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Therapeutic drug monitoring in inflammatory bowel disease:The dawn of reactive monitoring

World Journal of Gastroenterology 2021年第37期27卷 6231-6247页

作者： Farah Albader petra anna golovics Lorant Gonczi Talat Bessissow Waqqas Afif Peter Laszlo Lakatos Department of Internal Medicine McGill UniversityMontreal H3G1A4QuebecCanada Division of Gastroenterology Hungarian Defence ForcesMedical CentreBudapest H-1062Hungar Division of Gastroenterology McGill UniversityMontreal H3G 1A4QuebecCanada First Department of Medicine Semmelweis UniversityBudapest H-1083Hungary Division of Gastroenterology McGill University Health CentreMontreal H3G 1A4QuebecCanada

Inflammatory bowel disease(IBD)is a chronic condition that significantly affects the quality of life of its *** drugs have been the mainstay treatment in the management of IBD patients but despite their significant contribution,there remains a proportion of patients that do not respond or lose response to *** drug monitoring(TDM)involves measuring levels of serum drug concentrations and anti-drug *** of biologic drugs initially emerged to understand treatment failure in other immune mediated inflammatory *** was then introduced in IBD to rationalize primary non-response or secondary loss of response,given that low serum drug concentrations or the formation of anti-drug antibodies are variably associated with treatment *** aim of this narrative review is to provide an overview regarding the current use of TDM in clinical practice and to present the evidence available regarding its use in both proactive and reactive clinical settings in preventing and managing treatment *** review also presents the existing evidence regarding the association of various clinical outcomes with specific thresholds of drug concentrations,in everyday practice.A narrative review of published articles and conference abstracts regarding the use of TDM in IBD management,through an electronic search using PubMed and *** has proven to be superior and more cost effective in guiding management of patients with treatment failure compared to empiric dose escalation or change in *** a trend towards an association between clinical outcomes and drug concentrations,proactive TDM based strategies have not been shown to achieve clear benefit in long-term *** the clinical setting,TDM has proven to be useful in managing IBD patients,and its use in the reactive setting,as an additional tool to help manage patients with treatment failure,is being promoted as newer guidelines and consensus groups implement

关键词： Therapeutic drug monitoring Inflammatory bowel disease Biologic therapies Loss of response Reactive Proactive

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Effectiveness, safety, and drug sustainability of biologics in elderly patients with inflammatory bowel disease: A retrospective study

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World Journal of Gastroenterology 2022年第33期28卷 4823-4833页

作者： Gustavo Drugg Hahn Jean-Frederic LeBlanc petra anna golovics Panu Wetwittayakhlang Abdulrahman Qatomah anna Wang Levon Boodaghians Jeremy Liu Chen Kiow Maryam Al Ali Gary Wild Waqqas Afif Alain Bitton Peter Laszlo Lakatos Talat Bessissow Division of Gastroenterology IBD CenterMcGill University Health CenterMontreal H3G 1A4QuebecCanada School of Medicine Graduate Course Sciences in Gastroenterology and HepatologyUniversidade Federal do Rio Grande do SulPorto Alegre 90000-000Brazil Division of Gastroenterology McGill University Health CentreMontreal H3G 1A4QuebecCanada Department of Gastroenterology Hungarian Defense ForcesMedical CentreBudapest 1134Hungary Unit of Gastroenterology and Hepatology Division of Internal MedicineFaculty of MedicinePrince of Songkla UniversitySongkhla 90110Thailand Department of Gastroenterology Centre Hospitalier de l’Universitede MontrealMontreal H2X 3E4QuebecCanada

