Comparative Analysis Of Adverse Events Between Infl Iximab And Adalimumab In Crohn's Disease Management: A Brazilian Single-centre Experience [análise Comparativa Dos Eventos Adversos Entre Infliximabe E Adalimumabe No Tratamento Da Doença De Crohn: Experiěncia Em Um Centro Brasileiro]

Introduction: Data is scarce regarding adverse events (AE) of biological therapy used in the management of Crohn's Disease (CD) among Brazilian patients. Objectives: To analyse AE prevalence and profile in patients with CD treated with Infliximab (IFX) or Adalimumab (ADA) and to verify whether there are differences between the two drugs. Method: Retrospective observational single-centre study of CD patients on biological therapy. Variables analysed: Demographic data, Montreal classifi cation, biological agent administered, treatment duration, presence and type of AE and the need for treatment interruption. Results: Forty-nine patients were analysed, 25 treated with ADA and 24 with IFX. The groups were homogeneous in relation to the variables studied. The average follow-up period for the group treated with ADA was 19.3 months and 21.8 months for the IFX group (p = 0.585). Overall, 40% (n = 10) of patients taking ADA had AE compared with 50% (n = 12) of IFX users (p = 0.571). There was a tendency towards higher incidence of cutaneous and infusion reactions in the IFX group and higher incidence of infections in the ADA treated group, although without significant difference. Conclusions: No difference was found in the AE prevalence and profile between ADA and IFX CD patients in the population studied. © 2013 Elsevier Editora Ltda. All rights reserved.3313338Rutgeerts, P., van Assche, G., Vermeire, S., Review article: Infliximab therapy for inflammatory bowel disease - seven years on (2006) Aliment Pharmacol Ther, 23, pp. 451-463Colombel, J.F., Sandborn, W.J., Panaccione, R., Robinson, A.M., Lau, W., Li, J., Adalimumab safety in global clinical trials of patients with Crohn's disease (2009) Infl Amm Bowel Dis, 15, pp. 1308-1319Colombel, J.F., Sandborn, W.J., Rutgeerts, P., Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: The CHARM trial (2007) Gastroenterology, 132, pp. 52-65Papadakis, K.A., Targan, S.R., Tumor necrosis factor: Biology and therapeutic inhibitors (2000) Gastroenterology, 119, pp. 1148-1157van Deventer, S.J., Tumour necrosis factor and Crohn's disease (1997) Gut, 40, pp. 443-448Hanauer, S.B., Feagan, B.G., Lichtenstein, G.R., Mayer, L.F., Schreiber, S., Colombel, J.F., Rachmilewitz, D., Rutgeerts, P., Maintenance infl iximab for Crohn's disease: The ACCENT I randomised trial (2002) Lancet, 359, pp. 1541-1549Targan, S.R., Hanauer, S.B., van Deventer, S.J., Mayer, L., Present, D.H., Braakman, T., Dewoody, K.L., Rutgeerts, P.J., A short term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alpha for Crohn's disease (1997) N Engl J Med, 337, pp. 1029-1035. , Crohn's Disease cA2 Study GroupSands, B.E., Anderson, F.H., Bernstein, C.N., Chey, W.Y., Feagan, B.G., Fedorak, R.N., Kamm, M.A., van Deventer, S.J., Infl iximab maintenance therapy for fi stulizing Crohn's disease (2004) N Engl J Med, 350, pp. 876-885Hyams, J., Crandall, W., Kugathasan, S., Induction and maintenance infl iximab therapy for the treatment of moderate-to-severe Crohńs disease in children (2007) Gastroenterology, 132 (3), pp. 863-873Sandborn, W.J., Rutgeerts, P., Enns, R., Hanauer, S.B., Colombel, J.F., Panaccione, R., Adalimumab induction therapy for Crohn's disease previously treated with infl iximab: A randomized trial (2007) Ann Intern Med, 146, pp. 829-838Zorzi, F., Zuzzi, S., Onali, S., Calabrese, E., Condino, G., Petruzziello, C., Effi cacy and safety of infl iximab and adalimumab in Crohn's disease: A single centre study (2012) Aliment Pharmacol Ther, 35 (12), pp. 1397-1407Burmester, G.R., Mease, P., Dijkmas, B.A.C., Gordon, K., Lovell, D., Panaccione, R., Adalimumab Safety and Mortality Rates from Global Clinical Trials of Six Immune-Mediated Infl ammatory Diseases (2009) Ann Rheum Dis. Ann Rheum Dis, 68, pp. 1863-1869Colombel, J.F., Rutgeerts, P., Reinisch, W., SONIC study group. Infl iximab, azathioprine, or combination therapy for Crohn's disease (2010) N Engl J Med, 362, pp. 1383-1395Present, D.H., Rutgeerts, P., Targan, S., Hanauer, S.B., Mayer, L., van Hogezand, R.A., Podolsky, D.K., van Deventer, S.J., Infl iximab for the treatment of fi stulas in patients with Crohn's disease (1999) N Engl J Med, 340, pp. 1398-140

