of functional dyspepsia with antisecretory and eradication drugs. There were no changes when varying the prevalence of H. pylori in dyspepsia. CONCLUSIONS: We would recommend stratifying patients by a score system, referring first to endoscopy those patients at higher risk of organic dyspepsia.

[Prospective validation of a clinical scoring system for the diagnosis of organic dyspepsia]. / Estudio prospectivo de un modelo clínico predictivo de dispepsia orgánica.

BACKGROUND AND OBJECTIVE: Predictive symptomatic scoring models have been proposed to select patients with dyspepsia, who may be candidates to endoscopy. In a previous study performed by gastroentrologists from our group, we obtained three scales of symptoms to predict organic dyspepsia, peptic ulcer and esophagitis, respectively. Here we analyze the reproducibility of those scoring models of symptoms when used either by other gastroenterologists or general practitioners. PATIENTS AND METHOD: It was a clinical prospective study of 230 patients from the Viladecans hospital area (120 from primary healthcare and 110 from the gastroenterologist's consultation). The three validation scales were performed in each patient. Then, we performed a diagnostic gastroscopy which allowed to classify patients into those with organic dyspepsia (ulcer, esophagitis, cancer) or those with functional dyspepsia. We calculated the overall predictive accuracy for the gastroenterologist and the general practitioner and for the three diagnoses (organic dyspepsia, ulcer or esophagitis) using the C statistic. RESULTS: Discriminative capacities were 0.75 and 0.82 for organic dyspepsia, 0.78 and 0.86 for ulcer disease, and 0.78 and 0.82 for esophagitis, for the general practitioner and the gastroenterologist, respectively. In this validation study, the best cut-off value, namely the one combining good sensitivity and specificity, was found to be 7. CONCLUSIONS: A correct predictive capacity of the symptomatic score models when used by other gastroenterologists or by primary healthcare practioners confirms its reproducibility and transferability. The use of predictive symptomatic score models in everyday clinical practice can allow to rationalize the referral for endoscopy in our local setting.

Estudio prospectivo de un modelo clínico predictivo de dispepsia orgánica / Prospective validation of a clinical scoring system for the diagnosis of organic dyspepsia

FUNDAMENTO Y OBJETIVO: Los modelos predictivos basados en un conjunto de síntomas pueden ser útiles para seleccionar a los pacientes con dispepsia candidatos a endoscopia. Un estudio previo realizado por gastroenterólogos obtuvo tres escalas de síntomas con alto valor predictivo para dispepsia orgánica, úlcera péptica y esofagitis. El objetivo del presente estudio fue validar de forma prospectiva la reproducibilidad de dichos modelos al ser utilizados por médicos de atención primaria o por otros gastroenterólogos. PACIENTES Y MÉTODO: Estudio clínico prospectivo en 230 pacientes del área del hospital de Viladecans (120 de atención primaria y 110 de consulta de gastroenterología) a los que se aplicaron las tres escalas a validar. Posteriormente se realizó una endoscopia que clasificó a los pacientes en dispepsia orgánica (úlcera, esofagitis, cáncer) o funcional. La capacidad discriminante para dispepsia orgánica, úlcera y esofagitis del médico de primaria y del gastroenterólogo al aplicar cada una de las escalas se calculó mediante el estadístico c. RESULTADOS: Las capacidades discriminantes fueron 0,75 y 0,82 para dispepsia orgánica, 0,78 y 0,86 para úlcera, y 0,78 y 0,82 para esofagitis, para médicos de atención primaria y para gastroenterólogos, respectivamente. El punto de corte óptimo para discriminar dispepsia orgánica, el que combina la mayor sensibilidad con la mayor especificidad, subió de 6 a 7 puntos en esta validación con respecto al estudio inicial. CONCLUSIONES: La confirmación de la reproducibilidad y transferibilidad de un modelo predictivo sencillo de dispepsia orgánica abre la posibilidad de utilizar este tipo de instrumentos para conseguir un abordaje más eficiente de la dispepsia (AU)