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1.
BMC Gastroenterol ; 21(1): 269, 2021 Jun 29.
Artículo en Inglés | MEDLINE | ID: mdl-34187376

RESUMEN

BACKGROUND: Anemia is a common extraintestinal manifestation of Inflammatory Bowel Disease (IBD) affecting negatively the patients' quality of life. The aim of this study was to determine the frequency and real-life management of anemia in IBD patients in Greece. METHODS: This study was conducted in 17 Greek IBD referral centers. Demographic, clinical, laboratory, IBD and anemia treatment data were collected and analyzed retrospectively. RESULTS: A total of 1394 IBD patients [560 ulcerative colitis (UC), 834 Crohn's disease (CD)] were enrolled. Anemia at any time was reported in 687 (49.3%) patients of whom 413 (29.6%) had episodic and 274 (19.7%) had recurrent/persistent anemia. Anemia was diagnosed before IBD in 45 (6.5%), along with IBD in 269 (39.2%) and after IBD in 373 (54.3%) patients. In the multivariate analysis the presence of extraintestinal manifestations (p = 0.0008), IBD duration (p = 0.026), IBD related surgeries and hospitalizations (p = 0.026 and p = 0.004 accordingly) were risk factors of recurrent/persistent anemia. Serum ferritin was measured in 839 (60.2%) IBD patients. Among anemic patients, 535 (77.9%) received treatment. Iron supplementation was administered in 485 (90.6%) patients, oral in 142 (29.3%) and intravenous in 393 (81%). CONCLUSIONS: The frequency of anemia in IBD patients, followed at Greek referral centers, is approximately 50%. Development of recurrent/persistent anemia may be observed in 20% of cases and is independently associated with the presence of extraintestinal manifestations, IBD duration, IBD related surgeries and hospitalizations. Anemia treatment is administered in up to [Formula: see text] of anemia IBD patients with the majority of them receiving iron intravenously.


Asunto(s)
Anemia , Colitis Ulcerosa , Enfermedades Inflamatorias del Intestino , Anemia/epidemiología , Anemia/etiología , Colitis Ulcerosa/complicaciones , Colitis Ulcerosa/tratamiento farmacológico , Colitis Ulcerosa/epidemiología , Grecia/epidemiología , Humanos , Enfermedades Inflamatorias del Intestino/complicaciones , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Enfermedades Inflamatorias del Intestino/epidemiología , Calidad de Vida , Estudios Retrospectivos
2.
Dig Dis ; 39(2): 171-178, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-32777788

RESUMEN

BACKGROUND AND AIMS: Documentation of complications of gastrointestinal endoscopy within the commonly used endoscopy documentation systems are mostly limited to acute complications during endoscopy included in the post-procedural endoscopy report. We tested a documentation system-based filter to reduce the workload by maintaining a high sensitivity to recognize post-endoscopy complications. METHODS: Of all inpatient endoscopic resections during 1 year and all endoscopic retrograde cholangiopancreatography (ERCP) procedures during 4 months in 1 tertiary referral centre, post-procedural complications during hospital stay were individually analyzed retrospectively from the hospital databases (gold standard). In comparison, information technology-based filters were assessed searching for specific tests and data within 2 days after endoscopy and/or until discharge. These were second endoscopy, surgery, or an abdominal computed tomography (CT) or haemoglobin drop ≥2 g/dL for endoscopic resection. For ERCP cases, any case with lipase determination and post-ERCP CT scan was selected. Main outcomes were the sensitivity of these filters to recognize post-endoscopy complications and the percentage of workload reduction. RESULTS: Three hundred twenty-two inpatients who underwent endoscopic resections and 302 ERCP cases (all inpatients) were included. Post-endoscopy complications occurred in 7.14% (endoscopic resection) and 3.7% (ERCP). The above-mentioned filters identified 100% of all resection and post-ERCP complications compared to detailed case file analysis, at the same time reducing the quality management workload to 14 and 31%, respectively. CONCLUSIONS: Post-procedural monitoring of advanced endoscopic procedures performed on inpatient procedures has a high sensitivity (100%) and reduces case-by-case screening workload for complications by 70-85%. Outpatient interventions, however, require a different system for monitoring of post-endoscopy complications after discharge.


