María Isabel Vera

María Isabel Vera
Hospital Universitario Puerta de Hierro-Majadahonda · Departamento de Gastroenterología

MD, phD

About

161
Publications
8,783
Reads
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1,970
Citations
Citations since 2016
81 Research Items
1284 Citations
2016201720182019202020212022050100150200
2016201720182019202020212022050100150200
2016201720182019202020212022050100150200
2016201720182019202020212022050100150200
Additional affiliations
January 2011 - present
Universidad Autónoma de Madrid
Position
  • Professor (Associate)
January 1996 - April 2016
Hospital Universitario Puerta de Hierro-Majadahonda
Position
  • Adjunto
January 1992 - present
Hospital Universitario Puerta de Hierro-Majadahonda
Position
  • Médico Adjunto de Gastroenterología y hepatologia

Publications

Publications (161)
Article
Full-text available
Background Optimal thresholds for golimumab concentrations during maintenance for important outcomes are lacking. Aim The aim of the study was to investigate the association of golimumab trough concentrations during maintenance with key outcomes, including endoscopic and histologic remission, and long‐term event‐free persistence with golimumab, in...
Article
Background: Colorectal cancer (CRC) is a potentially life-threatening complication of long-standing ulcerative colitis (UC). MicroRNAs are epigenetic regulators that have been involved in the development of UC associated CRC. However, their role as potential mucosal biomarkers of neoplastic progression has not been adequately studied. Methods: I...
Article
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Background: Recently, increased tissue levels of AIF-1 have been shown in experimental colitis, supporting its role in intestinal inflammation. Therefore, we studied the levels of AIF-1 in Crohn's disease (CD). Methods: This study included 33 patients with CD (14 men and 19 women) who participated in the PREDICROHN project, a prospective multice...
Article
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Background Previous studies comparing immigrant ethnic groups and native patients with IBD have yielded clinical and phenotypic differences. To date, no study has focused on the immigrant IBD population in Spain.Methods Prospective, observational, multicenter study comparing cohorts of IBD patients from ENEIDA-registry who were born outside Spain w...
Article
Background and aims: Crohn's disease (CD) can develop penetrating complications at any time during the disease course. Enterocutaneous fistulae (ECF) are disease-related complications with an important impact on quality of life. Our aim was to describe the outcomes of this complication, including its medical and/or surgical management and their te...
Article
Background and aim There is conflicting evidence regarding the prevalence of and risk factors for metabolic-associated fatty liver disease (MAFLD) in patients with inflammatory bowel disease (IBD). We aimed to determine MAFLD prevalence and risk factors in IBD patients. Methods Cross-sectional, case–control study that included all consecutive IBD...
Article
Background Ulcerative proctitis may have a mild and less aggressive course, although evidence is scarce because these patients are excluded from participation in randomized controlled clinical trials. The aim is to identify clinical characteristics and complications associated with ulcerative proctitis refractory to conventional therapy. Methods P...
Article
Background It has been reported that familial aggregation occurs in 10–20% of inflammatory bowel disease (IBD) patients1. Familial IBD has been associated with disease anticipation2 and with an increased need for immunosuppressants3 and surgery4. However, most studies were performed before the widespread use of biological agents and this may impact...
Article
Background The aim of this study was to investigate the association of serum golimumab concentrations (SGC) during maintenance therapy in UC with clinical outcomes including endoscopic and histologic healing. Methods This multicentre, cross-sectional cohort study included UC patients who had received at least 5 maintenance doses of golimumab. A co...
Article
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We aim to describe the incidence and source of contagion of COVID-19 in patients with IBD, as well as the risk factors for a severe course and long-term sequelae. This is a prospective observational study of IBD and COVID-19 included in the ENEIDA registry (53,682 from 73 centres) between March–July 2020 followed-up for 12 months. Results were comp...
Article
Background Immunomediated adverse events (IAEs) are the most frequently reported infliximab-related adverse events. Combination therapy may reduce their incidence, although this strategy is not recommended in elderly patients. Aims To compare the rates of infliximab-related IAE and loss of response (LOR) in elderly and younger patients. Methods A...
Article
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Inflammatory bowel diseases (IBD), represented by ulcerative colitis (UC) and Crohn's disease (CD), are characterized by chronic inflammation of the gastrointestinal tract, what leads to diarrhea, malnutrition, and weight loss. Depression of the growth hormone-insulin-like growth factor-1 axis (GH-IGF-1 axis) could be responsible of these symptoms....
