Evaluation of factors affecting the frequency and clinical course of COVID-19 in patients using anti-TNF-alpha agents

SUMMARY OBJECTIVES: Patients being treated with anti-tumor necrosis factor-alpha (anti-TNF-alpha) agents were reported to have better prognosis related to COVID-19. We evaluated the factors affecting the frequency, clinical course, and outcome of COVID-19 in patients treated with anti-TNF-alpha agents. METHODS: Patients with rheumatoid diseases and chronic inflammatory bowel diseases treated with anti-TNF-alpha agents were evaluated retrospectively. The laboratory data in routine visits, frequency of COVID-19, pneumonia, hospitalization and/or intensive care unit (ICU) follow-up and, mortality were recorded. The factors related to COVID-19 frequency and clinical outcome were evaluated. RESULTS: A total of 324 patients (177 males [54.6%] and 147 females [45.4%], mean age: 45.3±12.16 years) was included in the study. In all, 44 (13.6%) patients had COVID-19; of these, 11 (25%) developed pneumonia, 7 (15.9%) were hospitalized, and 1 (2.3%) was followed up in ICU. There was no mortality. The patients with COVID-19 pneumonia were older (mean age: 52±11 years versus 41±12 years, p=0.01), had hypertension and coronary artery disease more frequently (5 cases [55.6%] versus 4 cases [44.4], p=0.02 and 2 cases [100%] versus 0 cases [0%], p=0.014, respectively), and lower eosinophil % (1.35±1.79% versus 2.3±1.45%, p=0.016). The diabetes mellitus was more frequent (66.7 versus 33.3%, p=0.013), and mean eosinophil % was lower among inpatients compared with outpatients (1.29±2.22% versus 2.19±1.37%, p=0.02). CONCLUSIONS: We concluded that the patients treated with anti-TNF-alpha agents having COVID-19 might have mild clinical course and better prognosis.

Indicadores do estado corporal do ferro e indicadores de inflamação durante o tratamento da doença inflamatória intestinal em crianças e adolescentes / Body iron status indicators and inflammation indicators during inflammatory bowel disease therapy in children and adolescentes

ABSTRACT BACKGROUND: The treatment of patients with inflammatory bowel disease (IBD) consists of the induction and maintenance remission of the disease. Iron status indicators would be useful for the diagnosis of iron deficiency anemia, whereas the inflammation indicators would be for the diagnosis of chronic disease anemia. OBJECTIVE: To assess body iron status indicators and inflammation indicators during the treatment of IBD, consisted of conventional or infliximab therapy in children and adolescents. METHODS: A case-control study of a sample of 116 individuals, of which 81 patients with IBD, 18 of them receiving conventional therapy, 20 infliximab therapy, and 43 who were in remission of the disease, and 35 healthy (control group) children and adolescents. Iron status and inflammation indicators were investigated at baseline, and 2 and 6 months of both therapies - conventional and infliximab. RESULTS: The mean age was 12.1±4.3 years. At baseline, both groups - conventional therapy and infliximab - presented significant differences in most markers studied compared to the control group. After 2 months of conventional therapy, hemoglobin and serum iron levels were lower than those of the control group; and red cells distribution width (RDW), total iron-binding capacity, transferrin receptor/ferritin ratio, and interleukin-6 were higher than the control group. After 2 months of infliximab treatment, hemoglobin and serum iron levels were lower than those of the control group; and RDW, soluble transferrin receptor, soluble transferrin receptor/ferritin ratio, and interleukin-6 were higher than the control group. After 6 months of conventional therapy, hemoglobin and serum iron levels were lower than those of the control group, and RDW and interleukin-6 were higher than those of the control group. After 6 months of infliximab treatment, the hemoglobin and serum iron levels were lower than the control group, and RDW, soluble transferrin receptor, soluble transferrin receptor/ferritin ratio, erythrocyte sedimentation rate, and platelets were higher than the control group. Regarding patients under treatment for at least one year (remission group), all markers studied, except transferrin, were similar to the control group. CONCLUSION: In conclusion, there were some contradictions among the different body iron status indicators and inflammation indicators at two and 6 months of treatment with conventional and infliximab therapy, however after one year of treatment, as shown by the remission group, all indicators studied, except transferrin, were similar to healthy children and adolescents.

RESUMO CONTEXTO: O tratamento de pacientes com doença inflamatória intestinal (DII) consiste na indução e manutenção da remissão da doença. Os indicadores do estado corporal do ferro seriam úteis para o diagnóstico da anemia por deficiência de ferro, enquanto os indicadores de inflamação para o diagnóstico da anemia da doença crônica. OBJETIVO: Avaliar os indicadores do estado corporal do ferro e os indicadores de inflamação durante o tratamento da doença inflamatória intestinal, com terapia convencional ou infliximabe em crianças e adolescentes. MÉTODOS: Estudo de caso-controle de uma amostra de 116 indivíduos, sendo 81 pacientes com DII, dos quais 18 com terapia convencional, 20 infliximabe e 43 em remissão da doença, e 35 crianças e adolescentes saudáveis (grupo controle). Os indicadores do estado do ferro e os indicadores de inflamação foram avaliados no início, 2 e 6 meses de dois tipos de tratamento - terapia convencional e terapia com infliximabe. RESULTADOS: A média de idade foi de 12,1±4,3 anos. No início do tratamento, ambos os grupos - terapia convencional e infliximabe - apresentaram diferenças significantes com relação à maioria dos marcadores estudados comparados ao grupo controle. Após 2 meses de terapia convencional, os níveis de hemoglobina e ferro sérico foram inferiores em comparação ao grupo controle; e amplitude de distribuição dos eritrócitos (RDW), capacidade total de ligação do ferro, razão entre o receptor de transferrina solúvel e ferritina e interleucina-6 foram superiores aos do grupo controle. Após 2 meses de tratamento com infliximabe os níveis de hemoglobina e ferro sérico foram inferiores em comparação ao grupo controle, e RDW, receptor de transferrina solúvel e interleucina-6 foram superiores aos do grupo controle. Após 6 meses de terapia convencional, os níveis de hemoglobina e ferro sérico foram inferiores aos do grupo controle, e RDW e interleucina-6 superiores aos do grupo controle. Após 6 meses de tratamento com infliximabe, os níveis de hemoglobina e ferro sérico foram inferiores comparados ao grupo controle, e RDW, receptor de transferrina solúvel, razão receptor de transferrina solúvel e ferritina, taxa de sedimentação de eritrócitos e plaquetas foram superiores ao do grupo controle. Quanto aos pacientes que estavam em tratamento há mais de um ano (grupo remissão), todos os marcadores, exceto a transferrina, foram similares ao grupo controle. CONCLUSÃO: Houve contradições entre os diferentes indicadores do estado corporal do ferro e dos indicadores de inflamação aos 2 e 6 meses de tratamento com terapia convencional e infliximabe, no entanto após um ano de tratamento, conforme observado pelo grupo em remissão, todos os indicadores estudados, exceto a transferrina, foram semelhantes aos das crianças e adolescentes saudáveis.