Asunto(s)
Bases de Datos como Asunto , Endoscopía Gastrointestinal/efectos adversos , Pacientes Internos , Complicaciones Posoperatorias/etiología , Garantía de la Calidad de Atención de Salud , Carga de Trabajo , Anciano , Colangiopancreatografia Retrógrada Endoscópica , Colonoscopía , Neoplasias Colorrectales/cirugía , Recolección de Datos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos
3.
Adv Exp Med Biol ; 1337: 345-354, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-34972923

RESUMEN

Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder that affects a considerable percentage of the global population, mainly middle-aged women. IBS causes a constellation of symptoms with repercussions on patients' physical, psychological, and social well-being. Stress seems to play an important role in the pathogenesis of the disease as well as in its management. This study evaluated the effects of a novel non-pharmacological 8-week stress management intervention, the Pythagorean Self-Awareness Intervention (PSAI), in patients with IBS. In this non-randomized controlled trial, 60 IBS patients were assigned to an intervention and a control group. Self-reported questionnaires were used for the evaluation of IBS symptoms and a variety of biopsychological characteristics, pre- and post-intervention. All IBS-related symptoms were significantly reduced in the intervention group compared to the control group with 50% of the patients in the intervention group reporting less abdominal pain. The most potent effects of the intervention were observed in anger externalization, anger control, visuospatial memory, information processing speed, verbal memory, sense of coherence, stress, anxiety, and anger internalization. No side effects in the PSAI group were noted. In conclusion, PSAI was beneficial for patients suffering from IBS. Future research should expand and validate the results of this study.


Asunto(s)
Síndrome del Colon Irritable , Ansiedad , Cognición , Femenino , Humanos , Síndrome del Colon Irritable/terapia , Persona de Mediana Edad , Calidad de Vida , Encuestas y Cuestionarios , Resultado del Tratamiento
4.
Small ; 16(36): e2001080, 2020 09.
Artículo en Inglés | MEDLINE | ID: mdl-32548897

RESUMEN

This study presents the results of applying deep learning methodologies within the ecotoxicology field, with the objective of training predictive models that can support hazard assessment and eventually the design of safer engineered nanomaterials (ENMs). A workflow applying two different deep learning architectures on microscopic images of Daphnia magna is proposed that can automatically detect possible malformations, such as effects on the length of the tail, and the overall size, and uncommon lipid concentrations and lipid deposit shapes, which are due to direct or parental exposure to ENMs. Next, classification models assign specific objects (heart, abdomen/claw) to classes that depend on lipid densities and compare the results with controls. The models are statistically validated in terms of their prediction accuracy on external D. magna images and illustrate that deep learning technologies can be useful in the nanoinformatics field, because they can automate time-consuming manual procedures, accelerate the investigation of adverse effects of ENMs, and facilitate the process of designing safer nanostructures. It may even be possible in the future to predict impacts on subsequent generations from images of parental exposure, reducing the time and cost involved in long-term reproductive toxicity assays over multiple generations.


Asunto(s)
Daphnia , Aprendizaje Profundo , Ecotoxicología , Nanoestructuras , Animales , Simulación por Computador , Daphnia/efectos de los fármacos , Ecotoxicología/métodos , Nanoestructuras/toxicidad , Contaminantes Químicos del Agua/toxicidad
5.
Clin Gastroenterol Hepatol ; 14(10): 1426-1432.e1, 2016 10.
Artículo en Inglés | MEDLINE | ID: mdl-27317850

RESUMEN

BACKGROUND & AIMS: Infliximab is a safe and effective therapy for ulcerative colitis (UC). We conducted a multicenter retrospective cohort study that included 7 European countries and Israel to examine whether infliximab discontinuation can be considered for patients who achieve sustained remission. METHODS: We performed a retrospective cohort study, collecting medical records from 13 tertiary care referral inflammatory bowel disease centers of all patients with UC treated with infliximab (n = 193). We compared the disease course of patients with at least 12 months of clinical remission who discontinued infliximab (n = 111) with that of patients who continued scheduled treatment (controls, n = 82). We examined the incidence rates of relapse, hospitalization and colectomy, the comparative effectiveness of different therapeutic strategies after discontinuation, and assessed the rates of response, remission, and adverse effects after infliximab re-initiation. Statistical analyses used time-to-event methods. RESULTS: In the entire cohort, 67 patients (34.7%) relapsed during the follow-up period. The incidence rate of relapse was significantly higher after discontinuation (23.3 per 100 person-years) compared with the control group (7.2 per 100 person-years) in univariable analysis (log-rank P < .001; hazard ratio, 3.41; 95% confidence interval, 1.88-6.20) and multivariable analysis (hazard ratio, 3.70; 95% confidence interval, 2.02-6.77). Rates of hospitalization and colectomy did not differ between groups. Thiopurines appeared to be the best treatment option after infliximab discontinuation (incidence of relapse: 15.0 per 100 person-years for thiopurines, 27.4 per 100 person-years for thiopurines plus aminosalicylates, and 31.2 per 100 person-years for aminosalicylates alone; log-rank P = .032). Response was regained in 77.1% of patients and remission in 51.4% of patients who re-initiated infliximab. However, 17.1% had infusion reactions and 17.1% reported other adverse events. CONCLUSIONS: In a multinational retrospective cohort study of patients with UC in sustained clinical remission, we associated discontinuation of infliximab with an increased risk of relapse. Treatment re-initiation is effective and safe.