BACKGROUND Biologic therapy resulted in a significant positive impact on the management of inflammatory bowel disease(IBD) however data on the efficacy and side effects of these therapies in the elderly is *** To evaluate retrospectively the drug sustainability, effectiveness, and safety of the biologic therapies in the elderly IBD *** Consecutive elderly(≥ 60 years old) IBD patients, treated with biologics [infliximab(IFX), adalimumab(ADAL), vedolizumab(VDZ), ustekinumab(UST)] followed at the McGill University Inflammatory Bowel Diseases Center were included between January 2000 and *** was measured by clinical scores at 3, 6-9 and 12-18 mo after initiation of the biologic therapy. Patients completing induction therapy were included. Adverse events(AEs) or serious AE were collected during and within three months of stopping of the biologic *** We identified a total of 147 elderly patients with IBD treated with biologicals during the study period, including 109 with Crohn’s disease and 38 with ulcerative colitis. Patients received the following biologicals: IFX(28.5%), ADAL(38.7%), VDZ(15.6%), UST(17%). The mean duration of biologic treatment was 157.5(SD = 148) wk. Parallel steroid therapy was given in 34% at baseline,19% at 3 mo, 16.3% at 6-9 mo and 6.5% at 12-18 mo. The remission rates at 3, 6-9 and 12-18 mo were not significantly different among biological therapies. Kaplan-Meyer analysis did not show statistical difference for drug sustainability(P = 0.195), time to adverse event(P = 0.158) or infection rates(P = 0.973) between the four biologics studied. The most common AEs that led to drug discontinuation were loss of response, infusion/injection reaction and *** Current biologics were not different regarding drug sustainability, effectiveness, and safety in the elderly IBD population. Therefore, we are not able to suggest a preferred sequencing order among biologicals.

关键词： Inflammatory bowel disease Biologics Elderly Efficacy Safety Adverse events

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Is early limited surgery associated with a more benign disease course in Crohn's disease?

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World Journal of Gastroenterology 2013年第43期19卷 7701-7710页

作者： petra anna golovics Laszlo Lakatos Attila Nagy Tunde Pandur Istvan Szita Mihaly Balogh Csaba Molnar Erzsebet Komaromi Barbara Dorottya Lovasz Michael Mandel Gabor Veres Lajos S Kiss Zsuzsanna Vegh Peter Laszlo Lakatos First Department of Medicine Semmelweis UniversityH-1083 BudapestHungary Department of Medicine Csolnoky F Province HospitalH-8200 VeszpremHungary Department of Surgery Csolnoky F Province HospitalH-8200 VeszpremHungary Department of Medicine Grof Eszterhazy HospitalH-8500 PapaHungary Department of Infectious Diseases Magyar Imre HospitalH-8400 AjkaHungary Department of Gastroenterology Municipal HospitalH-8100 VarpalotaHungary First Department of Pediatrics Semmelweis UniversityH-1083 BudapestHungary

AIM:To analyze the difference in disease course and need for surgery in patients with Crohn’s disease(CD).METHODS:Data of 506 patients with incident CD were analyzed(age at diagnosis:31.5±13.8 years).Both hospital and outpatient records were collected prospectively with a complete clinical follow-up and comprehensively reviewed in the population-based Veszprem province database,which includes incident CD patients diagnosed between January 1,1977 and December 31,***-up data were collected until December 31,*** patients included had at least 1year of follow-up *** with indeterminate colitis at diagnosis were excluded from the ***:Overall,73 patients(14.4%)required resective surgery within 1 year of *** exposure and need for biological therapy were lower in patients with early limited surgery(P<0.001 and P=0.09).In addition,surgery rates during follow-up in patients with and without early surgery differed significantly after matching on propensity scores(P<0.001,HR=0.23).The need for reoperation was also lower in patients with early limited resective surgery(P=0.038,HR=0.42)in a Kaplan-Meier and multivariate Cox regression(P=0.04)***,this advantage was not observed after matching on propensity scores(PLogrank=0.656,PBreslow=0.498).CONCLUSION:Long-term surgery rates and overall exposure to steroids and biological agents were lower in patients with early limited resective surgery,but reoperation rates did not differ.

