Epidemiological profile of 175 patients with Crohn's disease submitted to biological therapy

INTRODUCTION: There is currently an increasing use of biological agents in the management of Crohn's disease (CD). There is lack of data regarding the epidemiological profile of patients on infliximab (IFX) and adalimumab (ADA) for CD in Brazil. OBJECTIVE: To identify the epidemiological characteristics of patients with CD who underwent biological therapy. METHOD: Retrospective multicenter study, with CD patients on biological therapy. Analyzed variables: gender, age at treatment initiation, Montreal classification, concomitant perianal disease and smoking status. RESULTS: 175 patients without previous exposure to biological agents were included, 93 (53%) were male. The mean age at treatment initiation was 35.5 (2-79) years old an the mean disease duration was 46.9 (0-480) months. Overall, 117 (66.9%) patients used IFX and 58 (33.1%), ADA. Montreal classification: age at diagnosis ― A1 (n=21; 12%), A2 (n=102; 58.3%), and A3 (n=52; 29.7%). CD location ― L1 (n=42; 24%), L2 (n=51; 29.1%), L3 (n=81; 46.3%), and L4 (n=1, 0.6%). Phenotype ―B1 (n=59; 33.7%), B2 (n=46; 26.3%), and B3 (n=70; 40%). Perianal disease was found in 89 (50.9%) patients. CONCLUSIONS: The epidemiological profile of patients was similar to the literature. There was a high prevalence of patients with fistulizing CD.INTRODUÇÃO: Atualmente há uso crescente dos agentes biológicos no manejo da doença de Crohn (DC). Há escassez de dados referentes ao perfil epidemiológico dos usuários de infliximabe (IFX) e adalimumabe (ADA) para DC no Brasil. OBJETIVO: Identificar as características epidemiológicas dos pacientes com DC submetidos à terapia biológica. MÉTODO: Estudo retrospectivo, multicêntrico, com portadores de DC que utilizaram terapia biológica. Variáveis analisadas: gênero, idade ao início do tratamento, classificação de Montreal, doença perianal concomitante e tabagismo. RESULTADOS: Foram incluídos 175 pacientes, sem exposição prévia a biológicos, sendo 93 (53%) homens. A média de idade no início do tratamento biológico foi de 35,5 (2-79) anos. O tempo médio de doença ao início do tratamento foi de 46,9 (0-480) meses. Do total da amostra, 117 (66,9%) utilizaram IFX e 58 (33,1%) ADA. Classificação de Montreal: idade ao diagnóstico ― A1 (n=21; 12%), A2 (n=102; 58,3%) e A3 (n=52; 29,7%). Localização da DC ― L1 (n=42; 24%), L2 (n=51; 29,1%), L3 (n=81; 46,3%) e L4 (n=1; 0,6%). Forma de apresentação ― B1 (n=59; 33,7%), B2 (n=46; 26,3%) e B3 (n=70; 40%). Doença perianal foi encontrada em 89 (50,9%) dos pacientes. CONCLUSÕES: Os dados epidemiológicos dos pacientes foram compatíveis com os da literatura internacional. Houve uma alta prevalência de pacientes com a forma fistulizante da DC.39540

Postoperative mortality in inflammatory bowel disease patients

Introduction: Since the 1960s, mortality in Crohn's disease and Ulcerative Colitis patients had a significant decrease due to advances in medical and surgical therapy. An important proportion of these patients are submitted to surgical procedures during their disease course, with postoperative mortality between 4 and 10%. Methods: 157 inflammatory bowel disease patients submitted to surgical therapy were retrospectively identified and allocated in 2 groups (Crohn's and colitis). Deaths were individually discriminated in detail. Results: 281 surgical procedures were performed. In the colitis group, 43 operations were performed in 24 patients; in the abdominal Crohn's subgroup, 127 procedures in 90 patients and in the perineal Crohn's subgroup, 115 in 64 patients, respectively. Nine postoperative deaths were observed (3 in the colitis and 6 in the Crohn's groups). Overall postoperative mortality was 5.7% (4.5% for Crohn's; 6.6% in abdominal Crohn's and 12.5% for Colitis). Most of deaths were related to emergency procedures and previous use of corticosteroids. The cause of death in all patients was sepsis. Conclusions: Overall postoperative mortality in inflammatory bowel disease was 5.7%, and it was attributed to the severity of the cases referred. Resumo: Introdução: A partir da década de 60, a mortalidade dos portadores de doença de Crohn (DC) e a Retocolite Ulcerativa Inespecífica (RCUI) teve declínio devido a novas terapêuticas clínicas e cirúrgicas. Importante proporção destes pacientes é submetida a procedimentos cirúrgicos no decorrer das suas vidas, com taxas de mortalidade variando entre 4 e 10%. Método: Foram identificados retrospectivamente 157 pacientes portadores de doenças inflamatórias intestinais (DII), submetidos a operações abdominais ou perineais, divididos em dois grupos (DC e RCUI). Os casos de óbitos foram discriminados e avaliados individualmente, de forma descritiva. Resultados: 281 operações foram realizadas. No grupo RCUI foram realizadas 43 operações em 24 pacientes, no subgrupo DC abdominal, 127 operações em 90 pacientes e no subgrupo DC perineal, 115 em 64 pacientes, respectivamente. Do total de 9 óbitos, 3 ocorreram no grupo RCUI e 6 no DC. A mortalidade geral nas DII foi de 5,7%. Para a DC, 4,5%. No subgrupo de operações abdominais foi de 6,6% e para a RCUI 12,5%. A maior parte dos óbitos estavam relacionados a procedimentos de urgência/emergência, com uso prévio de corticoterapia. A causa mortis em todos os pacientes foi sepse. Conclusões: A taxa de mortalidade cirúrgica nas DII foi de 5,7%, atribuidas pela severidade dos casos. Keywords: Mortality, Crohn's disease, Ulcerative colitis, Surgery, Palavras-chave: Mortalidade, Doença de Crohn, Retocolite ulcerativa, Cirurgi