Asunto(s)
Colitis Ulcerosa/tratamiento farmacológico , Fármacos Gastrointestinales/administración & dosificación , Infliximab/administración & dosificación , Privación de Tratamiento , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Europa (Continente) , Femenino , Humanos , Israel , Masculino , Persona de Mediana Edad , Recurrencia , Estudios Retrospectivos , Medición de Riesgo , Adulto Joven
7.
Scand J Gastroenterol ; 50(12): 1451-5, 2015.
Artículo en Inglés | MEDLINE | ID: mdl-26139305

RESUMEN

OBJECTIVE: Patients with inflammatory bowel disease (IBD) should be routinely screened for latent tuberculosis (LTB) before starting anti-TNF therapy in order to prevent reactivation of LTB. Besides tuberculin skin test (TST), QuantiFERON-TB Gold In-Tube (QFT-G-IT) has gained wide acceptance as a screening strategy for LTB in IBD, although it may be negatively influenced by the prior use of immunomodulators (IMM) such as azathioprine or methotrexate. This study aimed to assess the impact of IMM on the TST and the QFT-G-IT for LTB screening in IBD patients scheduled for anti-TNF therapy. MATERIAL AND METHODS: This observational, prospective, single-center study included consecutive IBD patients scheduled for anti-TNF therapy undergoing on the same day both TST and QFT-G-IT for screening of LTB, between 2008 and 2010. Patients with a prior history of known or suspicious (L)TB receiving (prophylactic) anti-TB therapy were excluded. RESULTS: Seventy-five patients were finally included; 28 were treated with thiopurines (IMM group), while 47 (control group) received either 5-aminosalicylic acid (n = 41) or no therapy (newly diagnosed patients, n = 6). Overall, TST and QFT-G-IT were positive in 14 (18.7%) and 16 (21.3%) patients, respectively. There was no statistically significant difference between the two groups regarding the TST (p = 0.761) and QFT-G-IT (0.572) positivity. The overall concordance between the two tests was moderate (kappa = 0.584), being substantial in the IMM group (kappa = 0.700) and moderate in the control group (kappa = 0.498). CONCLUSION: These preliminary results suggest that IMM may not have a significant impact on either QFT-G-IT or TST, although larger, prospective studies are certainly warranted.


Asunto(s)
Inmunosupresores/uso terapéutico , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Tuberculosis Latente/diagnóstico , Mesalamina/uso terapéutico , Prueba de Tuberculina/métodos , Adulto , Femenino , Humanos , Inmunoterapia , Masculino , Tamizaje Masivo/métodos , Persona de Mediana Edad , Estudios Prospectivos , Factor de Necrosis Tumoral alfa/antagonistas & inhibidores
8.
Biology (Basel) ; 13(5)2024 May 16.
Artículo en Inglés | MEDLINE | ID: mdl-38785833

RESUMEN

Microarray experiments, a mainstay in gene expression analysis for nearly two decades, pose challenges due to their complexity. To address this, we introduce DExplore, a user-friendly web application enabling researchers to detect differentially expressed genes using data from NCBI's GEO. Developed with R, Shiny, and Bioconductor, DExplore integrates WebGestalt for functional enrichment analysis. It also provides visualization plots for enhanced result interpretation. With a Docker image for local execution, DExplore accommodates unpublished data. To illustrate its utility, we showcase two case studies on cancer cells treated with chemotherapeutic drugs. DExplore streamlines microarray data analysis, empowering molecular biologists to focus on genes of biological significance.