Impact of biological therapy in postoperative morbidity in elective surgical resections in Crohn's disease

101S305S30

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.324395401Colombel, J.F., Sandborn, W.J., Reinisch, W., Mantzaris, G.J., Kornbluth, A., Rachmilewitz, D., Infliximab, azathioprine, or combination therapy for Crohn's disease (2010) N Engl J Med, 362 (15), pp. 1383-1395Souza, M.H.L.P., Troncon, L.E.A., Rodrigues, C.M., Viana, C.F.G., Onofre, P.H.C., Monteiro, R.A., Evolução da ocorrência (1980-1999) da doença de Crohn e da retocolite ulcerativa idiopática e análise das suas características clínicas em um hospital universitário do sudeste do Brasil (2002) Arq Gastroenterol, 39 (2), pp. 98-105Sedlack, R.E., Whisnant, J., Elveback, L.R., Kurland, L.T., Incidence of Crohn's disease in Olmsted County, Minnesota, 1935-1975 (1980) Am J Epidemiol, 112 (6), pp. 759-763Sonnenberg, A., Geographic variation in the incidence of and mortality from inflammatory bowel disease (1986) Dis Colon Rectum, 29 (12), pp. 854-861Yanai, H., Hanauer, S.B., Assessing response and loss of response to biological therapies in IBD (2011) Am J Gastroenterol, 106 (4), pp. 685-698Chaparro, M., Panés, J., García, V., Merino, O., Nos, P., Domènech, E., Long-term durability of response to adalimumab in Crohn's disease (2012) Inflamm Bowel Dis, 18 (4), pp. 685-690Rutgeerts, P., van Assche, G., Vermeire, S., Optimizing anti-TNF treatment in inflammatory bowel disease (2004) Gastroenterology, 126 (6), pp. 1593-1610Wu, E.G., Mulani, P.M., Yu, A.P., Tang, J., Pollack, P.F., Loss of treatment response to infliximab maintenance therapy in Crohn's disease: A payor perspective (2008) Value Health, 11 (5), pp. 820-829Dignass, A., van Assche, G., Lindsay, J.O., Lémann, M., Söderholm, J., Colombel, J.F., The second European evidence-based Consensus on the diagnosis and management of Crohn's disease: Current management (2010) J Crohns Colitis, 4 (1), pp. 28-62Silverberg, M.S., Satsangi, J., Ahmad, T., Arnott, I.D., Bernstein, C.N., Brant, S.R., Toward an integrated clinical, molecular and serological classification of inflammatory bowel disease: Report of a Working Party of the 2005 Montreal World Congress of Gastroenterology (2005) Can J Gastroenterol, 19 (SUPPL. A), pp. 5-36Panaccione, R., Loftus, E.V., Binion, D., McHugh, K., Alam, S., Chen, N., Efficacy and safety of adalimumab in Canadian patients with moderate to severe Crohn's disease: Results of the Adalimumab in Canadian SubjeCts with ModErate to Severe Crohn's DiseaSe (ACCESS) trial (2011) Can J Gastroenterol, 25 (8), pp. 419-425Colombel, J.F., Sandborn, W.J., Rutgeerts, P., Enns, R., Hanauer, S.B., Panaccione, R., Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: The CHARM trial (2007) Gastroenterology, 132 (1), pp. 52-65Lichtiger, S., Binion, D.G., Wolf, D.C., Present, D.H., Bensimon, A.G., Wu, E., The CHOICE trial: Adalimumab demonstrates safety, fistula healing, improved quality of life and increased work productivity in patients with Crohn's disease who failed prior infliximab therapy (2010) Aliment Pharmacol Ther, 32 (10), pp. 1228-1239Hanauer, S.B., Feagan, B.G., Lichtenstein, G.R., Mayer, L.F., Schreiber, S., Colombel, J.F., Maintenance infliximab for Crohn's disease: The ACCENT I randomised trial (2002) Lancet, 359 (9317), pp. 1541-1549Sands, B.E., Anderson, F.H., Bernstein, C.N., Chey, W.Y., Feagan, B.G., Fedorak, R.N., Infliximab maintenance therapy for fistulizing Crohn's disease (2004) N Engl J Med, 350 (9), pp. 876-885Schnitzler, F., Fidder, H., Ferrante, M., Noman, M., Arijs, I., van Assche, G., Long-term outcome of treatment with infliximab in 614 patients with Crohn's disease: Results from a single-centre cohort (2009) Gut, 58 (4), pp. 492-500Cosnes, J., Gower-Rousseau, C., Seksik, P., Cortot, A., Epidemiology and natural history of inflammatory bowel diseases (2011) Gastroenterology, 140 (6), pp. 1785-1794Kotze, P.G., Vieira, A., Sobrado, C.W., Salem, J.B., Kotze, L.M.S., Adalimumab in the induction of Crohn's disease remission: Results of a Brazilian multicenter case series (2011) J Coloproctol, 31 (3), pp. 233-240Poli, D.D., (2007) Aspectos Da Raça E Da Ancestralidade Na Apresentação E Evolução Da DC No Brasil [Dissertação De Mestrado], p. 51. , São Paulo: Faculdade de Medicina da Universidade de São PauloSouza, M.M., Belasco, A.G.S., Aguilar-Nascimento, J.E., Perfil epidemiológico dos pacientes portadores de doença inflamatória intestinal do estado de Mato Grosso (2008) Rev Bras Colo-proctol, 28 (3), pp. 324-328Teixeira, M.G., Habr-Gama, A., Takiguti, C.K., Brunetti, N.C., Pinotti, H.W., Aspectos epidemiológicos da doença de Cröhn em 140 pacientes do serviço de Colo-Proctologia do HCFMUSP (1993) Rev Bras Colo-Proctol, 13 (4), pp. 128-13

