96 results on '"Fábio Vieira Teixeira"'
Search Results
2. Adalimumab Serum Concentrations, Clinical and Endoscopic Disease Activity in Crohn’s Disease: A Cross-Sectional Multicentric Latin American Study
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Letícia Rodrigues de Souza, Daniela Oliveira Magro, Fábio Vieira Teixeira, Rogério Serafim Parra, Eron Fábio Miranda, Omar Féres, Rogério Saad-Hossne, Giedre Soares Prates Herrerias, Renato Mitsunori Nisihara, Claudio Saddy Rodrigues Coy, Ligia Yukie Sassaki, and Paulo Gustavo Kotze
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adalimumab ,Crohn’s disease ,inflammatory bowel diseases ,dosage ,therapeutic drug monitoring ,Pharmacy and materia medica ,RS1-441 - Abstract
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 remission
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- 2023
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3. Biosimilar knowledge and viewpoints among Brazilian inflammatory bowel disease patients
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Karoline Soares Garcia, Bianca Pocopetz Facas, Marta Brenner Machado, Fábio Vieira Teixeira, Luisa Avedano, Sanna Lönnfors, Rogério Saad Hossne, Laurent Peyrin-Biroulet, and Natália Sousa Freitas Queiroz
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Diseases of the digestive system. Gastroenterology ,RC799-869 - Abstract
Background: In this analysis we aimed to describe Brazilian inflammatory bowel disease (IBD) patients’ knowledge and perceptions regarding biosimilars and compare with viewpoints from non-Brazilian patients. Methods: An online survey consisting of 19 questions was made available by the European Federation of Crohn’s and Ulcerative Colitis Associations between July 2018 and December 2018. Only respondents who had heard of biosimilars were asked to respond to all of the questions. Results: A total of 102 Brazilian IBD patients responded to the survey. The majority (78.4%) of patients had been exposed to anti-tumor-necrosis-factor drugs and 63.4% of them had heard of biosimilars. Brazilian respondents worried significantly more about biosimilars being less effective than the originator (62.5% versus 47.9%, p value 0.03) and molecular differences between biosimilars and originators (53.1% versus 31.8, p value 0.001) as compared with non-Brazilian IBD patients. The majority of Brazilian (75%) and non-Brazilian (64.1%) respondents thought that the lower cost of biosimilars should not come before their safety and efficacy ( p value 0.09). In addition, 79.1% of Brazilian respondents believed that the arrival of biosimilars will have an impact on the management of IBD. Conclusions: Brazilian patients reported higher rates of misconceptions regarding biosimilars than non-Brazilian IBD patients. Although patients still worry about different aspects regarding biosimilars, they also tend to be confident that biosimilars will have an impact on the management of their disease. With the recent approval of many biosimilars in Brazil and the imminent widespread use of these drugs, our data raise awareness for the need of providing patient education to prevent negative expectations toward switching to biosimilars.
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- 2021
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4. Conventional Versus Biological Therapy for Prevention of Postoperative Endoscopic Recurrence in Patients With Crohn's Disease: an International, Multicenter, and Observational Study
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Paulo Gustavo Kotze, Antonino Spinelli, Rodolff Nunes da Silva, Ivan Folchini de Barcelos, Fábio Vieira Teixeira, Rogério Saad-Hossne, Idblan Carvalho de Albuquerque, Marcia Olandoski, Lorete Maria da Silva Kotze, Yasuo Suzuki, Akihiro Yamada, Ken Takeuchi, Matteo Sacchi, and Takayuki Yamamoto
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Crohn disease ,Recurrence ,Tumor necrosis factor-alpha ,Medicine ,Diseases of the digestive system. Gastroenterology ,RC799-869 - Abstract
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.
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- 2015
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5. BIOSIMILARS IN INFLAMMATORY BOWEL DISEASES: an important moment for Brazilian gastroenterologists
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Fábio Vieira TEIXEIRA, Paulo Gustavo KOTZE, Aderson Omar Mourão Cintra DAMIÃO, and Sender Jankiel MISZPUTEN
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Medicamentos biossimilares ,Colite ulcerativa ,Doença de Crohn ,Diseases of the digestive system. Gastroenterology ,RC799-869 - Abstract
ABSTRACT Biosimilars are not generic drugs. These are more complex medications than small molecules, with identical chemical structures of monoclonal antibodies that lost their patency over time. Besides identical to the original product at the end, the process of achieving its final forms differs from the one used in the reference products. These differences in the formulation process can alter final outcomes such as safety and efficacy of the drugs. Recently, a biosimilar of Infliximab was approved in some countries, even to the management of inflammatory bowel diseases. However, this decision was based on studies performed in rheumatologic conditions such as rheumatoid arthritis and ankylosing spondylitis. Extrapolation of the indications from rheumatologic conditions was done for Crohn’s disease and ulcerative colitis based on these studies. In this article, the authors explain possible different mechanisms in the pathogenesis between rheumatologic conditions and inflammatory bowel diseases, that can lead to different actions of the medications in different diseases. The authors also alert the gastroenterological community for the problem of extrapolation of indications, and explain in full details the reasons for being care with the use of biosimilars in inflammatory bowel diseases without specific data from trials performed in this scenario.
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- 2015
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6. VEDOLIZUMABE NA INDUÇÃO DA REMISSÃO NA RETOCOLITE ULCERATIVA: UM ESTUDO PILOTO OBSERVACIONAL E MULTICÊNTRICO
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Patrícia Zacharias, Rodrigo Bremer Nones, Fábio Vieira Teixeira, Marco Antonio Zeroncio, Cristina Flores, Eron Fábio Miranda, and Paulo Gustavo Kotze
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Diseases of the digestive system. Gastroenterology ,RC799-869 - Published
- 2017
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7. ADALIMUMAB FOR ULCERATIVE COLITIS: RESULTS OF A BRAZILIAN MULTICENTER OBSERVATIONAL STUDY
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Patrícia ZACHARIAS, Aderson Omar Mourão Cintra DAMIÃO, Antonio Carlos MORAES, Fábio Vieira TEIXEIRA, Juliano Coelho LUDVIG, Rodrigo Bremer NONES, Rogerio SAAD-HOSSNE, Ligia Yukie SASSAKI, Rosemary Pereira Lino da SILVA, Luiza FACCHIN, Marcia OLANDOSKI, and Paulo Gustavo KOTZE
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Proctocolite ,Colite ulcerativa ,Adalimumabe ,Doenças inflamatórias intestinais ,Diseases of the digestive system. Gastroenterology ,RC799-869 - Abstract
ABSTRACT BACKGROUND: Adalimumab is a monoclonal antibody, tumor necrosis factor-alpha (TNFα) inhibitor that has efficacy for inducing and maintaining remission in moderate-to-severe ulcerative colitis. Real world studies with adalimumab in Latin American ulcerative colitis patients are scarce. OBJECTIVE: To assess the clinical remission rates in induction and maintenance with adalimumab therapy in ulcerative colitis. METHODS: Observational, multicenter and retrospective study on a case series of patients with moderate-to-severe ulcerative colitis under adalimumab therapy. The variables analyzed were: demographic data, previous infliximab status, concomitant drugs, the Montreal Classification, disease activity (Mayo score) at weeks 0, 8, 26 and 52, or until the last follow-up. Clinical remission was defined as a partial Mayo score ≤2 and Last observation carried forward (LOCF) and Non responder imputation (NRI) analysis were used. RESULTS: Thirty-six patients were included in the study. With LOCF analysis, remission rates at weeks 8, 26 e 52 were of 41.7%, 47.2% and 47.2%, respectively. With NRI analysis, remission rates at weeks 8, 26 and 52 were of 41.7%, 41.7% and 27.8%, respectively. CONCLUSION: Adalimumab was effective in the treatment of moderate-to-severe ulcerative colitis. Clinical remission was observed in approximately 40% of the patients at weeks 8 and 26, and in almost a quarter of the patients after 1 year of follow up.
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- 2017
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8. Risk factors for postoperative endoscopic recurrence in Crohn's disease: a Brazilian observational study
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Ivan Folchini de Barcelos, Rodolff Nunes da Silva, Fábio Vieira Teixeira, Idblan Carvalho de Albuquerque, Rogério Saad-Hossne, Renato Vismara Ropelato, Lorete Maria da Silva Kotze, Márcia Olandoski, and Paulo Gustavo Kotze
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Diseases of the digestive system. Gastroenterology ,RC799-869 - Abstract
Introduction: Postoperative endoscopic recurrence (PER) is the initial event after intestinal resection in Crohn's disease (CD), and after a few years most patients present with progressive symptoms and complications related to the disease. The identification of risk factors for PER can help in the optimization of postoperative therapy and contribute to its prevention. Methods: Retrospective, longitudinal, multicenter, observational study involving patients with CD who underwent ileocolic resections. The patients were allocated into two groups according to the presence of PER and the variables of interest were analyzed to identify the associated factors for recurrence. Results: Eighty-five patients were included in the study. The mean period of the first postoperative colonoscopy was 12.8 (3–120) months and PER was observed in 28 patients (32.9%). There was no statistical difference in relation to gender, mean age, duration of CD, family history, previous intestinal resections, smoking, Montreal classification, blood transfusion, residual CD, surgical technique, postoperative complications, presence of granulomas at histology, specimen extension and use of postoperative biological therapy. The preoperative use of corticosteroids was the only variable that showed a significant difference between the groups in univariate analysis, being more common in patients with PER (42.8% vs. 21%; p = 0.044). Conclusions: PER was observed in 32.9% of the patients. The preoperative use of corticosteroids was the only risk factor associated with PER in this observational analysis. Resumo: Introdução: Recorrência endoscópica pós-operatória (REP) é evento inicial após ressecções intestinais na doença de Crohn (DC) e grande parte dos pacientes progride com sintomas e complicações relacionados à doença em alguns anos. A identificação dos fatores de risco para REP pode auxiliar na otimização da terapia pós-operatória e contribuir para sua prevenção. Método: Estudo retrospectivo, longitudinal, multicêntrico e observacional, realizado com pacientes portadores de DC, submetidos à ressecção ileocólica. Os pacientes foram alocados em dois grupos de acordo com a presença de REP e as variáveis de interesse foram analisadas a fim de se identificar os fatores associados à recorrência. Resultados: Oitenta e cinco pacientes foram incluídos no estudo. O tempo médio da primeira colonoscopia pós-operatória foi de 12,8 (3-120) meses e REP foi observada em 28 pacientes (32,9%). Não houve diferença estatística entre os grupos em relação a gênero, média de idade, duração da DC, história familiar, ressecção intestinal prévia, tabagismo, classificação de Montreal, transfusão sanguínea, DC residual, técnica cirúrgica, complicações pós-operatórias, presença de granuloma, extensão do espécime e utilização de biológicos após a cirurgia. O uso pré-operatório de corticosteroides foi a única variável que apresentou significativa diferença na análise univariada, sendo mais frequente nos pacientes que apresentaram REP (42.8% vs. 21%, p = 0.044). Conclusões: REP foi observada em 32.9% dos pacientes. A utilização pré-operatória de corticosteroides foi o único fator associado à REP nesta análise observacional. Keywords: Crohn disease, Recurrence, Risk factors, Palavras-chave: Doença de Crohn, Recorrência, Fatores de risco
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- 2014
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9. Appendiceal endometriosis as a rare cause of abdominal pain: a case report and literature review
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Rafael Denadai, Rafael Aliceda Ferraz, Ricardo de Álvares Goulart, Rogério Saad-Hossne, and Fábio Vieira Teixeira
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endometriose ,trato gastrointestinal ,apêndice ,dor abdominal ,apendicectomia ,endometriosis ,gastrointestinal tract ,appendix ,abdominal pain ,appendectomy ,Diseases of the digestive system. Gastroenterology ,RC799-869 - Abstract
Endometriosis is an estrogen-dependent inflammatory disease, common in young women, characterized by the presence of endometrial tissue outside the uterine cavity. This ectopic endometrial tissue is most commonly found in the ovaries, peritoneum, uterosacral ligaments and rectovaginal cul-de-sac, with extremely rare involvement of the appendix. The main symptom is chronic abdominal pain, and the diagnosis is often made later, after the result of the histopathological examination. This study reports a 34-year-old patient complaining of chronic pelvic pain refractory to medical treatment, having undergone diagnostic laparotomy. During the surgery, we observed the presence of endometrioma fixed to the uterine wall, and the appendix was enlarged, but without evidence of inflammation. Endometrioma resection and appendectomy were performed, with good postoperative recovery. The anatomopathological exam showed endometriosis in the cecal appendix.Endometriose é uma doença inflamatória estrogênio-dependente frequente em mulheres jovens, caracterizada pela presença de tecido endometrial fora da cavidade uterina. Esse tecido ectópico de endométrio é mais comumente encontrado nos ovários, peritônio, ligamentos uterossacros e fundo de saco retovaginal, sendo o acometimento do apêndice cecal extremamente raro. O quadro clínico predominante é o de dor abdominal crônica, sendo muitas vezes o diagnóstico feito posteriormente, após o resultado do anatomopatológico. Relatamos o caso de uma paciente de 34 anos com queixa de dor pélvica crônica, refratária ao tratamento clínico, tendo sido submetida à laparotomia exploradora diagnóstica. Durante o ato cirúrgico, observamos a presença de endometrioma fixo à parede uterina, bem como apêndice cecal aumentado de volume, porém sem evidência de sinais flogísticos. Procedeu-se à ressecção do endometrioma e apendicectomia, com boa evolução pós-operatória. O resultado do exame anatomopatológico revelou a presença de endometriose no apêndice cecal.
