ABSTRACT
El tratamiento de la enfermedad inflamatoria intestinal (EII) ha sufrido una gran transformación tras la introducción de los fármacos biológicos. Gracias a ellos, los objetivos del tratamiento han evolucionado desde la respuesta y remisión clínica a objetivos más ambiciosos, como la remisión endoscópica o radiológica. Sin embargo, aunque los biológicos son muy eficaces, un porcentaje importante de pacientes no obtendrá una respuesta inicial o la perderá a lo largo del tiempo. Sabemos que existe una relación directa entre las concentraciones valle del biológico y su eficacia terapéutica, que cuanto más exigente sea el objetivo terapéutico serán necesarios niveles superiores del fármaco y que es frecuente la exposición insuficiente al mismo. La monitorización terapéutica de medicamentos biológicos, así como los modelos farmacocinéticos, nos brindan la posibilidad de ofrecer un enfoque personalizado del abordaje en pacientes con EII. Durante los últimos años se ha acumulado información relevante respecto a su utilidad durante o después de la inducción, así como en el mantenimiento del tratamiento biológico, en estrategias reactivas o proactivas y antes de la retirada o desintensificación del esquema.El objetivo de este documento es establecer recomendaciones sobre la utilidad de la monitorización terapéutica de biológicos en pacientes con EII, en los diferentes escenarios de la práctica clínica e identificar las áreas donde su utilidad es evidente, prometedora o controvertida. (AU)
The treatment of inflammatory bowel disease has undergone a significant transformation following the introduction of biologic drugs. Thanks to these drugs, treatment goals have evolved from clinical response and remission to more ambitious objectives, such as endoscopic or radiologic remission. However, even though biologics are highly effective, a significant percentage of patients will not achieve an initial response or may lose it over time. We know that there is a direct relationship between the trough concentrations of the biologic and its therapeutic efficacy, with more demanding therapeutic goals requiring higher drug levels, and inadequate exposure being common.Therapeutic drug monitoring of biologic medications, along with pharmacokinetic models, provides us with the possibility of offering a personalized approach to treatment for patients with IBD. Over the past few years, relevant information has accumulated regarding its utility during or after induction, as well as in the maintenance of biologic treatment, in reactive or proactive strategies, and prior to withdrawal or treatment de-escalation.The aim of this document is to establish recommendations regarding the utility of therapeutic drug monitoring of biologics in patients with inflammatory bowel disease, in different clinical practice scenarios, and to identify areas where its utility is evident, promising, or controversial. (AU)
Subject(s)
Humans , Inflammatory Bowel Diseases , Crohn Disease , Colitis, Ulcerative , Pharmacokinetics , Spain , Drug Monitoring , eHealth StrategiesABSTRACT
The treatment of inflammatory bowel disease has undergone a significant transformation following the introduction of biologic drugs. Thanks to these drugs, treatment goals have evolved from clinical response and remission to more ambitious objectives, such as endoscopic or radiologic remission. However, even though biologics are highly effective, a significant percentage of patients will not achieve an initial response or may lose it over time. We know that there is a direct relationship between the trough concentrations of the biologic and its therapeutic efficacy, with more demanding therapeutic goals requiring higher drug levels, and inadequate exposure being common. Therapeutic drug monitoring of biologic medications, along with pharmacokinetic models, provides us with the possibility of offering a personalized approach to treatment for patients with IBD. Over the past few years, relevant information has accumulated regarding its utility during or after induction, as well as in the maintenance of biologic treatment, in reactive or proactive strategies, and prior to withdrawal or treatment de-escalation. The aim of this document is to establish recommendations regarding the utility of therapeutic drug monitoring of biologics in patients with inflammatory bowel disease, in different clinical practice scenarios, and to identify areas where its utility is evident, promising, or controversial.
