Long-term effectiveness and safety of ustekinumab in bio-naïve and bio-experienced anti-tumor necrosis factor patients with Crohn's disease: a real-world multicenter Brazilian study.

BACKGROUND: The effectiveness of ustekinumab (UST) in the treatment of Crohn's disease (CD) has been demonstrated in the pivotal Phase 3 UNITI 1 and 2 and IM-UNITI studies in both anti-TNF-naïve and anti-TNF-exposed patients. Given the selective nature of pivotal trial designs, real-world effectiveness and safety studies are warranted. We report our experience with UST treatment in a large, real-world multicenter cohort of Brazilian patients with CD. METHODS: We performed a retrospective multicenter study including patients with CD, predominantly biologically refractory CD, who received UST. The primary endpoint was the proportion of patients in clinical remission at weeks 8, 24 and 56. Possible predictors of clinical and biological response/remission and safety outcomes were also assessed. RESULTS: Overall, 245 CD (mean age 39.9 [15-87]) patients were enrolled. Most patients (86.5%) had been previously exposed to biologics. According to nonresponder imputation analysis, the proportions of patients in clinical remission at weeks 8, 24 and 56 were 41.0% (n = 98/239), 64.0% (n = 153/239) and 39.3% (n = 94/239), respectively. A biological response was achieved in 55.4% of patients at week 8, and 59.3% were in steroid-free remission at the end of follow-up. No significant differences in either clinical or biological remission were noted between bio-naïve and bio-experienced patients. Forty-eight patients (19.6%) presented 60 adverse events during the follow-up, of which 8 (13.3%) were considered serious adverse events (3.2% of 245 patients). Overall, a proximal disease location, younger age, perianal involvement, and smoking were associated with lower rates of clinical remission over time. CONCLUSIONS: UST therapy was effective and safe in the long term in this large real-life cohort of Brazilian patients with refractory CD, regardless of previous exposure to other biological agents.

Effectiveness and Safety of Ustekinumab for Ulcerative Colitis: A Brazilian Multicentric Observational Study.

Background: Real-world data on the effectiveness and safety of ustekinumab (UST) in ulcerative colitis (UC) are lacking in Latin America. In this study, we aimed to describe the effectiveness and safety of UST in a real-world multicenter cohort of Brazilian patients with UC. Methods: We conducted a multicenter retrospective observational cohort study, including patients with moderate-to-severe UC (total Mayo score 6-12, with an endoscopic subscore of 2 or 3) who received UST. The co-primary endpoints were clinical remission, defined as a total Mayo score ≤2 at 1 year, with a combined rectal bleeding and stool frequency subscore of ≤1, and endoscopic remission (endoscopic Mayo subscore of 0) within 1 year from baseline. Secondary endpoints included clinical response between weeks 12 and 16, endoscopic response within 1 year of starting UST, steroid-free clinical remission at week 52, and biochemical remission at week 52. We also evaluated UST treatment persistence and safety. Results: A total of 50 patients were included (female, n = 36, 72.0%), with a median disease duration of 9.2 years (1-27). Most patients had extensive colitis (n = 38, 76.0%), and 43 (86.0%) were steroid dependent at baseline. Forty patients (80.0%) were previously exposed to biologics (anti-TNF drugs, n = 31; vedolizumab [VDZ], n = 27). The co-primary endpoints of clinical remission at 1 year and endoscopic remission within 1 year were achieved by 50.0% and 36.0% of patients, respectively. Clinical response at weeks 12-16 was 56.0%, and endoscopic response, steroid-free clinical remission, and biochemical remission at week 52 were 68.0%, 46.5%, and 50.0%, respectively. The UST treatment persistence rate at 24 months was 73.7%. During the follow-up, 10 patients (20.0%) were hospitalized, mostly due to disease progression, and 3 patients required colectomy. Nine patients (18.0%) discontinued the drug mainly due to a lack of effectiveness. Twenty-seven adverse events (AEs) were reported, 16 of which were considered as serious AEs. Conclusions: In this real-world cohort of difficult-to-treat UC patients, UST was associated with improvements in clinical, biochemical, and endoscopic outcomes. The safety profile was favorable, consistent with the known profile of UST.

Comfort, safety and quality of upper gastrointestinal endoscopy after 2 hours fasting: a randomized controlled trial.