Research progress of phosphodiesterase inhibitors in inflammatory bowel disease treatment / 浙江大学学报·医学版

Inflammatory bowel disease is a recurrent chronic intestinal inflammatory disease with unknown etiology and no effective treatment. Phosphodiesterase (PDE) regulates a variety of physiological and pathophysiological processes by mediating the hydrolysis of intracellular second messengers cyclic adenosine monophosphate and cyclic guanosine monophosphate. In recent years, a series of researches suggest that PDE inhibitors such as several PDE4 inhibitors, PDE5 inhibitors (sildenafil, tadalafil and vardenafil), PDE3 inhibitors (cilostazol), PDE9 inhibitor (PF-04447943) and PDE3/PDE4 double inhibitor (pumafentrine) have ameliorating effect on experimental colitis in animals. In clinical trials, PDE4 inhibitor apremilast showed more therapeutic advantage than tetomilast. This article reviews the recent research progress of PDE inhibitors in treatment of inflammatory bowel disease.

Assistência à saúde de pessoas com doenças colorretais no sistema público a perspectiva do usuário / Health care for people with colorectal diseases in the public system: the user's perspective

Trata-se de um estudo de desenho misto, do tipo sequencial explanatório, sendo que na etapa quantitativa descritiva e transversal, objetivou-se analisar a demanda de atendimento de assistência de pessoas com queixas colorretais em Unidades de Saúde da Família no Sistema Único de Saúde (SUS); e na etapa qualitativa exploratória, interpretar o mapa de cuidado de pessoas com adoecimento colorretal crônico no SUS (Parecer No. 210/2018 CEP/EERP-USP). Na etapa quantitativa aplicou-se um instrumento de coleta de dados, elaborado pelas pesquisadoras, com base na revisão de literatura, para caracterização sociodemográfica, clínica, terapêutica e de referência de participantes usuários da Estratégia Saúde da Família com queixas colorretais, mediante critérios de inclusão e exclusão, no período de abril a setembro de 2019. A análise estatística descritiva dos dados indicou, que do total de 107 participantes, predominou 78 (72,9%) que tinham idade acima de 60 anos, 64 (59,8%) eram do sexo feminino, 61 (57%) tinham até oito anos de estudos, 68 (63,65) com companheiro, 56 (52,3%) eram aposentados, 45 (42,1%) apresentavam renda de até um salário mínimo e 95 (88,8%) não possuíam plano de saúde privado, sendo que o encaminhamento para o nível secundário foi devido ao protocolo de rastreamento para 62 (57,9%) e 45 (42,1%) por queixa colorretal, todos haviam realizado a Pesquisa de Sangue Oculto e destes, 78% tiveram resultado positivo; todos os entrevistados haviam recebido encaminhamento para realizar a colonoscopia. Além disso, 78 (72,9%) eram sedentários; e 66 (61,7%) consumiam carne vermelha e 45 (42,1%) embutidos. A análise univariada da associação das variáveis hábitos de vida, resultado de colonoscopia, presença de alterações displásicas ou doença colorretal não foi estatisticamente significante entre consumo de carne vermelha, consumo de embutidos ou ambos com o desfecho de colonoscopia normal, displasia intestinal com potencial neoplásico e doença diverticular ou orificial. Estes resultados dimensionaram o contexto de atendimento desta clientela na Atenção Primária à Saúde (APS), auxiliando o refinamento dos critérios de seleção dos possíveis participantes da etapa qualitativa. A etapa qualitativa foi realizada, no período de junho de 2020 a julho de 2020, mediante os critérios de seleção: pessoas acima de 18 anos, de ambos os sexos, com diagnóstico colorretal crônico: Doença inflamatória intestinal ou Neoplasia colorretal em internação especialidade de Coloproctologia de um hospital universitário público, de assistência terciária/quaternária. Nesta etapa, os dados foram coletados por meio de entrevistas individuais em profundidade com 14 participantes, cuja caracterização sociodemográfica, clínica e terapêutica revelou internação para tratamento cirúrgico, com maior gravidade clínica, sendo que 13 apresentavam diagnóstico de Neoplasia colorretal. Utilizou-se questões norteadoras, diário de campo, observação não participante e participante para a obtenção dos dados, que foram interpretados com Análise Temática, fundamentado pela Epidemiologia Social. O Mapa de Cuidado construído por estes, iniciou-se com queixas e sinais/sintomas gastrointestinais, envolvendo situações de maior gravidade clínica, com sofrimento físico e psicoemocional; diagnosticados como parasitose, hemorroidas e anemia na APS, cujos tratamentos não foram resolutivos. Para esta interpretação, articulou-se as ações destes participantes às suas queixas, à condição socioeconômica, cultural e psicoemocional, assim como à capacidade de enfrentamento do adoecimento oncológico e dos tratamentos, no qual ocorreu a focalização da vida destes e de suas famílias nos acontecimentos clínicos e terapêuticos do contexto de atendimento terciário/quaternário. O acesso aos serviços do SUS ocorreu de diferentes maneiras, com utilização de estratégias que agilizaram e asseguraram a resolução do seu problema de saúde, sendo que o agir leigo foi uma produção social, no cotidiano do SUS, mediado pelos acontecimentos, pelas ações dos profissionais e de suas próprias ações ou pelo sistema de apoio social, enfatizando-se o sofrimento desta clientela na busca pela assistência à saúde. Este mapa de cuidado mostrou que o agir leigo constituiu uma regulação assistencial no SUS, tão importante quanto as outras formas, composto pelos vínculos dos pacientes com profissionais dos serviços dos níveis primário, secundário, terciário/quaternário, de suas necessidades e possibilidades, além dos pontos de acesso ao sistema. Estes resultados poderão contribuir na implementação da gestão de cuidados de pessoas com adoecimento colorretal crônico no SUS, dando voz e protagonismo àquele que busca pela assistência à saúde