关键词： Crohn’s disease Early surgery Disease course Disease behavior Treatment strategy

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Evolution of disease phenotype in adult and pediatric onset Crohn's disease in a population-based cohort

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World Journal of Gastroenterology 2013年第14期19卷 2217-2226页

作者： Barbara Dorottya Lovasz Laszlo Lakatos Agnes Horvath Istvan Szita Tunde Pandur Michael Mandel Zsuzsanna Vegh petra anna golovics Gabor Mester Mihaly Balogh Csaba Molnar Erzsebet Komaromi Lajos Sandor Kiss Peter Laszlo Lakatos First Department of Medicine Semmelweis University Department of Medicine Csolnoky F Province Hospital Department of Pediatrics Csolnoky F Province Hospital Department of Medicine Grof Eszterhazy Hospital Department of Infectious Diseases Magyar Imre Hospital Department of Gastroenterology Municipal Hospital

AIM:To investigate the evolution of disease phenotypein adult and pediatric onset Crohn's disease(CD) populations,diagnosed between 1977 and ***:Data of 506 incident CD patients were analyzed(age at diagnosis:28.5 years,interquartile range:22-38 years).Both in-and outpatient records were collected prospectively with a complete clinical follow-up and comprehensively reviewed in the population-based Veszprem province database,which included incident patients diagnosed between January 1,1977 and December 31,2008 in adult and pediatric onset CD *** phenotype according to the Montreal classification and long-term disease course was analysed according to the age at onset in time-dependent univariate and multivariate ***:Among this population-based cohort,seventy-four(12.8%) pediatric-onset CD patients were identified(diagnosed ≤ 17 years of age).There was no significant difference in the distribution of disease behavior between pediatric(B1:62%,B2:15%,B3:23%) and adult-onset CD patients(B1:56%,B2:21%,B3:23%) at diagnosis,or during ***,the probability of developing complicated disease behaviour was 49.7% and 61.3% in the pediatric and 55.1% and 62.4% in the adult onset patients after 5-and 10-years of ***,time to change in disease behaviour from non stricturing,non penetrating(B1) to complicated,stricturing or penetrating(B2/B3) disease was not significantly different between pediatric and adult onset CD in a Kaplan-Meier *** year of diagnosis(P = 0.04),ileal location(P < 0.001),perianal disease(P < 0.001),smoking(P = 0.038) and need for steroids(P < 0.001) were associated with presence of,or progression to,complicated disease behavior at diagnosis and during follow-up.A change in disease location was observed in 8.9% of patients and it was associated with smoking status(P = 0.01),but not with age at ***:Long-term evolution of disease behavior was not different in pediatric-a

关键词： Crohn’s disease Age at diagnosis Disease behavior Disease course

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Inflammatory bowel disease course in Crohn's disease:Is the natural history changing?

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World Journal of Gastroenterology 2014年第12期20卷 3198-3207页

作者： petra A golovics Michael D Mandel Barbara D Lovasz Peter L Lakatos First Department of Medicine Semmelweis University

Crohn’s disease (CD) is a multifactorial potentially debilitating disease. It has a variable disease course, but the majority of patients eventually develop penetrating or stricturing complications leading to repeated surgeries and disability. Studies on the natural history of CD provide invaluable data on its course and clinical predictors, and may help to identify patient subsets based on clinical phenotype. Most data are available from referral centers, however these outcomes may be different from those in population-based cohorts. New data suggest the possibility of a change in the natural history in Crohn’s disease, with an increasing percentage of patients diagnosed with inflammatory disease behavior. Hospitalization rates remain high, while surgery rates seem to have decreased in the last decade. In addition, mortality rates still exceed that of the general population. The impact of changes in treatment strategy, including increased, earlier use of immunosuppressives, biological therapy, and patient monitoring on the natural history of the disease are still conflictive. In this review article, the authors summarize the available evidence on the natural history, current trends, and predictive factors for evaluating the disease course of CD.

