Santiago García López

Hospital Universitario Miguel Servet · Aparato Digestivo

Biologics have completely changed the treatment (and life) of patients with inflammatory bowel disease (IBD). After the first ones, anti-tumor necrosis factor (TNF) biologics, two new biologics, with other therapeutic targets, are now in routine use in our patients, and some others are in different stages of research. They share many aspects, but d...

Background Inflammatory bowel disease (IBD) is a complex multi-factorial disease characterized by chronic inflammation of the gastrointestinal tract. Despite significant efforts to understand the pathogenetic mechanisms of IBD, the elucidation of its etiopathology and progression is far from fully understood. The direct analysis of the intestinal t...

Background COVID-19 vaccination has been suggested as very effective in patients with Inflammatory Bowel Disease (IBD), but most studies assess antibody levels within a few weeks after vaccination and do not use the most recent recommendations as seroconversion cut-off. The objective of VACOVEII study is to evaluate the antibody response to vaccina...

Background The etiology and pathogenesis of inflammatory bowel disease (IBD), Crohn's disease (CD), and ulcerative colitis (UC) are complex and the mechanisms that lead to the development of these diseases remain unclear. Extracellular vesicles (EVs) are small particles covered with a cell membrane, originating from the emitting cell, excreted into...

Background Female sex has been associated with a worse response to anti-TNF drugs and with discontinuation of these drugs in immune-mediated diseases. Data in Inflammatory Bowel Disease (IBD) are unclear. The aims of study are to assess possible differences in long-term treatment persistence and safety of biological drugs between women and men with...

Background Inflammatory bowel disease (IBD) is an idiopathic and chronic disorder that includes ulcerative colitis (UC) and Crohn’s disease (CD). Both diseases are different but show an uncontrolled intestinal immune response that generates tissue inflammation. Dendritic cells (DC) are phagocytic professional antigen presenting cells that link the...

Background Biologics have been a breakthrough in the management of patients with inflammatory bowel disease (IBD). However, we lack predictors of response to these drugs. A recent study has shown a significant association between HLA DQA*105 mutations and the development of loss of response to anti-TNF mediated by immunogenicity. The high quality o...

Background Some patients with Inflammatory Bowel Disease (IBD) who are treated with anti-TNFα therapy develop a drug-induced psoriasis (IP) as an adverse event. There are some therapeutic approaches, being more frequent to change the biologic therapy to ustekinumab, effective and approved for the treatment of both entities. This could be the best o...

Background The use of ustekinumab (UST) and vedolizumab (VDZ) as first line therapy for inflammatory bowel disease (IBD) is increasing due to safety reasons and contraindications of anti-TNFs. However, there are no studies evaluating their efficacy and safety in clinical practice under these circumstances. Thus, our aims were to describe bionaïve p...

Background Inflammatory bowel diseases (IBD) are chronic, heterogeneous, and inflammatory conditions mainly affecting the gastrointestinal tract. Currently, endoscopy is the gold standard test for assessing mucosal activity and healing in clinical practice; however, it is a costly, time-consuming, invasive, and uncomfortable procedure for patients....

(1) Scant information is available concerning the characteristics that may favour the acquisition of COVID-19 in patients with inflammatory bowel disease (IBD). Therefore, the aim of this study was to assess these differences between infected and noninfected patients with IBD. (2) This nationwide case–control study evaluated patients with inflammat...

Gastrointestinal (GI) bleeding is associated with considerable morbidity and mortality. Red blood cell (RBC) transfusion has long been the cornerstone of treatment for anemia due to GI bleeding. However, blood is not devoid of potential adverse effects, and it is also a precious resource, with limited supplies in blood banks. Nowadays, all patients...

Ustekinumab has shown efficacy in Crohn’s Disease (CD) patients. To identify patient profiles of those who benefit the most from this treatment would help to position this drug in the therapeutic paradigm of CD and generate hypotheses for future trials. The objective of this analysis was to determine whether baseline patient characteristics are pre...

Background and Aims Clinical trials and real-life studies with ustekinumab in Crohn's disease (CD) have shown a good efficacy and safety profile. However, these data are scarcely available in elderly patients. Therefore, we aim to assess the effectiveness and safety of ustekinumab in elderly patients with CD. Methods Elderly patients (>60 years ol...

(1) Aims: Patients receiving antitumor necrosis factor (anti-TNF) therapy are at risk of developing tuberculosis (TB), usually due to the reactivation of a latent TB infection (LTBI). LTBI screening and treatment decreases the risk of TB. This study evaluated the diagnostic performance of different LTBI screening strategies in patients with inflamm...

Objective Measurement of patient-perceived outcomes in inflammatory bowel disease (IBD) care is becoming increasingly important. A simple and validated tool exists in English for this purpose, the “IBD-Control”. Our aim is to translate it into Spanish, adapt and validate it. Patients and methods The IBD-Control was translated into the Spanish inst...