This is a study of mixed design, of an explanatory sequential type, and in the quantitative descriptive and transversal stage, the objective was to analyze the demand for assistance from people with colorectal symptoms in Family Health Units in the Unified System Health (SUS); and in the qualitative exploratory stage, interpret the care map for people with chronic colorectal illness in SUS (Note Nº. 210/2018 CEP / EERP-USP). In the quantitative stage, a data collection instrument was developed by the researchers, based on the literature review, for sociodemographic, clinical, therapeutic, and reference characterization of participating users of the Family Health Strategy with colorectal symptoms, considering inclusion and exclusion criteria, from April to September 2019. The descriptive statistical analysis of the data indicated that, out of a total of 107 participants, 78 (72.9%) predominated who were over 60 years old, 64 (59.8%) were female, 61 (57%) had up to eight years of study, 68 (63.65) with a partner, 56 (52.3%) were retired, 45 (42.1%) had an income of up to one minimum wage and 95 (88.8%) did not have a private health plan, and the referral to the secondary level was due to the screening protocol for 62 (57.9%) and 45 (42.1%) due to colorectal complaints, all had carried out the Occult Blood Survey and of these, 78% had a positive result; all respondents had been referred for colonoscopy. In addition, 78 (72.9%) were sedentary; and 66 (61.7%) consumed red meat and 45 (42.1%) sausages. The univariate analysis of the association of the variables life habits, the result of colonoscopy, presence of dysplastic changes or colorectal disease was not statistically significant between consumption of red meat, consumption of sausages or both with the outcome of normal colonoscopy, intestinal dysplasia with neoplastic potential and diverticular or artificial disease. These results have dimensioned the context of care for this clientele in Primary Health Care (PHC), helping to refine the selection criteria of possible participants in the qualitative stage. The qualitative stage was carried out, from June 2020 to July 2020, using the selection criteria: people over 18 years of age, of both sexes, with chronic colorectal diagnosis: Inflammatory bowel disease or Colorectal neoplasia in Coloproctology specialty hospitalization of a public university hospital, of tertiary/quaternary assistance. In this stage, data were collected through in-depth individual interviews with 14 participants, whose sociodemographic, clinical, and therapeutic characterization revealed hospitalization for surgical treatment, with greater clinical severity, with 13 presenting a diagnosis of colorectal neoplasia. Guiding questions, field diary, non-participant and participant observation were used to obtain the data, which were interpreted with Thematic Analysis, based on Social Epidemiology. The Care Map built by them started with gastrointestinal complaints and signs/symptoms, involving situations of greater clinical severity, with physical and psycho-emotional suffering; diagnosed as parasitosis, hemorrhoids, and anemia in PHC, whose treatments were not effective. For this interpretation, the actions of these participants were linked to their complaints, to their socioeconomic, cultural, and psycho-emotional condition, as well as to their ability to cope with oncological illness and treatments, in which the lives of these and their families were focused on the events and therapeutic aspects of the tertiary/quaternary care context. Access to SUS services occurred in different ways, using strategies that streamlined and ensured the resolution of their health problem, and the lay agency as social production, in the daily routine of SUS, mediated by events, by the actions of professionals and their actions or the social support system, emphasizing the suffering of this clientele in the search for health care. This care map showed that the lay act constituted an assistance regulation in SUS, as important as the other forms, composed by the bonds of patients with professionals from the services of the primary, secondary, tertiary/quaternary levels, of their needs and possibilities, in addition to the access points to the system. These results may contribute to the implementation of the care management of people with chronic colorectal illness in SUS, giving voice and leadership to those seeking health care.

Utilização da monitorização terapêutica com níveis séricos de infliximabe nas doenças inflamatórias intestinais: um algoritmo simplificado baseado em evidências / Induction therapeutic drug monitoring regimen with infliximab: a simplified evidence-based algorithm for inflammatory bowel disease

ABSTRACT Therapeutic drug monitoring (TDM) of infliximab (IFX) has been recognized as an important strategy in the management of secondary loss of response to this agent, guiding clinical decision-making in the management of inflammatory bowel diseases (IBD). Although most of the data on the application of TDM for IFX refer to the maintenance phase of treatment, many studies have associated higher drug concentrations, specially in the induction phase, with achievement of important treatment targets, such as clinical remission and mucosal healing. This brief communication aims to summarize the literature on the use of TDM during induction phase of IFX and propose application of a simplified approach which can be useful into clinical practice, aiming better outcomes to IBD patients.

RESUMO A monitorização terapêutica dos níveis séricos (Therapeutic drug monitoring - TDM) de infliximabe (IFX) é uma estratégia reconhecida na tomada de decisão clínica frente a perda de resposta secundária a esta droga no manejo das doenças inflamatórias intestinais (DII). Embora a maioria dos dados sobre a aplicação dessa estratégia para IFX se refira à fase de manutenção do tratamento, muitos estudos associaram concentrações mais altas de IFX, especialmente na fase de indução, com o alcance de importantes alvos de tratamento, como remissão clínica e cicatrização da mucosa. Este artigo visa resumir as evidências da literatura sobre o uso de níveis séricos durante a fase de indução do IFX e propor a aplicação de uma abordagem simplificada que pode ser extremamente útil na prática clínica, visando melhores resultados para os pacientes.

Fatores associados com a escolha da terapia nos pacientes com doença inflamatória intestinal no Brasil / Factors associated with patient´s preference in choosing their therapy for inflammatory bowel disease in brazil

BACKGROUND: Biological therapy and new drugs have revolutionized the treatment of inflammatory bowel disease. Ideally, the choice of medication should be a shared decision with the patient, aiming at greater satisfaction, compliance, and consequently, favorable clinical outcome. OBJECTIVE: This study aims to evaluate patient's preferences in the choice of their therapy and the factors that influence this choice. METHODS: This cross-sectional study enrolled 101 outpatients with Crohn's disease or ulcerative colitis. The inclusion criteria were age ≥18 years and no previous exposure to biological therapy. Patients' preferences were assessed through questions that addressed the preferred mode of administration (oral, subcutaneous, or intravenous) and the factors that determined the choice of medication (efficacy, medical indication, fear of medication, convenience, mode of application, and personal doctors' indication). RESULTS: The mean age was 43.6±13.5 years, 75.3% were female, and 81.2% were cases of ulcerative colitis. Regarding the mode of administration, the majority of patients preferred oral (87.1%), followed by intravenous (6.93%) and subcutaneous (5.94%) medications. The reasons were "I prefer to take it at home" (42.57%), "I have more freedom" (36.63%), "I don't like self-application" (29.70%), and "I believe it works better" (19.80%). Younger patients and patients in clinical disease activity preferred intravenous mode compared to the oral route (P<0.05). Doctor's opinion (98%) was an important factor associated with the medication choice. CONCLUSION: Oral route was the preferred mode of administration and most patients took their physician's opinion into account in their choice of medication.

