Vedolizumab in Mild-to-Moderate Crohn's Disease Patients Naïve to Biological Therapy: A Multicentric Observational Study.

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.

Effectiveness and Safety of Tofacitinib in the Management of Ulcerative Colitis: A Brazilian Observational Multicentric Study.

Background: Ulcerative colitis (UC) is a chronic inflammatory bowel disease which affects the colorectal mucosa with a relapsing-remitting pattern. The therapeutic options currently available for the medical management of UC include many options. Tofacitinib is an oral small molecule, Janus kinase (JAK) inhibitor, more selective for JAK1 and JAK3, which reduces the inflammatory process involved in the pathogenesis of UC. Methods: Retrospective observational multicentric study of patients with UC who used tofacitinib in any phase of their treatment. Clinical remission and response (according to Mayo score), mucosal healing, primary and secondary loss of response, discontinuation of the drug with possible causes, and the need for dose optimization or switching to biologicals, need for surgery and adverse events were evaluated. Results: From a total of 56 included patients, clinical remission was observed in 43.6% at week 12, 54.5% at week 26, 57.9% at week 52, and 40% at the last follow-up visit. Clinical response was observed in 71.4%, 81.8%, 89.5%, and 61.8% at the same time periods, respectively. Mucosal healing rates were 50% and 17.8% needed colectomy. Conclusions: Tofacitinib was effective in induction and maintenance of clinical response and remission rates, compatible to other international real-word studies and meta-analyses.

Intra-Esophageal pH Monitoring on Two Consecutive Days in Patients With Gastroesophageal Reflux Symptoms.

BACKGROUND: The best method to measure the frequency and duration of gastroesophageal reflux is 24-h pH or 24-h pH/impedance monitoring. However, the detection of reflux can vary when measured on different days. Our aim was to evaluate the possibility that the severity of gastroesophageal reflux is different even under similar conditions on two consecutive days. METHODS: We performed a 48-h pH monitoring in 12 subjects, aged 25 - 63 years, who complaint of heartburn and regurgitation, ten with esophagitis and two with non-erosive disease. The pH measurement was conducted at 5 cm from the lower esophageal sphincter. The patients stayed at the Clinical Investigation Ward of the hospital for 48 h. On each day, they consumed a 2,000 calorie diet. The results obtained on the first day were compared with those on the second day. RESULTS: Mean reflux index in the upright position was different between the two days. Results of the pH-monitoring within the 2 h after the meal revealed differences in the number of acidic reflux and reflux index episodes. Three patients had abnormal DeMeester score on one day and normal score on the other day. Considering the upper limit of 6.0% of the test duration with esophageal pH < 4 as indicative of gastroesophageal reflux disease, two patients showed abnormal results on one day and normal results on the other day. CONCLUSIONS: The 24-h pH monitoring, performed on two consecutive days under similar conditions, can lead to different diagnosis of gastroesophageal reflux disease in symptomatic patients.

The performance of a rapid response team in the management of code yellow events at a university hospital.

OBJECTIVE: To describe the epidemiological data of the clinical instability events in patients attended to by the rapid response team and to identify prognostic factors. METHODS: This was a longitudinal study, performed from January to July 2010, with an adult inpatient population in a hospital environment. The data collected regarding the code yellow service included the criteria of the clinical instability, the drug and non-drug therapies administered and the activities and procedures performed. The outcomes evaluated were the need for intensive care unit admission and the hospital mortality rates. A level of p=0.05 was considered to be significant. RESULTS: A total of 150 code yellow events that occurred in 104 patients were evaluated. The most common causes were related to acute respiratory insufficiency with hypoxia or a change in the respiratory rate and a concern of the team about the patient's clinical condition. It was necessary to request a transfer to the intensive care unit in 80 of the 150 cases (53.3%). It was necessary to perform 42 procedures. The most frequent procedures were orotracheal intubation and the insertion of a central venous catheter. The patients who were in critical condition and had to wait for an intensive care unit bed had a higher risk of death compared to the other patients (hazard ratio: 3.12; 95% CI: 1.80-5.40; p<0.001). CONCLUSIONS: There are patients in critical condition that require expert intensive care in the regular ward unit hospital beds. The events that most frequently led to the code yellow activation were related to hemodynamic and respiratory support. The interventions performed indicate the need for a physician on the team. The situation of pent-up demand is associated with a higher mortality rate.

Atuação do time de resposta rápida em hospital universitário no atendimento de código amarelo / The performance of a rapid response team in the management of code yellow events at a university hospital

OBJETIVO: Descrever dados epidemiológicos de eventos de instabilidade clínica em pacientes atendidos pelo time de resposta rápida e identificar fatores prognósticos. MÉTODOS: Estudo longitudinal, realizado de janeiro a junho de 2010, com população adulta internada em ambiente hospitalar. Os dados coletados sobre o atendimento do código amarelo foram critérios de instabilidade clínica, terapia medicamentosa e não medicamentosa, orientações e procedimentos. Os desfechos avaliados foram necessidade de admissão em unidade de terapia intensiva e mortalidade hospitalar. O nível de significância utilizado foi de p=0,05. RESULTADOS: Foram avaliados 150 códigos amarelos que ocorreram com 104 pacientes. Os motivos mais frequentes estiveram relacionados à insuficiência respiratória aguda, apresentando hipóxia ou alteração da frequência respiratória, e preocupação da equipe com o estado clínico do paciente. Houve necessidade de solicitação de transferência para unidade de terapia intensiva em 80/150 (53,3%) ocasiões. Foi necessária a realização de 42 procedimentos, sendo os mais frequentes a intubação orotraqueal e a inserção de cateter venoso central. Os pacientes graves que aguardavam leito de unidade de terapia intensiva apresentaram maior chance de morte, comparados aos demais pacientes (hazard ratio: 3,12; IC95%: 1,80-5,40; p<0,001). CONCLUSÃO: Existem pacientes graves que necessitam de tratamento intensivo especializado nos leitos comuns de enfermarias dos hospitais. Os eventos que mais levaram ao acionamento do código amarelo estiveram relacionados a suporte respiratório e hemodinâmico. As intervenções realizadas caracterizam a necessidade do médico na equipe. A situação de demanda reprimida está associada à maior mortalidade.

OBJECTIVE: To describe the epidemiological data of the clinical instability events in patients attended to by the rapid response team and to identify prognostic factors. METHODS: This was a longitudinal study, performed from January to July 2010, with an adult inpatient population in a hospital environment. The data collected regarding the code yellow service included the criteria of the clinical instability, the drug and non-drug therapies administered and the activities and procedures performed. The outcomes evaluated were the need for intensive care unit admission and the hospital mortality rates. A level of p=0.05 was considered to be significant. RESULTS: A total of 150 code yellow events that occurred in 104 patients were evaluated. The most common causes were related to acute respiratory insufficiency with hypoxia or a change in the respiratory rate and a concern of the team about the patient's clinical condition. It was necessary to request a transfer to the intensive care unit in 80 of the 150 cases (53.3%). It was necessary to perform 42 procedures. The most frequent procedures were orotracheal intubation and the insertion of a central venous catheter. The patients who were in critical condition and had to wait for an intensive care unit bed had a higher risk of death compared to the other patients (hazard ratio: 3.12; 95% CI: 1.80-5.40; p<0.001). CONCLUSIONS: There are patients in critical condition that require expert intensive care in the regular ward unit hospital beds. The events that most frequently led to the code yellow activation were related to hemodynamic and respiratory support. The interventions performed indicate the need for a physician on the team. The situation of pent-up demand is associated with a higher mortality rate.