Browsing by Author "Svorcan, Petar (8950517800)"

Introduction/Aim. Anemia is a common extraintestinal manifestation of inflammatory bowel diseases (IBDs). Recognizing and treating anemia in patients with IBD is vital for improving the quality of life and reducing complications. The aim of this study was to assess the effectiveness and safety of the liposomal iron formulation in the treatment of anemia in patients with Crohn's disease and ulcerative colitis. Method. Among 447 patients in the state of clinical remission of ucerative colitis and Crohn's disease treated with biological therapy, there were 37 patients with confirmed sideropenic anemia (Hb 10 g/dl – 12 g/l, ferritin less than 100) who received a liposomal iron pyrophosphate preparation at the dose of 30 mg daily for one month. Parameters such as hemoglobin level, hematocrit, ferritin, and mean corpuscular volume (MCV) were monitored, along with anemia symptoms, and correlated with the onset of therapy; quality of life was also assessed. Statistical analysis was performed using the SPSS program.Results. The application of liposomal iron over one month resulted in a statistically significant increase in hemoglobin levels, averaging 3 g/dL (p = 0.021). A significant increase in hemoglobin was observed in patients in endoscopic remission, almost 10 g/dL (p = 0.008). Additionally, there was an average increase in ferritin levels by almost 2 ng/mL (p = 0.514) and hematocrit by 0.006% (p = 0.126), although these increases did not reach statistical significance. Analyzing the results based on the type of IBD, greater efficacy was observed in patients with ulcerative colitis, showing a significant increase in hemoglobin of 8 g/dL (p = 0.012) compared to patients with Crohn's disease. Two patients reported abdominal discomfort and diarrhea (5.4%) as adverse effects.Conclusion. Our results suggest that 8.3% of IBD patients in clinical remission have anemia and liposomal iron is an effective and safe option for treating anemia in patients. Further research is needed to evaluate the long-term effectiveness and safety of liposomal iron in this patient population. © 2024 University of Nis, Faculty of Medicine. All rights reserved.

[No abstract available]

Introduction The triple therapy which consists of one of the protease inhibitor plus pegylated interferon and ribavirin (P/R) is the standard of care for the treatment of chronic hepatitis C virus (HCV) genotype 1(G1) infection both in treatment-naive and experienced patients. Objective The aim of this study was to analyze the efficacy and tolerability of this regime in hospital practice in Serbia. Methods From July 2012 to October 2012, 20 previously treated patients with advanced fibrosis and HCV G1 infection were included in the triple antiviral regimen in six referral centers in Serbia. All patients were treated with response guide therapy (RGT) regime according to the boceprevir treatment protocol. During the 4-week lead-in period all patients received peginterferon plus ribavirin. After the lead-in period boceprevir was added in the dosage of 800 mg three times a day orally. The subsequent treatment varied according to virologic response and fibrosis. During the therapy HCV RNA level was measured at week 4, 8, 12, 24 of the treatment for the assessment of virologic response profile. All patients who completed therapy were assessed at the end of the treatment and at the end of an additional 24-week treatment-free period for a sustained virologic response (SVR). Results The total of 20 patients with advanced fibrosis was treated. Among patients with an undetectable HCV RNA level at week 8 the rate of SVR was 100%. No patient with decrease in the HCV RNA level <1 log 10 IU/ml at treatment week 4 achieved SVR. The overall rate of SVR was 55%. The safety profile of the treatment regimen was good. Anemia was reported in 25% of patients. There was no life-threatening treatment adverse event. Conclusion Boceprevir in combination with P/R achieved fairly good SVR rates in patients that were "most difficult to treat" who failed on dual therapy and was effective among patients with cirrhosis. © 2015 Serbia Medical Society. All rightsreserved.