RESUMO CONTEXTO: A terapia biológica e os novos medicamentos revolucionaram o tratamento da doença inflamatória intestinal. A escolha do medicamento deve ser compartilhada com o paciente, visando maior satisfação, adesão e, consequentemente, desfecho clínico favorável. OBJETIVO: Este estudo teve como objetivo avaliar as preferências do paciente na escolha de sua terapia e os fatores que influenciaram essa escolha. MÉTODOS: Este estudo transversal incluiu 101 pacientes ambulatoriais com doença de Crohn ou retocolite ulcerativa. Os critérios de inclusão foram idade ≥18 anos e nenhuma exposição prévia à terapia biológica. A preferência dos pacientes foi avaliada por meio de perguntas que abordaram o modo de administração preferido (oral, subcutâneo ou intravenoso) e os fatores que determinaram a escolha do medicamento (eficácia, indicação médica, medo da injeção, conveniência, modo de aplicação e opinião pessoal do médico). RESULTADOS: A idade média foi de 43,6±13,5 anos, 75,3% eram mulheres e 81,2% eram portadores de retocolite ulcerativa. Em relação ao modo de administração, a maioria dos pacientes preferiu os medicamentos orais (87,1%), seguidos dos endovenosos (6,93%) e subcutâneos (5,94%). Os motivos foram "prefiro aplicar em casa" (42,57%), "tenho mais liberdade com essa medicação" (36,63%), "não gosto de autoaplicação" (29,70%) e "acredito que funcione melhor" (19,80%). Pacientes jovens e pacientes em atividade clínica preferiram a via intravenosa em comparação com a via oral (P<0,05). A opinião do médico (98%) foi um fator importante associado à escolha do medicamento. CONCLUSÃO: A via oral foi preferida e a maioria dos pacientes levou em consideração a opinião do seu médico na escolha do medicamento.

Potential impact of COVID-19 on colorectal disease management / Impacto potencial da COVID-19 no manuseio das doenças colorretais

Abstract The current recommendations for management of colorectal diseases are still evolving, due to the limited experience on this issue. As the new coronavirus can be transmitted through breath droplets, by contact and orofecally, there is no consensus of how this fact may affect the investigation and treatment of anorectal diseases. Thus, high-quality multicenter studies are urgently needed to provide better information to both patients and the multiprofessional team, in order to build an effective pandemic response plan in our specialty. As a greater operative risk for infected patients has already been demonstrated, the next step lies on the identification of new therapeutic strategies that could minimize this effect on an individual basis. There is a present understanding that the COVID-19 pandemic should change some traditional practices. Therefore, the surgical treatment of suspected or known COVID-19 case demands specific insights. This article analyses potential influences regarding the treatment of patients with Colorectal Cancer (CRC) and Inflammatory Bowel Diseases (IBD). At present, elective surgery must be avoided, and the colorectal surgeon must carefully evaluate the risks and benefits of such decision. Within this context, a change toward nonsurgical and less aggressive modalities of CRC treatment may help to postpone definitive treatment. We also discuss the concerns regarding the viral infection among the population, the influence on clinical symptoms and the proposed modifications on therapeutic schemes.

Resumo As recomendações atuais para manuseio das doenças colorretais ainda estão em evolução, devido à limitada experiência nesse tema. Como o novo coronavírus pode ser transmitido em gotículas da respiração, por contato ou por via oro-fecal, ainda não existe consenso de como este fato pode afetar a investigação e o tratamento de doenças anorretais. Assim, são necessários estudos multicêntricos de qualidade para prover melhor informação ao paciente e equipe multiprofissional, possibilitando a formulação de uma resposta efetiva à pandemia em nossa especialidade. Uma vez que o risco operatório de pacientes infectados é maior, o passo subsequente reside em identificar novas estratégias terapêuticas que possam minimizar esse efeito individualmente. Assim, reconhece-se atualmente que a pandemia pelo COVID-19 deve alterar algumas práticas tradicionais. Consequentemente, o tratamento cirúrgico de um doente infectado ou suspeito demanda reflexões específicas. Esse artigo analisa influências potenciais relacionadas ao tratamento do Câncer Colorretal (CCR) e Doenças Inflamatórias Intestinais (DII). No atual momento, cirurgias eletivas devem ser postergadas e o cirurgião colorretal deve avaliar cuidadosamente os riscos e benefícios dessa decisão. Nesse contexto, uma mudança na direção de modalidades não-cirúrgicas e menos agressivas do CCR pode favorecer a prorrogação do tratamento definitivo. Aqui também se discutem as preocupações sobre a infecção viral em pacientes com DII, sua influência sobre os sintomas clínicos e as modificações propostas nos esquemas terapêuticos.

Análise crítica do uso dos anti-TNF na era dos novos agentes biológicos na doença inflamatória intestinal / Critical analysis of anti-tnf use in the era of new biological agents in inflammatory bowel disease

ABSTRACT BACKGROUND: Inflammatory bowel diseases (IBD), both Crohn's disease and ulcerative colitis, are chronic immune-mediated diseases that present a relapsing and remitting course and requires long-term treatment. Anti-tumor necrosis factor (anti-TNF) therapy has changed the management of the disease by reducing the need for hospitalizations, surgeries and improving patient´s quality of life. OBJECTIVE: The aim of this review is to discuss the role of anti-TNF agents in IBD, highlighting the situations where its use as first-line therapy would be appropriate. METHODS: Narrative review summarizing the best available evidence on the topic based on searches in databases such as MedLine and PubMed up to April 2020 using the following keywords: "inflammatory bowel disease'', "anti-TNF agents" and ''biologic therapy''. CONCLUSION: Biological therapy remains the cornerstone in the treatment of IBD. In the absence of head-to-head comparisons, the choice of the biological agent may be challenging and should take into account several variables. Anti-TNF agents should be considered as first line therapy in specific scenarios such as acute severe ulcerative colitis, fistulizing Crohn's disease and extra-intestinal manifestations of IBD, given the strong body of evidence supporting its efficacy and safety in these situations.

RESUMO CONTEXTO: As doenças inflamatórias intestinais (DII), tanto a doença de Crohn (DC) como a retocolite ulcerativa (RCU), são doenças crônicas imunomediadas que se apresentam com períodos de surto e remissão e requerem terapia a longo prazo. A terapia com anti-fator de necrose tumoral (anti-TNF) tem mudado o manejo da doença reduzindo a necessidade de hospitalizações, cirurgias e melhorando a qualidade de vida dos pacientes. OBJETIVO: O objetivo do presente trabalho é apresentar uma revisão sobre a importância dos agentes anti-TNF no contexto da DII, levando em consideração situações em que essas drogas são usadas como terapia de primeira linha. MÉTODOS: Revisão narrativa baseada nas melhores evidências disponíveis na literatura através de buscas feitas nas bases de dados MedLine e PubMed até abril de 2020, utilizando as seguintes palavras chaves: "doença inflamatória intestinal'', "agentes anti-TNF" e "terapia biológica". CONCLUSÃO: A terapia biológica permanece sendo fundamental no tratamento da DII. Na ausência de estudos "head-to-head'' comparando os biológicos entre si, a escolha do agente biológico pode ser um desafio na prática clínica e múltiplas variáveis devem ser levadas em consideração. Os agentes anti-TNF devem ser considerados terapia de primeira linha em situações específicas como na colite ulcerativa aguda grave, na doença de Crohn fistulizante e nas manifestações extra-intestinais da doença inflamatória intestinal, uma vez que há evidências científicas robustas que sustentam a sua eficácia e segurança nessas situações.