BACKGROUND: Upper gastrointestinal endoscopy has been performed after fasting 8 or more hours, which can be harmful to the patients. We assessed comfort, safety and quality of endoscopy under moderate sedation after 2 hours fasting for clear liquids. METHODS: In this clinical trial, patients referred for elective endoscopy were randomly assigned to a fasting period of 8 hours (F8) or a shorter fasting (F2), in which 200 ml of clear liquids were ingested 2 hours before the procedure. Endoscopists blinded to patients fasting status carried out the endoscopies. Comfort was rated by the patients, whereas safety and quality were determined by the endoscopists. RESULTS: Ninety-eight patients were studied (aging 48.5 ± 16.5 years, 60% women): 50 patients (51%) in F2 and 48 in F8. Comfort was higher in F2 than F8 in regard to anxiety (8% vs. 25%; P = 0.029), general discomfort (18% vs. 42%; P = 0.010), hunger (44% vs. 67%; P = 0.024), and weakness (22% vs. 42%; P = 0.034). Regurgitation of gastric contents into the esophagus after endoscopic intubation did not differ between F2 and F8 (26% vs. 19%; P = 0.471). There was no case of pulmonary aspiration. Gastric mucosal visibility was normal in most patients either in F2 or F8 (96% vs. 98%; P = 0.999). CONCLUSIONS: Elective upper GI endoscopy after 2 hours fasting for clear liquids was more comfortable and equally safe compared to conventional fasting. This preparation might be cautiously applied for patients in regular clinical conditions referred for elective endoscopy. TRIAL REGISTRATION: SAMMPRIS ClinicalTrial.gov number, NCT01492296.

Evaluation of proactive therapeutic drug monitoring application in infliximab users in ulcerative colitis

Objective: To evaluate the application of proactive pro-drug therapy (TDM) at week six in users of infliximab therapy in ulcerative colitis patients and to analyze the need for further disease optimization. Method: This is a retrospective analysis that will be carried out simultaneously at the Hospital de Clínicas de Passo Fundo and at the Endoclin Diagnostic Center in the city of Passo Fundo, with secondary data collection between January 2020 and May 2022. The sample included patients from both sexes, regardless of age, who are being followed up in the services mentioned above, by signing the informed Free and Clarified Consent Term. Results: 63.2% of patients required optimization of their treatment based on the serum level assessment at week six. Conclusion: Proactive TDM performed at week six benefits patients in order to complete indications for treatment to avoid lack of drug response and complications from the disease. (AU)

Hepatite auto-imune e colangite esclerosante primária: síndrome de superposição / Autoimmune hepatitis and primary sclerosing cholangitis: overlap syndrome

Raramente, pacientes apresentam concomitância de achados clínicos, bioquímicas e histológicos de hepatite auto-imune e de colangite esclerasante primária. Essa situação denomina-se síndrome de superposição, que, com freqüência, representa um desafio diagnóstico. Apresenta-se o caso de um paciente masculino de 17 anos, que consultou por icterícia e sintomas constitucionais. Apresentava elevação das aminotransferases, da gamaglobulina e auto-anticorpos circulantes, preenchendo critérios definitivos para hepatite auto-imune. A biópsia hepática demonstrou achados característicos de hepatite auto-imune, como infiltrado rico em plasmócitos, formação rosetóide de hepatócitos e hepatite de interface intensa, mas, também, alterações típicas de colangite esclerosante primária, como a fibrose concêntrica periductal do tipo "casca de cebola". A colangiopancreatografia retrógrada endoscópica foi altamente sugestiva de colangite esclerosante primária. Estabelecido o diagnóstico de síndrome de superposição, rescreveram-se corticosteróides, azatioprina e ácido ursodeoxicólico. Houve excelente resposta clínica e laboratorial. Conclusão: Esta apresentação visa a alertar o gastroenterologista para tal doença, proporcionando, assim, quando de seu diagnóstico, uma proposta terapêutica mais eficaz.

Videoesplenectomia em Púrpura Trombocitopênica Imunológica / Videolaparoscopi splenectomy in immune thrombocytopenic purpura

A púrpura trombocitopênica imunológica é uma síndorme auto-imune, onde há deposição de anticorpos nas plaquetas, ocorrendo sua destruição precoce no sistema retículo endotelial. Uma das formas terapêuticas é a esplenectomia, que produz boa resposta em significativa parcela dos pacientes refratários a tratamento clínico. Com o desenvolvimento das técnicas laparoscópicas, a videoesplenectomia pode ser realizada com exito. Relatam-se três casos de pacientes portadores desta patologia e submetidos ao tratamento

Salvamento de membros na infecçäo de prótese vascular / Axillo-popliteal bypass: member salvation in prsthetic vascular graft infection

A infecção de próteses vasculares é um dos maiores desafios terapêuticos dentro da cirurgia vascular periférica, causando inúmeras dificuldades técnicas e altos índices de morbi-moralidade. Relata-se caso de paciente portador de enxerto aorto-bifemoral com infecção da prótese e oclusão das artérias femorais bilateralmente, que foi submetido a bypass axilo-poplíteo suprapatelar, com abordagem lateral da artéria poplítea

Ectasia vascular antral gástrica / Gastric antral vascular ectasia

A Ectasia vascular antral gástrica ou Watermelon Stomach (estômago em melancia) é uma causa rara, porém importante, de hemorragia digestiva alta. Por se tratar de uma patologia que apresenta quadro clínico, achados endoscópicos e histopatológicos característicos, relatamos o caso de paciente feminino com perda crônica de sangue pelo trato gastrointestinal devido a presença de ectasia vascular antral gástrica