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- 2012
10. The onset of psoriasis during the treatment of inflammatory bowel diseases with infliximab: should biological therapy be suspended?
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Rafael Denadai, Fábio Vieira Teixeira, and Rogério Saad-Hossne
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Doença inflamatória intestinal ,Infliximabe ,Psoríase ,Terapia biológica ,Diseases of the digestive system. Gastroenterology ,RC799-869 - Abstract
CONTEXT: Several paradoxical cases of infliximab-induced or-exacerbated psoriatic lesions have been described in the recent years. There is disagreement regarding the need to discontinue infliximab in order to achieve the resolution of these adverse cutaneous reactions specifically in inflammatory bowel disease (IBD) patients. OBJECTIVE: To systematically review the literature to collect information on IBD patients that showed this adverse cutaneous reaction, focusing mainly on the therapeutic approach. METHODS: A systematic literature review was performed utilizing Medline, Embase, SciELO and Lilacs databases. Published studies were identified, reviewed and the data were extracted. RESULTS: Thirty-four studies (69 IBD patients) met inclusion criteria for review. There was inconsistency in reporting of some clinical and therapeutic aspects. Most patients included had Crohn's disease (89.86%), was female (47.83%), had an average age of 27.11 years, and no reported history of psoriasis (84.05%). The patients developed primarily plaque-type psoriasis (40.58%). There was complete remission of psoriatic lesions in 86.96% of IBD patients, existing differences in the therapeutic approaches; cessation of infliximab therapy led to resolution in 47.83% of cases and 43.48% of patients were able to continue infliximab therapy. CONCLUSION: As increasing numbers of IBD patients with psoriasis induced or exacerbated by infliximab, physicians should be aware of its clinical manifestations so that appropriate diagnosis and treatment are properly established. The decision whether to continue or discontinue infliximab should be individualized.
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- 2012
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11. ADALIMUMABE NO MANEJO DA RETOCOLITE ULCERATIVA INESPECÍFICA: RESULTADOS DE UM ESTUDO MULTICÊNTRICO OBSERVACIONAL BRASILEIRO
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Patrícia Zacharias, Rogerio Saad‐Hossne, Juliano Coelho Ludvig, Fábio Vieira Teixeira, Antonio Carlos Moraes, Aderson Omar Mourão Cintra Damião, and Paulo Gustavo Kotze
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Diseases of the digestive system. Gastroenterology ,RC799-869 - Published
- 2017
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12. Treatment of rectal leiomyoma by endoscopic resection
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Rafael Denadai Pigozzi Silva, Rogério Saad-Hossne, Rafael Aliceda Ferraz, Marcus de Medeiros Matsushita, Roberto Falzoni, and Fábio Vieira Teixeira
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neoplasia retal ,leiomioma ,colonoscopia ,rectal neoplasm ,leiomyoma ,colonoscopy ,Diseases of the digestive system. Gastroenterology ,RC799-869 - Abstract
Leiomyomas of the rectum are rare, with low reported incidence in literature. In most cases, patients are asymptomatic, and are often incidental endoscopic findings. The difficult distinction from leiomyosarcomas, associated with the possibility of recurrence, implies the absence of a standard treatment. Endoscopic resection, if well indicated, may be a therapeutic option. In this study, we report two cases of asymptomatic leiomyoma of the rectum in two patients, discovered incidentally during a routine colonoscopy, removed by conventional polypectomy and discuss its diagnostic and therapeutic aspects based on a literature review.Os leiomiomas de reto são raros, com baixa incidência relatada na literatura; na maioria dos casos os pacientes são assintomáticos, sendo que em muitos casos são achados incidentais endoscópicos. A dificuldade de distinguí-los dos leiomiossarcomas, aliada a possibilidade de recorrência, implica na inexistência de um tratamento padrão. A ressecção endoscópica desde que bem indicada pode ser uma opção terapêutica. Reportamos dois casos de leiomioma de reto assintomáticos em dois pacientes, descobertos casualmente durante exame colonoscópico de rotina, removidos por polipectomia convencional e discutimos seus aspectos diagnósticos e terapêuticos, através de uma revisão da literatura.
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- 2011
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13. Biological therapy in the treatment of moderate-to-severe ulcerative colitis patients: can colectomy be prevented?
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Fábio Vieira Teixeira, Rogério Saad Hossne, Paulo Gustavo Kotze, Rafael Denadai, and Sender Jankiel Miszputen
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terapia biológica ,colectomia ,colite ulcerativa ,resultado do tratamento ,biological therapy ,colectomy ,colitis, ulcerative ,treatment outcome ,Diseases of the digestive system. Gastroenterology ,RC799-869 - Abstract
Ulcerative colitis treatment intends to induce remission, and its maintenance. Biological drugs, such as infliximab, have been indicated in moderate and severe cases of the disease, which are unresponsive to conventional medication. Randomized controlled trials proved the efficacy of biological treatment with high rates of sustained disease remission and mucosal healing. Recently, the concept of mucosal healing has been inversely associated with surgical treatment. Patients treated with infliximab have lower colectomy rates than those receiving conventional therapies. We suppose that earlier use of biological drugs in disease's course would lead to better clinical control and mucosal healing, with a consequent reduction in colectomy rates. To support this hypothesis, a literature review from January, 1996 to April, 2011 was performed.O tratamento da colite ulcerativa tem como objetivo induzir a remissão, além da manutenção da remissão da doença. Agentes biológicos como o infliximabe têm sido indicados em casos moderados e graves da doença, os quais não respondem à medicação convencional. Ensaios clínicos randomizados comprovaram a eficácia do tratamento biológico com altas taxas de remissão da doença e cicatrização sustentada da mucosa. Recentemente, o conceito de cicatrização da mucosa tem sido inversamente associado com o tratamento cirúrgico. Pacientes tratados com infliximabe têm taxas mais baixas de colectomia se comparados com aqueles que receberam terapias convencionais. Supõe-se que quanto mais cedo for introduzida a terapia biológica no curso da doença, melhor seriam o controle clínico e a cicatrização da mucosa, com consequente redução nas taxas de colectomia. Para apoiar esta hipótese, foi realizada uma revisão da literatura entre janeiro de 1996 e abril de 2011.
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- 2011
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14. Fitobezoar em íleo terminal: uma causa rara de obstrução intestinal Phytobezoar in the terminal ileum: an uncommon cause of bowel obstruction
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Rafael Denadai Pigozzi Silva, Rogério Saad-Hossne, Rafael Aliceda Ferraz, and Fábio Vieira Teixeira
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Surgery ,RD1-811 ,Diseases of the digestive system. Gastroenterology ,RC799-869 - Published
- 2011
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15. SERUM INFLIXIMAB MEASUREMENT IN INFLAMMATORY BOWEL DISEASE PATIENTS IN REMISSION: A COMPARATIVE ANALYSIS OF TWO DIFFERENT METHODS IN A MULTICENTRIC BRAZILIAN COHORT
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Fábio Vieira TEIXEIRA, Ligia Yukie SASSAKI, Rogerio SAAD-HOSSNE, Julio Pinheiro BAIMA, Daniéla Oliveira MAGRO, Claudio Saddy Rodrigues COY, and Paulo Gustavo KOTZE
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Doença de Crohn ,Proctocolite ,Infliximab ,Monitoramento de medicamentos ,Diseases of the digestive system. Gastroenterology ,RC799-869 - Abstract
ABSTRACT BACKGROUND: Infliximab (IFX) therapeutic drug monitoring is an important tool to guide therapeutic decision in inflammatory bowel disease patients. Currently, there are two methods to measure trough levels of IFX, ELISA assays or rapid tests. Despite that the ELISA assay is the most used method in therapeutic drug monitoring, the results take long to be available for clinical use, and it needs to be performed by trained personnel. In contrary, the results of a rapid test take 20 to 30 minutes to be available and can be performed by non-trained lab personnel. OBJECTIVE: The aim of the study was to compare a rapid test (QB-IFX) for quantitative determination of IFX level to one ELISA assay in a cohort of inflammatory bowel disease patients. METHODS: Cross-sectional multicentric study with 49 inflammatory bowel disease patients on maintenance therapy with IFX. Blood samples for IFX serum levels were collected immediately before infusion. IFX serum levels were classified as undetectable, low (7.1 μg/mL). A sensitivity and specificity of each test and a comparison between tests was based on ROC curves. RESULTS: Thirty-four Crohn’s disease patients and 15 ulcerative colitis patients in clinical remission were evaluated. The majority of patients had low or adequate serum levels of IFX. In relation to the serum levels proportions with the two methods, there was no significant difference (P=0.84). The ROC analysis identified a concentration threshold >2.9 μg/mL with the QB-IFX test (area under the ROC, 0.82; P3.83 μg/mL using the ELISA assay (area under the ROC, 0.96; P
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16. VEDOLIZUMAB IN THE MANAGEMENT OF INFLAMMATORY BOWEL DISEASES: A BRAZILIAN OBSERVATIONAL MULTICENTRIC STUDY
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Ramir Luan PERIN, Aderson Omar Mourão Cintra DAMIÃO, Cristina FLORES, Juliano Coelho LUDVIG, Daniéla Oliveira MAGRO, Eron Fábio MIRANDA, Antonio Carlos de MORAES, Rodrigo Bremer NONES, Fábio Vieira TEIXEIRA, Marco ZERONCIO, and Paulo Gustavo KOTZE
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Crohn disease ,Ulcerative colitis ,Inflammatory bowel diseases ,Integrins ,Monoclonal antibodies ,Diseases of the digestive system. Gastroenterology ,RC799-869 - Abstract
ABSTRACT BACKGROUND: There is scarce data regarding efficacy and safety of vedolizumab in inflammatory bowel diseases in Latin America. OBJECTIVE: To describe the first observational real-world experience with vedolizumab in Latin American inflammatory bowel diseases patients. METHODS: Retrospective observational multicentric study of patients with Crohn’s disease (CD) and ulcerative colitis (UC) who used vedolizumab at any phase of their treatment. Clinical remission and response (according to Harvey-Bradshaw index for CD and Mayo score for UC), mucosal healing, need for surgery and adverse events were evaluated. RESULTS: A total of 90 patients were included (52 with CD and 38 with UC), the majority with previous exposure to anti-TNF agents (88.46% in CD and 76.31% in UC). In CD (as observed analysis) remission rates at weeks 12, 26 and 52 were 42.89% (21/49), 61.9% (26/42) and 46.15% (12/26), respectively. In UC, remission rates at weeks 12, 26 and 52 were 28.94% (11/38), 36.66% (11/30) and 41.17% (7/17). Mucosal healing rates were 36.11% in CD and 43.4% in UC. During the study period, 7/52 CD patients underwent major abdominal surgery and 4/38 UC patients needed colectomy. CONCLUSION: Vedolizumab was effective in induction and maintenance of clinical response and remission in CD and UC, with no new safety signs.