9.
Ann Gastroenterol ; 37(2): 199-205, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38481786

RESUMEN

Background: The existing literature does not provide adequate guidance on the diagnosis and management of patients with nonspecific terminal ileitis, while data regarding the percentage of patients who ultimately develop Crohn's disease (CD) are scarce. We evaluated the prevalence and natural course of nonspecific terminal ileitis in patients who underwent colonoscopy during a 11-year period. Methods: All patients with endoscopic findings of terminal ileitis and nonspecific histological findings were included. Exclusion criteria were a clinical history of CD or any other disease that can cause terminal ileitis, or a recent history of using drugs implicated in lesions of the terminal ileum. Results: From 5353 colonoscopies, 92 patients with nonspecific terminal ileitis were identified (prevalence: 1.7%). Among these patients, 56 (61%) had available follow up for ≥6 months after the initial endoscopy. Main indications for endoscopy were chronic diarrhea (37.5%), screening endoscopy (23%), and abdominal pain (20%). Sixteen (29%) patients received medical treatment, while recession of symptoms was recorded in 19 of 43 symptomatic patients (44.1%). Twenty-three (41%) of the 56 patients underwent a second endoscopy and 15 (65.2%) cases had persistent endoscopic findings. Eleven (19.6%) of the 56 patients were eventually diagnosed with CD. The probability of CD diagnosis was significantly higher in patients with persistent symptoms (P=0.002) and endoscopic findings at follow up (P=0.038). Conclusions: Nonspecific terminal ileitis generally has a benign clinical course. However, patients with persistent symptoms and endoscopic lesions are at increased risk for subsequent development of CD.

10.
Inflamm Bowel Dis ; 29(2): 228-237, 2023 02 01.
Artículo en Inglés | MEDLINE | ID: mdl-35394529

RESUMEN

BACKGROUND: Four EMA-approved vaccines against SARS-CoV-2 are currently available. Data regarding antibody responses to initial vaccination regimens in patients with inflammatory bowel diseases (IBD) are limited. METHODS: We conducted a prospective, controlled, multicenter study in tertiary Greek IBD centers. Participating patients had completed the initial vaccination regimens (1 or 2 doses, depending on the type of COVID-19 vaccine) at least 2 weeks before study enrolment. Anti-S1 IgG antibody levels were measured. Demographic and adverse events data were collected. RESULTS: We tested 403 patients (Crohn's disease, 58.9%; male, 53.4%; median age, 45 years) and 124 healthy controls (HCs). Following full vaccination, 98% of patients seroconverted, with mRNA vaccines inducing higher seroconversion rates than viral vector vaccines (P = .021). In total, IBD patients had lower anti-S1 levels than HCs (P < .001). In the multivariate analysis, viral vector vaccines (P < .001), longer time to antibody testing (P < .001), anti-TNFα treatment (P = .013), and age (P = .016) were independently associated with lower anti-S1 titers. Vedolizumab monotherapy was associated with higher antibody levels than anti-TNFα or anti-interleukin-12/IL-23 monotherapy (P = .023 and P = .032). All anti- SARS-CoV-2 vaccines were safe. CONCLUSIONS: Patients with IBD have impaired antibody responses to anti-SARS-CoV-2 vaccination, particularly those receiving viral vector vaccines and those on anti-TNFα treatment. Older age also hampers antibody production after vaccination. For those low-response groups, administration of accelerated or prioritized booster vaccination may be considered.


Thisis a multicenter study on IBD patients after COVID-19 vaccination and anti-S1 IgG antibody levels measurement. Patients with IBD have lower antibody responses than healthy controls, particularly those receiving viral vector vaccines and those on anti-TNFα or combination treatment.