Aim To assess practical accuracy of revised Bethesda criteria (BGrev), pathological predictive model (MsPath), and histopathological parameters for detection of high-frequency of microsatellite instability (MSI-H) phenotype in patients with colorectal carcinoma (CRC). Method Tumors from 150 patients with CRC were analyzed for MSI using a fluorescence-based pentaplex polymerase chain reaction technique. For all patients, we evaluated age, sex, family history of cancer, localization, tumor differentiation, mucin production, lymphocytic infiltration (TIL), and Union for International Cancer Control stage. Patients were classified according to the BGrev, and the groups were compared. The utility of the BGrev, MsPath, and clinical and histopathological parameters for predicting microsatellite tumor status were assessed by univariate logistic regression analysis and by calculating the sensitivity, specificity, and positive (PPV) and negative (NPV) predictive values. Results Fifteen out of 45 patients who met and 4 of 105 patients who did not meet the BGrev criteria had MSI-H CRC. Sensitivity, specificity, PPV, and NPV for BGrev were 78.9%, 77%, 30%, and 70%, respectively. MSI histology (the third BGrev criterion without age limit) was as sensitive as BGrev, but more specific. MsPath model was more sensitive than BGrev (86%), with similar specificity. Any BGrev criterion fulfillment, mucinous differentiation, and right-sided CRC were singled out as independent factors to identify MSI-H colorectal cancer. Conclusion The BGrev, MsPath model, and MSI histology are useful tools for selecting patients for MSI testing.

The purpose of the study was to point to the importance of measuring intra-abdominal pressure (IAP) and of early recognition of the consequences of increased IAP on basic vital functions. Measurement of IAP via urinary bladder was conducted every 12 hours in 70 surgical patients with acute abdominal syndromes not previously operated on. Based on the measured IAP values, all patients were divided into groups of patients with normal IAP values (n=20) and patients with increased IAP values (n=50). Vital functions and basic laboratory analysis were monitored and the values obtained were compared with IAP in both patient groups. A statistically significant difference was found in body weight, body mass index, urine output, creatinine, urea, heart rate, partial pressure of oxygen (PaO2) and partial pressure of carbon dioxide (PaCO2) between patients with normal and increased IAP values. The increase in IAP values was found to be associated with an increase in PaCO2, respiratory rate, peak inspiratory pressure, central venous pressure, heart rate, Acute Physiology, Age and Chronic Health Evaluation II score, mortality rate, creatinine and urea values, and number of days of treatment in the intensive care unit. At the same time, the values of PaO2, blood oxygen saturation, diuresis and abdominal perfusion pressure were declining. IAP measurement is an old, cost-effective, reliable technique that is easy to perform and should be applied in all high risk patients.

Background: Serbia has an intermediate estimated prevalence of chronic hepatitis C (CHC) infection, approximately 1.13%, with hepatitis C remaining one of the leading causes of liver-related morbidity and mortality in Serbia with impaired quality of life and overwhelming cost of treating its complications As the availability of new treatment options and resources for screening remains limited, micro-elimination of CHC becomes a top priority. Methods: Review of the available published data related to the clinical and epidemiological situation of the hepatitis C infection in Serbia, including the unpublished data from the databases of four major reference centres in Serbia (Clinical Center Serbia, Clinical Center Niš, Clinical Center Vojvodina and Clinical Center Kragujevac). Results: Currently in Serbia, micro-elimination appears to be realistic in the patients with haemophilia, who represent a small, well-defined subpopulation, under constant monitoring by the healthcare system. Other feasible targets for micro-elimination of CHC infection in Serbia are patients on hemodialysis, prisoners and people who inject drugs. Conclusions: Micro-elimination is feasible in Serbia, especially in the subpopulation of patients with haemophilia. This may represent an initial step towards achieving the WHO objective to eliminate hepatitis C infection by 2030. © 2020 Bojovic et al.

Background: Serbia has an intermediate estimated prevalence of chronic hepatitis C (CHC) infection, approximately 1.13%, with hepatitis C remaining one of the leading causes of liver-related morbidity and mortality in Serbia with impaired quality of life and overwhelming cost of treating its complications As the availability of new treatment options and resources for screening remains limited, micro-elimination of CHC becomes a top priority. Methods: Review of the available published data related to the clinical and epidemiological situation of the hepatitis C infection in Serbia, including the unpublished data from the databases of four major reference centres in Serbia (Clinical Center Serbia, Clinical Center Niš, Clinical Center Vojvodina and Clinical Center Kragujevac). Results: Currently in Serbia, micro-elimination appears to be realistic in the patients with haemophilia, who represent a small, well-defined subpopulation, under constant monitoring by the healthcare system. Other feasible targets for micro-elimination of CHC infection in Serbia are patients on hemodialysis, prisoners and people who inject drugs. Conclusions: Micro-elimination is feasible in Serbia, especially in the subpopulation of patients with haemophilia. This may represent an initial step towards achieving the WHO objective to eliminate hepatitis C infection by 2030. © 2020 Bojovic et al.

