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Crohn Disease: HELP
Articles by Paulo Gustavo Kotze
Based on 55 articles published since 2010
(Why 55 articles?)
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Between 2010 and 2020, P. G. Kotze wrote the following 55 articles about Crohn Disease.
 
+ Citations + Abstracts
Pages: 1 · 2 · 3
1 Guideline Diagnosis and treatment of inflammatory bowel disease: First Latin American Consensus of the Pan American Crohn's and Colitis Organisation. 2017

Yamamoto-Furusho, J K / Bosques-Padilla, F / de-Paula, J / Galiano, M T / Ibañez, P / Juliao, F / Kotze, P G / Rocha, J L / Steinwurz, F / Veitia, G / Zaltman, C. ·Clínica de Enfermedad Inflamatoria Intestinal, Departamento de Gastroenterología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Ciudad de México, México. Electronic address: kazuofurusho@hotmail.com. · Gastroenterology Division, Hospital Universitario "Dr. José Eleuterio González", Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, México; Escuela de Medicina y Ciencias de la Salud, Tecnológico de Monterrey, Monterrey, México. · Servicio de Gastroenterología, Hospital Italiano, Buenos Aires, Argentina. · Clínica de Enfermedad Inflamatoria Intestinal, Clínica Marly, Bogotá, Colombia. · Programa de Enfermedad Inflamatoria Intestinal, Departamento de Gastroenterología, Clínica Las Condes, Santiago, Chile. · Clínica de Enfermedad Inflamatoria Intestinal, Hospital Pablo Tobón Uribe, Medellín, Colombia. · Hospital Universitario Cajuru, Universidad Católica del Paraná (PUCPR), Curitiba, Brasil. · Grupo Académico y de Investigación sobre Enfermedad de Crohn y Colitis Ulcerosa Crónica Idiopática de México, Ciudad de México, México. · Hospital Israelita Albert Einstein, São Paulo, Brasil. · Servicio de Gastroenterología, Hospital Vargas, Caracas, Venezuela. · Servicio de Gastroenterología, Hospital Clementino Fraga Filho, Departamento de Medicina Interna, Universidade Federal do Rio de Janeiro (UFRJ), Río de Janeiro, Brasil. ·Rev Gastroenterol Mex · Pubmed #27979414.

ABSTRACT: The incidence and prevalence of inflammatory bowel disease (IBD) has increased in recent years in several Latin American countries. There is a need to raise awareness in gastroenterologists and the population in general, so that early diagnosis and treatment of ulcerative colitis (UC) and Crohn's Disease (CD) can be carried out. It is important for all physicians to have homogeneous criteria regarding the diagnosis and treatment of IBD in Latin America. The Pan American Crohn's and Colitis Organisation (PANCCO) is an organization that aims to include all the countries of the Americas, but it specifically concentrates on Latin America. The present Consensus was divided into two parts for publication: 1) Diagnosis and treatment and 2) Special situations. This is the first Latin American Consensus whose purpose is to promote a perspective adapted to our Latin American countries for the diagnosis, treatment, and monitoring of patients with UC and CD.

2 Editorial Anal Fistula Plug for Perianal Fistulising Crohn's Disease: an Important Trial for Inflammatory Bowel Disease Surgeons. 2016

Spinelli, Antonino / Kotze, Paulo Gustavo. ·Division of Colon and Rectal Surgery, Humanitas Research Hospital, University of Milan, Rozzano, Milano, Italy antonino.spinelli@humanitas.it. · Colorectal Surgery Unit, Catholic University of Paraná, Curitiba, PR, Brazil. ·J Crohns Colitis · Pubmed #26363516.

ABSTRACT: -- No abstract --

3 Editorial Research in inflammatory bowel diseases in Latin America: a challenge ahead. 2014

Kotze, Paulo Gustavo. ·Unidade de Cirurgia Colorretal, Hospital Universitário Cajuru - PUCPR, Curitiba, PR, Brasil. ·Arq Gastroenterol · Pubmed #25591152.

ABSTRACT: -- No abstract --

4 Editorial Burrill Bernard Crohn (1884-1983): the man behind the disease. 2013

de Campos, Fábio Guilherme M C / Kotze, Paulo Gustavo. · ·Arq Bras Cir Dig · Pubmed #24510030.

ABSTRACT: -- No abstract --

5 Review Mesenchymal Stem Cells for Perianal Crohn's Disease. 2019

Carvello, Michele / Lightner, Amy / Yamamoto, Takayuki / Kotze, Paulo Gustavo / Spinelli, Antonino. ·Colon and Rectal Surgery Unit, Humanitas Clinical and Research Center, 20089 Rozzano, Italy. · Department of Colon and Rectal Surgery, Cleveland Clinic, Cleveland, OH 44195, USA. · Inflammatory Bowel Disease Centre, Yokkaichi Hazu Medical Centre, Yokkaichi, Mie 510-0016, Japan. · Colorectal Surgery Unit, Cajuru University Hospital, Catholic University of Paraná, Curitiba 80215-901, Brazil. · Colon and Rectal Surgery Unit, Humanitas Clinical and Research Center, 20089 Rozzano, Italy. antonino.spinelli@humanitas.it. · Department of Biomedical Sciences, Humanitas University, 20089 Rozzano, Italy. antonino.spinelli@humanitas.it. ·Cells · Pubmed #31340546.

