Maria Cristina Sartor

ADALIMUMAB FOR MAINTENANCE THERAPY FOR ONE YEAR IN CROHN’S DISEASE: results of a Latin American single-center observational study

CONTEXT Adalimumab is a fully-human antibody that inhibits TNF alpha, with a significant efficacy for long-term maintenance of remission. Studies with this agent in Latin American Crohns disease patients are scarce. OBJECTIVES The objective of this study was to outline clinical remission rates after 12 months of adalimumab therapy for Crohns disease patients. METHODS Retrospective, single-center, observational study of a Brazilian case series of Crohns disease patients under adalimumab therapy. Variables analyzed: demographic data, Montreal classification, concomitant medication, remission rates after 1, 4, 6 and 12 months. Remission was defined as Harvey-Bradshaw Index ≤ 4, and non-responder-imputation and last-observation-carried-forward analysis were used. The influence of infliximab on remission rates was analyzed by Fischer and Chi-square tests (P<0.05). RESULTS Fifty patients, with median age of 35 years at therapy initiation, were included. Remission rates after 12 months of therapy were 54% under non-responder-imputation and 88% under last-observation-carried-forward analysis. After 12 months, remission on patients with previous infliximab occurred in 69.23% as compared to 94.59% in infliximab-naïve patients (P = 0.033). CONCLUSIONS Adalimumab was effective in maintaining clinical remission after 12 months of therapy, with an adequate safety profile, and was also more effective in infliximab naïve patients.

Analgesia pós-operatória por não especialistas em dor

BACKGROUND AND OBJECTIVES: Postoperative analgesia is often administered by the assistant physician non-specialist in pain management. This study aimed at evaluating the efficacy of immediate postoperative period analgesia with drugs prescribed by the assistant physician, non-specialist in pain. METHODS: This is a prospective, descriptive and observational study carried out by means of interviews with 186 patients operated in Hospital Santa Cruz. Postoperative pain was evaluated after 12 and 24 hours, in addition to drugs used and possible adverse effects. RESULTS: In the first evaluation, 12 hours after surgery, prevalence of pain was 59%, being 35% from moderate to severe. In the second evaluation, 24 hours after surgery, prevalence of pain was 22% being 12% from moderate to severe. Variables “type of surgery” and “drugs used” have not influenced pain intensity in the postoperative period of 12 hours. However, “type of surgery” has influenced pain intensity (p=0.02) in the postoperative period of 24 hours, being that patients submitted to orthopedic procedures were more likely to report pain (49.57%) as compared to other types of surgery. Opioids had significant association with the presence of adverse effects in the first evaluation (p=0.0001). CONCLUSION: Our data have shown that analgesia with drugs prescribed by physicians non-specialists in pain management was effective when compared to other studies not using specialized pain services. However, a multimodal approach to acute pain management, coordinated by a specialized service, could further decrease this prevalence.

Análise da prevalência de entidades coloproctológicas nos pacientes idosos do serviço de coloproctologia de um hospital universitário

INTRODUCTION: It is expected that in 2020, elderly people will reach 13% of the Brazilian population. This involves epidemiologic and medical concerns. There is few data in the literature regarding colorectal and anal diseases in this population. OBJECTIVE: to compare data about colorectal and anal conditions in elderly people (older than 60 years) with younger patients, including associated diseases, surgical procedures and complications. METHOD: The charts of the patients of the outpatient colorectal unit were retrospectively reviewed. They were divided in two groups: older than 60 years (group I) and younger than 60 years (controls, group II). RESULTS: 1126 patients were included in this study. 19,36% were older than 60 years. The average number of complaints in the group I was 1,21. Abdominal pain, constipation, diarrhea and positive fecal occult blood test were more frequent in the elderly. Anorectal complaints were more prevalent in the control group. The more prevalent conditions in group I, with statistical significance, were: diverticular disease, colorectal polyps and colorectal cancer. In group I, 58,36% had associated diseases. There was no statistical significance between the groups regarding surgical procedures and complications. CONCLUSIONS: Colonic diseases were more prevalent in the elderly group. They had more associated diseases compared with younger patients. There was no statistical difference between the groups regarding surgical treatment and complications.