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17. TOFACITINIB IN THE MANAGEMENT OF ULCERATIVE COLITIS REFRACTORY TO ANTI-TNF AND ANTI-INTEGRIN THERAPIES
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Fábio Vieira TEIXEIRA, Adérson Omar Mourão Cintra DAMIÃO, and Paulo Gustavo KOTZE
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Proctocolitis, therapy ,Biological factors ,Monoclonal antibodies ,Janus kinase inhibitors, therapeutic use ,Diseases of the digestive system. Gastroenterology ,RC799-869 - Abstract
ABSTRACT Janus kinases inhibitors have already been incorporated into the management of immune-mediated diseases, such as rheumatoid arthritis, and are being investigated for the treatment of psoriasis and inflammatory bowel diseases, both ulcerative colitis and Crohn’s disease. Tofacitinib is an oral small-molecule drug that inhibits Janus kinases 1, Janus kinases 3, and, to a lesser extent, Janus kinases 2. This inhibition ends up blocking signals for several inflammatory cytokines that are involved in the pathogenesis of inflammatory bowel diseases and play a role in many immune signaling routes, including lymphocyte activation, function, and proliferation. We report a patient with active ulcerative colitis with primary non-response to three biologics (infliximab, adalimumab and vedolizumab), with different mechanisms of action, who refused surgical treatment and had a favorable response to tofacitinib with clinical and endoscopic remission. No adverse events were observed with the use of the agent. This case illustrates the difficulties we may face regarding the identification of the expression of proper mechanism of action involved in the pathogenesis of ulcerative colitis patients and the importance of having another treatment option with different mechanism of action, like tofacitinib.
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18. Teníase: uma causa rara de apendicite aguda
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Fábio Vieira Teixeira, Amadeu Fernandes Filho, Antonely de Cassio Alves de Carvalho, Talita Junqueira, and Priscila Cordeiro
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Appendix ,Appendicitis ,Helminthes ,Parasitic diseases ,Surgery ,RD1-811 - Abstract
Acute appendicitis is the most common surgical condition of acute abdomen. Approximately 7 percent of the population will have appendicitis during their lifetime, with the peak incidence occurring between 10 through 30 years-old. Obstruction of the appendix lumen with subsequent bacterial infection initiates the pathophysiological sequence of acute appendicitis. Obstruction may have multiple causes, including fecalith, lymphoid hyperplasia (related to viral illnesses, including upper respiratory infection, mononucleosis, and gastroenteritis), foreign bodies, carcinoid tumor, and parasites. In Asia, Africa and Latin America, Enterobius vermicularis has been reported as the main parasite that causes appendix obstruction. Rarely, Taenia sp., has been pointed as a cause of parasitic appendicitis. We reported a 30 years-old patient clinically diagnosed with acute appendicitis. The appendectomy was performed through a McBurney incision. The patient's convalescence was uneventful, and he was discharged from hospital 48 hours after operation. Histological examination of the appendix showed acute appendicitis, and it was found a parasite (Taenia sp.) lying inside of the appendix lumen at a transverse section. He has received 10 mg/Kg weight of praziquantel for taeniasis treatment.
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19. BRAZILIAN IBD STUDY GROUP POSITION STATEMENT ON SARS-COV2 VACCINATION
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Natália Sousa Freitas QUEIROZ, Fábio Vieira TEIXEIRA, Caio Cesar Furtado FREIRE, Marina Pamponet MOTTA, Marcela Almeida Menezes de VASCONCELLOS, Liliana Andrade CHEBLI, and Rogerio SAAD-HOSSNE
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Diseases of the digestive system. Gastroenterology ,RC799-869 - Abstract
ABSTRACT Mass vaccination offers the best strategy to fight against COVID-19 pandemic, and SARS-CoV2 vaccines are being approved in several countries for emergency use. In Brazil, vaccine approval is expected in the next few days, however potential concerns exist regarding vaccine recommendations for specific populations, such as patients with inflammatory bowel disease (IBD). To address these questions, the Brazilian IBD Study Group (GEDIIB) provides this practical advice with key recommendations about the COVID-19 vaccines in IBD population.
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20. ANVISA APPROVES THE FIRST BIOSIMILAR MONOCLONAL ANTIBODY BASED ON COMPARABILITY IN BRAZIL
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Fábio Vieira TEIXEIRA, Paulo Gustavo KOTZE, and Adérson Omar Mourão Cintra DAMIÃO
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Medicamentos biossimilares ,Doença de Crohn ,Colite ulcerativa ,Diseases of the digestive system. Gastroenterology ,RC799-869 - Full Text
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21. Biological Therapy in Ulcerative Colitis
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Fábio Vieira Teixeira and Rogério Saad Hossne
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- 2022
22. International consensus on the prevention of venous and arterial thrombotic events in patients with inflammatory bowel disease
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Tim Raine, Siew C. Ng, Edouard Louis, David T. Rubin, Peter Bossuyt, Fernando Magro, Laurent Peyrin-Biroulet, Subrata Ghosh, Silvio Danese, Paulo Gustavo Kotze, Véronique Regnault, Fábio Vieira Teixeira, Patrick Lacolley, Alfredo Papa, Taku Kobayashi, Stéphane Zuily, Richard B. Gearry, Sameer Al Awadhi, Pablo Olivera, Zuily, Stephane [0000-0002-9326-6881], Kotze, Paulo G [0000-0002-9632-6691], Bossuyt, Peter [0000-0003-4027-7365], Ghosh, Subrata [0000-0002-1713-7797], Kobayashi, Taku [0000-0002-2073-4234], Ng, Siew C [0000-0002-6850-4454], Papa, Alfredo [0000-0002-4186-7298], Raine, Tim [0000-0002-5855-9873], Rubin, David T [0000-0001-5647-1723], Danese, Silvio [0000-0001-7341-1351], Peyrin-Biroulet, Laurent [0000-0003-2536-6618], Apollo - University of Cambridge Repository, Centro de Educación Médica e Investigaciones Clínicas (CEMIC), Défaillance Cardiovasculaire Aiguë et Chronique (DCAC), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), Pontifical Catholic University of Paraná (PUCPR), Pontifical Catholic University of Paraná, Rashid Hospital, Imelda General Hospital, University of Otago [Dunedin, Nouvelle-Zélande], University of Birmingham [Birmingham], Kitasato University, NIHR Biomedical Research Centre [London], Guy's and St Thomas' NHS Foundation Trust-King‘s College London, Centre Hospitalier Universitaire de Liège (CHU-Liège), Hospital de São João [Porto], The Chinese University of Hong Kong [Hong Kong], Fondazione 'Policlinico Universitario A. Gemelli' [Rome], Cambridge University Hospitals - NHS (CUH), University of Cambridge [UK] (CAM), The University of Chicago Medicine [Chicago], Istituto Clinico Humanitas [Milan] (IRCCS Milan), Humanitas University [Milan] (Hunimed), Nutrition-Génétique et Exposition aux Risques Environnementaux (NGERE), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL)
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Evidence-Based Guidelines ,medicine.medical_specialty ,[SDV]Life Sciences [q-bio] ,International Cooperation ,Settore MED/12 - GASTROENTEROLOGIA ,education ,Anti-Inflammatory Agents ,MEDLINE ,030204 cardiovascular system & hematology ,Risk Assessment ,Inflammatory bowel disease ,03 medical and health sciences ,0302 clinical medicine ,Fibrinolytic Agents ,Risk Factors ,Epidemiology ,Humans ,Medicine ,In patient ,Risk factor ,Intensive care medicine ,Hepatology ,business.industry ,Patient Acuity ,Gastroenterology ,Thrombosis ,Guideline ,Evidence-based medicine ,Inflammatory Bowel Diseases ,medicine.disease ,digestive system diseases ,3. Good health ,Hospitalization ,Cardiovascular diseases ,030211 gastroenterology & hepatology ,business - Abstract
Patients with inflammatory bowel disease (IBD) are at increased risk of thrombotic events. Therapies for IBD have the potential to modulate this risk. The aims of this Evidence-Based Guideline were to summarize available evidence and to provide practical recommendations regarding epidemiological aspects, prevention and drug-related risks of venous and arterial thrombotic events in patients with IBD. A virtual meeting took place in May 2020 involving 14 international IBD experts and 3 thrombosis experts from 12 countries. Proposed statements were voted upon in an anonymous manner. Agreement was defined as at least 75% of participants voting as ‘fully agree’ or ‘mostly agree’ with each statement. For each statement, the level of evidence was graded according to the Scottish Intercollegiate Guidelines Network (SIGN) grading system. Consensus was reached for 19 statements. Patients with IBD harbour an increased risk of venous and arterial thrombotic events. Thromboprophylaxis is indicated during hospitalization of any cause in patients with IBD. Disease activity is a modifiable risk factor in patients with IBD, and physicians should aim to achieve deep remission to reduce the risk. Exposure to steroids should be limited. Antitumour necrosis factor agents might be associated with a reduced risk of thrombotic events., Patients with inflammatory bowel disease (IBD) are at increased risk of thrombotic events. This Evidence-Based Guideline presents an international consensus on the prevention of venous and arterial thrombotic events in patients with IBD, and includes 19 recommendations for clinical practice.