ABSTRACT: Perianal fistulizing Crohn's disease (PFCD) is associated with significant morbidity and might negatively impact the quality of life of CD patients. In the last two decades, the management of PFCD has evolved in terms of the multidisciplinary approach involving gastroenterologists and colorectal surgeons. However, the highest fistula healing rates, even combining surgical and anti-TNF agents, reaches 50% of treated patients. More recently, the administration of mesenchymal stem cells (MSCs) have shown notable promising results in the treatment of PFCD. The aim of this review is to describe the rationale and the possible mechanism of action of MSC application for PFCD and the most recent results of randomized clinical trials. Furthermore, the unmet needs of the current administration process and the expected next steps to improve the outcomes will be addressed.

6 Review Darvadstrocel for the treatment of patients with perianal fistulas in Crohn's disease. 2019

Kotze, P G / Spinelli, A / Warusavitarne, J / Di Candido, F / Sahnan, K / Adegbola, S O / Danese, S. ·IBD Unit, Health Sciences Postgraduate Program (PPGCS), Catholic University of Paraná (PUCPR), Curitiba, Brazil. pgkotze@hotmail.com. · Department of Biomedical Sciences, Humanitas University, Rozzano, Milan, Italy; Colon and Rectal Surgery Division, Humanitas Clinical and Research Center, Rozzano, Milan, Italy. · Robin Phillips' Fistula Research Unit, St. Mark's Hospital, Harrow, UK; Department of Surgery and Cancer, Imperial College, London, UK. · Colon and Rectal Surgery Division, Humanitas Clinical and Research Center, Rozzano, Milan, Italy. · Department of Biomedical Sciences, Humanitas University, Rozzano, Milan, Italy; IBD Center, Department of Gastroenterology, Humanitas Research Hospital, Rozzano, Milan, Italy. ·Drugs Today (Barc) · Pubmed #30816884.

ABSTRACT: Despite significant advances in medical and surgical therapy for perianal fistulas in Crohn's disease (CD), treatment results are still modest, and a specific need for more effective therapies is a reality. Darvadstrocel is composed of expanded human allogeneic mesenchymal adult stem cells extracted from adipose tissue and constitutes the first stem cell therapy for perianal fistulizing CD to receive approval from the European Medicines Agency (EMA). This therapy is injected in both internal and external openings, as well as inside the fistula tracks, to induce fistula healing. In this monograph, the authors review the preclinical pharmacology of darvadstrocel, as well as pharmacokinetics and metabolism, and cover the main indications and detailed information on the efficacy and safety profile of the agent. Possible interactions with other agents used to treat CD are also explored. Darvadstrocel is a safe and effective therapy for perianal complex fistulas in CD, and represents the beginning of a new era of mesenchymal stem cell therapy in this difficult phenotype of the disease.

7 Review Fistula-associated anal carcinoma in Crohn's disease. 2018

Yamamoto, Takayuki / Kotze, Paulo Gustavo / Spinelli, Antonino / Panaccione, Remo. ·a Inflammatory Bowel Disease Center & Department of Surgery , Yokkaichi Hazu Medical Center , Yokkaichi , Japan. · b Colorectal Surgery Unit , Catholic University of Parana (PUCPR) , Curitiba , Brazil. · c Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology , University of Calgary , Calgary , Canada. · d Department of Biomedical Sciences , Humanitas University , Milano , Italy. · e Division of Colon and Rectal Surgery , Humanitas Clinical and Research Center , Milano , Italy. ·Expert Rev Gastroenterol Hepatol · Pubmed #29999429.

ABSTRACT: INTRODUCTION: Fistula-associated anal carcinoma in patients with Crohn's disease (CD) is a rare condition. More recently, this entity has been increasingly reported likely due to increased recognition, and the incidence may be greater than once appreciated. There remains a paucity of data regarding the incidence, diagnosis, treatment, and outcome of fistula-associated anal carcinoma. Area covered: This review evaluates the clinical features, pathology, treatment, and prognosis of fistula-associated anal carcinoma in patients with CD. A strategy for surveillance of this carcinoma is proposed by the authors based on the evidence obtained from this review. Expert commentary: Clinicians caring for patients with CD and perianal involvement need to be aware of the rare yet extremely important association of long-standing perianal disease and fistula-associated carcinoma. Only through awareness, a high level of suspicion will be diagnosed in a timely manner. This involves a thorough history, a proper, and complete anorectal examination, along with early imaging and examination under anesthesia. Through this approach, it is hoped that early diagnose can be achieved in at-risk patients and change the significant morbidity and mortality associated with this diagnosis.

8 Review Clinical utility of ustekinumab in Crohn's disease. 2018

Kotze, Paulo Gustavo / Ma, Christopher / Almutairdi, Abdulelah / Panaccione, Remo. ·Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada. · Inflammatory Bowel Disease Outpatient Clinics, Colorectal Surgery Unit, Catholic University of Paraná, Curitiba, Brazil. · Department of Medicine, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia. ·J Inflamm Res · Pubmed #29445293.