Comparação entre as soluções orais de manitol a 10% e bifosfato de sódio no preparo mecânico do cólon

BACKGROUND: To compare the use of sodium biphosphate and 10% mannitol solutions for mechanical bowel preparation in terms of cleansing quality, tolerability, disorder in water and electrolyte balance, and plasma osmolality. METHOD: Sixty patients who had been referred for colonoscopy were analyzed in a randomized, double-blind, prospective study. The quality of bowel cleansing was analyzed by the examiner using Becks classification. Ingestion tolerability was established by investigating taste, whether the patient felt any discomfort or not, the development of adverse effects and the amount of solution ingested. The following measurements were made before and after ingestion of the oral bowel preparation solution: sodium, potassium, calcium, magnesium, phosphorus, urea, creatinine, glucose, hematocrit, hemoglobin and plasma osmolality. RESULTS: Both solutions resulted in bowel preparations that were classified as good or superior in over 80% of the patients. The use of sodium biphosphate resulted in less discomfort and better tolerance, although it was not superior to mannitol in terms of taste or the presence of adverse effects. Sodium biphosphate led to an increase, and mannitol to a decrease, in osmolality, reflecting the changes in plasma sodium in both groups. The former also resulted in a significant measurement change in serum phosphorus, calcium, magnesium and potassium levels, without any clinical repercussions. CONCLUSION: Both types of bowel preparation resulted in adequate cleansing. Sodium biphosphate, although better tolerated, leads to more alterations in water and electrolyte balance.

P-124 Adalimumab for Maintenance Therapy for One Year in Crohnʼs Disease: Results of a Latin American Single-center Observational Study

BACKGROUND: Adalimumab (ADA) is a fully-human antibody that inhibits TNF alpha, with a significant efficacy and defined safety profile for long-term maintenance of remission. Studies with this agent in Latin American Crohn’s disease (CD) patients are scarce. The primary objective of this study was to outline clinical remission rates after 12 months of ADA therapy for CD patients. Secondary objectives were to analyze demographic data, remission rates after 1, 4 and 6 months of therapy, adverse events (AE) and the influence of previous Infliximab (IFX) on remission rates. METHODS: Retrospective, single-center, observational study of a Brazilian case series of CD patients under ADA therapy. Inclusion criteria: CD patients, that had ADA therapy at any moment of their treatment. Exclusion criteria: patients with ulcerative colitis or indeterminate inflammation, with stomas and CD patients with less than 2 months of ADA therapy. Variables analyzed: demographic data, Montreal classification, concomitant medication, remission rates after 1, 4, 6 and 12 months, presence of AE and previous IFX. Remission was defined as Harvey-Bradshaw Index (HBI) ⩽ 4, and non-responder-imputation (NRI) and last-observation-carried-forward (LOCF) analysis were used. Data were described with frequency tables and 95% confidence intervals (CI). The influence of IFX on remission rates was analyzed by Fischer and Chi-square tests, as well as with the inverted Kaplan-Meier method (P < 0.05). RESULTS: Fifty patients, with median age of 35 years at therapy initiation, were included. Mean CD duration was 73.6 months. Ileocolic CD was observed in 58% of the cases studied; 76% had penetrating disease, and perianal involvement was observed in 78% of patients. In relation to the remission rates, in LOCF analysis, after 12 months from the beginning of ADA therapy, 44 patients (88%) were in clinical remission (CI 95% 0.790–0.970). By taking into account the NRI evaluation, clinical remission rate decreased to 27 patients, corresponding to 54% of the cases (CI 95% 0.402–0.678). These findings are described in Figure 1. AE occurred in 16% of the patients, with only one serious event observed (herpes zoster infection). After 12 months, remission on patients with previous IFX occurred in 69.23% as compared to 94.59% in IFX-naïve patients (P = 0.033), detailed in Figure 2. CONCLUSIONS: ADA therapy resulted in significant rates of CD clinical remission, reaching 54% of the patients after 12 months of therapy according to the NRI analysis and 88% according to the LOCF analysis. AE were observed in only 16% of the patients, and only 1 event was considered to be severe. The main cause for ADA discontinuation was the loss of access to the drug in the public health care system. The remission rates observed in patients with prior IFX therapy were lower than in those without previous exposure before ADA initiation. The importance of the findings in the present study, that must be interpreted with caution, is based on the fact that they constitute the first experience with ADA in the maintenance therapy for CD management in Latin American patients. Figure. No caption available. Figure. No caption available.