Article
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Background A recently registered device containing 80 mg of adalimumab (ADA) allows an alternative dose escalation regimen with ADA 80 mg every other week (EOW) given as a single subcutaneous injection instead of 40 mg every week. The ADASCAL study evaluated the preferences and satisfaction of inflammatory bowel disease (IBD) patients after switchi...
Article
Background Studies to evaluate the use of mycophenolate mofetil (MMF) in inflammatory bowel disease (IBD) are limited after the appearance of biological treatments. Aims Our primary objective was to evaluate the effectiveness and safety of MMF in IBD. Methods IBD patients who had received MMF were retrieved from the ENEIDA registry. Clinical acti...
Article
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Background Quality of care (QoC) is a highly important topic in inflammatory bowel disease (IBD). We recently elaborated a decalogue of QoC indicators (IQCARO-QoC) developed by IBD patients. The aim of the present study was to assess the factors associated with patients’ evaluation of QoC in Spain using the IQCARO-QoC Decalogue recently developed b...
Article
Background aims: Current therapeutic goals in ulcerative colitis (UC) include clinical and endoscopic remission, named mucosal healing (MH). Despite MH, a proportion of patients suffer a clinical relapse, which has been related to histological inflammation. We aimed to identify which histopathological features or histopathological index cut-off wa...
Article
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(1) Aims: To assess the incidence of inflammatory bowel disease (IBD) in Spain, to describe the main epidemiological and clinical characteristics at diagnosis and the evolution of the disease, and to explore the use of drug treatments. (2) Methods: Prospective, population-based nationwide registry. Adult patients diagnosed with IBD—Crohn’s disease...
Article
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Background The management of inflammatory bowel disease (IBD) has substantially changed in the last decades, both in relation to medical and surgical treatments. Aims Principal: To know the rate of surgery in a newly diagnosed IBD cohort within the first year after diagnosis. Secondary: To describe the type of surgeries and indications in this coh...
Article
Background Adalimumab (ADA) dose escalation from 40 mg SC every other week (EOW) to 40 mg weekly is approved for IBD patients with loss of response. A recently registered device containing 80 mg of ADA will allow an alternative dose escalation regimen with SC doses of 80 mg EOW. The ADASCAL study aimed to evaluate the preferences and satisfaction o...
Article
Background Previous studies comparing inflammatory bowel disease(IBD) features between migrant and native patients have shown clinical phenotype differences. To date, no study has focused on IBD immigrants(MP) in Spain. The aim of this study was to explore the features of MP in Spain and to compare age of disease onset, IBD phenotype and therapeuti...
Article
Background Adalimumab (ADA) intensification is recommended for inadequate or loss of response in inflammatory bowel disease (IBD) patients. A new presentation of ADA 80mg administered every other week (eow) has been approved as an alternative to ADA 40mg every week (ew). Data regarding impact of ADA 80mg eow in clinical practice is still scarce. Th...
Article
Full-text available
Background The information regarding IBD patients with COVID-19 suggests that the factors related to bad outcome are older age and comorbidity whereas immunosuppressants do not have a significant impact worsening the disease evolution. To date, there is no information to assess if there are differences in epidemiological, demographical, and clinica...
Article
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Background: Methotrexate can be used to maintain remission in Crohn's disease patients who are intolerant to thiopurines. Data on its use as monotherapy in other scenarios are limited. Aim: To assess the effectiveness of methotrexate monotherapy in Crohn's disease patients after previous failure to anti-tumour necrosis factor (anti-TNFα) drugs....
Article
Background: The development program (UNIFI) has shown promising results of ustekinumab in ulcerative colitis (UC) treatment that should be confirmed in clinical practice. Aims: To evaluate the durability, effectiveness and safety of ustekinumab in UC in real-life. Methods: Patients included in the prospectively maintained ENEIDA registry who r...
Article
Background Measuring quality of care (QoC) from a patient’s perspective is becoming increasingly important in inflammatory bowel disease.Objective The objective of this study was to determine whether patients’ evaluations of QoC correlate with better inflammatory bowel disease outcomes.MethodsA survey including patients’ characteristics, a decalogu...
