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6 result(s) for "Faria, Mikaell Alexandre Gouvea"
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Banded RYGB Ring Slippage Endoscopic Removal with Self-expandable Stents: a Comparative Study Between Metallic and Plastic One
Purpose Banded Roux-en-Y gastric bypass (RYGB) was a common bariatric procedure in the 2000s, and the ring slippage is one of its late adverse events. Both plastic and metallic stents have been reported as adjunct methods to induce erosion and facilitate endoscopic removal of the ring. Objective To compare the safety and effectiveness of self-expanding metallic stents (SEMS) and plastic stents (SEPS) to treat ring slippage. Materials and Methods We conducted a retrospective longitudinal study analyzing consecutive patients with ring dysfunction treated with stents plus endoscopic removal. Results Ninety patients were enrolled (36 SEMS vs. 54 SEPS). The mean age was 48.56 ± 13.07 and 45.6 ± 12.1 in the SEMS and SEPS groups, respectively. All patients had band slippage, but 24 from SEMS group and 23 from SEPS group had further complications. There were more complications in metallic stent concerning mean absolute number of therapy-related adverse events (1.33 ± 0.48 vs. 1.72 ± 0.5, p  > 0.05) and time until erosion (14.9 ± 1.6 vs. 13.8 ± 1.4 days, p  > 0.05). Female sex and age > 41 years old correlated with longer time to band erosion and higher incidence of adverse events in SEMS patients. In SEPS group, only female sex was a risk factor for adverse events. Conclusion Both procedures were efficient at inducing band erosion with similar safety profiles. Older and female patients are at a higher risk of treatment-related adverse events, especially those receiving SEMS. Graphical abstract
Real-World Effectiveness and Safety of Golimumab in Patients with Ulcerative Colitis: A Retrospective Cohort Study
Background/Objectives: Golimumab has proven efficacy in inducing and maintaining remission in moderate-to-severe ulcerative colitis (UC). This study evaluated the short-term and long-term effectiveness and safety of golimumab for the treatment of patients with active UC in Brazil. Methods: This observational, multicenter, retrospective, cohort study included patients with moderate-to-severe UC treated with golimumab. The primary outcome was corticosteroids-free clinical remission at weeks 24 and 54, defined as a partial Mayo score (PMS) of 0 or 1, without the need for corticosteroids (CS,) in continued treatment with golimumab. Secondary outcomes were clinical response, defined as a reduction in PMS of 50% or 3 points, and endoscopic remission, defined as a Mayo endoscopic subscore of 0. We also evaluated persistence with golimumab during follow-up. Results: Seventy-three patients were enrolled in the study. The rates of CS-free remission at weeks 24 and 54 were 43.8% and 63%, respectively. Clinical response was achieved in 50.7% and 71.2% of patients at weeks 24 and 48, respectively. Among patients undergoing endoscopic evaluation, CS-free endoscopic remission was observed in 80.8% of patients at week 24 and in 84.4% at week 54. The cumulative probability of retaining golimumab was 86.1% (95% CI 78–94) at 54 weeks. Adverse events leading to golimumab discontinuation occurred in three patients (4.1%). Conclusions: Golimumab was effective and safe as induction and maintenance therapy in patients with moderate-to-severe ulcerative colitis, leading to a high rate of persistence with golimumab maintenance after 1 year of follow-up.