ABSTRACT: The introduction of anti-tumor necrosis factor (TNF) therapy marked an important milestone in the management of moderate-to-severe Crohn's disease (CD). However, there remains a pressing demand for alternative therapeutic options for patients with primary nonresponse, secondary loss of response, or intolerable side effects to conventional treatment and TNF antagonists. Ustekinumab (UST) is a fully human IgG1κ monoclonal antibody that inhibits the p40 subunit shared by the proinflammatory cytokines, the interleukin (IL)-12 and -23. This blockade leads to dampening of the inflammatory cascade and differentiation of inflammatory T cells. The clinical development program for UST in CD includes dose finding Phase II (Crohn's Evaluation of Response to Ustekinumab Anti-Interleukin-12/23 for Induction [CERTIFI]) and the pivotal Phase III (UNITI) trials that demonstrated both the clinical efficacy and safety in anti-TNF-naive and anti-TNF-exposed patients. Real-world evidence has further defined the role of UST in CD management. In this review, we discuss the mechanism of action of UST, describe the results of the randomized controlled trials with this agent, and review the real-world efficacy and safety data from observational cohorts. Finally, we identify areas of future research in the IL-12/23 inflammatory pathway and discuss the positioning of this novel therapeutic option in CD treatment algorithms.

9 Review Modern management of perianal fistulas in Crohn's disease: future directions. 2018

Kotze, Paulo Gustavo / Shen, Bo / Lightner, Amy / Yamamoto, Takayuki / Spinelli, Antonino / Ghosh, Subrata / Panaccione, Remo. ·Division of Gastroenterology and Hepatology, Inflammatory Bowel Disease Unit, Cumming School of Medicine, University of Calgary, Calgary, Canada. · Interventional IBD Unit, Cleveland Clinic Foundation, Cleveland, Ohio, USA. · Division of Colorectal Surgery, Mayo Clinic, Rochester, Minnesota, USA. · IBD Centre, Yokkaichi Hazu Medical Centre, Yokkaichi, Japan. · Division of Colon and Rectal Surgery, Humanitas Clinical and Research Center, Rozzano, Italy. · Institute of Translational Medicine, University of Birmingham, Birmingham, UK. ·Gut · Pubmed #29331943.

ABSTRACT: Perianal fistulae in patients with Crohn's disease (CD) can be associated with significant morbidity resulting in negative impact on quality of life. The last two decades have seen significant advancements in the management of perianal fistulas in CD, which has evolved into a multidisciplinary approach that includes gastroenterologists, colorectal surgeons, endoscopists and radiologists. Despite the introduction of new medical therapies such as antitumour necrosis factor and novel models of care delivery, the best fistula healing rates reported with combined medical and surgical approaches are approximately 50%. More recently, newer biologics, cell-based therapies as well as novel endoscopic and surgical techniques have been introduced raising new hopes that outcomes can be improved upon. In this review, we describe the modern management and the most recent advances in the management of complex perianal fistulising CD, which will likely impact clinical practice. We will explore optimal use of both older and newer biological agents, as well as new data on cell-based therapies. In addition, new techniques in endoscopic and surgical approaches will be discussed.

10 Review Can Surgery for Inflammatory Bowel Disease be Personalized? 2018

Spinelli, Antonino / Marano, Alessandra / Bacchelli, Claudio / Mariani, Nicolo Maria / Montorsi, Marco / Kotze, Paulo Gustavo. ·Department of Biomedical Sciences, Humanitas University, via Manzoni 113, 20089 Rozzano, Milano, Italy. · Colon and Rectal Surgery Unit, Department of Surgery, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy. · Colorectal Surgery Unit, Cajuru University Hospital, Catholic University of Paraná (PUCPR), Curitiba, Brazil. ·Curr Drug Targets · Pubmed #28068895.

ABSTRACT: BACKGROUND: In the treatment of Inflammatory Bowel Diseases (IBD) despite advances in medical therapies, surgery has maintained a leading role in the management of complications of the disease, as well as in cases of failure of medical therapy. OBJECTIVE: discuss the possible role for a personalization in debated fields of surgical treatment of Crohn's disease and ulcerative colitis. CONCLUSIONS: Surgery has become more and more minimally invasive, struggling for a difficult balance between guidelines and personalized treatment tailored on the single patient's need. There is no room for fixed management for surgery in IBD. A tailored approach is key to better outcome in each specific patient.

11 Review Postoperative Approach for Crohn's Disease: The Right Therapy to the Right Patient. 2018

Kotze, Paulo Gustavo / Yamamoto, Takayuki / Damiao, Aderson O M C. ·Colorectal Surgery Unit, Catholic University of Parana (PUCPR), Curitiba, Brazil. · IBD Centre, Yokkaichi Hazu Medical Centre, Yokkaichi, Japan. · Gastroenterology Department, University of Sao Paulo Medical School (FMUSP), Sao Paulo, Brazil. ·Curr Drug Targets · Pubmed #26521776.