关键词： Crohn’ s disease, Natural history, Surgery, Mortality, Disease course, Inflammatory bowel disease

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Burden of Clostridium difficile infection between 2010 and 2013:Trends and outcomes from an academic center in Eastern Europe

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World Journal of Gastroenterology 2015年第21期21卷 6728-6735页

作者： Zsuzsanna Kurti Barbara D Lovasz Michael D Mandel Zoltan Csima petra A golovics Bence D Csako anna Mohas Lorant Gnczi Krisztina B Gecse Lajos S Kiss Miklos Szathmari Peter L Lakatos 1~(st) Department of Medicine Semmelweis University Institute of Health Care Development and Clinical Methodology Semmelweis University

AIM:To analyze the incidence and possible risk factors in hospitalized patients treated with Clostridium difficile infection(CDI).METHODS:A total of 11751 patients were admitted to our clinic between 1 January 2010 and 1 *** hundred and forty-seven inpatients were prospectively diagnosed with *** the risk analysis a 1:3 matching was *** of 732 patients matched for age,sex,and inpatient care period and unit were compared to those of the CDI *** records were collected from an electronic hospital database and comprehensively ***:Incidence of CDI was 21.0/1000 admissions(2.1%of all-cause hospitalizations and 4.45%of total inpatient days).The incidence of severe CDI was 12.6%(2.63/1000 of all-cause hospitalizations).Distribution of CDI cases was different according to the unit type,with highest incidence rates in hematology,gastroenterology and nephrology units(32.9,25 and24.6/1000 admissions,respectively) and lowest rates in 1.4%(33/2312) in endocrinology and general internal medicine(14.2 and 16.9/1000 admissions)*** of CDI was 11.3%within 12 wk after *** of hospital stay was longer in patients with CDI compared to controls(17.6 ± 10.8d vs 12.4 ± 7.71 d).CDI accounted for 6.3%of allinpatient deaths,and 30-d mortality rate was 21.9%(54/247 cases).Risk factors for CDI were antibiotic therapy[including third-generation cephalosporins or fluoroquinolones,odds ratio(OR) = 4.559;P < 0.001],use of proton pump inhibitors(OR = 2.082,P< 0.001),previous hospitaiization within 12 mo(OR = 3.167,P < 0.001),previous CDI(OR = 15.32;P < 0.001),while presence of diabetes mellitus was associated with a decreased risk for CDI(OR = 0.484;P< 0.001).Treatment of recurrent cases was significantly different from primary infections with more frequent use of vancomycin alone or in combination(P < 0.001),and antibiotic therapy duration was longer(P < 0.02).Severity,mortality and outcome of primary infections and relapsing

关键词： Clostridium difficile infection Hospitalization Antibiotics Proton pump inhibitors

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Prevalence and predictors of hospitalization in Crohn's disease in a prospective population-based inception cohort from 2000-2012

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World Journal of Gastroenterology 2015年第23期21卷 7272-7280页

作者： petra A golovics Laszlo Lakatos Michael D Mandel Barbara D Lovasz Zsuzsanna Vegh Zsuzsanna Kurti Istvan Szita Lajos S Kiss Tunde Pandur Peter L Lakatos First Department of Medicine Semmelweis University Department of Medicine Csolnoky Ferenc Province Hospital