Taxas de descontinuação do tratamento após a troca de um biológico originador por um biossimilar em pacientes com doenças inflamatórias intestinais: revisão sistemática e metanálise / Discontinuation rates following a switch from a reference to a biosimilar biologic in patients with inflammatory bowel disease: a systematic review and meta-analysis

ABSTRACT BACKGROUND: Biologics have revolutionized the treatment of inflammatory bowel disease (IBD). However, these drugs had a significant influence on treatment-related costs, which resulted in the development of biosimilars. OBJECTIVE: This systematic review and meta-analysis aimed to evaluate the drug discontinuation rate in the IBD population who switched from originator to biosimilars in real-world switching studies and address potential nocebo effects as reasons for drug discontinuation. METHODS: Medline (via PubMed), EMBASE, Cochrane Library, and abstract databases of selected congresses were screened for reports of monoclonal antibody (mAb) switching with a minimum post-switch follow-up of >6 months or three infusions. All available information on discontinuation rates was assessed. RESULTS: A total of 30 observational studies were included, involving 3,594 patients with IBD. Twenty-six studies reported a switch from infliximab to CT-P13, two studies involved a switch to SB2, and switching information was not available in two studies. The discontinuation rates were 8%, 14%, and 21% at 6, 12, and 24 months, respectively. The main reasons for drug discontinuation and their respective risks were: disease worsening (2%), remission (4%), loss of adherence (4%), adverse events (5%), and loss of response (7%). The quality of the evidence ranged from low to very low depending on the outcome analyzed. Subjective symptoms leading to drug discontinuation were infrequently reported, and the nocebo effect was clearly assessed in just one of the included papers. CONCLUSION: Discontinuation rates following a switch to a biosimilar in patients with IBD increase over time. However, it was not possible to confirm the nocebo effect as a reason for discontinuation. Therefore, long-term studies evaluating the use of biosimilars to monitor adverse events and potential nocebo effects in post-marketing surveillance are still needed.

RESUMO CONTEXTO: Os biológicos revolucionaram o tratamento da doença inflamatória intestinal (DII). Ademais, esses medicamentos influenciaram os custos relacionados ao tratamento. Tal aumento significativo nos gastos com o tratamento motivou desenvolvimento dos biossimilares. OBJETIVO: Esta revisão sistemática e metanálise objetivou avaliar a taxa de descontinuação de medicamentos na população com DII que foi submetida à troca do biológico originador para um biossimilar, em estudos observacionais que abordaram possíveis razões para a descontinuação do tratamento. MÉTODOS: Tendo como base de dados Medline (via PubMed), EMBASE, Cochrane Library e resumos de congressos médicos, foram rastreados artigos com relatos de troca de um biológico originador por um biossimilar, com acompanhamento pós-troca de no mínimo 6 meses ou três infusões. Todas as informações disponíveis sobre as taxas de descontinuação foram avaliadas. RESULTADOS: Foram incluídos no total 30 estudos observacionais, envolvendo 3.594 pacientes com DII. Vinte e seis estudos relataram uma mudança do infliximabe para CT-P13, dois estudos envolveram uma mudança para o SB2, e as informações sobre a troca não estavam disponíveis em dois estudos. As taxas de descontinuação foram de 8%, 14% e 21% aos 6, 12 e 24 meses, respectivamente. Os principais motivos para a descontinuação do medicamento e seus respectivos riscos foram: agravamento da doença (2%), remissão (4%), perda de adesão (4%), eventos adversos (5%) e perda de resposta (7%). A qualidade da evidência variou de baixa a muito baixa, dependendo do resultado analisado. Os sintomas subjetivos que levaram à descontinuação do medicamento foram relatados com pouca frequência, e o efeito nocebo foi claramente avaliado em apenas um dos artigos incluídos. CONCLUSÃO: As taxas de descontinuação após a mudança para um biossimilar em pacientes com DII aumentam com o tempo. No entanto, não foi possível confirmar o efeito nocebo como motivo da descontinuação. Portanto, ainda são necessários estudos em longo prazo avaliando o uso de biossimilares para monitorar eventos adversos e potenciais efeitos nocebo na vigilância pós-comercialização.

Riesgo de infección en pacientes con enfermedades inmunológicas y oncológicas tratados con biológicos: revisión panorámica

Biological medications are effective for the treatment of cancer and inflammatory diseases. The aim of this review is to summarize the available evidence in systematic reviews or meta-analyses about the risk of infection in patients with cancer, arthritis, psoriasis and inflammatory bowel disease who use biological medications. We included systematic reviews or meta-analyses of controlled clinical trials and case/control studies that analyze infections during and after treatment with FDA-approved biological medications for the treatment of cancer, arthritis, inflammatory bowel disease and psoriasis, both in adults and children. The following databases were consulted: PubMed, Epistemonikos, Crochrane reviews, JIB, and Prospero. A quality guideline (AMSTAR) was applied to the selected studies. We included 26 studies. The risk of infections in patients with solid organ cancer is consistent in the literature. In psoriasis there is a risk of non-serious infections. In arthritis and other inflammatory diseases there is a risk of serious infections. In inflammatory bowel disease there is a risk for opportunistic infections. In conclusion, in patients with cancer and inflammatory diseases use biological medications entails a risk of infection. The evidence is different depending on the underlying disease of each patient.

Hepatitis B and C viral infections screening in a Tunisian IBD population under immunosuppressive therapies / Detección de infecciones virales de hepatitis B y C en una población de EII de Túnez sometida a terapias inmunosupresoras

ABSTRACT Background : Immunosuppressive drugs have become a mainstay of therapy for the inflammatory bowel diseases (IBD). These treatments expose to a risk of hepatitis B and C reactivation. Objective: The aim of this study was to assess the prevalence of hepatitis B and C viruses in Tunisian IBD patients on immunosuppressive treatments. Materials and methods : Patients with inflammatory bowel disease were consecutively recruited over a 2 years period (2017-2018). Prevalence of viral hepatitis B and C as well as clinical, biological and virological presentation, management and outcome were assessed. Factors associated to hepatitis B and C were also analyzed (SPSS software, p value <0.05). Results : Seventy four patients with IBD were included: 38 women and 36 men. Among them 62 (83.8%) had CD and (16.2%) had UC. Mean age was 43.5±14.2 years. Six patients (8.1%) had at least one positive HVB marker. Hepatitis C infection was found in 4% patients. HBs Ag was positive in only one patient (1.3%) with positive HBV DNA. Anti HBc and anti HBs antibodies were positive respectively in 6 and 4 patients. Vaccination against hepatitis B was proposed for 22% of our patients with negative anti HBc antibodies and HBs Ag. Two patients presented non-severe acute hepatitis C with sustained virological response after antiviral treatment. IBD did not relapse under antiviral treatment. A 3rd patient had chronic hepatitis C infection. She was treated with Pegylated Interferon alpha and Ribavirine. No cases of viral reactivation have been reported. Noassociated factors to hepatitis B and C viral infections were identified in our study. Conclusion : The prevalence of hepatitis B infection in IBD patients under immunosuppressive therapy was similar to the general population, while the hepatitis C prevalence was higher than the national prevalence. Screening for hepatitis B and C viral infections is mandatory in inflammatory bowel disease patients. Vaccination against hepatitis B is highly recommended.