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- 2021
23. Risk stratification and geographical mapping of Brazilian inflammatory bowel disease patients during the COVID-19 outbreak: Results from a nationwide survey
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Natália Sousa Freitas Queiroz, Fábio Vieira Teixeira, Camilla de Almeida Martins, Liliana Andrade Chebli, Marina Pamponet Motta, Aderson Omar Mourão Cintra Damião, Adriano Akira Ferreira Hino, Paulo Gustavo Kotze, Rogerio Saad-Hossne, Abel Botelho Quaresma, Alexandre Augusto de Paula da Silva, Universidade de São Paulo (USP), Gastrosaúde Clinic, Universidade Federal da Bahia (UFBA), Universidade Federal de Juiz de Fora, Pontifícia Universidade Católica do Paraná (PUCPR), Universidade do Oeste de Santa Catarina (UNOESC), Universidade Estadual Paulista (Unesp), and Pontificia Universidade Católica do Paraná (PUCPR)
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Male ,Crohn’s disease ,Observational Study ,Ulcerative ,Risk Assessment ,Inflammatory bowel disease ,03 medical and health sciences ,0302 clinical medicine ,Health care ,Pandemic ,Humans ,Medicine ,Socioeconomic status ,Crohn's disease ,SARS-CoV-2 ,business.industry ,Mortality rate ,Gastroenterology ,COVID-19 ,Outbreak ,General Medicine ,Inflammatory Bowel Diseases ,Colitis ,medicine.disease ,030220 oncology & carcinogenesis ,Female ,Colitis, Ulcerative ,030211 gastroenterology & hepatology ,business ,Risk assessment ,Brazil ,Demography - Abstract
Made available in DSpace on 2021-06-25T11:14:20Z (GMT). No. of bitstreams: 0 Previous issue date: 2021-03-28 BACKGROUND Coronavirus disease 2019 (COVID-19) pandemic is still evolving globally, and Brazil is currently one of the most affected countries. It is still debated whether patients with inflammatory bowel disease (IBD) are at a higher risk for developing COVID-19 or its complications. AIM To assess geographical distribution of IBD patients at the highest risk and correlate these data with COVID-19 mortality rates in Brazil. METHODS The Brazilian IBD Study Group (Grupo de Estudos da Doença Inflamatória Intestinal do Brasil) developed a web-based survey adapted from the British Society of Gastroenterology guidelines. The included categories were demographic data and inquiries related to risk factors for complications from COVID-19. Patients were categorized as highest, moderate or lowest individual risk. The Spearman correlation test was used to identify any association between highest risk and mortality rates for each state of the country. RESULTS A total of 3568 patients (65.3% females) were included. Most participants were from the southeastern and southern regions of Brazil, and 84.1% were using immunomodulators and/or biologics. Most patients (55.1%) were at moderate risk, 23.4% were at highest risk and 21.5% were at lowest risk of COVID-19 complications. No association between the proportion of IBD patients at highest risk for COVID-19 complications and higher mortality rates was identified in different Brazilian states (r = 0.146, P = 0.467). CONCLUSION This study indicates a distinct geographical distribution of IBD patients at highest risk for COVID-19 complications in different states of the country, which may reflect contrasting socioeconomic, educational and healthcare aspects. No association between high risk of IBD and COVID-related mortality rates was identified. Department of Gastroenterology University of São Paulo School of Medicine IBD Unit Gastroenterology Department Gastrosaúde Clinic School of Medicine Federal University of Bahia IBD Outpatient Clinics Universidade Federal de Juiz de Fora Health Sciences Postgraduate Program Pontifícia Universidade Católica do Paraná (PUCPR) Departamento de Ciências da Saúde Universidade do Oeste de Santa Catarina (UNOESC) Botucatu Medical School Paulista State University (UNESP) IBD Outpatient Clinics Pontificia Universidade Católica do Paraná (PUCPR) Botucatu Medical School Paulista State University (UNESP)
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- 2021
24. Anti-TNF and Postoperative Complications in Abdominal Crohn's Disease Surgery
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Fábio Vieira Teixeira, Silvio Danese, Rogerio Saad-Hossne, Paulo Gustavo Kotze, Takayuki Yamamoto, Yamamoto, T, Teixeira, Fv, Saad-Hossne, R, Kotze, Pg, and Danese, S
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Male ,medicine.medical_specialty ,Clinical Biochemistry ,Disease ,Inflammatory bowel disease ,Sepsis ,03 medical and health sciences ,Postoperative Complications ,0302 clinical medicine ,Crohn Disease ,Drug Discovery ,medicine ,Humans ,Prospective cohort study ,Digestive System Surgical Procedures ,Pharmacology ,Biological Products ,Crohn's disease ,Tumor Necrosis Factor-alpha ,business.industry ,Incidence ,Retrospective cohort study ,medicine.disease ,Surgery ,Clinical trial ,030220 oncology & carcinogenesis ,Molecular Medicine ,Female ,030211 gastroenterology & hepatology ,business ,Abdominal surgery - Abstract
Background: : Biological therapy with anti-Tumour Necrosis Factor (TNF)-α agents revolutionised the treatment of inflammatory bowel disease over the last decades. However, there may be an increased risk of postoperative complications in Crohn’s disease (CD) patients treated with anti-TNF-α agents prior to abdominal surgery. Objective:: To evaluate the effects of preoperative anti-TNF-α therapy on the incidence of complications after surgery. Methods: : A critical assessment of the results of clinical trial outcomes and meta-analyses on the available data was conducted. Results: : Based on the outcomes of previous reports including meta-analyses, preoperative use of anti- TNF-α agents modestly increased the risk of overall complications and particularly infectious complications after abdominal surgery for CD. Nevertheless, previous studies have several limitations. The majority of them were retrospective research with heterogeneous outcome measures and single centre trials with relatively small sample size. In retrospective studies, the standard protocol for assessing various types of postoperative complications was not used. The most serious limitation of the previous studies was that multiple confounding factors such as malnutrition, use of corticosteroids, and preoperative sepsis were not taken into consideration. Conclusion:: Among patients treated with preoperative anti-TNF-α therapy, the risk of overall complications and infectious complications may slightly increase after abdominal surgery for CD. Nevertheless, the previous reports reviewed in this study suffered from limitations. To rigorously evaluate the risk of anti-TNF-α therapy prior to surgery, large prospective studies with standardised criteria for assessing surgical complications and with proper adjustment for confounding variables are warranted.
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- 2019
25. GUIDELINE ON ULCERATIVE COLITIS
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Aderson Omar Mourão Cintra Damião, Sender Jankiel Miszputen, Andrea Vieira, José Miguel Luz Parente, Julio Maria Fonseca Chebli, Orlando Ambrogini Junior, Fábio Vieira Teixeira, Rogerio Saad-Hossne, Eduardo Garcia Vilela, Clinica GastroSaúde Coloproctology, Marília, Sp, Brazil., and Idblan Carvalho de Albuquerque
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medicine.medical_specialty ,business.industry ,Internal medicine ,Medicine ,Guideline ,business ,medicine.disease ,Ulcerative colitis ,Gastroenterology - Published
- 2019
26. ARE WE READY FOR MULTIPLE SWITCHES BETWEEN REFERENCE PRODUCTS AND BIOSIMILARS?
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Fabio Vieira TEIXEIRA, Laurent PEYRIN-BIROULET, and Silvio DANESE
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biosimilar ,inflammatory bowel disease ,infliximab ,SB2 ,CT-P13 ,Diseases of the digestive system. Gastroenterology ,RC799-869 - Abstract
ABSTRACT Inflammatory bowel diseases (IBD) currently impose an immense social and economic burden on society in terms of both direct and indirect healthcare costs. Their incurable and progressive nature results in an unavoidable lifetime expense. The introduction of infliximab more than two decades ago had revolutionized IBD treatment. Nowadays, while biologic drugs comprise various vital therapeutic options for patients, they can be associated to significant costs to healthcare systems. The most crucial benefit of biosimilars is that they bring more significant cost reduction and increase access to advanced therapies. They also allow the treatment of newly diagnosed patients and dose optimization for those who need it. There is an inverse relationship between price and demand for treatment with biologics. For a more significant reduction in cost to be possible, greater use of biosimilars is necessary. For this to occur, it is imperative not only to use biosimilars in naïve patients but also to switch to biosimilars in those patients who have started therapy with reference biologics. At present, randomized and observational studies have demonstrated effectiveness and safety results in recommending a single switch between a reference product and a biosimilar, and vice versa. The purpose of this manuscript is to review the literature and discuss whether scientific evidence is enough to support multiple switches of biologics and biosimilars in IBD patients.
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- 2024
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27. Exploring the Relationship Between Biologics and Postoperative Surgical Morbidity in Ulcerative Colitis: A Review
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Fábio Vieira Teixeira, Abel Botelho Quaresma, Paulo Gustavo Kotze, Rogerio Saad-Hossne, and Fernanda da Silva Barbosa Baraúna
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medicine.medical_specialty ,Population ,monoclonal ,lcsh:Medicine ,Review ,Vedolizumab ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,medicine ,postoperative complications ,antibodies ,infections ,education ,Prospective cohort study ,ulcerative colitis ,education.field_of_study ,business.industry ,lcsh:R ,Postoperative complication ,General Medicine ,medicine.disease ,necrosis tumor factor-alpha ,Ulcerative colitis ,Surgical morbidity ,Systematic review ,030220 oncology & carcinogenesis ,integrins ,030211 gastroenterology & hepatology ,Complication ,business ,medicine.drug - Abstract
Background: With the paradigm shift related to the overspread use of biological agents in the treatment of inflammatory bowel diseases (IBD), several questions emerged from the surgical perspective. Whether the use of biologicals would be associated with higher rates of postoperative complications in ulcerative colitis (UC) patients still remains controversial. Aims: We aimed to analyze the literature, searching for studies that correlated postoperative complications and preoperative exposure to biologics in UC patients, and synthesize these data qualitatively in order to check the possible impact of biologics on postoperative surgical morbidity in this population. Methods: Included studies were identified by electronic search in the PUBMED database according to the PRISMA (Preferred Items of Reports for Systematic Reviews and Meta-Analysis) guidelines. The quality and bias assessments were performed by MINORS (methodological index for non-randomized studies) criteria for non-randomized studies. Results: 608 studies were initially identified, 22 of which were selected for qualitative evaluation. From those, 19 studies (17 retrospective and two prospective) included preoperative anti-TNF. Seven described an increased risk of postoperative complications, and 12 showed no significant increase postoperative morbidity. Only three studies included surgical UC patients with previous use of vedolizumab, two retrospective and one prospective, all with no significant correlation between the drug and an increase in postoperative complication rates. Conclusions: Despite conflicting results, most studies have not shown increased complication rates after abdominal surgical procedures in patients with UC with preoperative exposure to biologics. Further prospective studies are needed to better establish the impact of preoperative biologics and surgical complications in UC.