Manifestações extra-intestinais em doença de Crohn e retocolite ulcerativa: prevalência e correlação com o diagnóstico, extensão, atividade, tempo de evolução da doença Extra-intestinal manifestations Crohn disease and ulcerative rectocolitis: prevalence na correlation with diagnosis, extension, activity, disease evolution time

INTRODUÇÃO: Existe uma grande prevalência de manifestações extra-intestinais(MEI) em portadores de doença de Crohn(DC) e de retocolite ulcerativa(RCU), variando de 24 a 65%. OBJETIVO: Determinar a prevalência de MEI em RCU e DC, correlacionando com diagnóstico do tipo de doença inflamatória intestinal, extensão, tempo de evolução e atividade da doença. MÉTODOS: Mil pacientes foram avaliados no Hospital das Clínicas da FMUSP no período de 1984 a 2004. Foram estudadas manifestações articulares, dermatológicas, oftalmológicas, urológicas, hepáticas, pulmonares e vasculares. RESULTADOS: Foram estudados 468 pacientes com DC(46,8%) e 532 com RCU(53,2%). Encontrados 627 pacientes (59,2% com RCU e 66,7% com DC) com pelo menos uma forma de MEI. A média de tempo de doença dos pacientes com MEI foi de 10 anos. As MEI foram mais freqüentes após o início dos sintomas intestinais. CONCLUSÕES: Tanto na RCU quanto na DC,quanto maior a extensão da doença no cólon, maior a incidência de MEI. As manifestações urológicas foram mais freqüentes na DC. As manifestações articulares e dermatológicas foram mais prevalentes no sexo feminino nos dois grupos. Manifestações hepáticas foram mais prevalentes na DC. As manifestações articulares, dermatológicas e vasculares tiveram correlação com a atividade da doença intestinal em ambos os grupos.<br>INTRODUCTION: There is great prevalence of extra-intestinal manifestations (EIM) in Crohn's disease(CD) and ulcerative rectocolitis (UR), varying from 24 to 65%. AIM: To determine the prevalence of EIM in UR and CD, establishing a correlation with the diagnosis of the kind of intestinal inflammatory disease, extension, evolution time and disease activity. METHODS: One thousand patients were evaluated at the Hospital das Clínicas da FMUSP, along the 1984 to 2004 period. Articular, dermatological, ophthalmologic, urologic, hepatic, pulmonary and vascular manifestations were studied. RESULTS: 468 patients were studied with CD (46.8%) were studied and 532 with UR (53.2%). 627 patients found (59.2% with UR and 66.7% with CD) with at least one form of EIM. The average disease time of the EIM patients was of 10 years. EIM were more frequent after the beginning of the intestinal symptoms. CONCLUSIONS: Both in UR as in CD, the greater the extension of the disease in the colon, the greater is the EIM incidence. Urologic manifestations were more frequent in CD. Articular and dermatological manifestations were more prevalent in the feminine sex in both groups. Hepatic manifestations were more prevalent in CD. Articular, dermatological and vascular manifestations were related with the activity of the intestinal disease in both groups