Vedolizumab in Mild-to-Moderate Crohn’s Disease Patients Naïve to Biological Therapy: A Multicentric Observational Study
Abstract Background In real-world experience, the number of patients using vedolizumab as first-line biological therapy was low. We aimed to evaluate the effectiveness and safety of vedolizumab in mild-to-moderate Crohn’s disease (CD) biologic-naïve patients. Methods We performed a retrospective multicentric cohort study with patients who had clinical activity scores (Harvey–Bradshaw Index [HBI]) measured at baseline and weeks 12, 26, 52, as well as at the last follow-up. Clinical response was defined as a reduction ≥3 in HBI, whereas clinical remission as HBI ≤4. Mucosal healing was defined as the complete absence of ulcers in control colonoscopies. Kaplan–Meier survival analysis was used to assess the persistence with vedolizumab. Results From a total of 66 patients, 53% (35/66) reached clinical remission at week 12. This percentage increased to 69.7% (46/66) at week 26, and 78.8% (52/66) at week 52. Mucosal healing was achieved in 62.3% (33/53) of patients. Vedolizumab was well tolerated, and most adverse events were minor. During vedolizumab treatment, 3/66 patients underwent surgery. Conclusions This study demonstrates the effectiveness and safety of vedolizumab as a first-line biological agent in patients with mild-to-moderate CD. Lay Summary This study confirmed the effectiveness and safety of vedolizumab as a first-line biologic in patients with mild-to-moderate Crohn’s disease who are unresponsive to conventional therapy and biologic naïve. Graphical Abstract Graphical Abstract
Low toxicity and favorable clinical and quality of life impact after non-myeloablative autologous hematopoietic stem cell transplant in Crohn’s disease
Objective The incidence of adverse events in myeloablative transplant protocols is high in refractory Crohn’s disease; this study used low doses of cyclophosphamide. Fourteen patients were submitted to non-myeloablative autologous hematopoietic stem cell transplantation. Results The average number of days of anemia (hemoglobin < 10 g/dL) was 5.4 ± 4.2 and 14 ± 2.4 in the mobilization and conditioning phases, respectively. The mean number of days of neutropenia (neutrophils < 0.5 × 10 9 /L) in the mobilization phase was 1.7 ± 1.5 while it was 7.6 ± 1.4 in the conditioning phase. When comparing the conditioning and mobilization phases, there was an increased number days of leukopenia (white blood cells < 1.0 × 10 9 /L), lymphocytopenia (lymphocytes < 0.5 × 10 9 /L) and thrombocytopenia (platelets < 25 × 10 9 /L). Crohn’s Disease Activity Index values before the transplant ranged from 155 to 450.5 (mean 281.2 ± 79.0) and at 30 days after the procedures they ranged from 45.4 to 177 (mean 95.8 ± 35.4). Moreover, the procedure improved in overall quality of life of patients. Non-myeloablative autologous hematopoietic stem cell transplantation with lower doses of cyclophosphamide leads to lower rates of hematological toxicity and adverse events compared to protocols described in the literature. Trial registration NCT 03000296: Date 9 December 2016
Clinical factors associated with severity in patients with inflammatory bowel disease in Brazil based on 2-year national registry data from GEDIIB
The Brazilian Organization for Crohn's Disease and Colitis (GEDIIB) established a national registry of inflammatory bowel disease (IBD). The aim of the study was to identify clinical factors associated with disease severity in IBD patients in Brazil. A population-based risk model aimed at stratifying the severity of IBD based on previous hospitalization, use of biologics, and need for surgery for ulcerative colitis (UC) and Crohn’s Disease (CD) and on previous complications for CD. A total of 1179 patients (34.4 ± 14.7y; females 59%) were included: 46.6% with UC, 44.2% with CD, and 0.9% with unclassified IBD (IBD-U). The time from the beginning of the symptoms to diagnosis was 3.85y. In CD, 41.2% of patients presented with ileocolic disease, 32% inflammatory behavior, and 15.5% perianal disease. In UC, 46.3% presented with extensive colitis. Regarding treatment, 68.1%, 67%, and 47.6% received biological therapy, salicylates and immunosuppressors, respectively. Severe disease was associated with the presence of extensive colitis, EIM, male, comorbidities, and familial history of colorectal cancer in patients with UC. The presence of Montreal B2 and B3 behaviors, colonic location, and EIM were associated with CD severity. In conclusion, disease severity was associated with younger age, greater disease extent, and the presence of rheumatic EIM.
Crohn's disease patients effectively mobilize peripheral blood stem cells to perform autologous haematopoietic stem cell transplantation
Background: Treatment with high doses chemotherapy followed by autologous haematopoietic stem cell transplantation is promising for refractory Crohn's disease patients with no therapeutic option and at imminent risk of further surgeries. Objectives: To evaluate the feasibility and efficacy of haematopoietic progenitor cell mobilization in a group of Crohn's disease patients preparing for autologous unselected haematopoietic stem cell transplantation in a single institution. This is the first study to evaluate mobilization for Crohn's disease. Methods: Patients were selected according to criteria of the European Bone Marrow Transplant Society. Results: All patients mobilized with the mean number of haematopoietic progenitor cells obtained and infused being 16.17 x 106/CD34+/kg. Most patients required only one leukapheresis session to reach the ideal number of cells. Grafting occurred around ten days after cells infusion. Complications and adverse events during the mobilization period were rare with only one patient presenting sepsis as a relevant event in the period. Most patients 20 (70%) had anaemia from the beginning of the mobilization but only 11 (37.9%) received packed red blood cell transfusions. Conclusion: Mobilization in patients with Crohn's disease is effective and it seems they are good mobilizers. Clinical Trial Registration ID #NCT03000296.