Subject(s)
Biological Products , Colitis, Ulcerative , Crohn Disease , Drug Monitoring , Humans , Colitis, Ulcerative/drug therapy , Crohn Disease/drug therapy , Biological Products/therapeutic use , Biological Products/pharmacokinetics , Inflammatory Bowel Diseases/drug therapyABSTRACT
Surgery in Crohn's disease may be the cause of short bowel syndrome that may lead to kidney dysfunction. Dual biologic therapy is rarely needed to control activity. We present a case of a 61-year-old steroid dependent (A2L1B3p) female who had undergone surgery on three occasions: ileocecal resection (resection of 15 cm of terminal ileum); resection of right and left colon up to sigmoid; proctectomy with intersphincteric resection along with ileostomy due to a rectovaginal fistula. She had been previously treated with prednisone, azathioprine, methotrexate, infliximab and adalimumab but the treatment was discontinued owing to adverse effects. Vedolizumab was started, showing good control of the luminal activity but the rectovaginal fistula recurred. Treatment changed to ustekinumab, the fistula activity was controlled but the mucosa activity recurred. 11 months after commencing with ustekinumab, vedolizumab was added to the treatment and complete remission was achieved for three years. Simultaneously, the patient developed renal dysfunction derived from the short bowel syndrome that led to chronic kidney failure. In the face of potential renal replacement therapy, a new therapy with 2.5 mg/sc/d teduglutide was started achieving stable figures of creatinine and normalization of the glomerular filtration rate.
Subject(s)
Crohn Disease , Short Bowel Syndrome , Female , Humans , Middle Aged , Crohn Disease/complications , Crohn Disease/drug therapy , Crohn Disease/chemically induced , Ustekinumab/adverse effects , Short Bowel Syndrome/drug therapy , Rectovaginal Fistula , Biological Therapy , Treatment OutcomeABSTRACT
There are aspects of Janus kinase (JAK) inhibitors, specifically tofacitinib, that distinguish them from other drugs used in the treatment of ulcerative colitis (UC), such as their oral administration, their short half-life and their lack of immunogenicity. With the available evidence, we can highlight tofacitinib's quick action and flexibility of use, and its efficacy in patients, irrespective of whether or not they have previously been exposed to TNF inhibitors (anti-TNF drugs) and other biologic agents. Moreover, their safety profile is known and manageable, with certain considerations and precautions being factored in before and during treatment. In this review, we have defined various scenarios pertaining to this drug, e.g. its use in the event of failure or intolerance to previous treatment with biologics, when a quick response is required or in patients with other concurrent immune-mediated diseases.
ABSTRACT
We have read with interest the article published by Pérez et al., we really appreciate their interesting comments and would like to qualify some points. With the except of the clinical practice, currently there is no recommendation based on scientific evidence about the use of apheresis in the treatment of ulcerative colitis (UC), and even less in Crohn's disease (CD). However, the results obtained in the case of Pérez et al. in relation to systemic inflammation and pulmonary clinical improvement are very interesting from a pathophysiological and clinical point of view.
Subject(s)
Colitis, Ulcerative , Severe acute respiratory syndrome-related coronavirus , Betacoronavirus , COVID-19 , Coronavirus Infections , Digestive System , Humans , Pandemics , Pneumonia, Viral , SARS-CoV-2ABSTRACT
No disponible
Subject(s)
Humans , Colitis, Ulcerative/therapy , Coronavirus Infections , Pneumonia, Viral , Betacoronavirus , Blood Component Removal , Leukapheresis , PandemicsABSTRACT
El objetivo de esta revisión rápida es una puesta al día sobre el impacto de la infección por SARS-CoV-2 en los servicios de Gastroenterología y Hepatología, en nuestros pacientes, y en nuestra nueva forma de trabajar. El tracto gastrointestinal y el hígado se ven afectados por el SARSCoV-2, especialmente en pacientes con terapias inmunosupresoras. Los pacientes con trasplante de hígado deben ser seguidos de cerca. La endoscopia digestiva es un procedimiento de alto riesgo para la transmisión de SARS-CoV-2. Mientras dure la pandemia, debemos adaptar sus indicaciones y promover medidas de protección para pacientes y profesionales de la salud. La pandemia de COVID-19 ha cambiado nuestras prioridades y nuestra forma de trabajar, aunque no sabemos cuáles serán las repercusiones después del regreso a la normalidad
No disponible
Subject(s)
Humans , Gastrointestinal Diseases/virology , Gastrointestinal Diseases/diagnosis , Coronavirus Infections/complications , Coronavirus Infections/prevention & control , Endoscopy, Gastrointestinal/methods , Infectious Disease Transmission, Patient-to-Professional/prevention & control , Disinfection , Risk AssessmentABSTRACT
The purpose of this rapid review is to provide an update on the impact of SARS-CoV-2 infection on Gastroenterology and Hepatology departments, our patients, and our new way of working. The gastrointestinal tract and the liver are affected by SARS-CoV-2, especially in patients with immunosuppressive therapies. Patients with liver transplantation should be followed closely. Digestive endoscopy is a high-risk procedure for the transmission of SARS-CoV-2. While the pandemic lasts, we must adapt its indications and promote protective measures for patients and healthcare professionals alike. The COVID-19 pandemic has changed our priorities and the way we work, although we do not know what the repercussions will be after normality is reinstated.
