Browsing by Author "Portela, F."
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- Clinical profile and treatment outcomes in patients receiving advanced therapies for ulcerative colitis – the READ-UC real-world studyPublication . Fernandes, S. R.; Sousa, H. Tavares de; Portela, F.; Ministro, P.; Lago, P.; Branquinho, D.; Freitas, I.; Machado, N. Martins; Magro, F.Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) that requires effective treatment with the main goal of inducing and maintaining remission. This study aimed to characterize UC patients receiving advanced therapies (AT), by describing their demographic and clinical characteristics and remission outcomes.
- Low Golimumab trough levels at week 6 are associated with poor clinical, endoscopic and histological outcomes in ulcerative colitis patients: pharmacokinetic and pharmacodynamic sub-analysis of the evolution studyPublication . Magro, F.; Lopes, S.; Silva, M.; Coelho, R.; Portela, F.; Branquinho, D.; Correia, L.; Fernandes, S.; Cravo, M.; Caldeira, Paulo; Sousa, Helena Tavares; Patita, M.; Lago, P.; Ramos, J.; Afonso, J.; Redondo, I.; Machado, P.; Cornillie, F.; Lopes, J.; Carneiro, F.Background and Aims: Golimumab has an established exposure-response relationship in patients with ulcerative colitis [UC]. However, the association of serum golimumab trough levels [TL] with objective markers of disease activity, such as endoscopic and histological activity scores and concentrations of biomarkers, remains less understood. This report describes the relationship of serum golimumab TL at the end of the induction period [Week 6] with clinical, endoscopic, histological, and biomarker parameters. Methods: This was an open-label, uncontrolled, prospective and interventional study. Moderate to severely active UC patients naive to biologic therapy were treated with golimumab. Serum golimumab TL and faecal calprotectin levels were measured at baseline [Week 0 of induction] and Week 6. Results: A total of 34 patients completed the induction phase [Week 6] and were included in this analysis. Overall, 47.1% and 14.7% of patients achieved clinical response and remission with significantly higher serum golimumab TL in patients with early response or remission [3.7 mu g/mL vs 1.3 mu g/mL, p = 0.0013; and 3.1 mu g/mL vs 1.7 mu g/mL, p = 0.0164, respectively]. In addition, golimumab TL were significantly higher in patients achieving histological remission [4.2 mu g/mL vs 1.7 mu g/mL, p = 0.0049]. Week 6 golimumab TL were inversely correlated with the total Mayo score [rs = -0.546; p = 0.0008], the Mayo endoscopic subscore [rs = -0.381; p = 0.0262], the Geboes histological activity score [rs = -0.464; p = 0.0057], and faecal calprotectin levels [rs = -0.497; p = 0.0044]. Conclusions: A higher early exposure to golimumab is associated with a better objective response in active UC patients and appears to drive the outcome at Week 6.
- Serum neutrophil biomarkers to predict crohn's disease progression and infliximab treatment outcomesPublication . Magalhaes, D.; Santiago, M.; Patita, M.; Arroja, B.; Lago, P.; Rosa, I.; Sousa, Helena Tavares; Ministro, P.; Mocanu, I.; Vieira, A.; Castela, J.; Moleiro, J.; Roseira, J.; Eugenia, C.; Sousa, P.; Portela, F.; Correia, L.; Dias, S.; Afonso, J.; Danese, S.; Peyrin‐Biroulet, L.; Dias, C. C.; Magro, F.Background and aims: Predicting the treatment outcomes of biological therapies is an unmet need in Crohn's Disease. In this study, we explored the potential of serum neutrophil-related biomarkers to predict infliximab therapeutic results and disease progression in Crohn's Disease patients, over a 2-year period, in a real-world setting. Methods: The study included 100 asymptomatic Crohn's Disease patients in the IFX maintenance phase from the prospective, observational, multicenter DIRECT study. Patients were categorized according to a composite outcome reflecting progression that included surgery, hospitalizations, new fistulae, abscess or stricture, and drug treatment escalation. Serum neutrophil elastase, lipocalin-2, lactoferrin, and resistin (non-neutrophil control) were analyzed via multiplex magnetic bead assays at multiple touchpoints. Fecal calprotectin was assessed by ELISA. Results: Over up to 2 years of follow-up, serum biomarkers did not differentiate between the composite outcome groups, whereas fecal calprotectin was significantly higher in patients with worse outcomes. During the infliximab maintenance phase, there was a significant, sustained reduction of neutrophil elastase (p < 0.001), lipocalin-2 (p < 0.001), and lactoferrin (p < 0.001), but not of resistin, despite stable neutrophil levels. Correlations between NE and NGAL levels were strong (Pearson correlations 0.75-0.85); all other correlations were of small magnitude. Conclusion: Our real-world data do not support using serum neutrophil elastase, lipocalin-2, or lactoferrin concentrations as predictors of treatment outcomes or disease evolution in infliximab -treated Crohn's Disease patients. On the other hand, the sustained decrease in biomarkers over time suggests that neutrophil stabilization might be an additional infliximab mechanism of action.