58 research outputs found

    Evolution after Anti-TNF Discontinuation in Patients with Inflammatory Bowel Disease: A Multicenter Long-Term Follow-Up Study

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    OBJECTIVES:The aims of this study were to assess the risk of relapse after discontinuation of anti-tumor necrosis factor (anti-TNF) drugs in patients with inflammatory bowel disease (IBD), to identify the factors associated with relapse, and to evaluate the overcome after retreatment with the same anti-TNF in those who relapsed.METHODS:This was a retrospective, observational, multicenter study. IBD patients who had been treated with anti-TNFs and in whom these drugs were discontinued after clinical remission was achieved were included.RESULTS:A total of 1, 055 patients were included. The incidence rate of relapse was 19% and 17% per patient-year in Crohn''s disease and ulcerative colitis patients, respectively. In both Crohn''s disease and ulcerative colitis patients in deep remission, the incidence rate of relapse was 19% per patient-year. The treatment with adalimumab vs. infliximab (hazard ratio (HR)=1.29; 95% confidence interval (CI)=1.01-1.66), elective discontinuation of anti-TNFs (HR=1.90; 95% CI=1.07-3.37) or discontinuation because of adverse events (HR=2.33; 95% CI=1.27-2.02) vs. a top-down strategy, colonic localization (HR=1.51; 95% CI=1.13-2.02) vs. ileal, and stricturing behavior (HR=1.5; 95% CI=1.09-2.05) vs. inflammatory were associated with a higher risk of relapse in Crohn''s disease patients, whereas treatment with immunomodulators after discontinuation (HR=0.67; 95% CI=0.51-0.87) and age (HR=0.98; 95% CI=0.97-0.99) were protective factors. None of the factors were predictive in ulcerative colitis patients. Retreatment of relapse with the same anti-TNF was effective (80% responded) and safe.CONCLUSIONS:The incidence rate of inflammatory bowel disease relapse after anti-TNF discontinuation is relevant. Some predictive factors of relapse after anti-TNF withdrawal have been identified. Retreatment with the same anti-TNF drug was effective and safe

    Monoclonal Antibody and Fusion Protein Biosimilars Across Therapeutic Areas: A Systematic Review of Published Evidence

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    Guidelines for the use and interpretation of assays for monitoring autophagy (4th edition)

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    Guidelines for the use and interpretation of assays for monitoring autophagy (4th edition)1.

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    In 2008, we published the first set of guidelines for standardizing research in autophagy. Since then, this topic has received increasing attention, and many scientists have entered the field. Our knowledge base and relevant new technologies have also been expanding. Thus, it is important to formulate on a regular basis updated guidelines for monitoring autophagy in different organisms. Despite numerous reviews, there continues to be confusion regarding acceptable methods to evaluate autophagy, especially in multicellular eukaryotes. Here, we present a set of guidelines for investigators to select and interpret methods to examine autophagy and related processes, and for reviewers to provide realistic and reasonable critiques of reports that are focused on these processes. These guidelines are not meant to be a dogmatic set of rules, because the appropriateness of any assay largely depends on the question being asked and the system being used. Moreover, no individual assay is perfect for every situation, calling for the use of multiple techniques to properly monitor autophagy in each experimental setting. Finally, several core components of the autophagy machinery have been implicated in distinct autophagic processes (canonical and noncanonical autophagy), implying that genetic approaches to block autophagy should rely on targeting two or more autophagy-related genes that ideally participate in distinct steps of the pathway. Along similar lines, because multiple proteins involved in autophagy also regulate other cellular pathways including apoptosis, not all of them can be used as a specific marker for bona fide autophagic responses. Here, we critically discuss current methods of assessing autophagy and the information they can, or cannot, provide. Our ultimate goal is to encourage intellectual and technical innovation in the field

    How to incorporate patients preference into ulcerative colitis current clinical management: initial document from a Spanish multidisciplinary steering committee

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    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 Medline and in the Clinical Queries of PubMed. We performed primary searches with Mesh terms and free text to identify preferences of patients with UC as well as clinical scenarios that may determine specific preferences. We selected articles that included: patients with UC, adults, who analysed their preferences. Likewise, only the following designs were included: meta-analysis, systematic reviews, clinical trials, studies, observations, and qualitative studies. The quality of the studies was evaluated with the Oxford scale. The results of the literature review were presented and discussed in a nominal group meeting, composed by a multidisciplinary steering committee of 6 gastroenterologists, 1 primary care physician, 1 nurse, and 1 patient. After that, a series of clinical relevant scenarios were identified and related patient preferences were proposed for them. This was the base to the generation of a set of general recommendations. The level of agreement among the multidisciplinary steering committee with the recommendations was established in a Delphi process in which the members of the committee voted from 0 = totally disagree to 10 = totally agree. Agreement was defined if at least 70% of the participants voted ≥7. Results The review of the literature included 69 articles, most of them qualitative studies of moderate quality. UC patient’s preferences were classified according to different topics including information, treatment (pharmacological and non-pharmacological), disease follow-up, relations with health professionals, health system and with the administration. In the nominal group meeting several key clinical scenarios were identified: the diagnosis, follow-up, surgery and special clinical scenarios/patients profiles (children, teenagers, elderly, women, pregnancy and lactation, family, and socio-work environment). A total of 11 recommendations about the incorporation of UC patients into daily practice across the key clinical scenarios are were generated (see table). All of them reached the level of agreement establishe
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