Subject(s)
Betacoronavirus/pathogenicity , Coronavirus Infections/transmission , Digestive System Diseases/virology , Digestive System/virology , Pandemics , Pneumonia, Viral/transmission , COVID-19 , Coronavirus Infections/virology , Digestive System Diseases/diagnosis , Digestive System Diseases/therapy , Disease Transmission, Infectious/prevention & control , Endoscopy, Digestive System/adverse effects , Humans , Immunosuppressive Agents/adverse effects , Infection Control/methods , Liver Transplantation , Pneumonia, Viral/virology , SARS-CoV-2ABSTRACT
Vedolizumab es un anticuerpo monoclonal antiintegrina indicado para el tratamiento de pacientes con enfermedad de Crohn y colitis ulcerosa moderada a grave, tras fracaso a terapia convencional o a anti-TNF. El objetivo del presente artículo es dar respuesta a una serie de preguntas eminentemente prácticas respecto al manejo de ambas enfermedades con vedolizumab, tanto a través de la evidencia clínica publicada como de la experiencia adquirida por los autores en la práctica clínica a lo largo de los últimos años
Vedolizumab is an anti-integrin monoclonal antibody indicated for the treatment of patients with moderately to severely active Crohn's disease and ulcerative colitis who have failed conventional or anti-TNF therapies. The objective of this article is to answer a series of very practical questions regarding the management of both diseases with vedolizumab, based on data from published literature, as well as on the experience acquired by the authors in clinical practice in recent years
Subject(s)
Humans , Crohn Disease/diagnosis , Crohn Disease/therapy , Colitis, Ulcerative/drug therapy , Antibodies, Monoclonal/administration & dosage , Adrenal Cortex Hormones/administration & dosage , Immunologic Factors/therapeutic useABSTRACT
Vedolizumab is an anti-integrin monoclonal antibody indicated for the treatment of patients with moderately to severely active Crohn's disease and ulcerative colitis who have failed conventional or anti-TNF therapies. The objective of this article is to answer a series of very practical questions regarding the management of both diseases with vedolizumab, based on data from published literature, as well as on the experience acquired by the authors in clinical practice in recent years.
Subject(s)
Antibodies, Monoclonal, Humanized/therapeutic use , Colitis, Ulcerative/drug therapy , Crohn Disease/drug therapy , Gastrointestinal Agents/therapeutic use , Humans , Practice Guidelines as Topic , Treatment OutcomeABSTRACT
No disponible
Subject(s)
Humans , Male , Adult , Pulmonary Aspergillosis/complications , Pulmonary Aspergillosis/diagnostic imaging , Adalimumab/adverse effects , Steroids/adverse effects , Aspergillus fumigatus/isolation & purification , Voriconazole/administration & dosage , Pulmonary Aspergillosis/drug therapy , Crohn Disease/drug therapy , Adalimumab/administration & dosage , Steroids/administration & dosage , Radiography, Thoracic , Lung/diagnostic imaging , Lung/pathology , Bronchoscopy , Mycobacterium/isolation & purification , Imipenem/administration & dosageSubject(s)
Adalimumab/adverse effects , Adrenal Cortex Hormones/adverse effects , Anti-Inflammatory Agents/adverse effects , Crohn Disease/drug therapy , Immunosuppressive Agents/adverse effects , Opportunistic Infections/etiology , Pulmonary Aspergillosis/etiology , Adalimumab/therapeutic use , Adrenal Cortex Hormones/therapeutic use , Adult , Anti-Inflammatory Agents/therapeutic use , Antifungal Agents/therapeutic use , Cilastatin/therapeutic use , Crohn Disease/complications , Diagnosis, Differential , Disease Susceptibility , Humans , Imipenem/therapeutic use , Immunocompromised Host , Immunosuppressive Agents/therapeutic use , Male , Opportunistic Infections/diagnosis , Opportunistic Infections/drug therapy , Pulmonary Aspergillosis/diagnosis , Pulmonary Aspergillosis/drug therapy , Tomography, X-Ray Computed , Tuberculosis, Pulmonary/diagnosisABSTRACT
No disponible
Subject(s)
Humans , Inflammatory Bowel Diseases/drug therapy , Biosimilar Pharmaceuticals/therapeutic use , Infliximab/therapeutic use , Drug ApprovalABSTRACT
In 2013, the European Medicines Agency (EMA) approved the biosimilar infliximab (CT-P13) for the full range of indications of the originator product, based on data from two trials conducted in rheumatoid arthritis and ankylosing spondylitis. The same year, our Society published a position statement that was later reviewed.
