Comparative analysis of adverse events between infliximab and adalimumab in Crohn's disease management: a Brazilian single-centre experience

AbstractIntroductionData is scarce regarding adverse events (AE) of biological therapy used in the management of Crohn's Disease (CD) among Brazilian patients.ObjectivesTo 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.MethodRetrospective observational single-centre study of CD patients on biological therapy. Variables analysed: Demographic data, Montreal classification, biological agent adminis- tered, treatment duration, presence and type of AE and the need for treatment interruption.ResultsForty-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 reac- tions in the IFX group and higher incidence of infections in the ADA treated group, although without significant difference.ConclusionsNo difference was found in the AE prevalence and profile between ADA and IFX CD patients in the population studied

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

Conventional Versus Biological Therapy for Prevention of Postoperative Endoscopic Recurrence in Patients With Crohn's Disease: an International, Multicenter, and Observational Study

Background/AimsPostoperative endoscopic recurrence (PER) occurs in nearly 80% of patients 1 year after ileocecal resection in patients with Crohn's disease (CD). Biological agents were more effective in reducing the rates of PER in comparison with conventional therapy, in prospective trials. The aim of this study was to compare the PER rates of biological versus conventional therapy after ileocecal resections in patients with CD in real-world practice.MethodsThe MULTIPER (Multicenter International Postoperative Endoscopic Recurrence) database is a retrospective analysis of PER rates in CD patients after ileocecal resection, from 7 referral centers in 3 different countries. All consecutive patients who underwent ileocecal resections between 2008 and 2012 and in whom colonoscopies had been performed up to 12 months after surgery, were included. Recurrence was defined as Rutgeerts' score ≥i2. The patients were allocated to either biological or conventional therapy after surgery, and PER rates were compared between the groups.ResultsInitially, 231 patients were evaluated, and 63 were excluded. Of the 168 patients in the database, 96 received anti-tumor necrosis factor agents and 72 were treated with conventional therapy after resection. The groups were comparable regarding age, gender, and perianal disease. There was longer disease duration, more previous resections, and more open surgical procedures in patients on biologicals postoperatively. PER was identified in 25/96 (26%) patients on biological therapy and in 24/72 (33.3%) patients on conventional therapy (P=0.310).ConclusionsIn this retrospective observational analysis from an international database, no difference was observed between biological and conventional therapy in preventing PER after ileocecal resections in CD patients

Systematic review of studies generating individual participant data on the efficacy of drugs for treating soil-transmitted helminthiases and the case for data-sharing

Preventive chemotherapy and transmission control (PCT) by mass drug administration is the cornerstone of the World Health Organization (WHO)’s policy to control soil-transmitted helminthiases (STHs) caused by Ascaris lumbricoides (roundworm), Trichuris trichiura (whipworm) and hookworm species (Necator americanus and Ancylostama duodenale) which affect over 1 billion people globally. Despite consensus that drug efficacies should be monitored for signs of decline that could jeopardise the effectiveness of PCT, systematic monitoring and evaluation is seldom implemented. Drug trials mostly report aggregate efficacies in groups of participants, but heterogeneities in design complicate classical meta-analyses of these data. Individual participant data (IPD) permit more detailed analysis of drug efficacies, offering increased sensitivity to identify atypical responses potentially caused by emerging drug resistance

Completion of fit notes by GPs: a mixed methods study

Aims: The aim of this study was to investigate the completion of fit notes by UK general practitioners (GPs). A series of actual fit notes issued to employed patients were examined, and their GPs’ reflections and experiences of fit note completion explored. Methods: A mixed-methods design was used. Data were collected from copies of 94 fit notes issued to employed patients by 11 GPs, and from 86 questionnaires completed by these GPs reflecting on the fit notes they had issued. Face-to-face interviews were then conducted with each GP. Results: Fit note completion is not meeting expectations for a number of reasons. These include the following: limited knowledge and awareness of the guidance in fit note completion; problems with the fit note format; lack of mandatory training in completing fit notes; lack of incentive to change practice; incomplete implementation of the electronic fit note; GPs’ lack of confidence in, and doubts about the appropriateness of performing this role. Conclusion: If UK GPs are to continue their contractual responsibility for completing fit notes, further consideration of their education and training needs is urgently required. Weaknesses in the design and format of the fit note and the availability of the electronic version also need to be addressed