Complications after intestinal resection in Crohn's disease: laparoscopic versus conventional approach

BACKGROUND: significant advances in medical therapy for Crohn's disease (CD) occurred in the last 12 years, mainly due to the introduction of anti-TNF therapy. Laparoscopic colorectal surgery represented the most important advance on surgical treatment in the management of CD, as it also had developed in the treatment of other conditions. There is a tendency for lower complication rates after laparoscopic bowel resections as compared to open surgery. The aim of this study was to analyze and compare the complication rates after bowel resections for CD between the two approaches in a Brazilian case series. METHODS: this was a retrospective longitudinal study, including CD patients submitted to bowel resections from a single Brazilian Inflammatory Bowel Diseases (IBD) referral center, treated between January 2008 and June 2012 with laparoscopic approach (LA) or conventional approach (CA). VARIABLES ANALYZED: age at surgery, gender, Montreal classification, smoking, concomitant medication, type of surgery, surgical approach, presence and type of complication up to 30 days after the procedures. Readmission and reoperation rates, as well as mortality, were also analyzed. Patients were allocated in two groups regarding the type of procedure (LA or CA), and complication rates and characteristics were compared. Statistical analysis was performed with Mann-Whitney test (quantitative variables) and chi-square test (qualitative variables), with p < 0.05 considered significant. RESULTS: a total of 46 patients (25 men) were included (16 submitted to LA), with mean age of 38.1 (&#177; 12.7) years. The groups were considered homogeneous according to age, gender, CD location, perianal disease and concomitant medications. There were more patients with fistulizing CD on the CA group (p = 0.029). The most common procedure performed was ileocolic resection on both groups (56.7% of the CA and 75% of the LA patients - p = 0.566). Overall, total complications (surgical and medical, including minor and major issues) occurred in 60% (18/30) of the CA group and 12.5% (2/16) of the LA group (p = 0.002). Wound infection was the most frequent complication (10/30 on CA and 1/16 on the LA groups). There were 3 deaths in the CA group. Specific analysis of each complication did not demonstrate any difference between the groups regarding abdominal sepsis, urinary tract infections, pneumonia, readmission, reoperations and deaths (p = 0.074). CONCLUSIONS: there was a higher complication rate in patients operated with CA as compared to LA. This was probably due to patient selection for the laparoscopic approach, with severe cases, mostly due to fistulizing abdominal CD, being operated mainly by open surgery. LA tends to be the recommended approach in most cases of non-complicated CD

Adalimumab for maintenance therapy for one year in Crohn's disease: results of a Latin American single-center observational study

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 Crohn's disease patients are scarce. The objective of this study was to outline clinical remission rates after 12 months of adalimumab therapy for Crohn's disease patients. Retrospective, single-center, observational study of a Brazilian case series of Crohn's 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). 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). 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

Adalimumab Serum Concentrations, Clinical and Endoscopic Disease Activity in Crohn’s Disease: A Cross-Sectional Multicentric Latin American Study

Despite some variability in ideal serum Adalimumab (ADA) concentrations, there is increasing evidence that higher concentrations of anti-TNF-α agents can be associated with sustained efficacy, and low or undetectable levels may lead to loss of response. This study aims to correlate serum ADA concentrations with clinical and endoscopic activity in patients with Crohn’s disease (CD). A cross-sectional and multicentric study was performed with patients with CD, who used ADA for at least 24 weeks. Patients were allocated into groups according to the presence of clinical or endoscopic disease activity. Serum ADA concentrations were measured and compared between groups. Overall, 89 patients were included. A total of 27 patients had clinically active CD and 62 were in clinical remission. Forty patients had endoscopic disease activity and 49 were in endoscopic remission. The mean serum ADA concentration was 10.2 μg/mL in patients with clinically active CD and 14.3 μg/mL in patients in clinical remission (p = 0.395). The mean serum ADA concentration in patients with endoscopic activity was 11.3 μg/mL as compared to 14.5 μg/mL in those with endoscopic remission (p = 0.566). There was no difference between serum ADA concentrations regarding clinical or endoscopic activity in CD, as compared to patients in remissio