Asunto(s)
COVID-19 , Enfermedades Inflamatorias del Intestino , Vacunas Virales , Humanos , Masculino , Persona de Mediana Edad , Vacunas contra la COVID-19 , Formación de Anticuerpos , Estudios Prospectivos , COVID-19/prevención & control , SARS-CoV-2 , Vacunación , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Anticuerpos Antivirales
11.
J Clin Med ; 12(8)2023 Apr 21.
Artículo en Inglés | MEDLINE | ID: mdl-37109360

RESUMEN

BACKGROUND: The Inflammatory Bowel Disease-Disk (IBD-Disk) is a physician-administered tool that evaluates the functional status of patients with Inflammatory Bowel Disease (IBD). The aim of our study was to validate the content of the IBD-Disk in a Greek cohort of IBD patients. METHODS: Two questionnaires [the IBD Disk and the IBD-Disability Index (IBD-DI)] were translated into Greek and administered to IBD patients at baseline visit, after 4 weeks and 6 months. Validation of the IBD Disk included measuring of concurrent validity, reproducibility, and internal consistency. RESULTS: A total of 300 patients were included at baseline and 269 at follow-up. There was a good correlation between the total scores of the IBD-Disk and IBD-DI at baseline (Pearson correlation 0.87, p < 0.001). Reproducibility of the total IBD-Disk score was very good [intra-class correlation coefficient (ICC), 95% confidence interval (CI) 0.89 (0.86-0.91)]. Cronbach's coefficient alpha for all items achieved 0.90 (95%CI 0.88-0.92), demonstrating a very good homogeneity of the IBD-Disk items. Female gender and extraintestinal manifestations were significantly associated with a higher IBD-Disk total score. CONCLUSIONS: The Greek version of the IBD-Disk proved to be a reliable and valid tool in detecting and assessing IBD-related disability in a Greek cohort of IBD patients.

12.
Eur J Gastroenterol Hepatol ; 34(2): 153-160, 2022 02 01.
Artículo en Inglés | MEDLINE | ID: mdl-33653987

RESUMEN

BACKGROUND: The prevalence and incidence of inflammatory bowel diseases (IBDs) vary among countries. Data regarding prevalence of IBD in Greece are limited or outdated. METHODS: We reviewed the medical records of IBD patients from a population of 551,808 Greek Army recruits in a 13-year period (2006-2018). Study population consisted of males 18-37 of age from Northwest, Central Greece (including Attica), Peloponnese, and Aegean Sea Islands. Age, disease distribution, pharmaceutical treatment and IBD-related surgery at the time of patients' admission were recorded. RESULTS: The prevalence of IBD among male recruits during the studied period was 0.15% (839/551 808, 95% confidence interval 0.14-0.16%). Of these, 448 (53.4%) had Crohn's disease (CD) and 391 (46.6%) ulcerative colitis (UC). Although 32.1% of CD patients had been treated with biologics, most often infliximab (60% of them), azathioprine was the most common as monotherapy (27% of patients). Among UC patients, mesalamine was the most often prescribed treatment (64.2%), whereas treatment with biologics as monotherapy or in combination with azathioprine was used in a ratio 1:2 compared to CD patients. A gradual reduction in steroid use was noted from 2006 to 2018, coinciding with the advent and increasing use of biologics. IBD-related surgery had been performed in 8% and 2.8% of CD and UC patients, respectively. CONCLUSION: The prevalence of IBD in Greek male recruits was 0.15% with a slight CD predominance. Remarkable changes in therapeutic trends were noted with an increasing use of biologics and reduced prescription of steroids, especially for CD.


Asunto(s)
Productos Biológicos , Colitis Ulcerosa , Enfermedad de Crohn , Enfermedades Inflamatorias del Intestino , Adolescente , Adulto , Azatioprina/uso terapéutico , Productos Biológicos/uso terapéutico , Enfermedad Crónica , Colitis Ulcerosa/diagnóstico , Colitis Ulcerosa/tratamiento farmacológico , Colitis Ulcerosa/epidemiología , Enfermedad de Crohn/diagnóstico , Enfermedad de Crohn/tratamiento farmacológico , Enfermedad de Crohn/epidemiología , Grecia/epidemiología , Humanos , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Enfermedades Inflamatorias del Intestino/epidemiología , Masculino , Prevalencia , Estudios Retrospectivos , Adulto Joven
13.
J Clin Med ; 11(3)2022 Jan 27.
Artículo en Inglés | MEDLINE | ID: mdl-35160092