ABSTRACT: BACKGROUND: Recurrence is a common event after surgical resections secondary to Crohn's disease (CD). Endoscopic signs of inflammation, defined as postoperative endoscopic recurrence (PER) occur in up to 90% of the patients after one year. PER precedes clinical recurrence and further need for reoperations due to consequent bowel damage. Therefore, controlling inflammation after surgery in a preventive way is essential for disease control. OBJECTIVE: to review data regarding PER in CD, and demonstrate algorithms for its management after surgery. RESULTS: There is no fixed strategy to prevent recurrence after surgery in CD. There are several risk factors that must be taken into consideration to guide physicians to choose the best therapeutic agents and strategies in this scenario. In this review, the authors describe in details the stratification based on risk factors, the therapeutic agents mostly used to prevent recurrence and discuss the several options for the postoperative management in CD. CONCLUSIONS: No fixed strategy is recommended after surgical resections in CD. Thus, the need for a personalized approach for each patient is emphasized, in accordance with several conditions and variables.

12 Review Preoperative use of anti-tumor necrosis factor therapy in Crohn's disease: promises and pitfalls. 2017

Kotze, Paulo Gustavo / Ghosh, Subrata / Bemelman, Willem A / Panaccione, Remo. ·Colorectal Surgery Unit, Cajuru University Hospital, Catholic University of Paraná, Curitiba, Brazil. · Institute of Translational Medicine, University of Birmingham, Edgbaston, Birmingham, UK. · Department of Surgery, Academic Medical Center, Amsterdam, The Netherlands. · Inflammatory Bowel Disease Unit, University of Calgary, Alberta, Canada. ·Intest Res · Pubmed #28522944.

ABSTRACT: Recent advances in medical and surgical therapy were achieved during the last two decades in the management of Crohn's disease (CD). Anti-tumor necrosis factor (anti-TNF) agents are widely used worldwide. However, a significant proportion of patients still need surgical resections. The impact of previous exposure to these agents on the perioperative and postoperative outcomes is still controversial. In this critical review, we aimed to position the strategy of intentional preoperative use of anti-TNF agents in the management of CD. The indications and contraindications for this strategy are detailed, and despite scarce evidence, the possible advantages and disadvantages of the intentional use of anti-TNF agents before abdominal surgery in CD are discussed.

13 Review 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. 2015

Azevedo, Valderílio Feijó / Meirelles, Eduardo de Souza / Kochen, Jussara de Almeida Lima / Medeiros, Ana Cristina / Miszputen, Sender J / Teixeira, Fábio Vieira / Damião, Adérson Osmar Mourão Cintra / Kotze, Paulo Gustavo / Romiti, Ricardo / Arnone, Marcelo / Magalhães, Renata Ferreira / Maia, Cláudia Pires Amaral / de Carvalho, André Vicente E. ·Brazilian Society of Rheumatology, Brazil. Electronic address: valderilio@hotmail.com. · Brazilian Society of Rheumatology, Brazil. · Brazilian Federation of Gastroenterology, Brazil; Brazilian Study Group on Inflammatory Bowel Disease, Brazil. · Brazilian Study Group on Inflammatory Bowel Disease, Brazil. · Brazilian Society of Dermatology, Brazil. ·Autoimmun Rev · Pubmed #25936608.

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.

14 Clinical Trial Adalimumab for maintenance therapy for one year in Crohn's disease: results of a Latin American single-center observational study. 2014

Kotze, Paulo Gustavo / Abou-Rejaile, Vinícius Rezende / Uiema, Luciana Aparecida / Olandoski, Marcia / Sartor, Maria Cristina / Miranda, Eron Fábio / Kotze, Lorete Maria da Silva / Saad-Hossne, Rogério. ·Unidade de Cirurgia Colorretal, Universidade Católica do Paraná, Curitiba, PR, Brasil. · Disciplina de Bioestatística, Universidade Católica do Paraná, Curitiba, PR, Brasil. · Unidade de Gastroenterologia, Universidade Católica do Paraná - PUCPR, Curitiba, PR, Brasil. · Depatamento de Ciurgia Digestiva, Universidade de São Paulo, UNESP, Botucatu, SP, Brasil. ·Arq Gastroenterol · Pubmed #24760063.

ABSTRACT: CONTEXT: Adalimumab is a fully-human antibody that inhibits TNF alpha, with a significant efficacy for long-term maintenance of remission. Studies with this agent in Latin American Crohn's disease patients are scarce. OBJECTIVES: The objective of this study was to outline clinical remission rates after 12 months of adalimumab therapy for Crohn's disease patients. METHODS: Retrospective, single-center, observational study of a Brazilian case series of Crohn's disease patients under adalimumab therapy. Variables analyzed: demographic data, Montreal classification, concomitant medication, remission rates after 1, 4, 6 and 12 months. Remission was defined as Harvey-Bradshaw Index ≤ 4, and non-responder-imputation and last-observation-carried-forward analysis were used. The influence of infliximab on remission rates was analyzed by Fischer and Chi-square tests (P<0.05). RESULTS: Fifty patients, with median age of 35 years at therapy initiation, were included. Remission rates after 12 months of therapy were 54% under non-responder-imputation and 88% under last-observation-carried-forward analysis. After 12 months, remission on patients with previous infliximab occurred in 69.23% as compared to 94.59% in infliximab-naïve patients (P = 0.033). CONCLUSIONS: Adalimumab was effective in maintaining clinical remission after 12 months of therapy, with an adequate safety profile, and was also more effective in infliximab naïve patients.