Article
Purpose: Biosimilar infliximab (CTP-13) has been recently approved for the treatment of several immune-mediated inflammatory disorders, including inflammatory bowel disease (IBD). Comparative studies between this biosimilar and original infliximab in the real clinical practice are scarce. The objective of the study is to compare short and long-ter...
Article
Full-text available
Golimumab has demonstrated its long-term efficacy and safety in ulcerative colitis in clinical trials, but no data of long-term persistence has been published from real world. To estimate long-term persistence of golimumab, as well as factors associated with longer persistence, in patients with ulcerative colitis in real life. Observational multice...
Article
Aim: To evaluate the effectiveness and safety of tofacitinib in ulcerative colitis [UC] in real life. Methods: Patients from the prospectively maintained ENEIDA registry and treated with tofacitinib due to active UC were included. Clinical activity and effectiveness were defined based on Partial Mayo Score [PMS]. Short-term response/remission wa...
Article
Aims: The aims of this study were (a) to know the kinetics of antitumor necrosis factor (TNF) drug serum levels during the induction phase in patients with Crohn's disease; (b) to identify variables associated with these levels; and (c) to assess the relation between these levels and short-term effectiveness in Crohn's disease patients. Methods:...
Article
Background & Aims Biological therapies may be changing the natural history of inflammatory bowel diseases, reducing the need for surgical intervention. We aimed to assess whether the availability of anti‐TNF agents impacts the need for early surgery in Crohn's disease (CD) and ulcerative colitis (UC). Methods Retrospective, cohort study of patient...
Article
Background and aims: Although commonly used in inflammatory bowel disease (IBD), thiopurines frequently cause intolerance and switching to a second thiopurine has only been reported in some small series. Ours aims in this study were to evaluate the safety of switching to a second thiopurine in a large cohort and to assess the impact of age on tole...
Article
Background Our aim was to evaluate the effectiveness and safety of tofacitinib in ulcerative colitis (UC) in real life. Methods Patients from the prospectively maintained ENEIDA registry treated with tofacitinib due to active UC were included. Clinical activity and effectiveness were defined based on Partial Mayo Score (PMS). The short-term respon...
Article
Full-text available
Background Current therapeutic goals in Crohn’s disease (CD) include not only the mere absence of symptoms but also the objective resolution of macroscopic lesions, so-called deep remission (DR), which has been related to better outcomes. DR is usually acknowledged by endoscopy, although magnetic resonance (MR) or intestinal ultrasound (IUS) are al...
Article
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Background Three anti-TNFs (one intravenous and two subcutaneous) are licensed for the treatment of ulcerative colitis (UC). However, it is not known if the efficacy of a second anti-TNF changes on whether it is intravenous or subcutaneous; this could justify the indication of biological agents with a different mechanism of action in second line. T...
Article
Background Mycophenolate mofetil (MMF) is an immunomodulatory drug that inhibits T and B cells, through a reversible inhibition of inositol monophosphate dehydrogenase. MMF is commonly used for prophylaxis of organ rejection after transplant. Studies to evaluate its use in inflammatory bowel disease (IBD) are limited especially after the appearance...
Article
Full-text available
Background Current therapeutic goals in inflammatory bowel disease (IBD) include not only the mere absence of symptoms but also the resolution of endoscopic lesions, so-called mucosal healing (MH), which has been related to better outcomes. Data regarding the achievement of MH with vedolizumab (VDZ) in real-life clinical practice is still scarce....
Article
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Background Vedolizumab (VDZ) has shown efficacy in the treatment of inflammatory bowel disease (IBD). Available data show better outcomes in naïve patients than in AntiTNFa experienced patients, and current ECCO guidelines support first-line use of VDZ since 2017. Nevertheless, reimbursement of VDZ was initially approved in Spain only in patients f...
Article
Background Quality improvement is a major topic in inflammatory bowel disease (IBD) care, and measuring quality of care (QoC) is necessary for QoC improvement. Most QoC projects or consensus statements are designed from the health care professional point of view. Having QoC indicators designed for and fully evaluable by patients may provide a key t...
Article
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Background The effect of low-frequency functional variation on anti-tumor necrosis factor alpha (TNF) response in Crohn’s disease (CD) patients remains unexplored. The objective of this study was to investigate the impact of functional rare variants in clinical response to anti-TNF therapy in CD. Methods CD anti-TNF naïve patients starting anti-TN...