RESUMEN

Since inflammatory bowel disease (IBD) patients were excluded from vaccine authorization studies, limited knowledge exists regarding perceptions and unfavorable effects of COVID-19 vaccination in this group. We aimed to investigate the real-world use and adverse events (AEs) of COVID-19 vaccines in Greek IBD patients. Fully vaccinated IBD patients followed in Greek centers were invited to participate. All patients filled out an anonymous online survey concerning the vaccination program, which included information regarding demographics, clinical characteristics, treatment, vaccination perceptions and potential AEs. Overall, 1007 IBD patients were included. Vaccine hesitancy was reported by 49%. Total AEs to vaccination were reported by 81% after dose 1 (D1) and 76% after dose 2 (D2), including isolated injection site reactions (36% and 24% respectively). Systemic AEs were more common after D2 (51%, D2 vs. 44%, D1, p < 0.0001). Very few patients reported new onset abdominal symptoms (abdominal pain 4% (D1), 6% (D2) and diarrhea 5% (D1), 7% (D2)). There were no serious AEs leading to emergency room visit or hospitalization. In multivariate analysis, AEs occurrence was positively associated with young age and female gender (p < 0.0005 for both doses), whereas inactive disease was negatively associated with AE in D1 (p = 0.044). SARS-CoV-2 vaccination in Greek IBD patients demonstrated a favorable and reassuring safety profile.

14.
Nat Nanotechnol ; 17(9): 924-932, 2022 09.
Artículo en Inglés | MEDLINE | ID: mdl-35982314

RESUMEN

Engineered nanomaterials (ENMs) enable new and enhanced products and devices in which matter can be controlled at a near-atomic scale (in the range of 1 to 100 nm). However, the unique nanoscale properties that make ENMs attractive may result in as yet poorly known risks to human health and the environment. Thus, new ENMs should be designed in line with the idea of safe-and-sustainable-by-design (SSbD). The biological activity of ENMs is closely related to their physicochemical characteristics, changes in these characteristics may therefore cause changes in the ENMs activity. In this sense, a set of physicochemical characteristics (for example, chemical composition, crystal structure, size, shape, surface structure) creates a unique 'representation' of a given ENM. The usability of these characteristics or nanomaterial descriptors (nanodescriptors) in nanoinformatics methods such as quantitative structure-activity/property relationship (QSAR/QSPR) models, provides exciting opportunities to optimize ENMs at the design stage by improving their functionality and minimizing unforeseen health/environmental hazards. A computational screening of possible versions of novel ENMs would return optimal nanostructures and manage ('design out') hazardous features at the earliest possible manufacturing step. Safe adoption of ENMs on a vast scale will depend on the successful integration of the entire bulk of nanodescriptors extracted experimentally with data from theoretical and computational models. This Review discusses directions for developing appropriate nanomaterial representations and related nanodescriptors to enhance the reliability of computational modelling utilized in designing safer and more sustainable ENMs.


Asunto(s)
Nanoestructuras , Simulación por Computador , Humanos , Nanoestructuras/química , Relación Estructura-Actividad Cuantitativa , Reproducibilidad de los Resultados
15.
J Crohns Colitis ; 15(10): 1694-1706, 2021 Oct 07.
Artículo en Inglés | MEDLINE | ID: mdl-33786600

RESUMEN

BACKGROUND AND AIMS: This study aimed to compare real-world clinical effectiveness and safety of vedolizumab, an α4ß7-integrin inhibitor, and anti-tumour necrosis factor-α [anti-TNFα] agents in biologic-naïve ulcerative colitis [UC] and Crohn's disease [CD] patients. METHODS: This was a 24-month retrospective medical chart study in adult UC and CD patients treated with vedolizumab or anti-TNFα in Canada, Greece and the USA. Inverse probability weighting was used to account for differences between groups. Primary outcomes were cumulative rates of clinical effectiveness [clinical response, clinical remission, mucosal healing] and incidence rates of serious adverse events [SAEs] and serious infections [SIs]. Secondary outcomes included cumulative rates of treatment persistence [patients who did not discontinue index treatment during follow-up] and dose escalation and incidence rates of disease exacerbations and disease-related surgeries. Adjusted analyses were performed using inverse probability weighting. RESULTS: A total of 1095 patients [604 UC, 491 CD] were included. By 24 months, rates of clinical effectiveness were similar between groups, but incidence rates of SAEs (hazard ratio [HR] = 0.42 [0.28-0.62]) and SIs (HR = 0.40 [0.19-0.85]) were significantly lower in vedolizumab vs anti-TNFα patients. Rates of treatment persistence [p < 0.01] by 24 months were higher in vedolizumab patients with UC. Incidence rates of disease exacerbations were lower in vedolizumab patients with UC (HR = 0.58 [0.45-0.76]). Other outcomes did not significantly differ between groups. CONCLUSION: In this real-world setting, first-line biologic therapy in biologic-naïve patients with UC and CD demonstrated that vedolizumab and anti-TNFα treatments were equally effective at controlling disease symptoms, but vedolizumab has a more favourable safety profile.