Aim: To investigate mononucleotide markers: BAT-25, BAT-26, NR-21, NR-22 and NR-24 in patients with colorectal cancer (CRC), and the status of HSP110T17, KRAS, BRAF and the MLH1 promoter mutations in microsatellite unstable CRC. Methods: Genetic assessments were performed on samples obtained following resection of CRC in 200 patients. Results: Allelic variations of HSP110T17 were found in all 18 patients with microsatellite instabilities (MSIs) in at least three markers (high-frequency MSI). By contrast, mutations of HSP110T17 were absent in all 20 patients with no MSI frequency. Eight out of 182 patients with low (instability in one marker) or no frequency MSI had allelic shifts due to polymorphisms of BAT-25 (1.5%), NR-21 (1.75%) and NR-24 (1.5%). BRAF mutations were associated with >5 bp shortening of HSP110T17. Conclusion: Patients with high-frequency MSI CRC had allelic variations of HSP110T17. BRAF mutations occur along with greater shortening in HSP110T17 during oncogenesis via the MSI pathway. © 2013 Future Medicine Ltd.

Aim: To investigate mononucleotide markers: BAT-25, BAT-26, NR-21, NR-22 and NR-24 in patients with colorectal cancer (CRC), and the status of HSP110T17, KRAS, BRAF and the MLH1 promoter mutations in microsatellite unstable CRC. Methods: Genetic assessments were performed on samples obtained following resection of CRC in 200 patients. Results: Allelic variations of HSP110T17 were found in all 18 patients with microsatellite instabilities (MSIs) in at least three markers (high-frequency MSI). By contrast, mutations of HSP110T17 were absent in all 20 patients with no MSI frequency. Eight out of 182 patients with low (instability in one marker) or no frequency MSI had allelic shifts due to polymorphisms of BAT-25 (1.5%), NR-21 (1.75%) and NR-24 (1.5%). BRAF mutations were associated with >5 bp shortening of HSP110T17. Conclusion: Patients with high-frequency MSI CRC had allelic variations of HSP110T17. BRAF mutations occur along with greater shortening in HSP110T17 during oncogenesis via the MSI pathway. © 2013 Future Medicine Ltd.

Small intestine mucosa is often affected with malabsorptive, autoimmune and inflammatory pathological processes. However, morphometric data on the healthy human small intestine mucosa, especially ileum, are scarce. We aimed to obtain histoquantitative data on the healthy jejunal and ileal mucosa and assess the effects of gender and ageing on these parameters. Computer-aided morphometric analysis was performed on 24 jejunal and 25 ileal biopsy samples collected upon routine endoscopy screening of healthy persons with a family history of intestinal malignancy. Subjects were distributed in four groups according to age and sex: adult (<60 years) and elderly (>60 years) males, and adult (<60 years) and elderly (>60 years) females. Results were statistically analyzed with Mann-Whitney U test. Jejunal mucosal thickness was significantly reduced in elderly subjects (p<0.05), especially in elderly females compared to adult ones (p<0.05). Jejunal villi were significantly wider in adult than in the elderly subjects (p<0.05), whereas ileal villi were significantly wider in elderly compared to adult subjects (p<0.01) and in male compared to female subjects (p<0.05). No statistically significant differences were found in other histoquantitative parameters (mucosa epithelium height, crypt numerical density, villous height, crypts and villous perimeter, diameter and epithelium height) of jejunal and ileal mucosa. This study provides complete morphometric data on the healthy human jejunum and the first relevant data on the healthy ileal mucosa, thus representing a valuable morphometric reference for future histoquantitative studies of human small bowel mucosa in both healthy and disease affected individuals.

