BACKGROUND Severe acute respiratory syndrome coronavirus 2 is the virus responsible for coronavirus disease 2019(COVID-19),a disease that has been blamed for inducing or exacerbating symptoms in patients with autoimmu...BACKGROUND Severe acute respiratory syndrome coronavirus 2 is the virus responsible for coronavirus disease 2019(COVID-19),a disease that has been blamed for inducing or exacerbating symptoms in patients with autoimmune diseases.Crohn's disease(CD)is an inflammatory bowel disease that affects genetically susceptible patients who develop an abnormal mucosal immune response to the intestinal microbiota.Patients who underwent hematopoietic stem cell transplantation(HSCT)are considered at risk for COVID-19.AIM To describe for the first time the impact of COVID-19 in CD patients who had undergone autologous,non-myeloablative HSCT.METHODS In this descriptive study a series of 19 patients were diagnosed with positive COVID-19.For two patients there were reports of the occurrence of two infectious episodes.Parameters related to HSCT,such as time elapsed since the procedure,vaccination status,CD status before and after infection,and clinical manifestations resulting from COVID-19,were evaluated.RESULTS Among the patients with COVID-19,three,who underwent Auto HSCT less than six months ago,relapsed and one,in addition to the CD symptoms,started to present thyroid impairment with positive anti-TPO.Only one of the patients required hospitalization for five days to treat COVID-19 and remained in CD clinical remission.Nine patients reported late symptoms that may be related to COVID-19.There were no deaths,and a statistical evaluation of the series of COVID-19 patients compared to those who did not present any infectious episode did not identify significant differences regarding the analyzed parameters.CONCLUSION Despite the change in CD status in three patients and the presence of nine patients with late symptoms,we can conclude that there was no significant adverse impact concerning COVID-19 in the evaluated patients who underwent HSCT to treat CD.展开更多
Crohn's disease(CD)is a chronic inflammatory bowel disease that can affect any part of the gastrointestinal tract.The etiology of CD is unknown;however,genetic,epigenetic,environmental,and lifestyle factors could ...Crohn's disease(CD)is a chronic inflammatory bowel disease that can affect any part of the gastrointestinal tract.The etiology of CD is unknown;however,genetic,epigenetic,environmental,and lifestyle factors could play an essential role in the onset and establishment of the disease.CD results from immune dysregulation due to loss of the healthy symbiotic relationship between host and intestinal flora and or its antigens.It affects both sexes equally with a male to female ratio of 1.0,and its onset can occur at any age,but the diagnosis is most commonly observed in the range of 20 to 40 years of age.CD diminishes quality of life,interferes with social activities,traumatizes due to the stigma of incontinence,fistulae,strictures,and colostomies,and in severe cases,affects survival when compared to the general population.Symptoms fluctuate between periods of remission and activity in which complications such as fistulas,strictures,and the need for bowel resection,surgery,and colostomy implantation make up the most severe aspects of the disease.CD can be progressive and the complications recurrent despite treatment with anti-inflammatory drugs,corticosteroids,immunosuppressants,and biological agents.However,over time many patients become refractory without treatment alternatives,and in this scenario,hematopoietic stem cell transplantation(HSCT)has emerged as a potential treatment option.The rationale for the use of HSCT for CD is anchored in animal studies and human clinical trials where HSCT could reset a patient's immune system by eliminating disease-causing effector cells and upon immune recovery increase regulatory and suppressive immune cells.Autologous HSCT using a non-myeloablative regimen of cyclophosphamide and anti-thymocyte globulin without CD34+selection has been to date the most common transplant conditioning regimen adopted.In this review we will address the current situation regarding CD treatment with HSCT and emphasize the medical,ethical,and legal aspects that permeate the procedure in Brazil.展开更多
Crohn's disease(CD) is an inflammatory bowel disease that can affect any site of the digestive system. It occurs due to an immunological imbalance and is responsible for intestinal mucosal lesions and complication...Crohn's disease(CD) is an inflammatory bowel disease that can affect any site of the digestive system. It occurs due to an immunological imbalance and is responsible for intestinal mucosal lesions and complications such as fistulas and stenoses. Treatment aims to stabilize the disease, reducing the symptoms and healing intestinal lesions. Surgical procedures are common in patients. Cell therapy was initially used to treat this disease in patients who also suffered from lymphoma and leukemia and were considered to be good candidates for autologous and allogeneic transplantation. After transplantation, an improvement was also observed in their CD. In 2003, the procedure began to be used to treat the disease itself, and several case series and randomized studies have been published since then; this approach currently comprises a new option in the treatment of CD. However, considerable doubt along with significant gaps in our knowledge continue to exist in relation to cell therapy for CD. Cell therapy is currently restricted to the autologous modality of hematopoietic stem cell transplantation and, experimentally, to mesenchymal stromal cells to directly treat lesions of the anal mucosa. This article presents the supporting claims for transplantation as well as aspects related to the mobilization regime, conditioning and perspectives of cell therapy.展开更多