Subject(s)
Anti-Inflammatory Agents/therapeutic use , Biosimilar Pharmaceuticals/therapeutic use , Inflammatory Bowel Diseases/drug therapy , Infliximab/therapeutic use , Humans , Practice Guidelines as TopicSubject(s)
Humans , Animals , Female , Adult , Crohn Disease/complications , Intestinal Diseases, Parasitic/complications , Myiasis/parasitology , Crohn Disease/drug therapy , Crohn Disease/parasitology , Diptera/growth & development , Disease Susceptibility , Feces/parasitology , Immunocompromised Host , Immunosuppressive Agents/therapeutic use , Intestinal Diseases, Parasitic/parasitology , Larva , Myiasis/complicationsSubject(s)
Crohn Disease/complications , Intestinal Diseases, Parasitic/complications , Myiasis/complications , Adult , Animals , Crohn Disease/drug therapy , Crohn Disease/parasitology , Diptera/growth & development , Disease Susceptibility , Feces/parasitology , Female , Humans , Immunocompromised Host , Immunosuppressive Agents/therapeutic use , Intestinal Diseases, Parasitic/parasitology , Larva , Myiasis/parasitologyABSTRACT
La Sociedad Española de Reumatología (SER), a través de una comisión multidisciplinar, ha elaborado un documento con recomendaciones específicas para los profesionales de Reumatología, atendiendo a las características propias de estos pacientes, con el objetivo de informar y orientar a los profesionales ante la situación actual de pandemia por gripe A/H1N1. Todas las recomendaciones están basadas en documentos previos elaborados por grupos de trabajo del Ministerio de Sanidad y Política Social y de comunidades autónomas, los cuales a su vez se basan en las guías y documentos que elaboran periódicamente el Center for Disease Control (CDC) de EEUU, como centro designado por la Organización Mundial de la Salud para la coordinación de la pandemia. Se insta a todos los reumatólogos y potenciales usuarios de estas recomendaciones a que consulten los documentos originales, así como las directrices generales que se establezcan en cada centro sanitario(AU)
The Spanish Society of Rheumatology (SER), through a multidiscipline task force, has elaborated a document with specific recommendations for specialists in Rheumatology, emphasizing the special needs of patients with rheumatic diseases, with the objective of informing and orienting health professionals about the current influenza A/H1N1 virus pandemic. All of the recommendations are based on prior documents elaborated by the Ministry of Health and Social Policy task forces, as well as those from the autonomous communities, which are themselves based on the guidelines and documents routinely published by the Centers for Disease Control (CDC) in the US, this being the center designated by WHO for the coordination of efforts against the pandemic. All rheumatologists and potential users of these recommendations are encouraged to consult the original documents, as well as the general guidelines established at each health center(AU)
Subject(s)
Humans , Immunocompromised Host , Influenza, Human/complications , Rheumatic Diseases/complications , Influenza, Human/drug therapy , Practice Patterns, Physicians' , Risk Groups , Antiviral Agents/therapeutic use , Disease Prevention , Haemophilus VaccinesABSTRACT
The Spanish Society of Rheumatology (SER), through a multidiscipline task force, has elaborated a document with specific recommendations for specialists in Rheumatology, emphasizing the special needs of patients with rheumatic diseases, with the objective of informing and orienting health professionals about the current influenza A/H1N1 virus pandemic. All of the recommendations are based on prior documents elaborated by the Ministry of Health and Social Policy task forces, as well as those from the autonomous communities, which are themselves based on the guidelines and documents routinely published by the Centers for Disease Control (CDC) in the US, this being the center designated by WHO for the coordination of efforts against the pandemic. All rheumatologists and potential users of these recommendations are encouraged to consult the original documents, as well as the general guidelines established at each health center.
