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Background and aims Effective management of inflammatory bowel disease (IBD) relies on a comprehensive understanding of infliximab (IFX) pharmacokinetics (PK). This study's primary goal was to develop a robust PK model, identifying key covariates influencing IFX clearance (CL), while concurrently evaluating the risk of disease progression during the maintenance phase of IBD treatment. Methods The multicenter, prospective, real-world DIRECT study was conducted in several care centers, which included 369 IBD patients in the maintenance phase of IFX therapy. A two-compartment population PK model was used to determine IFX CL and covariates. Logistic and Cox regressions were applied to elucidate the associations between disease progression and covariates embedded in the PK model. Results The PK model included the contributions of weight, albumin, antidrug antibody (ADA), and fecal calprotectin (FC). On average, higher ADA, FC concentration and weight, and lower albumin concentration resulted in higher IFX CL. In the multivariate regression analyses, FC levels influenced the odds of disease progression in the majority of its definitions, when adjusted for several confounding factors. Additionally, alongside FC, both IFX and CL demonstrated a significant impact on the temporal aspect of disease progression. Conclusion In this 2-year real-world study, readily available clinical covariates, notably FC, significantly impacted IFX availability in IBD patients. We demonstrated that subclinical active inflammation, as mirrored by FC or CRP, substantially influenced IFX clearance. Importantly, FC emerged as a pivotal determinant, not only of IFX pharmacokinetics but also of disease progression. These findings underscore the need to integrate FC into forthcoming IFX pharmacokinetic models, amplifying its clinical significance. [ABSTRACT FROM AUTHOR]

Introduction: Introduction: persistent dysphagia affects 15 % of stroke patients and contributes to malnutrition, aspiration, and death. This study aimed to characterize patients with post-stroke dysphagia who underwent percutaneous endoscopic gastrostomy (PEG), and to assess the impact of PEG feeding on nutritional status and outcome. Methods: an observational and retrospective study using records from patients with post-stroke dysphagia who underwent PEG. Body mass index (BMI), serum albumin, transferrin, and cholesterol were recorded at the time of PEG insertion (T0) and 3 months later (T3). The evolution of these parameters was analyzed and compared to survival. Results: we obtained data from 158 patients (53.2 % males) with a median age of 75 years. Most strokes were ischemic (n = 135, 85.4 %). Median time between stroke and PEG was 2 months. Median survival after gastrostomy was 16 months. At admission, 41.6 % of patients had low BMI, 62.3 % low albumin, 68.6 % low transferrin, and 59.6 % low cholesterol levels. The prevalence of low albumin and low transferrin was higher in the patients who underwent PEG more than 2 months after stroke. A significant increase in albumin and transferrin, and a normalization of cholesterol levels was observed after 3 months of PEG feeding. Mortality was 12.9 %, 27.7 %, and 40 % at 1, 3, and 12 months, respectively. Survival was lower in patients with low albumin, transferrin or total cholesterol at admission. Conclusions: the prevalence of malnutrition is high among patients with post-stroke dysphagia. PEG feeding improves albumin, transferrin, and cholesterol levels. Early post-PEG mortality is high and must be considered on an individual basis. [ABSTRACT FROM AUTHOR]

Competing Interests: The authors have no conflicts of interest to declare.

Introduction: Introduction: persistent dysphagia affects 15 % of stroke patients and contributes to malnutrition, aspiration, and death. This study aimed to characterize patients with post-stroke dysphagia who underwent percutaneous endoscopic gastrostomy (PEG), and to assess the impact of PEG feeding on nutritional status and outcome. Methods: an observational and retrospective study using records from patients with post-stroke dysphagia who underwent PEG. Body mass index (BMI), serum albumin, transferrin, and cholesterol were recorded at the time of PEG insertion (T0) and 3 months later (T3). The evolution of these parameters was analyzed and compared to survival. Results: we obtained data from 158 patients (53.2 % males) with a median age of 75 years. Most strokes were ischemic (n = 135, 85.4 %). Median time between stroke and PEG was 2 months. Median survival after gastrostomy was 16 months. At admission, 41.6 % of patients had low BMI, 62.3 % low albumin, 68.6 % low transferrin, and 59.6 % low cholesterol levels. The prevalence of low albumin and low transferrin was higher in the patients who underwent PEG more than 2 months after stroke. A significant increase in albumin and transferrin, and a normalization of cholesterol levels was observed after 3 months of PEG feeding. Mortality was 12.9 %, 27.7 %, and 40 % at 1, 3, and 12 months, respectively. Survival was lower in patients with low albumin, transferrin or total cholesterol at admission. Conclusions: the prevalence of malnutrition is high among patients with post-stroke dysphagia. PEG feeding improves albumin, transferrin, and cholesterol levels. Early post-PEG mortality is high and must be considered on an individual basis.

Competing Interests: The authors have no conflicts of interest to declare. Moreover, they are aware that the manuscript's copyright belongs to GE − Portuguese Journal of Gastroenterology.