BACKGROUND Understanding the treatment landscape of inflammatory bowel diseases(IBD)is essential for improving disease management and patient outcomes.Brazil is the largest Latin American country,and it presents socio...BACKGROUND Understanding the treatment landscape of inflammatory bowel diseases(IBD)is essential for improving disease management and patient outcomes.Brazil is the largest Latin American country,and it presents socioeconomic and health care differences across its geographical regions.This country has the highest increase in IBD incidence and prevalence in Latin America,but information about the clinical and treatment characteristics of IBD is scarce.AIM To describe the sociodemographic,clinical,and treatment characteristics of IBD outpatients in Brazil overall and in the Southeast,South and Northeast/Midwest regions.METHODS Multicenter,cross-sectional study with a 3-year retrospective chart review component.Patients with moderate-to-severe Crohn’s disease(CD)or ulcerative colitis(UC)were consecutively enrolled between October 2016 and February 2017.Active CD at enrollment was defined as a Harvey Bradshaw Index≥8 or a CD Activity Index≥220 or a calprotectin level>200μg/g or an active result based on colonoscopy suggestive of inadequate control during the previous year;active UC was defined as a partial Mayo score≥5.Descriptive statistics were used to analyze all variables.RESULTS In a total of 407 included patients,CD was more frequent than UC,both overall(264 CD/143 UC patients)and by region(CD:UC ratios of 2.1 in the Southeast,1.6 in the South and 1.2 in the Northeast/Midwest).The majority of patients were female(54.2%of CD;56.6%of UC),and the mean ages were 45.9±13.8 years(CD)and 42.9±13.0 years(UC).The median disease duration was 10.0(range:0.5-45)years for both IBD types.At enrollment,44.7%[95%confidence interval(CI):38.7-50.7]of CD patients and 25.2%(95%CI:18.1-32.3)of UC patients presented with active disease.More than 95%of IBD patients were receiving treatment at enrollment;CD patients were commonly treated with biologics(71.6%)and immunosuppressors(67.4%),and UC patients were commonly treated with mesalazine[5-Aminosalicylic acid(5-ASA)]derivates(69.9%)and immunosuppressors(44.1%).More than 50%of the CD patients had ileocolonic disease,and 41.7%presented with stricturing disease.One-quarter of CD patients had undergone CD-related surgery in the past 3 years,and this proportion was lower in the Northeast/Midwest region(2.9%).CONCLUSION In Brazil,there are regional variations in IBD management.CD outweighs UC in both frequency and disease activity.However,one-quarter of UC patients have active disease,and most are receiving 5-ASA treatment.展开更多
BACKGROUND Crohn’s disease(CD)and ulcerative colitis(UC)are inflammatory bowel diseases(IBDs)with a remission-relapsing presentation and symptomatic exacerbations that have detrimental impacts on patient quality of l...BACKGROUND Crohn’s disease(CD)and ulcerative colitis(UC)are inflammatory bowel diseases(IBDs)with a remission-relapsing presentation and symptomatic exacerbations that have detrimental impacts on patient quality of life and are associated with a high cost burden,especially in patients with moderate-to-severe disease.The Real-world Data of Moderate-to-Severe Inflammatory Bowel Disease in Brazil(RISE BR)study was a noninterventional study designed to evaluate disease control,treatment patterns,disease burden and health-related quality of life in patients with moderate-to-severe active IBD.We report findings from the prospective follow-up phase of the RISE BR study in patients with active UC or CD.AIM To describe the 12-mo disease evolution and treatment patterns among patients with active moderate-to-severe IBD in Brazil.METHODS This was a prospective,noninterventional study of adult patients with active Crohn’s disease(CD:Harvey-Bradshaw Index≥8,CD Activity Index≥220),inadequate CD control(i.e.,calprotectin>200μg/g or colonoscopy previous results),or active ulcerative colitis(UC:Partial Mayo score≥5).Enrollment occurred in 14 centers from October 2016 to February 2017.The proportion of active IBD patients after 9-12 mo of follow-up,Kaplan-Meier estimates of the time to mild or no activity and a summary of treatment initiation,discontinuation and dose changes were examined.RESULTS The study included 118 CD and 36 UC patients,with mean±SD ages of 43.3±12.6 and 44.9±16.5 years,respectively.The most frequent drug classes at index were biologics for CD(62.7%)and 5-aminosalicylate derivates for UC patients(91.7%).During follow-up,65.3%of CD and 86.1%of UC patients initiated a new treatment at least once.Discontinuations/dose changes occurred in 68.1%of CD patients[median 2.0(IQR:2-5)]and 94.3%of UC patients[median 4.0(IQR:3-7)].On average,CD and UC patients had 4.4±2.6 and 5.0±3.3 outpatient visits,respectively.The median time to first mild or no activity was 319(IQR:239-358)d for CD and 320(IQR:288-358)d for UC patients.At 9-12 mo,22.0%of CD and 20.0%of UC patients had active disease.CONCLUSION Although a marked proportion of active IBD patients achieved disease control within one year,the considerable time to achieve this outcome represents an unmet medical need of the current standard of care in a Brazilian real-world setting.展开更多