AIM: To analyze the prevalence, length and predictors of hospitalization in the biological era in the populationbased inception cohort from Veszprem ***: Data of 331 incident Crohn's disease(CD) patients diagnosed between January 1, 2000 and December 31, 2010 were analyzed(median age at diagnosis: 28; IQR: 21-40 years). Both in- and outpatient records were collected and comprehensively ***: Probabilities of first CD-related hospitalization and re-hospitalization were 32.3%, 45.5%,53.7% and 13.6%, 23.9%, 29.8%, respectively after one, three and five years of follow-up in Kaplan-Meier analysis. First-year hospitalizations were related to diagnostic procedures(37%), surgery or disease activity(27% and 21%). Non-inflammatory disease behavior at diagnosis(HR = 1.32, P = 0.001) and perianal disease(HR = 1.47, P = 0.04) were associated with time to first CD-related hospitalization, while disease behavior change(HR = 2.38, P = 0.002) and need for steroids(HR = 3.14, P = 0.003) were associated with time to first re-hospitalization in multivariate *** CD-related hospitalization(within the year of diagnosis) was independently associated with need for immunosuppressives(OR = 2.08, P = 0.001) and need for surgeries(OR = 7.25, P < 0.001) during the disease ***: Hospitalization and re-hospitalization rates are still high in this cohort, especially during the first-year after the diagnosis. Non-inflammatory disease behavior at diagnosis was identified as the pivotal predictive factor of both hospitalization and rehospitalization.

关键词： Crohn's disease Hospitalization Recurrence Predictor Population-based Biological therapy

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Importance of genetic polymorphisms in liver transplantation outcomes

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World Journal of Gastroenterology 2020年第12期26卷 1273-1285页

作者： Tomislav Kelava petra Turcic Antonio Markotic Ana Ostojic Dino Sisl anna Mrzljak Laboratory for Molecular Immunology Croatian Institute for Brain ResearchUniversity of ZagrebSchool of MedicineZagreb 10000Croatia Department of Pharmacology Faculty of Pharmacy and Biochemistry of University of ZagrebZagreb 10000Croatia Center for Clinical Pharmacology University Clinical Hospital MostarMostar 88000Bosnia and Herzegovina Department of Medicine Merkur University HospitalZagreb 10000Croatia Department of Medicine Merkur University HospitalSchool of MedicineUniversity of ZagrebZagreb 10000Croatia

Although,liver transplantation serves as the only curative treatment for patients with end-stage liver diseases,it is burdened with complications,which affect survival *** addition to clinical risk factors,contribution of recipient and donor genetic prognostic markers has been extensively studied in order to reduce the burden and improve the *** of single nucleotide polymorphisms(SNPs)is one of the most important tools in development of personalized transplant *** provide a better insight in recent developments,we review the studies published in the last three years that investigated an association of recipient or donor SNPs with most common issues in liver transplantation:Acute cellular rejection,development of new-onset diabetes mellitus and non-alcoholic fatty liver disease,hepatocellular carcinoma recurrence,and tacrolimus concentration *** studies confirmed previously established SNP prognostic factors,such as PNPLA3 rs738409 for nonalcoholic fatty liver disease development,or the role of CYP3A5 rs776746 in tacrolimus concentration *** also identified several novel SNPs,with a reasonably strong association,which have the potential to become useful predictors of post-transplant ***,as the studies were typically conducted in one center on relatively low-to-moderate number of patients,verification of the results in other centers is warranted to resolve these ***,of 29 reviewed studies,28 used gene candidate approach and only one implemented a genome wide association *** wide association multicentric studies are needed to facilitate the development of personalized transplant medicine.

关键词： Single nucleotide polymorphisms Liver transplantation Acute rejection Non-alcoholic fatty liver disease New-onset diabetes mellitus Hepatocellular carcinoma Tacrolimus

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Epidemiology of hepatitis E in South-East Europe in the "One Health" concept

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World Journal of Gastroenterology 2019年第25期25卷 3168-3182页

作者： anna Mrzljak petra Dinjar-Kujundzic Lorena Jemersic Jelena Prpic Ljubo Barbic Vladimir Savic Vladimir Stevanovic Tatjana Vilibic-Cavlek Department of Medicine Merkur University HospitalSchool of MedicineUniversity of ZagrebZagreb 10000Grad ZagrebCroatia Department of Medicine Merkur University HospitalZagreb 10000Grad ZagrebCroatia Croatian Veterinary Institute Zagreb 10000Grad ZagrebCroatia Faculty of Veterinary Medicine University of ZagrebZagreb 10000Grad ZagrebCroatia Department of Virology Croatian Institute of Public HealthSchool of MedicineUniversity of ZagrebZagreb 10000Grad ZagrebCroatia