15 Article BIOLOGICAL THERAPY PENETRATION FOR INFLAMMATORY BOWEL DISEASE IN LATIN AMERICA: CURRENT STATUS AND FUTURE CHALLENGES. 2019

Quaresma, Abel Botelho / Coy, Claudio Saddy Rodrigues / Damião, Aderson Omar Mourão Cintra / Kaplan, Gilaad G / Kotze, Paulo Gustavo. ·Universidade do Oeste de Santa Catarina. (UNOESC), Joaçaba, SC, Brasil. · Universidade Católica do Paraná (PUCPR), Programa de Pós-Graduação em Ciências da Saúde, Ambulatórios do IBD, Curitiba, PR, Brasil. · Universidade Estadual de Campinas (UNICAMP), Unidade de Cirurgia Colorretal, Campinas, SP, Brasil. · Universidade de São Paulo (USP), Departamento de Gastroenterologia, São Paulo, SP, Brasil. · University of Calgary, Departments of Medicine and Community Health Sciences, Calgary, Alberta, Canada. ·Arq Gastroenterol · Pubmed #31633732.

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

16 Article VEDOLIZUMAB IN THE MANAGEMENT OF INFLAMMATORY BOWEL DISEASES: A BRAZILIAN OBSERVATIONAL MULTICENTRIC STUDY. 2019

Perin, Ramir Luan / Damião, Aderson Omar Mourão Cintra / Flores, Cristina / Ludvig, Juliano Coelho / Magro, Daniéla Oliveira / Miranda, Eron Fábio / Moraes, Antonio Carlos de / Nones, Rodrigo Bremer / Teixeira, Fábio Vieira / Zeroncio, Marco / Kotze, Paulo Gustavo. ·Universidade Católica do Paraná, Unidade de Cirurgia Colorretal, Ambulatório de Doenças Inflamatórias Intestinais, Curitiba, PR, Brasil. · Universidade de São Paulo (USP), Departamento de Gastroenterologia, São Paulo, SP, Brasil. · Universidade Federal de Rio Grande do Sul (UFRGS), Hospital de Clínicas de Porto Alegre, Serviço de Gastroenterologia, Porto Alegre, RS, Brasil. · Clínica ESADI, Ambulatório de Doenças Inflamatórias Intestinais, Blumenau, SC, Brasil. · Universidade Estadual de Campinas (UNICAMP), Faculdade de Ciências Médicas, Departamento de Cirurgia, Campinas, SP, Brasil. · Universidade Federal do Rio de Janeiro (UFRJ), Hospital Clementino Fraga Filho, Departamento de Gastroenterologia; Hospital Copa D'Or, Rio de Janeiro, RJ, Brasil. · Hospital Nossa Senhora das Graças (HNSG), Departamento de Gastroenterologia, Curitiba, PR, Brasil. · Clínica GastroSaúde, Ambulatório de Doenças Inflamatórias Intestinais, Marília, SP, Brasil. · Clínica privada, Gastroenterologia, Natal, RN, Brasil. ·Arq Gastroenterol · Pubmed #31633731.

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.

17 Article Reduction in surgical stoma rates in Crohn's disease: a population-based time trend analysis. 2019

Ma, C / Almutairdi, A / Tanyingoh, D / Seow, C H / Novak, K L / Lu, C / Panaccione, R / Kaplan, G G / Kotze, P G. ·Division of Gastroenterology and Hepatology, University of Calgary, Calgary, Alberta, Canada. · Robarts Clinical Trials, Inc., London, Ontario, Canada. · Department of Medicine, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia. · Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada. · Inflammatory Bowel Disease Outpatient Clinics, Colorectal Surgery Unit, Catholic University of Paraná, Curitiba, Brazil. ·Colorectal Dis · Pubmed #31206974.

ABSTRACT: AIM: Trends in surgical rates for Crohn's disease (CD) in the biological era are controversial. We aim to assess modern trends in the formation rates of surgical stomas. METHOD: Population-based surveillance in the Calgary Health Zone (CHZ), Canada, was conducted between 1 April 2002 and 31 March 2011, using the Discharge Abstract Database to identify adult patients with CD admitted to hospital and treated with surgical stoma formation (n = 545). Annual stoma incidence was calculated by dividing the number of incident stomas by the prevalence of CD in the CHZ. Time trend analysis of the stoma-formation rate was performed, expressed as annual percentage change (APC) with 95% CI. Stoma-formation rates were stratified according to procedure (emergency vs elective) and duration of stoma [temporary (reversed within 2 years of formation) vs permanent]. RESULTS: The overall rate of stoma formation between 2002 and 2011 showed a downwards trend, of a mean of 5.2% (95% CI: -8.5 to -1.8) per year, from a rate of 2.30 stomas/100 person-years (PY) in 2002 to 1.51 stomas/100 PY in 2011. The rate of emergency stoma formation decreased significantly from 2002 to 2011 (mean APC = -9.4%; 95% CI: -15.6 to -2.8), while the rate of elective ostomies essentially showed no change (mean APC = -0.9%; 95% CI: -5.3 to 3.8). The rate of temporary stoma formation decreased significantly, by 4.6% (95% CI: -7.3 to -1.8) per year, while permanent stoma formation was stable (APC = 1.0%; 95% CI: -4.0 to +6.3). CONCLUSION: A reduction in the overall rate of stoma formation in CD has been driven by fewer emergency stomas, although rates of permanent stoma have remained stable.

