Therapeutic drug monitoring in inflammatory bowel diseases. Position statement of the Spanish Working Group on Crohn's Disease and Ulcerative Colitis. / Monitorización terapéutica de los fármacos biológicos en la enfermedad inflamatoria intestinal. Documento de Posicionamiento del Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU).

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.

Use of teduglutide for short bowel syndrome and Crohn's disease in a patient treated with ustekinumab and vedolizumab dual biologic therapy.

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.

Clinical settings with tofacitinib in ulcerative colitis.

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.

Author´s answer to: "Effect of adacolumn® in ulcerative colitis with COVID-19".

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.

COVID-19 and the digestive system: protection and management during the SARS-CoV-2 pandemic.

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.

Questions and answers about the management of Crohn's disease and ulcerative colitis with vedolizumab. / Preguntas y respuestas sobre el manejo de la enfermedad de Crohn y la colitis ulcerosa con vedolizumab.

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.

Update of the SEPD position statement on the use of biosimilars for inflammatory bowel disease.

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.

[Recommendations for the management of influenza A (H1N1) in rheumatic patients with immunosuppression]. / Recomendaciones de manejo de la gripe A (H1N1) en pacientes reumáticos con inmunosupresión.

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.