RESUMEN Antecedentes : Los fármacos inmunosupresores se han convertido en un pilar de la terapia para las enfermedades inflamatorias del intestino (EII). Estos tratamientos exponen al riesgo de reactivación de la hepatitis B y C. Objetivo: El objetivo de este estudio fue evaluar la prevalencia de los virus de la hepatitis B y C en pacientes tunecinos con EII que reciben tratamientos inmunosupresores. Materiales y métodos : Los pacientes con enfermedad inflamatoria intestinal fueron reclutados consecutivamente durante un período de 2 años (2017-2018). Se evaluó la prevalencia de las hepatitis virales B y C, así como la presentación, el tratamiento y los resultados clínicos, biológicos y virológicos. También se analizaron los factores asociados a la hepatitis B y C (software SPSS, valor de p<0,05). Resultados : Se incluyeron 74 pacientes con EII: 38 mujeres y 36 hombres. Entre ellos, 62 (83,8%) tenían EC y (16,2%) CU. La edad media fue de 43,5 ± 14,2 años. Seis pacientes (8,1%) tenían al menos un marcador HVB positivo. Se encontró infección por hepatitis C en el 4% de los pacientes. HBs Ag fue positivo en sólo un paciente (1,3%) con ADN del VHB positivo. Los anticuerpos anti-HBc y anti-HBs fueron positivos respectivamente en 6 y 4 pacientes. Se propuso la vacunación contra la hepatitis B para el 22% de nuestros pacientes con anticuerpos anti-HBc negativos y Ag HBs. Dos pacientes presentaron hepatitis C aguda no grave con respuesta virológica sostenida tras el tratamiento antiviral. La EII no recayó con el tratamiento antiviral. Un tercer paciente tenía infección crónica por hepatitis C. Fue tratada con interferón alfa pegilado y ribavirina. No se han notificado casos de reactivación viral. En nuestro estudio no se identificaron factores asociados a las infecciones virales por hepatitis B y C. Conclusión : La prevalencia de infección por hepatitis B en pacientes con EII bajo terapia inmunosupresora fue similar a la población general, mientras que la prevalencia de hepatitis C fue mayor que la prevalencia nacional. La detección de infecciones virales de hepatitis B y C es obligatoria en pacientes con enfermedad inflamatoria intestinal. Se recomienda encarecidamente la vacunación contra la hepatitis B.

Recomendaciones para el manejo de pacientes con enfermedad Inflamatoria Intestinal (EII) y COVID-19 / Recommendations for the management of patients with Inflammatory Bowel Disease (IBS) and COVID-19

The new Coronavirus (SARS-CoV-2) appeared in China in December 2019. Since then and until April 2020 it spread worldwide affecting more than three million people. Its exponential rise is still growing all over the world, taking thousands of lives. SARS-CoV-2 is very contagious, person to person, by droplets which can generate a respiratory infection known as COVID-19. Some patients are at higher risk: Older people, those with cardiovascular disease, diabetes and hypertension are the most prone to an unfavorable outcome. Our Inflammatory Bowel Disease (IBD) patients are a special cluster, with many of them taking immunosuppressive treatment for long periods, which could pose an important risk. Scientifics societies all over the world have joined efforts to generate data, share experiences and make recommendations for good clinical management. This is a review of the available evidence, expert opinion, and proposed ways of working during the pandemic

El nuevo coronavirus (SARS-CoV-2) apareció en China en diciembre de 2019. Desde su inicio hasta abril de 2020 se ha expandido por todo el mundo, afectando a más de tres millones de personas. Su ascenso exponencial sigue creciendo, generando miles de muertes. Su contagiosidad es persona a persona por gotitas, pudiendo llegar a generar un cuadro clínico de infección respiratoria conocido como COVID-19. Algunos pacientes tienen más riesgos de tener un curso desfavorable; adultos mayores, pacientes con enfermedad cardiovascular, hipertensos y diabéticos. Nuestros pacientes con enfermedad inflamatoria intestinal son un grupo de pacientes con características particulares, muchos de ellos reciben tratamiento inmunosupresor por largos períodos, lo que pudiese suponer un riesgo específico. Las sociedades científicas de Europa y Norteamérica han realizado un esfuerzo conjunto para generar datos, compartir experiencias y dictar recomendaciones de buen manejo clínico. Esta es una revisión de la evidencia disponible, opiniones de expertos y formas de trabajo propuestos durante la pandemia.

Pérdida de respuesta a terapia anti-TNF en enfermedad inflamatoria intestinal: experiencia en un hospital de referencia en Lima - Perú / Loss of response to anti-TNF therapy in inflammatory bowel disease: experience in a reference hospital in Lima - Peru

RESUMEN Objetivo: Evaluar la respuesta al tratamiento con anti-TNFs en pacientes con enfermedad inflamatoria intestinal. Materiales y métodos: Estudio prospectivo observacional realizado en el Servicio de Gastroenterología del Hospital Nacional Guillermo Almenara, de enero 2015 a agosto 2018. Resultados: Se evaluó 31 pacientes con enfermedad inflamatoria intestinal que recibían terapia de mantenimiento con Infliximab. Doce (38,7%) pacientes (3 con colitis ulcerativa y 9 con enfermedad de Crohn) presentaron pérdida de respuesta a partir de los 6 meses del inicio de la fase de mantenimiento: 2 entre 6-12 meses, 4 entre 12-18 meses y 6 entre 18-24 meses. Como primera medida se duplicó la dosis (10 mg/kg) a los 12 pacientes, obteniendo respuesta en 6 (50%) luego de 12 semanas. De los 6 pacientes restantes, 4 cambiaron a Adalimumab, 1 paciente presentó cáncer de colon y 1 paciente presentó anafilaxia y sarcoidosis. De los pacientes que recibieron Adalimumab, 3 presentaron recidiva endoscópica (75%) a partir de los 6 meses y 1 no respondió a la terapia de inducción y fue sometido a colectomía (25%). Conclusiones: Aproximadamente un tercio de nuestros pacientes presentó pérdida de respuesta a terapia de mantenimiento con Infliximab. El escalamiento de dosis como rescate tuvo éxito en la mitad de los pacientes. El cambio a Adalimumab en pacientes con pérdida de respuesta a un primer fármaco anti-TNF no parece ser efectivo.