Background/aim: Intraabdominal hypertension (IAH) occurs frequently in patients with acute pancreatitis and adds to their morbidity and mortality. The main aim of the study was to identify the determination of the predictive factors connected to IAH that influence the evolution of acute pancreatitis. Materials and methods: The prospective cohort study was conducted on 100 patients who had acute pancreatitis. According to obtained intraabdominal pressure (IAP) values, the patients were divided into two groups: one group (n = 40) with normal IAP values and the other (IAH group, n = 60) with increased IAP values. Deceased patients were specially analyzed within the IAH group in order to determine mortality predictors. Results: Statistical significance of IAP (P = 0.048), lactates (P = 0.048), peak pressure (P = 0.043), abdominal perfusion pressure (P = 0.05), and mean arterial pressure (P = 0.041) was greater for deceased than for surviving patients in the IAH group. High mortality appears for patients younger than 65 years old, with lactate level higher than 3.22 mmol/L and filtration gradient (GF) lower than 67 mmHg. Conclusion: Age, lactates, GF, and APACHE II score are determined as mortality predictors for patients suffering from acute pancreatitwho developed IAH. The mortality rate is higher when the level of GF is decreasing and the level of lactate increasing. © TÜBİTAK.

In the past couple of centuries, scientists proposed great number of aging theories but neither of them appears to be fully satisfactory. In the statistical sense, we are dealing with an even greater challenge because large array of factors affects the aging process. Although at this point the most of these factors are well known, it is the very fact of their innumerability that complicates approaches to the issue at hand. Both in life and in medicine, the cause behind an effect can rarely be unequivocally determined. Thus, it appears that through out human history longevity has been primarily affected by eradication of diseases, especially by eradication of infectious diseases and introduction of the vaccines. For that reason, maybe we should not be referring to this issue as the «fountain of youth» but rather as the «vaccine of youth». The postulate that genetic instability is the precipitating factor both of aging and cancer has withstood many tests and keeps on being reaffirmed. For this reason, it is legitimate to pose a question of whether long-lived individuals may be those with «selfish» genes and more stable genetic material. They certainly cannot avoid aging, but aging in such individuals could be delayed due to steady character of their genome, which is less susceptible to mutations. On the population level, they constitute minority because stable genome would represent an obstacle to successful evolution of the species. If this was not the case, we might not be writing all these texts today.

In the past couple of centuries, scientists proposed great number of aging theories but neither of them appears to be fully satisfactory. In the statistical sense, we are dealing with an even greater challenge because large array of factors affects the aging process. Although at this point the most of these factors are well known, it is the very fact of their innumerability that complicates approaches to the issue at hand. Both in life and in medicine, the cause behind an effect can rarely be unequivocally determined. Thus, it appears that through out human history longevity has been primarily affected by eradication of diseases, especially by eradication of infectious diseases and introduction of the vaccines. For that reason, maybe we should not be referring to this issue as the «fountain of youth» but rather as the «vaccine of youth». The postulate that genetic instability is the precipitating factor both of aging and cancer has withstood many tests and keeps on being reaffirmed. For this reason, it is legitimate to pose a question of whether long-lived individuals may be those with «selfish» genes and more stable genetic material. They certainly cannot avoid aging, but aging in such individuals could be delayed due to steady character of their genome, which is less susceptible to mutations. On the population level, they constitute minority because stable genome would represent an obstacle to successful evolution of the species. If this was not the case, we might not be writing all these texts today.