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- 2021
28. Adalimumabe no manejo da retocolite ulcerativa inespecífica: resultados de um estudo multicêntrico observacional brasileiro
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Antônio Carlos Moraes, R. Silva, Juliano Coelho Ludvig, Ligia Yukie Sassaki, Rogerio Saad-Hossne, Patricia Zacharias, Aderson Omar Mourão Cintra Damião, Rodrigo Bremer Nones, Fábio Vieira Teixeira, Marcia Olandoski, Luiza Facchin, and Paulo Gustavo Kotze
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Adult ,Male ,musculoskeletal diseases ,Proctocolitis ,medicine.medical_specialty ,Adolescent ,Proctocolite ,Anti-Inflammatory Agents ,Doenças inflamatórias intestinais ,Inflammatory bowel diseases ,Antibodies, Monoclonal, Humanized ,Severity of Illness Index ,Young Adult ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,medicine ,Adalimumab ,Humans ,Longitudinal Studies ,lcsh:RC799-869 ,Aged ,Retrospective Studies ,Colite ulcerativa ,business.industry ,Adalimumabe ,Gastroenterology ,Retrospective cohort study ,Middle Aged ,medicine.disease ,Ulcerative colitis ,Infliximab ,Treatment Outcome ,030220 oncology & carcinogenesis ,Concomitant ,Colitis, Ulcerative ,Female ,lcsh:Diseases of the digestive system. Gastroenterology ,030211 gastroenterology & hepatology ,Mayo score ,Observational study ,business ,medicine.drug - Abstract
BACKGROUND: Adalimumab is a monoclonal antibody, tumor necrosis factor-alpha (TNFα) inhibitor that has efficacy for inducing and maintaining remission in moderate-to-severe ulcerative colitis. Real world studies with adalimumab in Latin American ulcerative colitis patients are scarce. OBJECTIVE: To assess the clinical remission rates in induction and maintenance with adalimumab therapy in ulcerative colitis. METHODS: Observational, multicenter and retrospective study on a case series of patients with moderate-to-severe ulcerative colitis under adalimumab therapy. The variables analyzed were: demographic data, previous infliximab status, concomitant drugs, the Montreal Classification, disease activity (Mayo score) at weeks 0, 8, 26 and 52, or until the last follow-up. Clinical remission was defined as a partial Mayo score ≤2 and Last observation carried forward (LOCF) and Non responder imputation (NRI) analysis were used. RESULTS: Thirty-six patients were included in the study. With LOCF analysis, remission rates at weeks 8, 26 e 52 were of 41.7%, 47.2% and 47.2%, respectively. With NRI analysis, remission rates at weeks 8, 26 and 52 were of 41.7%, 41.7% and 27.8%, respectively. CONCLUSION: Adalimumab was effective in the treatment of moderate-to-severe ulcerative colitis. Clinical remission was observed in approximately 40% of the patients at weeks 8 and 26, and in almost a quarter of the patients after 1 year of follow up. RESUMO CONTEXTO: O adalimumabe é um anticorpo monoclonal, inibidor do TNF alfa, que tem eficácia comprovada na indução e manutenção da remissão na retocolite ulcerativa inespecífica moderada à severa. Há escassez de dados sobre o uso do adalimumabe na retocolite ulcerativa inespecífica em pacientes latino-americanos. OBJETIVO: Analisar as taxas de remissão clínica na indução e manutenção do tratamento da retocolite ulcerativa inespecífica com adalimumabe. MÉTODOS: Estudo observacional, multicêntrico e retrospectivo de uma série de casos de portadores de retocolite ulcerativa inespecífica moderada à grave que utilizaram adalimumabe. Variáveis analisadas: dados demográficos, uso prévio de infliximabe, medicações concomitantes, Classificação de Montreal, atividade da doença (escore parcial de Mayo) nas semanas 0, 8, 26 e 52, ou até o maior tempo de seguimento atingido. Remissão clínica foi definida como escore parcial de Mayo ≤2 e foi avaliada pelos métodos. Abordagem com base na observação mais recente (LOCF) e Imputação de não respondedores (NRI). RESULTADOS: Trinta e seis pacientes foram incluídos no estudo. Pela análise LOCF, as taxas de remissão nas semanas 8, 26 e 52 foram de 41,7%, 47,2% e 47,2%, respectivamente. Pela análise NRI, as taxas nas semanas 8, 26 e 52 foram de 41,7%, 41,7% e 27,8%, respectivamente. CONCLUSÃO: Adalimumabe foi eficaz no manejo da retocolite ulcerativa inespecífica moderada a grave. A remissão clínica foi observada em cerca de 40% dos pacientes nas semanas 8 e 26, e em cerca de 1/4 dos pacientes após 1 ano de seguimento.
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- 2017
29. Letter: thromboembolic and cardiovascular events with tofacitinib in ulcerative colitis-two cases in real world clinical practice
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Fábio Vieira Teixeira, Paulo Gustavo Kotze, and Aderson Omar Mourão Cintra Damião
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medicine.medical_specialty ,Tofacitinib ,Hepatology ,business.industry ,Gastroenterology ,MEDLINE ,medicine.disease ,Ulcerative colitis ,Clinical Practice ,Pyrimidines ,Piperidines ,Internal medicine ,medicine ,Humans ,Colitis, Ulcerative ,Pyrroles ,Pharmacology (medical) ,Colitis ,business - Published
- 2020
30. Serum levels of infliximab in Brazilian patients with Crohn's disease: what are the reasons for differences from previous studies?
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Paulo Gustavo Kotze, Omar Féres, Fábio Vieira Teixeira, and Rogério Serafim Parra
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musculoskeletal diseases ,medicine.medical_specialty ,Disease ,030204 cardiovascular system & hematology ,Gastroenterology ,Disease activity ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,Active disease ,medicine ,030212 general & internal medicine ,skin and connective tissue diseases ,Crohn's disease ,lcsh:R5-920 ,biology ,business.industry ,General Medicine ,medicine.disease ,Infliximab ,DOENÇAS AUTOIMUNES ,biology.protein ,Antibody ,business ,lcsh:Medicine (General) ,medicine.drug - Abstract
Dear Sir, It was with significant interest that we read the manuscript, entitled “Serum Levels of Infliximab and Anti-Infliximab Antibodies in Brazilian Patients with Crohn’s Disease”, recently published in this distinguished journal by Gomes et al. (). In this study, the authors measured the serum infliximab (IFX) levels of 40 patients with Crohn’s disease (CD) and correlated their findings with disease activity. There was no difference in the IFX level between patients with active disease and those with remission (p
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- 2019
31. Ulcerative colitis - treatment with biologicals
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Julio Maria Fonseca Chebli, José Miguel Luz Parente, Rogério Saad Hossne, Andrea Vieira, Orlando Ambrogini Junior, Eduardo Garcia Vilela, Sender Jankiel Miszputen, Fábio Vieira Teixeira, Idblan Carvalho de Albuquerque, and Aderson Omar Mourão Cintra Damião
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medicine.medical_specialty ,Treatment outcome ,Clinical Decision-Making ,MEDLINE ,Antibodies, Monoclonal, Humanized ,Gastroenterology ,Remission induction ,Text mining ,Clinical decision making ,Internal medicine ,medicine ,Humans ,Colitis ,lcsh:R5-920 ,business.industry ,Remission Induction ,Adalimumab ,Antibodies, Monoclonal ,General Medicine ,medicine.disease ,Ulcerative colitis ,Infliximab ,Treatment Outcome ,Monoclonal ,Cyclosporine ,Colitis, Ulcerative ,lcsh:Medicine (General) ,business ,Brazil - Abstract
The Guidelines Project, an initiative of the Brazilian Medical Association, aims to combine information from the medical field in order to standardize producers to assist the reasoning and decision-making of doctors. The information provided through this project must be assessed and criticized by the physician responsible for the conduct that will be adopted, depending on the conditions and the clinical status of each patient.
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- 2019
32. Results of the Fifth Scientific Workshop of the ECCO (II): Pathophysiology of Perianal Fistulizing Disease
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Roger Feakins, Giorgos Barmias, Gerhard Rogler, Fábio Vieira Teixeira, Britta Siegmund, Michael Scharl, Juliano Coelho Ludvig, Charité-Universitätsmedizin Berlin, Royal London Hospital, Laikon Hospital, Santa Isabel Hospital, Gastrosaude Clinic, Universidade Estadual Paulista (Unesp), and University of Zurich
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medicine.medical_specialty ,Fistula ,Intestinal microbiota ,Disease ,Mouse models ,Inflammatory bowel disease ,Disease course ,03 medical and health sciences ,0302 clinical medicine ,medicine ,Genetic predisposition ,Intensive care medicine ,Rectal fistula ,Crohn's disease ,Crohn disease ,business.industry ,Gastroenterology ,General Medicine ,medicine.disease ,Fibrosis ,Surgery ,Epithelial-to-mesenchymal transition ,030220 oncology & carcinogenesis ,Cytokines ,030211 gastroenterology & hepatology ,business - Abstract
Made available in DSpace on 2018-12-11T16:42:16Z (GMT). No. of bitstreams: 0 Previous issue date: 2016-04-01 The fifth scientific workshop of the European Crohn's and Colitis Organization (ECCO) focused on the relevance of fistulas to the disease course of patients with Crohn's disease (CD). The objectives were to reach a better understanding of the pathophysiological mechanisms underlying the formation of CD fistulas; to identify future topics in fistula research that could provide insights into pathogenesis; to develop novel therapeutic approaches; and to review current therapeutic strategies (with clarification of existing approaches to prevention, diagnosis and treatment). The results of the workshop are presented in two separate manuscripts. This manuscript describes current state-of-the-art knowledge about fistula pathogenesis, including the roles of epithelial-tomesenchymal transition and cytokine matrix remodelling enzymes, and highlights the common association between fistulas and stenosis in CD. The review also considers the possible roles that genetic predisposition and intestinal microbiota play in fistula development. Finally, it proposes future directions and needs for fistula research that might substantially increase our understanding of this complex condition and help unravel novel therapeutic strategies and specific targets for treatment. Overall, it aims to highlight unanswered questions in fistula research and to provide a framework for future research work. Department of Medicine (Gastroenterology Infectious Diseases Rheumatology) Charité-Universitätsmedizin Berlin Department of Histopathology Royal London Hospital Academic Department of Gastroenterology Ethnikon and Kapodistriakon University of Athens Laikon Hospital ESADI Clinic and Gastroenterology Unit Santa Isabel Hospital Colorectal Unit Gastrosaude Clinic Department of Surgery UNESP Botucatu Division of Gastroenterology and Hepatology University Hospital Zurich University of Zurich Department of Surgery UNESP Botucatu
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- 2015
33. P739 The progression of inflammatory bowel disease throughout Latin America: a systematic review
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D Simian, Gilaad G. Kaplan, A. O. M. C. Damião, Subrata Ghosh, Fox E. Underwood, Paulo Gustavo Kotze, Jose G. Ferraz, Francisco Bosques-Padilla, Fábio Vieira Teixeira, Remo Panaccione, Rogerio Saad-Hossne, M Toro, F. Juliao-Baños, and B. Iade
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medicine.medical_specialty ,Latin Americans ,business.industry ,Internal medicine ,Gastroenterology ,medicine ,General Medicine ,medicine.disease ,business ,Inflammatory bowel disease - Published
- 2019
34. Tratamento da retocolite ulcerativa: atualização clínica
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Rogerio Saad Hosne, Fábio Vieira Teixeira, and Carlos Walter Sobrado
- Subjects
0301 basic medicine ,medicine.medical_specialty ,Toxic megacolon ,Complications ,Perforation (oil well) ,MEDLINE ,RC799-869 ,Acute colitis ,Clinical treatment ,03 medical and health sciences ,0302 clinical medicine ,Quality of life ,medicine ,Intensive care medicine ,Tratamento clínico ,Management of ulcerative colitis ,Colite ulcerativa ,Cirurgia ,business.industry ,Gastroenterology ,Colite aguda ,Diseases of the digestive system. Gastroenterology ,medicine.disease ,Ulcerative colitis ,Surgery ,030104 developmental biology ,030211 gastroenterology & hepatology ,Observational study ,business ,Complicações - Abstract