Asunto(s)
Anticuerpos Monoclonales Humanizados/uso terapéutico , Fármacos Gastrointestinales/uso terapéutico , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Adulto , Estudios de Cohortes , Femenino , Humanos , Masculino , Persona de Mediana Edad , Inducción de Remisión , Estudios Retrospectivos , Factor de Necrosis Tumoral alfa/antagonistas & inhibidores
16.
Eur J Gastroenterol Hepatol ; 33(1S Suppl 1): e615-e624, 2021 12 01.
Artículo en Inglés | MEDLINE | ID: mdl-34034278

RESUMEN

BACKGROUND AND AIMS: This real-world study assessed the impact of golimumab on health-related quality of life (HRQoL) and other patient-reported outcomes (PROs) in patients with ulcerative colitis over 12 months in Greece. METHODS: GO-LIFE was a noninterventional, prospective, multicenter, 12-month study. Patients who had moderately-to-severely active ulcerative colitis were naïve to antitumor necrosis factor (anti-TNFα) therapy and had failed previous conventional therapy. Patients received golimumab as per label. The primary endpoint was patients achieving inflammatory bowel disease questionnaire 32-item (IBDQ-32) remission at 12 months. Secondary endpoints, at 6 and 12 months, included patients achieving IBDQ-32 response; the mean change in the treatment satisfaction questionnaire for medication (TSQM) and the work productivity and activity impairment in ulcerative colitis (WPAI:UC) questionnaires; changes in healthcare utilization; patients achieving clinical response and remission; adherence rates and the percentage of patients who discontinued golimumab. RESULTS: IBDQ-32 remission was achieved by 76.9% of patients at 12 months. Mean changes in all TSQM and WPAI:UC domain scores at 12 months were statistically significant. Clinical remission was achieved by 49.4 and 50.6% of patients at 6 and 12 months, and clinical response by 59.3 and 56.8%, respectively. All patients but one (80/81) had high adherence (≥80%) to golimumab treatment over 12 months. Ulcerative colitis-related health care resource utilization was reduced during the follow-up period. CONCLUSIONS: In real-world settings, treatment with golimumab resulted in meaningful improvements in HRQoL and other PROs, and in disease activity at 6 and 12 months in patients with moderately-to-severely active ulcerative colitis who were naïve to anti-TNFa therapy.


Asunto(s)
Colitis Ulcerosa , Calidad de Vida , Anticuerpos Monoclonales , Colitis Ulcerosa/complicaciones , Colitis Ulcerosa/diagnóstico , Colitis Ulcerosa/tratamiento farmacológico , Grecia , Humanos , Aceptación de la Atención de Salud , Medición de Resultados Informados por el Paciente , Estudios Prospectivos , Índice de Severidad de la Enfermedad
17.
Eur J Gastroenterol Hepatol ; 33(1S Suppl 1): e810-e817, 2021 12 01.
Artículo en Inglés | MEDLINE | ID: mdl-34402469

RESUMEN

OBJECTIVES: COVID-19 has evolved into a global health crisis, variably affecting the management of patients with chronic illnesses. Patients with inflammatory bowel disease (IBD) may represent a vulnerable population due to frequent administration of immune-modifying treatments. We aimed to depict the natural history of COVID-19 infection in Greek patients with IBD at a nationwide level via unbiased reporting of all cases that were registered during the sequential waves of the pandemic. METHODS: Following a national call from the Hellenic Society for the study of IBD, we enrolled all IBD patients with established diagnoses of COVID-19. Clinical and epidemiological data, including COVID-19 modifying factors and IBD-associated therapies, were analyzed against adverse outcomes (hospitalization, ICU admission and death). RESULTS: We identified 154 IBD patients who were diagnosed with COVID-19 (men: 58.4%; mean age=41.7 years [SD = 14.9]; CD: 64.3%). Adverse outcomes were reported in 34 patients (22.1%), including 3 ICU admissions (1.9%) and two deaths (1.3%). Multivariate logistic regression analysis showed that age (OR = 1.04, 95% CI, 1-1.08) and dyspnea at presentation (OR = 7.36, 95% CI, 1.84-29.46) were associated with worse outcomes of COVID-19 infection. In contrast, treatment with biologics, in particular anti-TNF agents, exerted a protective effect against an unfavorable COVID-19 disease course (OR = 0.4, 95% CI, 0.16-0.99). Patients on subcutaneous biologics were more likely to halt treatment due to the infection as compared to those on intravenous biologics. CONCLUSIONS: IBD patients who developed COVID-19 had a benign course with adverse outcomes being infrequent. Treatment with anti-TNF biologics had a protective effect, thus, supporting continuation of therapy during the pandemic.


