BACKGROUND AND AIMS:Evidence regarding the influence of vedolizumab (VDZ) on extraintestinal manifestations (EIMs) of inflammatory bowel disease (IBD) is limited. Our aim was to analyze the effectiveness of VDZ in preexisting EIMs and the occurrence of de novo EIMs during VDZ therapy for IBD. METHODS:This observational, multicenter, retrospective cohort study included patients from the Spanish ENEIDA registry. All EIMs were assessed at baseline, and clinical response and worsening of IBD and EIMs were evaluated at 3 and 12 months after VDZ initiation, according to the physician's assessment. RESULTS:We retrospectively identified 551 patients with IBD treated with VDZ. At baseline, 133 patients (24.1%) had preexisting EIMs, with 77 having active EIMs. At 3 months, 29.9% of these patients showed clinical improvement, 16.9% experienced worsening, and 53.2% remained unchanged. Clinical response of IBD at 3 months was the only factor associated with EIM improvement (OR 3.72; 95% CI 1.08-12.83). Among 56 patients with inactive EIMs at baseline, 13.5% experienced worsening after 12 months. During follow-up, 25 patients (4.5%) developed 27 de novo EIMs. The presence of 2 preexisting EIMs was the only factor associated with de novo EIM onset (OR 16.2; 95% CI 4.3-60.9). Worsening of preexisting EIMs or de novo EIMs led to VDZ discontinuation in 15 patients (5.8% of all patients who discontinued VDZ and 2.7% of the entire cohort). CONCLUSIONS:VDZ achieved clinical response of active EIMs in nearly one-third of patients after 3 months. Although infrequent, VDZ may exacerbate inactive EIMs and induce de novo EIMs during therapy, potentially leading to treatment discontinuation.
Introduction:Tezepelumab is an anti-thymic stromal lymphopoietin monoclonal antibody approved for the treatment of severe uncontrolled asthma regardless of inflammatory phenotype. Although its efficacy has been demonstrated in clinical trials, there is a growing need to evaluate its effectiveness in real-world clinical practice in Spain. The aim of this study was to evaluate the clinical impact of tezepelumab in patients with severe asthma treated in 5 hospitals in Castilla-La Mancha, Spain. Material and methods:This was a retrospective multicenter observational study. Adult patients with severe asthma treated with tezepelumab were included between January 2023 and April 2025. Clinical, functional, and laboratory parameters were evaluated between the 6-month baseline period (before treatment initiation) and the follow-up visit. Exacerbations, asthma control test (ACT), lung function (forced expiratory volume in 1 second [FEV1]), use of oral corticosteroids, and eosinophil count were analyzed. Results:A total of 48 patients were included (mean age 52.8 years; 70.8% women). The mean number of exacerbations decreased significantly from 2.06 to 0.22 per patient (p < 0.001), ACT scores increased from 12.8 to 19.2 points (p < 0.001), FEV1 improved by 170 mL (p = 0.01), and chronic use of oral corticosteroids fell from 14.5% to 4.2%. No significant differences were observed in inflammatory phenotype or prior history of biological treatment, except for a greater reduction in oral corticosteroid cycles in biologic-naïve patients. Clinical remission was achieved in 25% of patients. Conclusions:Tezepelumab was shown to be effective in real-world clinical practice, achieving a significant improvement in severe asthma control and lung function, while reducing exacerbations and oral corticosteroid use.
Background and Objectives: Psychological resilience is central to emotional adaptation in patients undergoing maintenance hemodialysis (HD). Although psychosocial determinants have been widely studied, the role of routinely monitored biochemical markers remains insufficiently defined. Materials and Methods: This study examined the associations between selected metabolic–inflammatory biomarkers and psychological resilience in adults receiving maintenance HD and explored potential gender-related differences. Resilience was assessed using the Resilience Scale–14 (RS-14). β2-microglobulin, serum albumin, calcium, and 25-hydroxyvitamin D were analyzed as continuous predictors. Multiple linear regression models with heteroscedasticity-consistent robust standard errors (HC3) were adjusted for age, HD vintage, diabetes, and cardiovascular disease. Two interaction terms (Gender × β2-microglobulin and Gender × albumin) were specified a priori. Model stability was evaluated using nonparametric bootstrap resampling (5000 iterations) and penalized regression with cross-validation. Results: In bivariate analyses, higher β2-microglobulin levels were associated with lower resilience (ρ = −0.24; p = 0.041), whereas serum albumin showed a positive but non-significant association (p = 0.14). These relationships did not remain statistically significant in fully adjusted models (β2-microglobulin: p = 0.107). No Gender × Biomarker interaction reached statistical significance (p = 0.162). Stratified analyses showed consistent directional patterns across gender groups. Conclusions: Metabolic–inflammatory biomarkers, particularly β2-microglobulin and serum albumin, may be associated with psychological resilience in HD. However, gender-specific effects were not supported in adjusted analyses. These findings require validation in larger, longitudinal, multicenter studies.