The objective of this study was to evaluate the consensus of expert societies and published guidelines on the management of ulcerative colitis, and to compare with the experience of the authors, in order to standardize procedures that would help the reasoning and decision-making process of the physician. A search was performed in scientific literature, specifically in electronic databases: Medline/Pubmed, SciELO, EMBASE and Cochrane, and the following descriptors were used: ulcerative colitis, acute colitis, clinical treatment, surgery and randomized trial. It can be concluded that the goals of therapy in ulcerative colitis are clinical and endoscopic remission, deep, sustained remission without corticosteroids, prevention of hospitalizations and surgeries, and improved quality of life. The surgical indications are reserved for selected cases, ranging from medical intractability, complications (severe refractory acute colitis, toxic megacolon, perforation and hemorrhage) and malignancy. Information in this review article must be submitted to evaluation and criticism of the specialist responsible for the conduct to be followed, in the face of his/her reality and the clinical status of each patient.The degree of recommendation and strength of evidence were based using the GRADE system (The Grades of Recommendation, Assessment, Development, and Evaluation) described below:1. A: Experimental or observational studies of higher consistency.2. B: Experimental or observational studies of lower consistency.3. C: Case reports (non-controlled studies).4. D: Opinion without critical evaluation, based on consensus, physiological studies or animal models. Resumo: O objetivo deste trabalho foi avaliar os consensos de sociedades de especialistas e guidelines publicados sobre o manejo da retocolite ulcerativa, e confrontar com a experiência dos autores, a fim de padronizar condutas que auxiliem o raciocínio e a tomada de decisão do médico. Foi realizada busca na literatura científica, mais precisamente nas bases de dados eletrônicos: Medline/Pubmed, SciELO, EMBASE e Cochrane, tendo sido utilizado os descritores: ulcerative colitis, acute colitis, clinical treatment, surgery e randomized trial. Pode-se concluir que os objetivos da terapia na retocolite ulcerativa são: remissão clínica e endoscópica, a remissão profunda sustentada sem corticosteróides, evitar hospitalizações e cirurgias, e melhora na qualidade de vida. As indicações cirúrgicas ficam reservadas para casos selecionados que variam de intratabilidade clínica, complicações (Colite aguda grave refratária, megacólon tóxico, perfuração e hemorragia) e malignização. As informações contidas neste artigo de revisão devem ser submetidas à avaliação e à crítica do médico especialista, responsável pela conduta a ser seguida, frente à sua realidade e ao estado clínico de cada paciente.O grau de recomendaçã̃o e forç̧a de evidência foram baseados usando o GRADE system (The Grades of Recomendation, Assessment, Development, and Evaluation), descrito abaixo:A: Estudos experimentais ou observacionais de melhor consistência.B: Estudos experimentais ou observacionais de menor consistência.C: Relatos de casos (estudos não controlados).D: Opinião desprovida de avaliação crítica, baseada em consensos, estudos fisiológicos ou modelos animais. Keywords: Ulcerative colitis, Acute colitis, Clinical treatment, Surgery, Complications, Palavras-chave: Colite ulcerativa, Colite aguda, Tratamento clínico, Cirurgia, Complicações
- Published
- 2015
35. Recommendations on the use of biosimilars by the Brazilian Society of Rheumatology, Brazilian Society of Dermatology, Brazilian Federation of Gastroenterology and Brazilian Study Group on Inflammatory Bowel Disease—Focus on clinical evaluation of monoclonal antibodies and fusion proteins used in the treatment of autoimmune diseases
- Author
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Fábio Vieira Teixeira, Ana Cristina Medeiros, Cláudia Pires Amaral Maia, Ricardo Romiti, Adérson Osmar Mourão Cintra Damião, Valderílio Feijó Azevedo, Eduardo de Souza Meirelles, André Vicente E. de Carvalho, Jussara de Almeida Lima Kochen, Marcelo Arnone, Renata Ferreira Magalhães, Sender Jankiel Miszputen, and Paulo Gustavo Kotze
- Subjects
medicine.medical_specialty ,Gastrointestinal Diseases ,Immunology ,Arthritis ,Gastroenterology ,Inflammatory bowel disease ,Autoimmune Diseases ,Psoriatic arthritis ,Internal medicine ,Pharmacovigilance ,medicine ,Animals ,Humans ,Immunology and Allergy ,Biosimilar Pharmaceuticals ,Societies, Medical ,Ankylosing spondylitis ,Crohn's disease ,business.industry ,Antibodies, Monoclonal ,Biosimilar ,medicine.disease ,Dermatology ,Recombinant Proteins ,Rheumatology ,business ,Brazil - Abstract
The Brazilian Societies of Rheumatology (SBR) and Dermatology (SBD), the Brazilian Federation of Gastroenterology (FBG) and the Brazilian Study Group on Inflammatory Bowel Disease (GEDIIB) gathered a group of their respective specialists on the topic of interest to discuss the most relevant issues regarding the clinical use of biosimilar medicines in Brazil. The main aim of that meeting was to prepare a document with recommendations to guide medical specialists and to help the national regulatory and policy-making agencies as concerns the authorization for marketing biosimilars used in autoimmune diseases, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Crohn's disease, juvenile idiopathic arthritis and ulcerative colitis. In addition to considerations on the typical differences between innovator medicines and biosimilars, the specialists established a set of seven recommendations on regulatory advances related to clinical studies, indication extrapolation, nomenclature, interchangeability, automatic substitution and pharmacovigilance.
- Published
- 2015
36. BIOSIMILARS IN INFLAMMATORY BOWEL DISEASES: an important moment for Brazilian gastroenterologists
- Author
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Paulo Gustavo Kotze, Fábio Vieira Teixeira, Sender Jankiel Miszputen, and Aderson Ornar Mourao Cintra Damiao
- Subjects
medicine.medical_specialty ,Pathology ,Doença de Crohn ,Disease ,Biosimilar Pharmaceuticals ,Crohn Disease ,Gastrointestinal Agents ,medicine ,Humans ,lcsh:RC799-869 ,Intensive care medicine ,Ankylosing spondylitis ,Gastrointestinal agent ,Colite ulcerativa ,business.industry ,Gastroenterology ,Antibodies, Monoclonal ,Biosimilar ,Inflammatory Bowel Diseases ,medicine.disease ,Ulcerative colitis ,Infliximab ,Medicamentos biossimilares ,Rheumatoid arthritis ,Colitis, Ulcerative ,lcsh:Diseases of the digestive system. Gastroenterology ,business ,Brazil ,medicine.drug - Abstract
ABSTRACT Biosimilars are not generic drugs. These are more complex medications than small molecules, with identical chemical structures of monoclonal antibodies that lost their patency over time. Besides identical to the original product at the end, the process of achieving its final forms differs from the one used in the reference products. These differences in the formulation process can alter final outcomes such as safety and efficacy of the drugs. Recently, a biosimilar of Infliximab was approved in some countries, even to the management of inflammatory bowel diseases. However, this decision was based on studies performed in rheumatologic conditions such as rheumatoid arthritis and ankylosing spondylitis. Extrapolation of the indications from rheumatologic conditions was done for Crohn’s disease and ulcerative colitis based on these studies. In this article, the authors explain possible different mechanisms in the pathogenesis between rheumatologic conditions and inflammatory bowel diseases, that can lead to different actions of the medications in different diseases. The authors also alert the gastroenterological community for the problem of extrapolation of indications, and explain in full details the reasons for being care with the use of biosimilars in inflammatory bowel diseases without specific data from trials performed in this scenario.
- Published
- 2015
37. Disease Duration Did Not Influence the Rates of Loss of Efficacy of the Anti-TNF Therapy in Latin American Crohn's Disease Patients
- Author
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Eron Fábio Miranda, Fábio Vieira Teixeira, Lorete Maria da Silva Kotze, Harry Kleinubing, Juliano Coelho Ludvig, Marcia Olandoski, Paulo Gustavo Kotze, Everson Fernando Malluta, and Marcelo Raisweiler Hardt
- Subjects
Adult ,Male ,musculoskeletal diseases ,medicine.medical_specialty ,Time Factors ,Disease duration ,Anti-Inflammatory Agents ,Drug Resistance ,Antibodies, Monoclonal, Humanized ,Gastroenterology ,Crohn Disease ,immune system diseases ,Internal medicine ,Adalimumab ,Humans ,Medicine ,skin and connective tissue diseases ,Digestive System Surgical Procedures ,Retrospective Studies ,Crohn's disease ,Dose-Response Relationship, Drug ,business.industry ,Incidence (epidemiology) ,fungi ,Antibodies, Monoclonal ,food and beverages ,Middle Aged ,medicine.disease ,Infliximab ,Treatment Outcome ,Monoclonal ,Immunology ,Disease Progression ,Female ,Steroids ,Tumor Necrosis Factor Inhibitors ,Anti-TNF therapy ,Tumor necrosis factor alpha ,business ,Brazil ,medicine.drug - Abstract
Background/Aims: The efficacy of both Infliximab (IFX) and Adalimumab (ADA) can be reduced over time. The aim of this study was to analyze the incidence of loss of efficacy (LOE) of both IFX and ADA, and outline the influence of disease duration on its occurrence. Methods: Retrospective, multicenter, observational cohort study, with CD patients treated with anti-TNF therapy. LOE was defined as the need for steroids, occurrence of major abdominal surgery during treatment, dose increase, interval shortening or switching of the anti-TNF agent. Patients were allocated in three subgroups based on disease duration (DD): 60 months. Results: 175 patients were included in the study (117 under IFX and 58 under ADA therapy). LOE occurred in 32% of patients with DD Conclusions: Disease duration (DD) did not influence LOE rates. These results suggest that in real-world observational practice, patients with early CD might have the same rates of LOE than patients with a disease prolonging for a longer duration.
- Published
- 2015
38. VEDOLIZUMABE NA INDUÇÃO DA REMISSÃO NA RETOCOLITE ULCERATIVA: UM ESTUDO PILOTO OBSERVACIONAL E MULTICÊNTRICO
- Author
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Paulo Gustavo Kotze, Patricia Zacharias, Cristina Flores, Eron Fábio Miranda, Marco Zeroncio, Rodrigo Bremer Nones, and Fábio Vieira Teixeira
- Subjects
Gastroenterology ,RC799-869 ,Diseases of the digestive system. Gastroenterology - Published
- 2017
39. P105 THE PROGRESSION OF INFLAMMATORY BOWEL DISEASE THROUGHOUT LATIN AMERICA: A SYSTEMATIC REVIEW
- Author
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Paulo Gustavo Kotze, Daniela Simian, Fox E. Underwood, Rogerio Saad-Hossne, Subrata Ghosh, Francisco Bosques-Padilla, Fabian Julian-Banos, Fábio Vieira Teixeira, Beatriz M. Iade Vergara, Remo Panaccione, Jose G. Ferraz, Siew C. Ng, Aderson Omar Mourão Cintra Damião, Martin Toro, and Gilaad G. Kaplan
- Subjects
Crohn's disease ,medicine.medical_specialty ,Latin Americans ,Hepatology ,business.industry ,medicine.medical_treatment ,Gastroenterology ,Bowel resection ,medicine.disease ,Ulcerative colitis ,Inflammatory bowel disease ,Anti-Tumor Necrosis Factor Therapy ,Internal medicine ,medicine ,Immunology and Allergy ,Biological response modifiers ,business ,Colectomy - Published
- 2019
40. Factors affecting the incidence of early endoscopic recurrence after ileocolonic resection for Crohn's disease: a multicentre observational study
- Author
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L. M. da Silva Kotze, Antonino Spinelli, Fábio Vieira Teixeira, I. F. de Barcelos, Yasuo Suzuki, Takayuki Yamamoto, Paulo Gustavo Kotze, I. C. de Albuquerque, and Rogerio Saad-Hossne
- Subjects
Adult ,Male ,medicine.medical_specialty ,Adolescent ,Colon ,Anastomosis ,03 medical and health sciences ,Young Adult ,0302 clinical medicine ,Postoperative Complications ,Crohn Disease ,Ileum ,Recurrence ,Risk Factors ,medicine ,Humans ,Risk factor ,Prospective cohort study ,Colectomy ,Retrospective Studies ,Univariate analysis ,Crohn's disease ,business.industry ,Incidence ,Gastroenterology ,Odds ratio ,Perioperative ,Colonoscopy ,medicine.disease ,Surgery ,Logistic Models ,030220 oncology & carcinogenesis ,Concomitant ,Preoperative Period ,030211 gastroenterology & hepatology ,Female ,Steroids ,business - Abstract
Aim Early endoscopic recurrence is frequently observed in patients following resection for Crohn's disease (CD). However, factors affecting the incidence of an early postoperative endoscopic recurrence (EPER) have not been fully determined. The aim of this study was to evaluate risk factors for EPER after ileocolonic resections for CD. Method This was a retrospective, international multicentre study, in which 127 patients with the first ileocolonoscopy conducted between 6 and 12 months after ileocolonic resections for CD were included. Endoscopic recurrence was defined as a Rutgeerts’ score of ≥ i2. The following variables were investigated as potential risk factors for EPER: gender, age at surgery, location and behaviour of CD, smoking, concomitant perianal lesions, preoperative use of steroids, immunomodulators and biologics, previous resection, blood transfusion, surgical procedure (open vs. laparoscopic approach), length of resected bowel, type of anastomosis (side-to-side vs. end-to-end), postoperative complications, granuloma, and postoperative biologic therapy. Variables related to the patient, disease and surgical procedure were investigated as potential risk factors for EPER. To identify potential risk factors, both univariate and multivariate (logistic regression) analyses were conducted. Results 43/127 (34%) patients had EPER at the time of the first postoperative ileocolonoscopy. In univariate analysis, only preoperative steroid use was significantly associated with a higher rate of EPER [21/45 patients (47%) on steroids and 22/82 patients (27%) without steroids (P=0.04)]. In multivariate analysis, only preoperative steroid use was a significant independent risk factor for EPER (odds ratio 3.28, 95% confidence interval 1.30 – 8.28; P=0.01). Conclusions This study found that only preoperative steroid use was a significant risk factor for EPER after ileocolonic resections for CD. Prospective studies are necessary to evaluate precisely the impact of perioperative medications on EPER rates. This article is protected by copyright. All rights reserved.