Asunto(s)
COVID-19 , Enfermedades Inflamatorias del Intestino , Adulto , Enfermedad Crónica , Humanos , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Enfermedades Inflamatorias del Intestino/epidemiología , Masculino , SARS-CoV-2 , Inhibidores del Factor de Necrosis Tumoral
18.
Ann Gastroenterol ; 33(6): 547-553, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-33162731

RESUMEN

Quality assessment and improvement of an endoscopic service has emerged as a basic component of everyday gastrointestinal endoscopy. In order to ensure a high level of quality, a series of actions must be adopted when performing an endoscopic examination. Nonetheless, quality still remains a qualitative parameter; thus, implementation of specific indicators of quality is warranted. Irrespective of the nature of the endoscopic procedure, quality indicators usually refer to either structural properties of an endoscopy unit (e.g., examination availability), procedural factors (e.g., diagnostic accuracy), or patient outcomes (e.g., occurrence of an adverse event related to performance of an endoscopic procedure). Moreover, they are usually classified into 3 distinct sections, according to the phase of the procedure they relate to: i.e., before, during, and after the examination. The aim of this review is to present measures that need to be adopted in order to reach an optimal quality level during an endoscopic ultrasound examination and to provide up-to-date data regarding the respective quality indicators implicated.

19.
Comput Struct Biotechnol J ; 18: 583-602, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32226594

RESUMEN

Nanotechnology has enabled the discovery of a multitude of novel materials exhibiting unique physicochemical (PChem) properties compared to their bulk analogues. These properties have led to a rapidly increasing range of commercial applications; this, however, may come at a cost, if an association to long-term health and environmental risks is discovered or even just perceived. Many nanomaterials (NMs) have not yet had their potential adverse biological effects fully assessed, due to costs and time constraints associated with the experimental assessment, frequently involving animals. Here, the available NM libraries are analyzed for their suitability for integration with novel nanoinformatics approaches and for the development of NM specific Integrated Approaches to Testing and Assessment (IATA) for human and environmental risk assessment, all within the NanoSolveIT cloud-platform. These established and well-characterized NM libraries (e.g. NanoMILE, NanoSolutions, NANoREG, NanoFASE, caLIBRAte, NanoTEST and the Nanomaterial Registry (>2000 NMs)) contain physicochemical characterization data as well as data for several relevant biological endpoints, assessed in part using harmonized Organisation for Economic Co-operation and Development (OECD) methods and test guidelines. Integration of such extensive NM information sources with the latest nanoinformatics methods will allow NanoSolveIT to model the relationships between NM structure (morphology), properties and their adverse effects and to predict the effects of other NMs for which less data is available. The project specifically addresses the needs of regulatory agencies and industry to effectively and rapidly evaluate the exposure, NM hazard and risk from nanomaterials and nano-enabled products, enabling implementation of computational 'safe-by-design' approaches to facilitate NM commercialization.

20.
Ann Gastroenterol ; 30(1): 131-133, 2017.
Artículo en Inglés | MEDLINE | ID: mdl-28042253

RESUMEN

Sprue-like enteropathy associated with treatment with olmesartan medoxomil, an angiotensin II receptor blocker, has been described recently. Herein, we report two patients who developed chronic severe non-bloody diarrhea, weight loss, and muscle wasting after prolonged use of olmesartan. Histologic and immunohistochemical examination of multiple duodenal biopsies revealed severe villous atrophy. Clinical signs ceased upon drug discontinuation. Physicians should be aware of this enteropathy even if olmesartan has been taken for months or years. Whether this adverse event is specific for olmesartan or is a class effect of angiotensin II receptor blockers is currently unknown. To the best of our knowledge, these case reports are the first reported in Greece.

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