This study, conducted between 4 October 2013, and 30 November 2018, tested the hypothesis that triple antimicrobial therapy, targeting Mycobacterium avium subspecies paratuberculosis (MAP), long considered a putative cause, would favorably affect Crohn’s disease. A double-blind multicenter study of adults with active Crohn’s disease, (i.e., Crohn’s Disease Activity Index [CDAI] 220–450 plus C-reactive protein ≥ 1.0 mg/dL, fecal calprotectin (FCP) >162.9 µg/g stool, or recent endoscopic or radiographic confirmation of active disease) receiving concomitant standard-of-care Crohn’s disease treatment (Clinicaltrials.gov: NCT01951326) were stratified by anti-tumor necrosis factor use and randomized (1:1) to anti-MAP RHB-104 (clarithromycin 95 mg, rifabutin 45 mg, and clofazimine 10 mg per capsule) (n = 166), resulting in clarithromycin 950 mg/day, rifabutin 450 mg/day, and clofazimine 100 mg/day, or placebo (n = 165) for up to 52 weeks. A greater proportion of RHB-104 versus placebo-treated patients met the primary endpoint—remission (i.e., CDAI < 150)—at week 26 (36.7% [61/166] vs. 22.4% [37/165], respectively; 95% CI for difference: 4.6, 24.0, p = 0.0048; chi-square test). Clinical response (reduction of CDAI by ≥100 points from baseline) at week 26 (first secondary endpoint) was also higher among the patients treated with RHB-104 (73/166 [44.0%]) compared with placebo (50/165 [30.3%]; 95% CI for difference: 3.4, 24.0, p = 0.0116), and it remained higher at week 52 among the patients treated with RHB-104 (59/166 [35.5%] vs. (35/165 [21.2%] for placebo; 95% CI for difference: 4.7, 23.9, p = 0.0042). A statistically significantly greater decline in FCP (another prospective efficacy endpoint) was also observed in RHB-104-treated patients, compared with placebo, at weeks 12, 26, and 52. The rates of serious adverse events were similar between groups (RHB-104: 18.7%; placebo: 18.8%). No patient died during the study. Antimicrobial therapy directed against MAP resulted in significantly greater improvement in clinical and laboratory (FCP) measures of active Crohn’s disease. © 2024 by the authors.

This study, conducted between 4 October 2013, and 30 November 2018, tested the hypothesis that triple antimicrobial therapy, targeting Mycobacterium avium subspecies paratuberculosis (MAP), long considered a putative cause, would favorably affect Crohn’s disease. A double-blind multicenter study of adults with active Crohn’s disease, (i.e., Crohn’s Disease Activity Index [CDAI] 220–450 plus C-reactive protein ≥ 1.0 mg/dL, fecal calprotectin (FCP) >162.9 µg/g stool, or recent endoscopic or radiographic confirmation of active disease) receiving concomitant standard-of-care Crohn’s disease treatment (Clinicaltrials.gov: NCT01951326) were stratified by anti-tumor necrosis factor use and randomized (1:1) to anti-MAP RHB-104 (clarithromycin 95 mg, rifabutin 45 mg, and clofazimine 10 mg per capsule) (n = 166), resulting in clarithromycin 950 mg/day, rifabutin 450 mg/day, and clofazimine 100 mg/day, or placebo (n = 165) for up to 52 weeks. A greater proportion of RHB-104 versus placebo-treated patients met the primary endpoint—remission (i.e., CDAI < 150)—at week 26 (36.7% [61/166] vs. 22.4% [37/165], respectively; 95% CI for difference: 4.6, 24.0, p = 0.0048; chi-square test). Clinical response (reduction of CDAI by ≥100 points from baseline) at week 26 (first secondary endpoint) was also higher among the patients treated with RHB-104 (73/166 [44.0%]) compared with placebo (50/165 [30.3%]; 95% CI for difference: 3.4, 24.0, p = 0.0116), and it remained higher at week 52 among the patients treated with RHB-104 (59/166 [35.5%] vs. (35/165 [21.2%] for placebo; 95% CI for difference: 4.7, 23.9, p = 0.0042). A statistically significantly greater decline in FCP (another prospective efficacy endpoint) was also observed in RHB-104-treated patients, compared with placebo, at weeks 12, 26, and 52. The rates of serious adverse events were similar between groups (RHB-104: 18.7%; placebo: 18.8%). No patient died during the study. Antimicrobial therapy directed against MAP resulted in significantly greater improvement in clinical and laboratory (FCP) measures of active Crohn’s disease. © 2024 by the authors.