- Published
- 2016
41. ANVISA APPROVES THE FIRST BIOSIMILAR MONOCLONAL ANTIBODY BASED ON COMPARABILITY IN BRAZIL
- Author
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Fábio Vieira Teixeira, Aderson Omar Mourão Cintra Damião, and Paulo Gustavo Kotze
- Subjects
0301 basic medicine ,medicine.medical_specialty ,Doença de Crohn ,Pharmacology ,03 medical and health sciences ,0302 clinical medicine ,Biosimilar Pharmaceuticals ,Biosimilar pharmaceuticals ,Pharmacovigilance ,Medicine ,lcsh:RC799-869 ,Reimbursement ,Colite ulcerativa ,business.industry ,Crohn disease ,Public health ,Comparability ,Gastroenterology ,Biosimilar ,Medicamentos biossimilares ,030104 developmental biology ,Ulcerative colitis ,Family medicine ,030211 gastroenterology & hepatology ,lcsh:Diseases of the digestive system. Gastroenterology ,business - Abstract
This measure by ANVISA is primarily aimed at cost reduction, because most of the individuals currently using IFX can only do it due to reimbursement by the Brazilian public health system. The achieve-ment is commendable and approved by all medical societies involved, in the specialties of rheumatol-ogy, gastroenterology and dermatology. However, scientific, safety and pharmacovigilance issues have arisen and should be carefully addressed and widely discussed within this new scenario for the benefit of patients. CT-P13 has been approved in Brazil based on comparability strictly following the regulations of ANVISA
- Published
- 2016
42. New monoclonal antibody biosimilars approved in 2015 in Latin America: Position statement of the Latin American Forum on Biosimilars in biosimilarity, interchangeability and extrapolation of indications
- Author
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Alejandra Babini, Igor Age Kos, Valderílio Feijó Azevedo, Fábio Vieira Teixeira, and Pablo Matar
- Subjects
0301 basic medicine ,Position statement ,CIENCIAS MÉDICAS Y DE LA SALUD ,Latin Americans ,Extrapolation ,Pharmacy ,Public administration ,Interchangeability ,Biotecnología de la Salud ,03 medical and health sciences ,0302 clinical medicine ,Drug Guides ,Medicine ,purl.org/becyt/ford/3.4 [https] ,030203 arthritis & rheumatology ,Biosimilarity ,business.industry ,Biosimilar ,Infliximab ,Monoclonal Antibodies ,030104 developmental biology ,Law ,purl.org/becyt/ford/3 [https] ,business ,Rituximab ,Otras Biotecnologías de la Salud - Abstract
Introduction: The Latin American Forum on Biosimilars (FLAB) is an annual meeting that brings together various stakeholders, including key opinion leaders, the pharmaceutical industry, academics, patients, lawyers and other healthcare professionals, to present and discuss recent findings regarding biosimilars. In 2015, the meeting theme was interchangeability and automatic substitution. Regarding biosimilarity, interchangeability and extrapolation of indications, the discussion centred on two products in Brazil and Argentina: CT-P13, an infliximab biosimilar; and RTXM83, a rituximab biosimilar. Here, we conduct a critical analysis of the available scientific and medical information on these products to establish a FLAB position statement in the context of the current regulations in Brazil and Argentina. Biosimilarity, interchangeability and extrapolation of indications: RTXM83 is still not approved in Brazil and is currently under a technology transfer agreement. In Argentina, the drug was approved for commercialization under the name Novex, with extrapolation of indications for rheumatoid arthritis, which according to the Argentinian Society of Rheumatology, lacks the necessary clinical data for such an approval. CT-P13 is already approved in Brazil, and is on the market. The approval was based on the data presented in the PLANETAS and PLANETRA studies. Interchangeability will not be considered for this product until further studies are presented. Discussion: Based on the available evidence, CT-P13 is the only biological molecule marketed in Latin America that can be considered a true biosimilar. Extrapolation is only acceptable when the diseases for which the reference product is intended to treat are entirely similar. Extrapolation based on only preclinical studies is not acceptable. Conversely, although the proposed rituximab biosimilar (RTXM83) was approved by ANMAT (National Administration for Medicines, Food and Medical Technology) in Argentina, clinical data demonstrating its equivalence with the reference rituximab, is necessary before RTXM83 can be considered a true biosimilar. Fil: Feijó Azevedo, Valderilio. Universidade Federal do Paraná; Brasil. Health Research and Educational Center; Brasil Fil: Babini, Alejandra. Hospital Italiano Córdoba; Argentina. Sociedad Argentina de Reumatología; Argentina Fil: Vieira Teixeira, Fabio. Clínica Gastrosaude de Marilia; Brasil. Grupo de Estudos de Doença Inflamatória Intestinal; Brasil Fil: Age Kos, Igor. Universidade Federal do Paraná; Brasil. Health Research and Educational Center; Brasil Fil: Matar, Pablo. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Rosario; Argentina
- Published
- 2016
43. Appendiceal endometriosis as a rare cause of abdominal pain: a case report and literature review
- Author
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Fábio Vieira Teixeira, Rafael Aliceda Ferraz, Rogerio Saad-Hossne, Ricardo de Álvares Goulart, Rafael Denadai, Hospital Municipal Dr. Mário Gatti, Santa Casa de Ourinhos, GASTROSAUDE Clinic, Sociedade Brasileira de Coloproctologia, and Universidade Estadual Paulista (Unesp)
- Subjects
endometriosis ,Abdominal pain ,medicine.medical_specialty ,medicine.medical_treatment ,Endometriosis ,RC799-869 ,appendix ,Resection ,Peritoneum ,trato gastrointestinal ,apendicectomia ,Laparotomy ,medicine ,endometriose ,business.industry ,Pelvic pain ,Gastroenterology ,abdominal pain ,dor abdominal ,apêndice ,Diseases of the digestive system. Gastroenterology ,medicine.disease ,appendectomy ,Appendix ,Surgery ,medicine.anatomical_structure ,Uterine cavity ,gastrointestinal tract ,medicine.symptom ,business - Abstract
Endometriosis is an estrogen-dependent inflammatory disease, common in young women, characterized by the presence of endometrial tissue outside the uterine cavity. This ectopic endometrial tissue is most commonly found in the ovaries, peritoneum, uterosacral ligaments and rectovaginal cul-de-sac, with extremely rare involvement of the appendix. The main symptom is chronic abdominal pain, and the diagnosis is often made later, after the result of the histopathological examination. This study reports a 34-year-old patient complaining of chronic pelvic pain refractory to medical treatment, having undergone diagnostic laparotomy. During the surgery, we observed the presence of endometrioma fixed to the uterine wall, and the appendix was enlarged, but without evidence of inflammation. Endometrioma resection and appendectomy were performed, with good postoperative recovery. The anatomopathological exam showed endometriosis in the cecal appendix.Endometriose é uma doença inflamatória estrogênio-dependente frequente em mulheres jovens, caracterizada pela presença de tecido endometrial fora da cavidade uterina. Esse tecido ectópico de endométrio é mais comumente encontrado nos ovários, peritônio, ligamentos uterossacros e fundo de saco retovaginal, sendo o acometimento do apêndice cecal extremamente raro. O quadro clínico predominante é o de dor abdominal crônica, sendo muitas vezes o diagnóstico feito posteriormente, após o resultado do anatomopatológico. Relatamos o caso de uma paciente de 34 anos com queixa de dor pélvica crônica, refratária ao tratamento clínico, tendo sido submetida à laparotomia exploradora diagnóstica. Durante o ato cirúrgico, observamos a presença de endometrioma fixo à parede uterina, bem como apêndice cecal aumentado de volume, porém sem evidência de sinais flogísticos. Procedeu-se à ressecção do endometrioma e apendicectomia, com boa evolução pós-operatória. O resultado do exame anatomopatológico revelou a presença de endometriose no apêndice cecal.