18 Article Pre-operative Exposure to Ustekinumab: A Risk Factor for Postoperative Complications in Crohn's Disease (CD)? 2019

Shim, Hang Hock / Ma, Christopher / Kotze, Paulo Gustavo / Panaccione, Remo. ·Department of Gastroenterology and Hepatology, Singapore General Hospital, Singapore. · Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, Canada. · Robarts Clinical Trials, Inc. London, Canada. · Inflammatory Bowel Disease Outpatient Clinics, Catholic University of Paraná (PUCPR), Curitiba, Brazil. ·Curr Drug Targets · Pubmed #31113343.

ABSTRACT: Crohn's disease (CD) is a chronic inflammatory condition of the intestinal tract that is characterised by a relapsing and remitting course. Despite advancements in therapeutic options for CD, a substantial number of patients still require surgery for medically refractory disease or disease-related complications. Given the widespread adoption of biologic therapies for the management of patients with moderate-to-severe CD, a high number of patients are likely to be on biologic therapy at the time of needing intestinal surgery: the safety of biologics in perioperative setting is of great interest. While more clinical data are available for TNF antagonists and vedolizumab, the safety data for ustekinumab, an IL 12/23 inhibitor, is lacking. Here, we review the available data from published literature on the postoperative outcomes for CD patients exposed to ustekinumab perioperatively.

19 Article Cell-based Therapy for Perianal Fistulising Crohn's Disease. 2019

Kotze, Paulo Gustavo / Spinelli, Antonino / Lightner, Amy Lee. ·Colorectal Surgery Unit, IBD outpatient clinics, Catholic University of Parana, Curitiba, Brazil. · Division of Colon and Rectal Surgery, Humanitas Clinical and Research Center, Rozzano, Italy. · Division of Colon and Rectal Surgery, Mayo Clinic, Rochester, United States. ·Curr Pharm Des · Pubmed #31092172.

ABSTRACT: BACKGROUND: The management of complex perianal fistulas in Crohn's disease (CD) represents a challenge for patients, gastroenterologists and colorectal surgeons. There are clear limitations with current medical and surgical options, and healing rates remain far from what is expected. A multidisciplinary approach with optimized medical therapy, usually anti-TNF agents, associated with setons and additional surgical techniques is currently the best strategy to aim fistula healing. METHODS: A comprehensive review of the literature was conducted on the use of mesenchymal stem cells (MSCs). RESULTS: The use of mesenchymal stem cells (MSCs) has recently emerged as a promising new therapeutic strategy for complex fistulas in CD patients. This review summarizes the evidence of the use of MSCs in complex CD fistulas, by exploring in detail the types of cells that can be used and their modes of delivery. Additionally, the results of the most recent phase III randomized trial with local MSCs injection are described, and future challenges of this therapeutic option are discussed. CONCLUSION: The use of MSCs represents hope for better outcomes in patients with CD-related perianal fistulas. More research in the field will help to position this specific therapy in treatment algorithms.

20 Article Anti-TNF and Postoperative Complications in Abdominal Crohn's Disease Surgery. 2019

Yamamoto, Takayuki / Teixeira, Fabio Vieira / Saad-Hossne, Rogerio / Kotze, Paulo Gustavo / Danese, Silvio. ·Department of Surgery and IBD Centre, Yokkaichi Hazu Medical Centre, Yokkaichi, Japan. · Department of Colorectal Surgery, Gastrosaude Clinic, Marilia, Brazil. · Digestive Surgery Department, Sao Paulo State University (UNESP), Botucatu, Brazil. · Colorectal Surgery Unit, Catholic University of Parana (PUCPR), Curitiba, Brazil. · IBD Centre, Department of Gastroenterology, Humanitas Clinical and Research Centre, Rozzano, Milan, Italy. ·Curr Drug Targets · Pubmed #30947671.

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.

21 Article Prevention of Postoperative Recurrence in CD: Tailoring Treatment to Patient Profile. 2019

Argollo, Marjorie / Kotze, Paulo Gustavo / Lamonaca, Laura / Gilardi, Daniela / Furfaro, Federica / Yamamoto, Takayuki / Danese, Silvio. ·Department of Gastroenterology, Universidade Federal de São Paulo, São Paulo, Brazil. · IBD Center, Department of Gastroenterology, Humanitas Clinical and Research Institute, Milan, Italy. · IBD outpatient clinics, Catholic University of Parana (PUCPR), Curitiba, Brazil. · Department of Surgery and IBD Centre, Yokkaichi Hazu Medical Centre, Yokkaichi, Japan. · Department of Biomedical Sciences, Humanitas University, Milan, Italy. ·Curr Drug Targets · Pubmed #30894106.