文摘BACKGROUND Severe acute respiratory syndrome coronavirus 2 is the virus responsible for coronavirus disease 2019(COVID-19),a disease that has been blamed for inducing or exacerbating symptoms in patients with autoimmune diseases.Crohn's disease(CD)is an inflammatory bowel disease that affects genetically susceptible patients who develop an abnormal mucosal immune response to the intestinal microbiota.Patients who underwent hematopoietic stem cell transplantation(HSCT)are considered at risk for COVID-19.AIM To describe for the first time the impact of COVID-19 in CD patients who had undergone autologous,non-myeloablative HSCT.METHODS In this descriptive study a series of 19 patients were diagnosed with positive COVID-19.For two patients there were reports of the occurrence of two infectious episodes.Parameters related to HSCT,such as time elapsed since the procedure,vaccination status,CD status before and after infection,and clinical manifestations resulting from COVID-19,were evaluated.RESULTS Among the patients with COVID-19,three,who underwent Auto HSCT less than six months ago,relapsed and one,in addition to the CD symptoms,started to present thyroid impairment with positive anti-TPO.Only one of the patients required hospitalization for five days to treat COVID-19 and remained in CD clinical remission.Nine patients reported late symptoms that may be related to COVID-19.There were no deaths,and a statistical evaluation of the series of COVID-19 patients compared to those who did not present any infectious episode did not identify significant differences regarding the analyzed parameters.CONCLUSION Despite the change in CD status in three patients and the presence of nine patients with late symptoms,we can conclude that there was no significant adverse impact concerning COVID-19 in the evaluated patients who underwent HSCT to treat CD.
文摘Crohn's disease(CD)is a chronic inflammatory bowel disease that can affect any part of the gastrointestinal tract.The etiology of CD is unknown;however,genetic,epigenetic,environmental,and lifestyle factors could play an essential role in the onset and establishment of the disease.CD results from immune dysregulation due to loss of the healthy symbiotic relationship between host and intestinal flora and or its antigens.It affects both sexes equally with a male to female ratio of 1.0,and its onset can occur at any age,but the diagnosis is most commonly observed in the range of 20 to 40 years of age.CD diminishes quality of life,interferes with social activities,traumatizes due to the stigma of incontinence,fistulae,strictures,and colostomies,and in severe cases,affects survival when compared to the general population.Symptoms fluctuate between periods of remission and activity in which complications such as fistulas,strictures,and the need for bowel resection,surgery,and colostomy implantation make up the most severe aspects of the disease.CD can be progressive and the complications recurrent despite treatment with anti-inflammatory drugs,corticosteroids,immunosuppressants,and biological agents.However,over time many patients become refractory without treatment alternatives,and in this scenario,hematopoietic stem cell transplantation(HSCT)has emerged as a potential treatment option.The rationale for the use of HSCT for CD is anchored in animal studies and human clinical trials where HSCT could reset a patient's immune system by eliminating disease-causing effector cells and upon immune recovery increase regulatory and suppressive immune cells.Autologous HSCT using a non-myeloablative regimen of cyclophosphamide and anti-thymocyte globulin without CD34+selection has been to date the most common transplant conditioning regimen adopted.In this review we will address the current situation regarding CD treatment with HSCT and emphasize the medical,ethical,and legal aspects that permeate the procedure in Brazil.
文摘Crohn's disease(CD) is an inflammatory bowel disease that can affect any site of the digestive system. It occurs due to an immunological imbalance and is responsible for intestinal mucosal lesions and complications such as fistulas and stenoses. Treatment aims to stabilize the disease, reducing the symptoms and healing intestinal lesions. Surgical procedures are common in patients. Cell therapy was initially used to treat this disease in patients who also suffered from lymphoma and leukemia and were considered to be good candidates for autologous and allogeneic transplantation. After transplantation, an improvement was also observed in their CD. In 2003, the procedure began to be used to treat the disease itself, and several case series and randomized studies have been published since then; this approach currently comprises a new option in the treatment of CD. However, considerable doubt along with significant gaps in our knowledge continue to exist in relation to cell therapy for CD. Cell therapy is currently restricted to the autologous modality of hematopoietic stem cell transplantation and, experimentally, to mesenchymal stromal cells to directly treat lesions of the anal mucosa. This article presents the supporting claims for transplantation as well as aspects related to the mobilization regime, conditioning and perspectives of cell therapy.