- Published
- 2012
44. VEDOLIZUMABE NA INDUÇÃO DA REMISSÃO NA DOENÇA DE CROHN: UM ESTUDO PILOTO OBSERVACIONAL E MULTICÊNTRICO
- Author
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Ramir Luan Perin, Aderson Omar Mourão Cintra Damião, Fábio Vieira Teixeira, Marco Zeroncio, Paulo Gustavo Kotze, Juliano Coelho Ludvig, and Cristina Flores
- Subjects
Gastroenterology ,RC799-869 ,Diseases of the digestive system. Gastroenterology - Published
- 2017
45. Instilação de formalina endoluminal como opção terapêutica da retite actínica hemorrágica Endoluminal formalin instillation as a therapeutic option of radiation-induced hemorrhagic proctitis
- Author
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Fábio Vieira Teixeira, Rafael Denadai, Rafael Aliceda Ferraz, Ricardo de Álvares Goulart, and Rogério Saad-Hossne
- Subjects
lcsh:Internal medicine ,lcsh:Specialties of internal medicine ,lcsh:R ,lcsh:Medicine ,proctology ,colonoscopia ,colonoscopy ,lcsh:RC581-951 ,resultado de tratamento ,treatment outcome ,formaldehyde ,lcsh:Diseases of the digestive system. Gastroenterology ,lcsh:RC799-869 ,lcsh:RC31-1245 ,proctologia ,formaldeído - Abstract
A retite actínica hemorrágica é um quadro grave que pode ocorrer em qualquer paciente submetido à radioterapia pélvica, por vezes, sendo necessária terapia transfusional e internação hospitalar. A abordagem terapêutica ainda é bastante controversa. Tanto para o tratamento inicial como para casos refratários, uma das opções é a aplicação de formalina. Este método é barato, facilmente disponível, de simples execução e eficaz no controle da hemorragia. Os autores relatam dois casos de retite actínica hemorrágica de pacientes tratados com instilação de formalina endoluminal, e sua eficácia terapêutica e complicações são discutidasThe radiation-induced hemorrhagic proctitis is a serious condition that can occur in any patient undergoing pelvic radiotherapy, sometimes being required hospitalization and transfusion therapy. The therapeutic approach is still very controversial. Both for the initial treatment and for refractory cases, one option is formalin application. This method is cheap, easily available, simple to perform, and effective in controlling bleeding. The authors report two cases of radiation-induced hemorrhagic proctitis treated with endoluminal instillation of formalin, and they discuss its therapeutic efficacy and complications
- Published
- 2011
46. VEDOLIZUMABE NA INDUÇÃO E MANUTENÇÃO DA REMISSÃO NA RETOCOLITE ULCERATIVA: UM ESTUDO PILOTO OBSERVACIONAL E MULTICÊNTRICO
- Author
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Ramir Luan Perin, Cristina Flores, Fábio Vieira Teixeira, Aderson Omar Mourão Cintra Damião, Paulo Gustavo Kotze, Eron Fábio Miranda, and Fernanda da Silva Barbosa
- Subjects
Gastroenterology - Published
- 2018
47. The use of a modified jacknife position for stapled hemorroidopexy procedure (PPH)
- Author
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Fábio Vieira Teixeira, Paulo Teixeira Júnior, Rogerio Saad-Hossne, Universidade Estadual Paulista (Unesp), and UNIGASTRO
- Subjects
Surgical treatment ,medicine.medical_specialty ,business.industry ,doença hemorroidária ,Gastroenterology ,tratamento cirúrgico ,Hemorrhoids ,Surgery ,Prolapsed hemorrhoids ,Staple line ,medicine ,In patient ,PPH ,business - Abstract
OBJETIVO: A doença hemorroidária(DH) é prevalente em cerca de 5% da população brasileira. Os casos mais avançados da DH são tratados com ressecção dos mamilos prolapsados (hemorroidectomia) e fechamento(técnica de Ferguson) ou não da ferida operatória(Miligan Morgan). No entanto, a dor no pós-operatório e o longo período de recuperação dos pacientes submetidos a hemorroidectomia convencional são os principais inconvenientes das técnicas. O método da hemorroidopexia ou procedimento para prolapso e hemorróidas(PPH) vem sendo realizado desde 1998, e tem como principal vantagem a resolução da DH com menos dor e recuperação mais rápida do paciente. Nosso objetivo é apresentar uma modificação técnica no posicionamento do paciente com DH que será submetido ao PPH. MÉTODOS E PACIENTES: Desde Janeiro de 2008 foram operados 5 pacientes no Hospital UNIMAR, Marília, São Paulo. Todos eram portadores de doença hemorroidária avançada - Grau III e IV. Os procedimentos foram realizados com bloqueio raqui-medular em sela com sufentanil associado à bupivacaína. Os pacientes foram posicionados em decúbito ventral com coxim de cerca de 20 cm de altura colocada na altura da espinha ilíaca ântero-superior. Foram usadas fitas adesivas para afastar lateralmente a região glútea. O cirurgião ficou posicionado no centro, no vão entre os membros inferiores do paciente. O primeiro auxiliar posicionando à direita e a instrumentadora à esquerda. O canal anal foi dilatado manualmente e fixado o dilatador do PPH. Em todos os pacientes a linha pectínea foi facilmente identificada, e obteve-se a exposição de 3 a 4 cm do reto acima da linha pectínea. A bolsa foi realizada com fio de polipropileno (Prolene ® 0 com agulha de 1,5 cm) sem a necessidade de utilização do afastador de 2 canas. Os pontos compreenderam a mucosa retal tomando-se cuidado em não incluir a camada muscular do reto. Após o disparo e retirada do aparelho, identificou-se com facilidade a linha de grampos sem a necessidade de colocar qualquer tipo de afastador auxiliar. Em nenhum dos casos foi necessário hemostasia adicional, com pontos aplicados sobre a linha de grampos. CONCLUSÕES: Pudemos observar que com esse posicionamento a exposição do canal anal fica mais fácil, sem a necessidade de utilizar qualquer tipo de afastador (tipo 2 canas) quando da confecção da sutura em bolsa. Além disso, com o decúbito ventral, o cirurgião opera em pé e a equipe cirúrgica tem maior mobilidade, o que não acontece quando o paciente está posicionado em litotomia. Ademais, o posicionamento do cirurgião de frente para a região anal facilita a confecção da bolsa, a atadura do nó, o disparo do aparelho e a revisão da linha de grampos.
- Published
- 2008
48. Risk factors for complications after ileocolonic resection for Crohn’s disease with a major focus on the impact of preoperative immunosuppressive and biologic therapy: A retrospective international multicentre study
- Author
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Rogerio Saad-Hossne, Ivan Folchini de Barcelos, Yasuo Suzuki, Takahiro Shimoyama, Idblan Carvalho de Albuquerque, Silvio Danese, Akihiro Yamada, Lorete Maria da Silva Kotze, Antonino Spinelli, Rodolff Nunes da Silva, Fábio Vieira Teixeira, Ken Takeuchi, Matteo Sacchi, Paulo Gustavo Kotze, Takayuki Yamamoto, Yokkaichi Hazu Medical Centre, University of Milan, Toho University, Universidade Estadual Paulista (Unesp), Gastrosaude, Heliopolis Hospital, Catholic University of Parana, and Humanitas Research Hospital
- Subjects
Crohn’s disease ,medicine.medical_specialty ,Crohn's disease ,ileocolonic resection ,business.industry ,Gastroenterology ,Original Articles ,medicine.disease ,intra-abdominal sepsis ,Surgery ,Resection ,Intra abdominal sepsis ,03 medical and health sciences ,0302 clinical medicine ,Oncology ,immunosuppressants ,030220 oncology & carcinogenesis ,Internal medicine ,postoperative complications ,Anastomotic leak ,Medicine ,biologics ,030211 gastroenterology & hepatology ,business - Abstract
Made available in DSpace on 2018-12-11T17:30:26Z (GMT). No. of bitstreams: 0 Previous issue date: 2016-12-01 Background: In the era of biologic agents, risk factors for complications following resection for Crohn’s disease have not been fully identified. In particular, the association of preoperative use of immunosuppressive and biologic agents with the incidence of complications after resection remains to be elucidated. Author note: TY, AS, YS, FVT and PGK designed the study. All authors did data collection and gave scientific contribution to the study design and discussion. TY, AS and PGK drafted the article. All authors read and approved the final version of the manuscript. Aim: This retrospective multicentre study aimed to identify risk factors for complications after ileocolonic resection for Crohn’s disease, with a major focus on the impact of preoperative immunosuppressive and biologic therapy. Methods: A total of 231 consecutive patients who underwent ileocolonic resections for active Crohn’s disease in seven inflammatory bowel disease referral centres from three countries (Japan, Brazil and Italy) were included. The following variables were investigated as potential risk factors: age at surgery, gender, behaviour of Crohn’s disease (perforating vs. non-perforating disease), smoking, preoperative use (within eight weeks before surgery) of steroids, immunosuppressants and biologic agents, previous resection, blood transfusion, surgical procedure (open vs. laparoscopic approach), and type of anastomosis (side-to-side vs. end-to-end). Postoperative complications occurring within 30 days after surgery were recorded. Results: The rates of overall complications, intra-abdominal sepsis, and anastomotic leak were 24%, 12% and 8%, respectively. Neither immunosuppressive nor biologic therapy prior to surgery was significantly associated with the incidence of overall complications, intra-abdominal sepsis or anastomotic leak. In multivariate analysis, blood transfusion, perforating disease and previous resection were significant risk factors for overall complications (odds ratio [OR] 3.02, 95% confidence interval [CI] 1.21–7.52; P = 0.02), intra-abdominal sepsis (OR 2.67, 95% CI 1.04–6.86; P = 0.04) and anastomotic leak (OR 2.87, 95% CI 1.01–8.18; P = 0.048), respectively. Conclusions: Blood transfusion, perforating disease and previous resection were significant risk factors for overall complications, intra-abdominal sepsis and anastomotic leak after ileocolonic resection for Crohn’s disease, respectively. Preoperative immunosuppressive or biologic therapy did not increase the risk of postoperative complications. IBD Centre Yokkaichi Hazu Medical Centre Colorectal Surgery Unit Humanitas Research Hospital Department of Medical Biotechnologies and Translational Medicine University of Milan Division of Gastroenterology and Hepatology Department of Internal Medicine Toho University Medical Centre Sakura Hospital Faculty of Medicine Toho University Digestive Surgery Department São Paulo State University (UNESP) Colorectal Surgery Gastrosaude IBD Unit Heliopolis Hospital Colorectal Surgery Unit Catholic University of Parana Gastroenterology Unit Catholic University of Parana Colorectal Surgery Unit Humanitas Research Hospital IBD Unit Humanitas Research Hospital Digestive Surgery Department São Paulo State University (UNESP)
- Published
- 2015
49. Anti-TNF therapy for ulcerative colitis in Brazil: a comparative real-world national retrospective multicentric study from the Brazilian study group of IBD (GEDIIB)
- Author
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Ligia Yukie Sassaki, Daniela Oliveira Magro, Rogerio Saad-Hossne, Julio Pinheiro Baima, Cristina Flores, Lucianna Motta Correia, Lívia Medeiros Soares Celani, Maria De Lourdes De Abreu Ferrari, Patricia Zacharias, Marley Ribeiro Feitosa, Carlos Henrique Marques Dos Santos, Manoel Alvaro De Freitas Lins Neto, Abel Botelho Quaresma, Sergio Figueiredo De Lima Junior, Graciana Bandeira Salgado De Vasconcelos, Ornella Sari Cassol, Arlene Dos Santos Pinto, Gustavo Kurachi, Francisco de Assis Goncalves Filho, Rodrigo Galhardi Gasparini, Thaísa Kowalski Furlan, Wilson Roberto Catapani, Cláudio Saddy Rodrigues Coy, Vivian De Souza Menegassi, Marilia Majeski Colombo, Renata de Sá Brito Fróes, Fabio Vieira Teixeira, Antonio Carlos Moraes, Genoile Oliveira Santana, José Miguel Luz Parente, Eduardo Garcia Vilela, Natália Sousa Freitas Queiroz, Paulo Gustavo Kotze, and GEDIIB (Brazilian Study Group of IBD)
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Anti-TNF therapy ,Adalimumab ,Infliximab ,Clinical remission ,Ulcerative colitis ,Diseases of the digestive system. Gastroenterology ,RC799-869 - Abstract
Abstract Background Anti-TNF therapy represented a landmark in medical treatment of ulcerative colitis (UC). There is lack of data on the efficacy and safety of these agents in Brazilian patients. The present study aimed to analyze rates of clinical and endoscopic remission comparatively, between adalimumab (ADA) and infliximab (IFX), in Brazilian patients with UC, and evaluate factors associated with clinical and endoscopic remission after 1 year of treatment. Methods A national retrospective multicenter study (24 centers) was performed including patients with UC treated with anti-TNF therapy. Outcomes as clinical response and remission, endoscopic remission and secondary loss of response were measured in different time points of the follow-up. Baseline predictive factors of clinical and endoscopic remission at week 52 were evaluated using logistic regression model. Indirect comparisons among groups (ADA and IFX) were performed using Student's t, Pearson χ2 or Fisher's exact test when appropriated, and Kaplan Meier analysis. Results Overall, 393 patients were included (ADA, n = 111; IFX, n = 282). The mean age was 41.86 ± 13.60 years, 61.58% were female, most patients had extensive colitis (62.40%) and 19.39% had previous exposure to a biological agent. Overall, clinical remission rate was 66.78%, 71.62% and 82.82% at weeks 8, 26 and 52, respectively. Remission rates were higher in the IFX group at weeks 26 (75.12% vs. 62.65%, p
- Published
- 2022
- Full Text
- View/download PDF
50. First biosimilar of infliximab approved in Brazil: response from the Brazilian IBD society
- Author
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Fábio Vieira Teixeira
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030203 arthritis & rheumatology ,medicine.medical_specialty ,business.industry ,Biosimilar ,Pharmacy ,Infliximab ,03 medical and health sciences ,0302 clinical medicine ,Drug Guides ,medicine ,030211 gastroenterology & hepatology ,business ,Intensive care medicine ,medicine.drug - Published
- 2016
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