Background/Aim. The era of direct-acting antiviral (DAA) regimen in the treatment of chronic hepatitis C virus (HCV) started in 2011. The aim of this study was to assess the antiviral efficacy and safety of DAA regimen, ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) + dasabuvir (DSV) + ribavirin (RBV), in patients with chronic HCV infection, genotype Methods. The real-life data were collected. The study was multicentric and included seven infectious diseases and hepatology departments in Serbia. A total of 21 patients were enrolled in the OBV/PTV/r + DSV + RBV early access program, 20 of which were previously treated with pegylated interferon + RBV, while 1 was treatment-naive. All patients received the adequate doses of these antiviral drugs. RBV was not given to the patients with HCV genotype 1b infection according to the therapeutic protocol. For the majority of patient, the treatment duration lasted for 12 weeks. For the patients with liver cirrhosis, who were infected with HCV genotype 1a, the duration of treatment was 24 weeks. Viremia was assessed at four points in time: At baseline, 4 weeks after the treatment beginning (rapid viral response, RVR), 12 or 24 weeks after the treatment beginning (end of treatment response – ETR) and 12 weeks after the end of treatment (sustained viral response – SVR). SVR, as a confirmation of the absence of HCV was considered as endpoint of successful treatment. Results. Complete RVR, ETR and SVR were achieved in 64.71%, 85.71% and 95.24% of the patients, respectively. Only 3 patients had mild adverse effects which did not required dose reduction. Conclusion. The treatment of the patients with a chronic HCV infection with OBV/PTV/r + DSV + RBV resulted in excellent antiviral activity and tolerability. Apstrakt Uvod/Cilj. Era direktno delujućeg antivirusnog (DAA) režima lečenja bolesnika sa hroničnom hepatitis C virusnom (HCV) infekcijom započela je 2011. godine. Cilj rada bio je ispitivanje efikasnosti i bezbednosti DAA režima ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) + dasabuvir (DSV) + ribavirin (RBV), kod bolesnika sa genotip 1 HCV infekci jom u Srbiji. Metode. U multicentričnu studiju je bilo uključeno sedam centara u Srbiji. Prikupljeni su podaci iz realnog života. U rani pristupni program OBV/PTV/r + DSV + RBV bio je uključen 21 bolesnik od kojih jedan nije prethodno lečen, dok je ostalih 20 prethodno lečeno pegilovanim interferonom i RBV. Svi bolesnici su dobijali odgovarajuće doze lekova. Bolesnici sa HCV genotipom 1b nisu dobijali RBV u skladu sa terapijskim protokolom. Za većinu bolesnika trajanje terapije je iznosilo 12 nedelja. Za četvoro bolesnika sa cirozom i HCV genotipom 1a trajanje terapije je iznosilo 24 nedelje. Viremija je određivana četiri puta: Pre početka terapije, 4 nedelje posle početka terapije (rapidni virusološko odgovor – RVR), 12 ili 24 nedelje nakon početka terapije (kraj terapije – ETR) i 12 nedelja nakon završetka terapije (stabilan virusološki odgovor – SVR). Postignut SVR kao potvrda odsustva virusne RNK u serumu, smatran je završnicom uspešnog lečenja. Rezultati. Kompletan RVR, ETR i SVR postignut je kod 64,71%, 85,71%, i 95,24% bolesnika sukcesivno. Samo 3 bolesnika imali su blage neželjene efekte koji nisu zahtevali korekciju doze lekova. Zaključak. Lečenje bolesnika sa hroničnom HCV infekcijom sa OBV/PTV/r + DSV + RBV pokazalo je odličnu antivirusnu aktivnost i podnošljivost. © 2019, Inst. Sci. inf., Univ. Defence in Belgrade. All rights reserved.

Background/Objectives: Several population pharmacokinetic models of vedolizumab (VDZ) are available for inflammatory bowel disease (IBD) patients. However, their predictive performance in real-world clinical settings remains unknown. This study aims to externally evaluate the published VDZ pharmacokinetic models, focusing on their predictive performance and simulation-based clinical applicability. Methods: A literature search was conducted through PubMed to identify VDZ population pharmacokinetic models. A total of 114 VDZ concentrations from 106 IBD patients treated at the University Medical Center “Zvezdara”, Republic of Serbia, served as the external evaluation cohort. The predictive performance of the models was assessed using prediction- and simulation-based diagnostics. Furthermore, the models were utilized for Monte Carlo simulations to generate concentration–time profiles based on 24 covariate combinations specified within the models. Results: Four published pharmacokinetic models of VDZ were included in the evaluation. Using the external dataset, the median prediction error (MDPE) ranged from 13.82% to 25.57%, while the median absolute prediction error (MAPE) varied between 41.64% and 47.56%. None of the models fully met the combined criteria in the prediction-based diagnostics. However, in simulation-based diagnostics, pvcVPC showed satisfactory results, despite wide prediction intervals. Analysis of NPDE revealed that only the models by Rosario et al. and Okamoto et al. fulfilled the evaluation criteria. Simulation analysis further demonstrated that the median VDZ concentration remains above 12 μg/mL at week 22 during maintenance treatment for approximately 45–60% of patients with the best-case covariate combinations and an 8-week dosing frequency. Conclusions: None of the published models satisfied the combined criteria (MDPE, MAPE, percentages of prediction error within ±20% and ±30%), rendering them unsuitable for a priori predictions. However, two models demonstrated better suitability for simulation-based applications. © 2024 by the authors.