Objective No studies evaluating the rapidity of response to biological therapies are available for Crohn's disease (CD). The aim of this study was to evaluate rapidity of onset of clinical response and impact on quality of life (QoL) of adalimumab therapy in adult anti-TNF-naïve patients with moderately-to-severely active CD. Patients and methods...

Background Large real-world-evidence studies are required to confirm the durability of response, effectiveness, and safety of ustekinumab in Crohn’s disease (CD) patients in real-world clinical practice. Methods A retrospective, multicentre study was conducted in Spain in patients with active CD who had received ≥1 intravenous dose of ustekinumab...

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...

Background Aims: 1) to compare persistence on adalimumab treatment over time in inflammatory bowel disease (IBD) patients who maintained adalimumab reference [non-switch cohort (NC)] vs. those who switched from adalimumab reference to adalimumab biosimilar [switch cohort (SC)]; 2) to compare loss of effectiveness of adalimumab treatment in the NC v...

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...

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...

Background Etrolizumab is a gut-targeted, anti-β7 integrin, monoclonal antibody. In an earlier phase 2 induction study, etrolizumab significantly improved clinical remission compared with placebo in patients with moderately to severely active ulcerative colitis. We aimed to evaluate the efficacy and safety of etrolizumab in patients with moderately...

RESUMEN Objetivo: La medida de los resultados percibidos por el paciente (PROM) en la asistencia de la enfermedad inflamatoria intestinal (EII) adquiere cada vez más importancia. Existe una herramienta sencilla y validada en inglés para este fin, el "IBD-control". Nuestro objetivo es traducirlo al español, adaptarlo y validarlo. Pacientes y métodos...

Objectives: 1)To analyze evidence about poor adherence / non-adherence including their prevalences, associated factors, and interventions in ulcerative colitis (UC) patients; 2)To provide a framework to improve poor adherence / non-adherence. Methods: A qualitative approach was applied. A literature review was performed using Medline. Primary se...

The small intestine is key in the digestion and absorption of macro and micronutrients. The large intestine is essential for the absorption of water, to allow adequate defecation, and to harbor intestinal microbiota, for which their nutritional role is as important as it is unknown. This article will describe the causes and consequences of malnutri...

Background Patients with inflammatory bowel disease (IBD) may present extraintestinal manifestations (EIMs) that affect the joints, skin, eyes, and hepatobiliary area, among others.AimsOur aim was to analyse the prevalence and characteristics of EIMs in patients with IBD and to identify the possible risk factors associated with the development of E...

Background Clinical trials and real-life studies with Ustekinumab in Crohn’s disease show its good efficacy and safety profile. However, there are hardly any data on elderly patients, who are excluded from these clinical trials. Our aim is to evaluate these variables in real-life practice. Methods Retrospective analysis of patients from the prospe...

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...

Background A less aggressive phenotype of Crohn’s disease (CD) has been reported in patients with elderly onset CD. Despite this, similar surgical rates among younger and older CD patients have been reported. However, scarce data are available about the risk of postoperative recurrence (POR) regarding the age, and no data are available about the us...

Objective: No studies evaluating the rapidity of response to biological therapies are available for Crohn’s disease (CD). The aim of this study was to evaluate rapidity of onset of clinical response and impact on quality of life (QoL) of adalimumab therapy in adult anti-TNF-naïve patients with moderately-to-severely active CD. Patients and methods....

Background To evaluate the cost-effectiveness of tofacitinib in comparison to vedolizumab for the treatment of moderate-to-severe ulcerative colitis (UC) after failure or intolerance to conventional therapy (bio-naive) or first-line biologic treatment (bio-experienced), from the Spanish National Health System (NHS) perspective. Methods A lifetime...

Background Data on the long‐term administration of ustekinumab in recommended doses are limited. Aim To assess the real‐world, long‐term effectiveness of ustekinumab in refractory Crohn's disease (CD). Methods Multicenter study of CD patients starting ustekinumab at the recommended dose, followed for 1 year. Values for the Harvey‐Bradshaw Index (...

Background and aims: Our objective was to define, describe and organize (on the basis of consensus) the patient's preferences in the management of ulcerative colitis (UC), in order to further incorporate them in daily practice and improve patients satisfaction, adherence to the treatment and quality of care. Methods: Qualitative study. A narrati...

Resumen Introducción Desde la publicación de la primera edición de la Guía en 2013, se ha generado mucha información en torno al tratamiento de la colitis ulcerosa, y se han introducido nuevos fármacos y protocolos de actuación. La práctica clínica ha variado substancialmente, lo que justifica nuevas aproximaciones y una revisión exhaustiva, así c...

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...

Introduction CT-P13 is a biosimilar drug of infliximab (IFX), effective in patients with inflammatory bowel disease (IBD). The monitoring of levels of IFX and anti-IFX antibodies is now considered part of the integral management. Objective To compare the clinical response according to a strictly clinical (CLN) or proactive (PRO) approach based on...