ABSTRACT Objective: To evaluate the response to treatment with anti-TNFs in patients with inflammatory bowel disease. Materials and methods: Prospective observational study conducted in the Gastroenterology service of the Guillermo Almenara National Hospital, from January 2015 to August 2018. Results: 31 patients with inflammatory bowel disease who received maintenance therapy with Infliximab were evaluated. Twelve (38.7%) patients (3 with ulcerative colitis and 9 with Crohn's disease) presented loss of response after 6 months of the beginning of the maintenance phase: 2 between 6-12 months, 4 between 12-18 months and 6 between 1824 months. As a first step, the dose was doubled (10 mg/kg) to the 12 patients, obtaining a response in 6 (50%) after 12 weeks. Of the remaining 6 patients, 4 switched to Adalimumab, 1 patient presented colon cancer and 1 patient presented anaphylaxis and sarcoidosis. Of the patients who received Adalimumab, 3 had endoscopic recurrence (75%) after 6 months and 1 did not respond to induction therapy and was subjected to colectomy (25%). Conclusions: Approximately one third of our patients presented loss of response to maintenance therapy with Infliximab. The dose escalation as a rescue therapy was successful in half of the patients. The change to Adalimumab in patients with loss of response to a first anti-TNF drug does not seem to be effective.

Frequência de utilização da terapia biológica para doenças inflamatórias intestinais na América Latina: situação atual e desafios futuros / Biological therapy penetration for inflammatory bowel disease in latin america: current status and future challenges

ABSTRACT BACKGROUND: The introduction of anti-TNF agents represented a landmark in the management of both Crohn's disease (CD) and ulcerative colitis (UC), with improved efficacy and safety when compared with conventional treatment. However, significant challenges still exist in Latin America to facilitate the access of biological agents for physicians and patients. OBJECTIVE: The aim of this review was to summarize current evidence on penetration of biological agents for CD and UC in Latin America. METHODS: Data are derived from a previous complete systematic review that explored different characteristics of inflammatory bowel diseases (IBD) in Latin America. The studies fully included in this previous systematic review which contained detailed descriptions of the percentage of use of biological agents in different cohorts throughout Latin American and Caribbean countries were included, and descriptive findings were compiled, describing CD and UC penetration of these drugs in different patient cohorts from different countries. RESULTS: From the 61 studies included in the original systematic review, only 19 included data of the percentage of patients treated with biological agents. Anti-TNF use in CD varied from 1.51% in Mexico up to 46.9% in Colombia, with most of the studies describing anti-TNF use in approximately 20%-40% of CD patients. On the other side, the frequency of the use of biologics was clearly lower in UC, varying from 0% in 2009 to up 16.2% in 2018, according to two different Mexican studies. Only two studies described the penetration of anti-TNF agents in IBD overall: 13.4% in a Colombian and 37.93% in a Brazilian study. No studies described percentage of use of new biologic agents (vedolizumab and ustekinumab). CONCLUSION: Penetration of anti-TNF agents in Latin America is comparable to the rest of the world in CD, but lower in UC. With the increase in the incidence and prevalence of IBD, specific strategies to increase access to anti-TNF agents in UC and new biological agents overall are warranted.

RESUMO CONTEXTO: A introdução dos agentes anti-TNF representou um marco no tratamento da doença de Crohn (DC) e da recocolite ulcerativa (RCU), com maior eficácia e segurança quando comparado ao tratamento convencional. No entanto, ainda existem desafios significativos na América Latina para facilitar o acesso dos agentes biológicos a médicos e pacientes. OBJETIVO: O objetivo desta revisão foi reunir as evidências atuais sobre a penetração de agentes biológicos para DC e RCU na América Latina. MÉTODOS: Os dados são derivados de uma revisão sistemática previamente publicada que explorou diferentes características das doenças inflamatórias intestinais (DII) na América Latina. Os estudos incluídos nesta revisão sistemática anterior que continham descrições detalhadas da percentagem do uso de agentes biológicos em coortes de pacientes em diferentes países da América Latina e Caribe foram incluídos, e os achados descritivos foram compilados detalhando a penetração destes medicamentos no manejo das DII. RESULTADOS: Dos 61 estudos incluídos na revisão sistemática original, apenas 19 incluíram dados de percentagem de pacientes tratados com agentes biológicos. O uso de anti-TNF na DC variou de 1,51% no México até 46,9% na Colômbia, com a maioria dos estudos descrevendo o uso em aproximadamente 20%-40% dos pacientes na DC. Por outro lado, a frequência do uso de biológicos foi claramente menor na RCU, variando de 0% em 2009 a 16,2% em 2018, de acordo com dois estudos mexicanos. Apenas dois estudos descreveram a penetração de agentes anti-TNF nas DII em geral: 13,4% em estudo colombiano e 37,93% em outro estudo brasileiro. Nenhum estudo descreveu o percentual de uso de novos agentes biológicos (vedulizumabe e ustekinumabe). CONCLUSÃO: A penetração de agentes anti-TNF na América Latina é comparável ao resto do mundo na DC, mas menor na RCU. Com o aumento da incidência e prevalência de DII, estratégias específicas para se aumentar o acesso a agentes anti-TNF na RCU e novos agentes biológicos nas DII em geral são justificadas.

Quality of life of patients with inflammatory bowel disease using immunobiological therapy / Qualidade de vida de pacientes com doença inflamatória intestinal em uso de terapia imunobiológica

ABSTRACT Objectives: To assess the quality of life of patients diagnosed with inflammatory bowel disease (IBD) using immunobiological therapy and to relate the general and domain scores of the Inflammatory Bowel Disease Questionnaire (IBDQ) to the immunobiological drug in use and the clinical and sociodemographic variables. Methods: This was a descriptive observational cross-sectional study, conducted from June to September 2018 in a tertiary hospital in Sergipe, which included 47 patients with a diagnosis of Crohn's disease. The IBDQ questionnaire was applied together with a sociodemographic questionnaire, and the clinical data and the history of the disease were analyzed. Results: Female, mixed-race, married patients from the countryside of the state of Sergipe, Brazil, who had never undergone any intestinal surgery, represented most of the study participants. 24 patients were on infliximab and 23 were on adalimumab. Variables such as gender, type of immunobiological drug and duration of its use, and association of therapy with other medications were shown to statistically significantly influence the report quality of life (p-value < 0.05). Conclusion: Further studies with larger samples are necessary to allow a more accurate delimitation of the impact of clinical and sociodemographic variables on the quality of life of patients with inflammatory bowel disease.