ABSTRACT: Crohn's disease (CD) is an immune-mediated condition characterized by the transmural inflammation of the gut tissue, associated with progressive bowel damage often leading to surgical intervention. As operative resection of the damaged segment is not curative, a majority of patients undergoing intestinal resections for complicated CD present disease recurrence within 3 years after the intervention. Postoperative recurrence can be defined as endoscopic, clinical, radiological or surgical. Endoscopic recurrence rates within 1 year exceed 60% and the severity, according to the Rutgeerts' score, is associated with worse prognosis and can predict clinical recurrence (in up to 1/3 of the patients). Most importantly, about 50% of patients will undergo a reoperation after 10 years of their first intestinal resection. Therefore, the prevention of postoperative recurrence in CD remains a challenge in clinical practice and should be properly managed. We aim to summarize the most recent data on the definition, risk factors, assessment and treatment of postoperative CD recurrence.

22 Article Hypoalbuminemia as a risk factor for thromboembolic events in inflammatory bowel disease inpatients. 2019

Imbrizi, Marcello Rabello / Magro, Daniela Oliveira / Secundo, Tirzah de Mendonça Lopes / Cunha-Silva, Marlone / Kotze, Paulo Gustavo / Montes, Ciro Garcia / Almeida, Jazon Romilson de Souza / Cabral, Virgínia Lúcia Ribeiro. ·Gastroenterology Unit, Department of Internal Medicine, Department of Surgery, University of Campinas (UNICAMP), Campinas, Brazil. · Colorectal Surgery Unit, Department of Surgery, University of Campinas (UNICAMP), Campinas, Brazil. · Colorectal Surgery Unit, IBD Outpatients Clinic, Cajuru University Hospital, Catholic University of Parana (PUCPR), Curitiba, Brazil. ·Intest Res · Pubmed #30678446.

ABSTRACT: BACKGROUND/AIMS: Inflammatory bowel disease (IBD) are chronic entities characterized by local and systemic inflammation and may be associated with thrombosis. The aim of this study was to identify the prevalence of thromboembolic events (TEE) in hospitalized IBD patients and identify risk factors for their occurrence. METHODS: This retrospective, single-center study included patients treated at a Brazilian IBD referral unit between 2004 and 2014. Patients hospitalized for more than 48 hours due to active IBD and who did not receive prophylaxis for TEE during hospitalization were included. Patients were allocated to 2 groups: those with TEE up to 30 days or at the time of hospitalization (TEE-group) and patients without TEE (control-group). Clinical and laboratory characteristics were evaluated. RESULTS: Of 53 patients evaluated, 69,8% with Crohn's disease (CD) and 30.2% with ulcerative colitis (UC). The prevalence of TEE 30 days before or during hospitalization was 15.1%, with 10.8% in CD and 25% in UC. In the TEE group, mean serum albumin was 2.06 g/dL versus 3.30 g/dL in the control group. Patients with albumin levels below 2.95 g/dL (43.18%) had a higher risk of developing TEE (relative risk, 1.72; 95% confidence interval, 1.17-2.53) (P<0.001). CONCLUSIONS: Albumin levels were significantly lower in patients with TEE, and hypoalbuminemia was considered a risk factor for the development of TEE in this population.

23 Article Preoperative Ustekinumab Treatment Is Not Associated With Increased Postoperative Complications in Crohn's Disease: A Canadian Multi-Centre Observational Cohort Study. 2018

Shim, Hang Hock / Ma, Christopher / Kotze, Paulo G / Seow, Cynthia H / Al-Farhan, Heba / Al-Darmaki, Ahmed K / Pang, Jack X Q / Fedorak, Richard N / Devlin, Shane M / Dieleman, Levinus A / Kaplan, Gilaad G / Novak, Kerri L / Kroeker, Karen I / Halloran, Brendan P / Panaccione, Remo. ·Division of Gastroenterology and Hepatology, University of Calgary, Calgary, Canada. · Department of Gastroenterology and Hepatology, Singapore General Hospital, Singapore. · Inflammatory Bowel Disease Outpatient Clinics, Catholic University of Paraná (PUCPR), Curitiba, Brazil. · Division of Gastroenterology, University of Alberta, Edmonton, Canada. ·J Can Assoc Gastroenterol · Pubmed #31294352.

ABSTRACT: Background: Ustekinumab (UST), an anti-IL12/23 inhibitor is indicated for moderate-to-severe Crohn's disease (CD). However, it is unclear if patients treated with UST are at increased risk for postoperative complications. Aim: To evaluate the postoperative safety outcomes in UST-treated CD patients. Methods: A multicentre cohort study of UST-treated CD patients at two tertiary care centres (University of Calgary, University of Alberta, Canada) undergoing abdominal surgery between 2009 and 2016 was performed. Postoperative outcomes were compared against a control cohort of anti-TNF-treated patients over the same time-period. The primary outcome was occurrence of postoperative complications up to six months postoperatively, stratified by timing (early <30 days vs. late complications ≥30 days). Results: Twenty UST-treated patients and 40 anti-TNF-treated patients were included with a median preoperative treatment exposure of 6.5 months and 18 months, respectively (p=0.01). Bowel obstruction was the most common surgical indication in both cohorts. UST-treated patients were more likely to require an ostomy (70.0% vs. 12.5%, p<0.001) and be on combination therapy with either systemic corticosteroids or concurrent immunomodulators (azathioprine or methotrexate) (25.0% vs. 2.5%, p=0.01). Despite the increased concomitant use of immunosuppression in the UST-treated cohort, there were no significant differences in early or late postoperative wound infections (1/20 in UST-cohort, 2/40 in anti-TNF cohort, p=1.00), anastomotic leak (0/20 in UST-cohort, 3/40 in anti-TNF cohort, p=0.54), or postoperative ileus/obstruction (3/20 in UST-cohort, 4/40 in anti-TNF cohort, p=0.67). Conclusions: CD patients receiving preoperative UST did not experience an increase in postoperative complications, despite increased use of concurrent immunosuppression.