Article
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Background The effectiveness of the switch to another anti–tumor necrosis factor (anti-TNF) agent is not known. The aim of this study was to analyze the effectiveness and safety of treatment with a second and third anti-TNF drug after intolerance to or failure of a previous anti-TNF agent in inflammatory bowel disease (IBD) patients. Methods We in...
Article
Background: In APPRECIA trial, Crohn's disease (CD) patients undergoing intestinal resection were randomized to postoperative adalimumab (ADA) or azathioprine (AZA). Aims: To evaluate health-related quality of life (HRQoL) in APPRECIA trial. Methods: HRQoL was evaluated using disease-specific shortened Spanish version of the IBDQ (SIBDQ-9) and...
Article
Objectives: Mobile apps are useful tools in e-health and self-management strategies in disease monitoring. We evaluated the Harvey-Bradshaw index (HBI) mobile app self-administered by the patient to see if its results agreed with HBI in-clinic assessed by a physician. Methods: Patients were enrolled in a 4-month prospective study with clinical ass...
Article
Background Measuring patient’s perceived quality of care (QoC) in inflammatory bowel disease (IBD) units is becoming increasingly important. The aim of this analysis was to assess the factors associated with QoC of IBD units from Spain, by measuring the fullfillment of a validated score of indicators by patients followed up by IBD specialists or ge...
Article
Full-text available
Background PURSUIT trial demonstrated the long-term efficacy of golimumab (GLM) in ulcerative colitis (UC). However, the long-term maintenance and safety of GLM in clinical practice has not been evaluated. Methods The aim is to assess the probability of maintenance of GLM in UC in real-life and the possible factors associated to long-term maintena...
Article
Full-text available
Background While the endoscopic remission is a well-established good prognostic factor, histological remission is a concept still to be defined, and therefore the importance of this in the evolution of patients with ulcerative colitis (UC) is still uncertain. Getting the histological remission may be the most ambitious stage. However, achieving it...
Article
Background Loss-of-function (LoF) variants are one of the most interesting forms of rare functional genetic variations as they impair the function of a gene and are more likely to lead to extreme phenotypes. Our aim was to know the impact of functional rare variants in clinical response to anti-TNF therapy in Crohn’s disease (CD). Methods CD anti-...
Article
Background Measuring quality of care (QoC) received in inflammatory bowel disease (IBD) units from patient’s perspective is becoming increasingly important. The aim of the IQCARO project was to assess the QoC of IBD units from Spain, by measuring the completion of a validated predefined decalogue of indicators by patients themselves. Methods A sur...
Article
Full-text available
Background The aim of the present study was to investigate the efficacy and safety of the sequential use of a second and a third anti-TNF agent after failing or developing intolerance to an anti-TNF drug. Methods Patients diagnosed with Crohn’s disease (CD) or ulcerative colitis (UC) from ENEIDA registry (a prospectively maintained registry from G...
Article
Background Patients with upper (L4) and diffuse (L1 + L4) Crohn's disease (CD) may have a more aggressive and refractory disease course. However, evidence on this particular sub-type of patients is scarce. Clinical guidelines do not offer specific protocols on how to manage them. Methods To identify the clinical characteristics, therapeutic requir...
Article
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Background Faecal calprotectin (FC) is a biomarker of bowel inflammation widely spread in diagnosis and follow-up of inflammatory bowel disease (IBD). It is classically estimated that 5% of patients with axial spondyloarthritis (SpA) also have IBD; coexistence of both conditions has definite impact in clinical decisions. Proactive detection of both...
Article
Background Infliximab is one of the most used biological drugs in inflammatory bowel disease (IBD). Immunomediated adverse events (IAE) are of the most frequent reported infliximab-related adverse events. Elderly patients have differential pharmacodynamic and pharmacokinetic characteristics. We recently reported an increased risk of thiopurine-rela...
Article
Full-text available
Background: Effectiveness of vedolizumab in real world clinical practice is unknown. Aim: To evaluate the short and long-term effectiveness of vedolizumab in patients with inflammatory bowel disease (IBD). Methods: Patients who received at least 1 induction dose of vedolizumab were included. Effectiveness was defined based on Harvey-Bradshaw i...
Article
Full-text available
Background Histological remission represents a target distinct from endoscopic healing in ulcerative colitis (UC) and seems a better predictor of clinical outcomes. AimsThe aim of this study was to assess the ability of adalimumab to achieve histological remission in UC patients. Methods Single-center, retrospective, open-label study of patients tr...