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...

Introduction Ustekinumab, a monoclonal antibody that blocks interleukins 12/23, has proven in clinical trials its efficacy in inducing and maintaining clinical remission of Crohn's disease (CD). Its effectiveness and safety in actual clinical practice is less known and may differ from trials. Objective To evaluate its effectiveness and safety in c...

Background Post-marketing data are required to confirm the durability and the long-term benefit and safety of UST in CD in clinical practice. Our aims were: (1) to evaluate the retention rate of UST in CD patients and to identify predictive factors of UST discontinuation; (2) to assess UST short-term effectiveness; (3) to analyse the durability of...

Background Breastfeeding is one of the most important environmental factors in early childhood for later development of an Inflammatory Bowel Disease. The duration of lactation is essential for it to have a protective effect. In addition to IBD patients, breastfeeding can have a beneficial effect for preventing disease relapse. For these reasons, w...

Background There are limited data of long-term ustekinumab administered according to the doses recommended in the UNITI studies. The objective of this study was to assess the real-world, long-term effectiveness of ustekinumab in refractory Crohn’s disease (CD) (LONG-CROHNUSK Study). Methods Multicentre study of CD patients starting ustekinumab at...

Introduction: Ustekinumab, a monoclonal antibody that blocks interleukins 12/23, has proven in clinical trials its efficacy in inducing and maintaining clinical remission of Crohn's disease (CD). Its effectiveness and safety in actual clinical practice is less known and may differ from trials. Objective: To evaluate its effectiveness and safety...

Introduction: CT-P13 is a biosimilar drug of infliximab (IFX), effective in patients with inflammatory bowel disease (IBD). The monitoring of levels of IFX and anti-IFX antibodies is now considered part of the integral management. Objective: To compare the clinical response according to a strictly clinical (CLN) or proactive (PRO) approach based...

Background: Thiopurines are the most widely used immunosuppressants in IBD although drug-related adverse events (AE) occur in 20%-30% of cases. Aim: To evaluate the safety of thiopurines in elderly IBD patients METHODS: Cohort study including all adult patients in the ENEIDA registry who received thiopurines. Patients were grouped in terms of ag...

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...

Background and aims: The aims of this study were to determine the prevalence of fatigue in patients with inflammatory bowel disease [IBD], to identify the factors associated with fatigue and its severity, to assess the impact of fatigue on quality of life [QoL], and to evaluate the relationship between fatigue and sleep disorders. Methods: This...

Background: There are limited data of ustekinumab administered according to the doses recommended in the UNITI studies. Aim: To assess the real-world, short-term effectiveness of ustekinumab in refractory Crohn's disease (CD). Methods: Multicentre study of CD patients starting ustekinumab after June 2017 at the recommend dose (260, 390 or 520...

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...

Background Thiopurines are the most commonly used immunosuppressants in inflammatory bowel disease (IBD), but their main limitation is the high rate of drug-related adverse events (AE) and treatment discontinuation. Switching to a second thiopurine may be an alternative in these cases, but series published up to now, include a limited number of pat...

Background To provide a patient-centred care in ulcerative colitis (UC), it is essential to address and to incorporate patient’s opinions, preferences, etc. Our aim was to define and integrate UC patient's preferences in the management of the disease in clinical practice. Methods Qualitative study. A review of the literature was carried out in Med...

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...

Background Ustekinumab is a monoclonal antibody targeting interleukins 12 and 23. Its effectiveness in clinical practice has not yet been demonstrated. The aim of this study was to assess the real-world, short-term effectiveness of ustekinumab in medically refractory Crohn’s disease (CD) (CROHNUSK study). Methods Multi-centre study of CD patients...

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...

Background Biological drugs for moderate-to-severe ulcerative colitis have changed the therapeutic perspective, while small-molecule inhibitors and new promising drugs suggest new options. Aim Assess comparative efficacy and safety of biological and new small oral drugs: commercialized and under-investigation ones for patients naïve to biological d...

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...

Background: Despite the increased use of rescue medical therapies for steroid refractory acute severe ulcerative colitis, mortality related to this entity still remains high. We aimed to assess the mortality and morbidity related to colectomy and their predictive factors in steroid refractory acute severe ulcerative colitis, and to evaluate the ch...

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...

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...

Background CT-P13 became the first Infliximab (IFX) biosimilar approved for the treatment of IBD in 2013. Measurement of IFX trough levels has been suggested as a new approach to monitor therapy. Few studies have analysed in clinical practice the potential benefits of a proactive measurement of IFX trough-level approach (PRO) compared with the stan...

Background Population-based studies comparing the characteristics of paediatric IBD with IBD diagnosed in the adulthood are scarce. The aims of this study were (i) To compare the characteristics of IBD in patients diagnosed during childhood (≤16 years) with those from patients diagnosed in adulthood; (ii) to compare the incidence rate of initiation...