Background/Objectives: Several population pharmacokinetic models of vedolizumab (VDZ) are available for inflammatory bowel disease (IBD) patients. However, their predictive performance in real-world clinical settings remains unknown. This study aims to externally evaluate the published VDZ pharmacokinetic models, focusing on their predictive performance and simulation-based clinical applicability. Methods: A literature search was conducted through PubMed to identify VDZ population pharmacokinetic models. A total of 114 VDZ concentrations from 106 IBD patients treated at the University Medical Center “Zvezdara”, Republic of Serbia, served as the external evaluation cohort. The predictive performance of the models was assessed using prediction- and simulation-based diagnostics. Furthermore, the models were utilized for Monte Carlo simulations to generate concentration–time profiles based on 24 covariate combinations specified within the models. Results: Four published pharmacokinetic models of VDZ were included in the evaluation. Using the external dataset, the median prediction error (MDPE) ranged from 13.82% to 25.57%, while the median absolute prediction error (MAPE) varied between 41.64% and 47.56%. None of the models fully met the combined criteria in the prediction-based diagnostics. However, in simulation-based diagnostics, pvcVPC showed satisfactory results, despite wide prediction intervals. Analysis of NPDE revealed that only the models by Rosario et al. and Okamoto et al. fulfilled the evaluation criteria. Simulation analysis further demonstrated that the median VDZ concentration remains above 12 μg/mL at week 22 during maintenance treatment for approximately 45–60% of patients with the best-case covariate combinations and an 8-week dosing frequency. Conclusions: None of the published models satisfied the combined criteria (MDPE, MAPE, percentages of prediction error within ±20% and ±30%), rendering them unsuitable for a priori predictions. However, two models demonstrated better suitability for simulation-based applications. © 2024 by the authors.

Background and Objectives: On 11 March 2020, our hospital adapted to the COVID-19 pandemic by becoming a temporary COVID-19 facility, leading to the suspension or delegation of non-COVID-19 services. Among the international IBD community, there were significant concerns regarding the neglect of immunocompromised IBD patients and their increased vulnerability to COVID-19. To address these challenges, the COVID-19 ECCO Taskforce recommended the implementation of telehealth. Following this recommendation, our hospital’s IT department integrated audiovisual hardware and software solutions to facilitate virtual consultations. This approach enabled patients and their local physicians to receive formal reports comparable to those issued during standard in-person care. Materials and Methods: We retrospectively analyzed data from patients diagnosed with Crohn’s disease and ulcerative colitis who participated in telemedicine consultations. Average distances and time saved were calculated using Google Maps, while carbon emissions and carbon footprint reductions were determined. Results: Between 11 August 2021 and 15 June 2023, 107 telehealth consultations were completed. Patients benefited from reduced travel distances, with an average saving of 168.28 km per consultation and a total reduction of 18,006 km. Travel time savings averaged 2 h and 22 min per consultation, amounting to a total of 252 h saved. The reduction in carbon emissions was calculated at 3.26 tons, equivalent to the annual absorption capacity of 109 fully grown trees, considering that an individual tree absorbs approximately 21.77 kg of CO2 annually. These findings underscore telemedicine’s role in reducing environmental impact while enhancing patient convenience. Conclusions: The adoption of telehealth successfully optimized outpatient clinic operations, maintaining high-quality patient outcomes while contributing to environmental sustainability. © 2025 by the authors.

[No abstract available]