Article
Background Focus groups and group interviews have re-emerged as a useful technique for gathering qualitative data among a wide range of research areas. The objective of the focus group of the IQCARO project was to assess the characteristics of the quality indicators of IBD care, from patient′s perspective. Methods After conducting an extensive lit...
Article
Background It is becoming increasingly necessary to measure the quality of care(QoC) that we provide to our patients with IBD. Patient’s perspective should be taken into account for all aspects of care. The aim of the IQCARO project was to select a decalogue of quality indicators of the IBD units, that were selected and could be reliably evaluated...
Article
Full-text available
Background It has been suggested that biological therapies might change the natural history of IBD, avoiding surgery in a proportion of patients. Retrospective series show controversial results and include small samples sizes. Methods To assess the impact of the availability of anti-TNF agents on the need for early surgery (within the first 5 year...
Article
Full-text available
Background Mobile Applications represent a promising tool to facilitate self-management as a new model of health care delivery for IBD. The MediCrohn study was designed to evaluate the diagnostic performance of the Harvey–Bradshaw index (HBI) self-administered by Crohn disease (CD) patients through a Mobile App, compared with the original HBI quest...
Article
Background Total proctocolectomy with definitive ileostomy (TPC-DI) may be the latest therapeutic option for patients with extensive colonic or severe perianal Crohn’s disease (CD) refractory to medical therapy and recurrence have been classically considered a rare condition. However, the rate of small-bowel recurrence after TPC-DI for CD varies de...
Article
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Objectives: To reach a situation diagnosis on the status of patient management at digestive care units (DCUs) in Spain. Material and methods: A cross-sectional descriptive study across DCUs in general acute care hospitals within the Spanish National Health System (data referred to 2015). The study variables were collected with a questionnaire inclu...
Article
Full-text available
Objectives: To reach a situation diagnosis on the status of patient management at digestive care units (DCUs) in Spain. Material and methods: A cross-sectional descriptive study across DCUs in general acute care hospitals within the Spanish National Health System (data referred to 2015). The study variables were collected with a questionnaire in...
Article
Background Rapid Urease Test (RUT) is a simple, cheap and relatively fast method for diagnosing Helicobacter pylori infection. It is therefore the preferred method used for patients undergoing gastroscopy. Most kits require 24 h to give results. The new Ultra-Rapid Urease Test (URUT) kit by Biohit® requires less than 1 h. Objective To determine UR...
Article
Full-text available
Functional gut disorders, including diarrhea-predominant irritable bowel syndrome, are highly prevalent conditions worldwide that significantly impact health economy and patient quality of life, yet lacking fully satisfactory therapeutic options. These circumstances fostered research on various molecules with more specific therapeutic targets, incl...
Article
Background: Rapid Urease Test (RUT) is a simple, cheap and relatively fast method for diagnosing Helicobacter pylori infection. It is therefore the preferred method used for patients undergoing gastroscopy. Most kits require 24h to give results. The new Ultra-Rapid Urease Test (URUT) kit by Biohit® requires less than 1h. Objective: To determine...
Article
Full-text available
Background and Aims Postoperative recurrence of Crohn’s disease (POR-CD) is almost certain if no prophylaxis is administered. Evidence for optimal treatment is lacking. Our aim was to compare the efficacy of adalimumab (ADA) and azathioprine (AZA) in this setting. Methods We performed a phase 3, 52-week, multicenter, randomized, superiority study...
Article
Background: The availability of a quantitative method to measure anti-infliximab (IFX) antibodies (ATI) would facilitate the implementation of therapeutic drug monitoring in clinical decision-making. Our aim was to standardize the homogeneous mobility shift assay (HMSA) used in the measure of ATI levels. Methods: In this prospective longitudinal...
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Full-text available
Objective: Outside clinical trials, the effectiveness of chromoendoscopy (CE) for long-standing IBD surveillance is controversial. We aimed to assess the effectiveness of CE for neoplasia detection and characterisation, in real-life. Design: From June 2012 to 2014, patients with IBD were prospectively included in a multicentre cohort study. Each...
Article
Introduction Multidisciplinary units are needed because of the growing complexity and volume of patients with inflammatory bowel disease (IBD). Objectives To evaluate the healthcare, economic and research impact of incorporating a nurse into the IBD unit of the Puerta de Hierro Majadahonda University Hospital. Methods We prospectively recorded th...