文摘BACKGROUND Understanding the treatment landscape of inflammatory bowel diseases(IBD)is essential for improving disease management and patient outcomes.Brazil is the largest Latin American country,and it presents socioeconomic and health care differences across its geographical regions.This country has the highest increase in IBD incidence and prevalence in Latin America,but information about the clinical and treatment characteristics of IBD is scarce.AIM To describe the sociodemographic,clinical,and treatment characteristics of IBD outpatients in Brazil overall and in the Southeast,South and Northeast/Midwest regions.METHODS Multicenter,cross-sectional study with a 3-year retrospective chart review component.Patients with moderate-to-severe Crohn’s disease(CD)or ulcerative colitis(UC)were consecutively enrolled between October 2016 and February 2017.Active CD at enrollment was defined as a Harvey Bradshaw Index≥8 or a CD Activity Index≥220 or a calprotectin level>200μg/g or an active result based on colonoscopy suggestive of inadequate control during the previous year;active UC was defined as a partial Mayo score≥5.Descriptive statistics were used to analyze all variables.RESULTS In a total of 407 included patients,CD was more frequent than UC,both overall(264 CD/143 UC patients)and by region(CD:UC ratios of 2.1 in the Southeast,1.6 in the South and 1.2 in the Northeast/Midwest).The majority of patients were female(54.2%of CD;56.6%of UC),and the mean ages were 45.9±13.8 years(CD)and 42.9±13.0 years(UC).The median disease duration was 10.0(range:0.5-45)years for both IBD types.At enrollment,44.7%[95%confidence interval(CI):38.7-50.7]of CD patients and 25.2%(95%CI:18.1-32.3)of UC patients presented with active disease.More than 95%of IBD patients were receiving treatment at enrollment;CD patients were commonly treated with biologics(71.6%)and immunosuppressors(67.4%),and UC patients were commonly treated with mesalazine[5-Aminosalicylic acid(5-ASA)]derivates(69.9%)and immunosuppressors(44.1%).More than 50%of the CD patients had ileocolonic disease,and 41.7%presented with stricturing disease.One-quarter of CD patients had undergone CD-related surgery in the past 3 years,and this proportion was lower in the Northeast/Midwest region(2.9%).CONCLUSION In Brazil,there are regional variations in IBD management.CD outweighs UC in both frequency and disease activity.However,one-quarter of UC patients have active disease,and most are receiving 5-ASA treatment.
文摘BACKGROUND Crohn’s disease(CD)and ulcerative colitis(UC)are inflammatory bowel diseases(IBDs)with a remission-relapsing presentation and symptomatic exacerbations that have detrimental impacts on patient quality of life and are associated with a high cost burden,especially in patients with moderate-to-severe disease.The Real-world Data of Moderate-to-Severe Inflammatory Bowel Disease in Brazil(RISE BR)study was a noninterventional study designed to evaluate disease control,treatment patterns,disease burden and health-related quality of life in patients with moderate-to-severe active IBD.We report findings from the prospective follow-up phase of the RISE BR study in patients with active UC or CD.AIM To describe the 12-mo disease evolution and treatment patterns among patients with active moderate-to-severe IBD in Brazil.METHODS This was a prospective,noninterventional study of adult patients with active Crohn’s disease(CD:Harvey-Bradshaw Index≥8,CD Activity Index≥220),inadequate CD control(i.e.,calprotectin>200μg/g or colonoscopy previous results),or active ulcerative colitis(UC:Partial Mayo score≥5).Enrollment occurred in 14 centers from October 2016 to February 2017.The proportion of active IBD patients after 9-12 mo of follow-up,Kaplan-Meier estimates of the time to mild or no activity and a summary of treatment initiation,discontinuation and dose changes were examined.RESULTS The study included 118 CD and 36 UC patients,with mean±SD ages of 43.3±12.6 and 44.9±16.5 years,respectively.The most frequent drug classes at index were biologics for CD(62.7%)and 5-aminosalicylate derivates for UC patients(91.7%).During follow-up,65.3%of CD and 86.1%of UC patients initiated a new treatment at least once.Discontinuations/dose changes occurred in 68.1%of CD patients[median 2.0(IQR:2-5)]and 94.3%of UC patients[median 4.0(IQR:3-7)].On average,CD and UC patients had 4.4±2.6 and 5.0±3.3 outpatient visits,respectively.The median time to first mild or no activity was 319(IQR:239-358)d for CD and 320(IQR:288-358)d for UC patients.At 9-12 mo,22.0%of CD and 20.0%of UC patients had active disease.CONCLUSION Although a marked proportion of active IBD patients achieved disease control within one year,the considerable time to achieve this outcome represents an unmet medical need of the current standard of care in a Brazilian real-world setting.