The significance of hepatitis E virus(HEV)as an important public health problem is *** a decade ago,cases of HEV infection in Eur-ope were mainly confined to returning travelers,but nowadays,hepatitis E represents an emerging zoonotic infection in many European *** aim of this manuscript is to perform a systematic review of the published literature on hepatitis E distribution in humans,animals and environmental samples("One Health"concept)in the South-Eastern European *** of the available data showed that the anti-HEV seroprevalence in the South-Eastern Europe varies greatly,depending on the population studied,geographical area and methods *** IgG seroprevalence rates in different population groups were found to be 1.1%-24.5%in Croatia,up to 20.9%in Bulgaria,5.9-%17.1%in Romania,15%in Serbia,up to 9.7%in Greece and 2%-9.7%in *** possible risk factors,older age was the most significant predictor for HEV seropositivity in most *** seroprevalence rates were found in *** IgG antibodies in domestic pigs were detected in 20%-54.5%,29.2%-50%,38.94%-50%and 31.1%-91.7%in Serbia,Bulgaria,Romania and Croatia,*** wild boars seroprevalence rates were up to 10.3%,30.3%and 31.1%in Romania,Slovenia and Croatia,respectively.A high HEV RNA prevalence in wild boars in some countries(Croatia and Romania)indicated that wild boars may have a key role in the HEV *** are very few data on HEV prevalence in environmental *** RNA was detected in 3.3%and 16.7%surface waters in Slovenia and Serbia,*** is no evidence of HEV RNA in sewage systems in this *** available data on genetic characterization show that human,animal and environmental HEV strains mainly belong to the genotype 3.

关键词： Hepatitis E virus "One-Health" Humans Animals Environment South-East Europe

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Perspectives of nano-carrier drug delivery systems to overcome cancer drug resistance in the clinics

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Cancer Drug Resistance 2021年第1期4卷 44-68页

作者： anna Ulldemolins Joaquin Seras-Franzoso Fernanda Andrade Diana Rafael Ibane Abasolo petra Gener Simo Schwartz Jr Drug Delivery and Targeting Group Molecular Biology and Biochemistry Research Centre for Nanomedicine(CIBBIM-Nanomedicine)Vall d’Hebron Institut de RecercaUniversitat Autonoma de BarcelonaBarcelona 08035Spain Networking Research Centre for Bioengineering Biomaterialsand Nanomedicine(CIBER-BBN)Instituto de Salud Carlos IIIZaragoza 50009Spain

Advanced cancer is still considered an incurable disease because of its metastatic spread to distal organs and progressive gain of *** though considerable treatment progress and more effective therapies have been achieved over the past years,recurrence in the long-term and undesired side effects are still the main drawbacks of current clinical ***,a majority of chemotherapeutic drugs are highly hydrophobic and need to be diluted in organic solvents,which cause high toxicity,in order to reach effective therapeutic *** limitations of conventional cancer therapies prompted the use of nanomedicine,the medical application of nanotechnology,to provide more effective and safer cancer *** of nanomedicines to overcome resistance,ameliorate solubility,improve pharmacological profile,and reduce adverse effects of chemotherapeutical drugs is thus highly *** use in the clinical setting has increased over the last *** the various existing nanosystems,nanoparticles have the ability to transform conventional medicine by reducing the adverse effects and providing a controlled release of therapeutic ***,their small size facilitates the intracellular ***,we provide a closer review of clinical prospects and mechanisms of action of nanomedicines to overcome drug *** significance of specific targeting towards cancer cells is debated as well.

关键词： Drug delivery systems resistance nanomedicine cancer treatment

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