RESUMEN Objectivos: Avaliar a qualidade de vida de pacientes diagnosticados com doença inflamatória intestinal (DII) em uso de terapia imunobiológica e relacionar o escore geral e por domínios do "Inflammatory Bowel Disease Questionnaire" (IBDQ) com o imunobiológico em uso e as variáveis clínicas e sociodemográficas. Métodos: Estudo observacional descritivo analítico transversal, realizado no período de junho a setembro de 2018, em hospital terciário de Sergipe, que incluiu 47 pacientes com diagnóstico de Doença de Crohn. Foi aplicado o questionário IBDQ, associado a um questionário sociodemográfico e analisados os dados clínicos e da história da doença. Resultados: Pacientes do sexo feminino, pardos, casados, procedentes do interior de Sergipe e que nunca foram submetidos a nenhuma cirurgia intestinal representaram a maioria dos participantes do estudo. 24 pacientes estavam em uso de Infliximabe e 23 em uso de Adalimumabe. Variáveis como o gênero, tipo de imunobiológico e duração de seu uso e associação da terapêutica com outras medicações mostraram influenciar a qualidade de vida relatada, com significância estatística (p-valor < 0,05). Conclusão: Novos estudos com amostras maiores são necessários para que se possa permitir uma delimitação mais acurada do impacto de variáveis clínicas e sociodemográficas na qualidade de vida dos pacientes com doença inflamatória intestinal.

Validación de Belief Medicines Questionnaire y Self-efficacy for Appropriate Medication Use Scale para medir adherencia al tratamiento farmacológico en pacientes con enfermedad inflamatoria intestinal / Validation of the Belief Medicines Questionnaire and Self-efficacy for Appropriate Medication Use Scale to measure adherence to pharmacological treatment in patients with inflammatory bowel disease

Resumen Introducción: La adherencia terapéutica es crucial en la enfermedad inflamatoria intestinal (EII) para evitar recaídas y complicaciones. En México no se dispone de una herramienta validada para evaluar adherencia en pacientes con EII. Objetivo: Traducir los instrumentos Belief Medicines Questionnaire (BMQ) y Self-Efficacy for Appropriate Medication Use Scale (SEAMS), y determinar su validez, fiabilidad y sensibilidad en pacientes mexicanos con diagnóstico de EII. Método: Se incluyeron 149 pacientes con diagnóstico de EII, previo consentimiento informado. Se tradujeron los instrumentos al español y posteriormente fueron aplicados durante la consulta médica. Para la SEAMS se realizó análisis factorial exploratorio, análisis de curva ROC y determinación del alpha de Cronbach; para el BMQ se empleó el coeficiente kappa de Cohen y su capacidad predictiva. Resultados: Se incluyeron 75 mujeres (50.3 %) con edad promedio de 44 años. La escala SEAMS mostró un único factor altamente confiable (alfa de Cronbach = 0.92) y un punto de corte de 33 para identificar a los pacientes adherentes. Las dimensiones “adherencia” y “barrera de recuerdo” del BMQ fueron adecuados predictores de adherencia. Conclusiones: Las versiones en español SEAMS y BMQ son válidas para medir autoeficacia y barreras para la adherencia al tratamiento farmacológico en pacientes mexicanos con EII.

Abstract Introduction: Treatment adherence is crucial in inflammatory bowel disease (IBD) to prevent relapses and complications. In Mexico, there is not a validated tool to assess adherence in patients with IBD. Objective: To translate the beliefs about medicines questionnaire (BMQ) and self-efficacy for appropriate medication use scale (SEAMS) instruments, as well as to determine their validity, reliability and sensitivity in IBD-diagnosed Mexican patients. Method: After informed consent was obtained, 149 IBD-diagnosed patients were included. The instruments were translated into Spanish and were subsequently applied during medical consultation. For SEAMS, exploratory factorial analysis and ROC curve analysis were carried out and Cronbach’s alpha was determined; for the BMQ, Cohen’s kappa coefficient and its predictive capacity were employed. Results: Seventy-five women (50.3%) were included, with an average age of 44 years. The SEAMS scale showed a single factor that was highly reliable (Cronbach’s alpha = 0.92) and a cutoff point of 33 to identify adherent patients. The “adherence” and “recall barrier” dimensions of the BMQ were adequate adherence predictors. Conclusions: The SEAMS and BMQ Spanish versions are valid for measuring self-efficacy and barriers to pharmacological treatment adherence in Mexican patients with IBD.

Terapia combinada en enfermedad inflamatoria intestinal: ¿una asociación necesaria? / Combination therapy in inflammatory bowel disease: a necessary association?

The management of inflammatory bowel disease (IBD) is constantly changing due to the arrival of new therapeutic agents. Combined therapy (biological associated with immunosuppressive therapy) has proven to be effective, reducing immunogenicity (antibody formation), optimizing the pharmacokinetics of biological therapy with anti-TNF. This therapeutic strategy has associated risks (neoplasia and intercurrent infections) that are not only explained by the use of drugs but also by the increase of cases in older ages. It is essential for the medical team to be familiar with the optimization and personalization of the therapy to achieve clear therapeutic objectives with the lowest possible risks.

El manejo de la enfermedad inflamatoria intestinal (EII) está en constante cambio, debido a la llegada de nuevos agentes terapéuticos. La terapia combinada (terapia biológica asociada a inmunosupresores) ha demostrado ser efectiva al disminuir la inmunogenicidad (formación de anticuerpos) permitiendo la optimización farmacocinética. Esta estrategia terapéutica tiene riesgos asociados (neoplasias e infecciones intercurrentes) que no sólo se explican por el uso de fármacos sino también por el aumento de casos en edades más avanzadas. Es fundamental que el equipo tratante este familiarizado con la optimización y personalización de la terapia para así lograr objetivos terapéuticos claros con los menores riesgos posibles.

Biosimilares en enfermedad inflamatoria intestinal: ¿será una alternativa útil en Chile? / Biosimilars for Inflammatory Bowel disease: would be an option in Chile?

Biological therapies have been essential for the management of inflammatory bowel disease; however, their high cost results in many patients being unable to access them. With time, commercial patents of many "original" biologics are reaching or almost in the point of reaching the expiration date of their licenses, which has allowed for the development of new agents known as biosimilars leading to a reduction of the cost of these therapies. The objective of this review is to explain what biosimilars are and show evidence of their effectiveness and safety.

Las terapias biológicas son parte fundamental en el manejo de la enfermedad inflamatoria intestinal, sin embargo los costos de éstas han hecho que muchos de los pacientes que tienen indicación de su uso, no puedan utilizarlas. Con el paso del tiempo, muchos biológicos "originales" están alcanzando o a punto de alcanzar el vencimiento de sus patentes, lo que ha llevado al desarrollo de nuevos agentes conocidos como biosimilares, determinando una disminución en los costos de estas terapias. Esta revisión tiene como objetivo explicar en qué consisten los biosimilares y la evidencia actual con respecto a su eficacia y seguridad.