24 Article Real-world clinical, endoscopic and radiographic efficacy of vedolizumab for the treatment of inflammatory bowel disease. 2018

Kotze, Paulo G / Ma, Christopher / Almutairdi, Abdulelah / Al-Darmaki, Ahmed / Devlin, Shane M / Kaplan, Gilaad G / Seow, Cynthia H / Novak, Kerri L / Lu, Cathy / Ferraz, Jose G P / Stewart, Michael J / Buresi, Michelle / Jijon, Humberto / Mathivanan, Meena / Heatherington, Joan / Martin, Marie-Louise / Panaccione, Remo. ·Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada. · Inflammatory Bowel Disease Outpatient Clinics, Catholic University of Paraná (PUCPR), Curitiba, PR, Brazil. · Robarts Clinical Trials Inc., Western University, London, ON, Canada. ·Aliment Pharmacol Ther · Pubmed #30063077.

ABSTRACT: BACKGROUND: Vedolizumab is an α4β7 integrin antagonist with proven efficacy for inducing and maintaining clinical response and remission in Crohn's disease (CD) and ulcerative colitis (UC). AIM: To evaluate clinical and objective response and remission rates with vedolizumab in a large, real world cohort. METHODS: A retrospective cohort study of adult CD and UC patients receiving vedolizumab between 2012 and 2017 was conducted. PRIMARY OUTCOME: clinical or objective response and remission at 3, 6 and 12 months after induction. Clinical remission was defined by complete, steroid-free absence of symptoms. Objective remission was defined by endoscopic mucosal healing or normalisation of radiographic appearance on contrast-enhanced ultrasound or CT/MR enterography. RESULTS: The study included 222 vedolizumab patients (122 CD, 100 UC). In CD, clinical remission at 3, 6 and 12 months was achieved in 19.8% (22/111), 22.1% (21/95) and 22.1% (15/68) of patients, respectively. Objective remission occurred in 11.5% (6/52), 21.2% (14/66), and 18.9% (7/37) of patients at 3, 6 and 12 months, respectively. In UC, clinical remission at 3, 6, and 12 months was 51.0% (51/100), 61.8% (55/89) and 61.9% (39/63), respectively. Endoscopic remission occurred in 27.5% (11/40), 41.0% (16/39) and 47.8% (22/46) of patients at 3, 6 and 12 months, respectively. In multivariable analysis, patients with UC as compared to CD, and those with milder disease activity were more likely to achieve objectively defined remission at both 6 and 12 months. CONCLUSIONS: Vedolizumab was effective for induction and maintenance of clinical and objective remission, both in Crohn's disease and ulcerative colitis.

25 Article SERUM INFLIXIMAB MEASUREMENT IN INFLAMMATORY BOWEL DISEASE PATIENTS IN REMISSION: A COMPARATIVE ANALYSIS OF TWO DIFFERENT METHODS IN A MULTICENTRIC BRAZILIAN COHORT. 2018

Teixeira, Fábio Vieira / Sassaki, Ligia Yukie / Saad-Hossne, Rogerio / Baima, Julio Pinheiro / Magro, Daniéla Oliveira / Coy, Claudio Saddy Rodrigues / Kotze, Paulo Gustavo. ·Clínica GastroSaúde, Marília, SP, Brasil. · Universidade Estadual Paulista (UNESP), Campus de Botucatu, Ambulatório de Doenças Inflamatóticas Intestinais, Faculdade de Medicina, Botucatu, SP, Brasil. · Unicamp, Faculdade de Ciências Médicas, Departamento de Cirurgia, Serviço de Coloproctologia, Campinas, SP, Brasil. · PUCPR, Hospital Universitário Cajuru, Unidade de Cirurgia Colorretal, Curitiba, PR, Brasil. ·Arq Gastroenterol · Pubmed #30043873.

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 (<3.0 μg/mL), adequate (3.1-7.0 μg/mL) or high (>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; P<0.0001, sensitivity, 100%; specificity, 61.9%), and >3.83 μg/mL using the ELISA assay (area under the ROC, 0.96; P<0.0001, sensitivity, 100%; specificity, 92.9%). CONCLUSION: QB-IFX and ELISA assays to measure IFX levels were comparable. Both methods had accurate sensitivity and specificity to detect undetectable, low and adequate levels, but had showed low specificity for supra therapeutic levels of IFX.

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