Does the Antitumor Necrosis Factor-α Therapy Decrease the Vertebral Fractures Occurrence in Inflammatory Bowel Disease?

BACKGROUND/OBJECTIVE: Osteoporosis and osteoporotic fracture risk are extraintestinal manifestations of the inflammatory bowel disease, whose etiopathogenic mechanisms have not been determined yet. Anti-tumor necrosis factor (TNF)-α are used in treatment of inflammatory bowel disease (IBD), but it is unknown if they play a role in osteoporotic fracture prevention. The objective of this study was to know if anti-TNF decreases fracture risk or modifies bone mineral density. To determine the possible risk factors associated with fractures, and assess the incidence of vertebral fractures in IBD patients. METHODS: Longitudinal prospective cohort study (7 yr of follow-up); which included 71 IBD patients, 23 received anti-TNF-α; the remaining 48 received conventional treatment, constituted the control group. Patients participated in a questionnaire which gathered risk factors associated with the development of osteoporosis and fractures. Radiographs of the dorsolumbar-spine were performed and also a bone density measurement. Their biochemical and bone remodeling parameters were determined. RESULTS: Although patients who did not receive anti-TNF-α, suffered more fractures but biologic therapy did not reduce the risk of new vertebral fractures. The increase of bone mass was significantly higher the group treated with anti-TNF-α. The increase in the lumbar spine was of 8% and in the femoral neck was of 6.7%. The only determinant factor for the incidence of vertebral fractures was a history of previous fractures (odds ratio of 12.8; confidence interval 95% 2.37-69.9; p = 0.003). The incidence of vertebral fractures in IBD patients was considerably high: 26.7/700 patient-yr. CONCLUSIONS: Anti-TNF-α, although increased bone mass in these patients, did not reduce the risk of new vertebral fractures. In this study, patients with IBD have a considerably high incidence of fractures. Only the existence of previous vertebral fractures was a predictive factor for consistent fractures.

Effectiveness and Safety of CT-P13 (Biosimilar Infliximab) in Patients with Inflammatory Bowel Disease in Real Life at 6 Months.

BACKGROUND: CT-P13 is a biosimilar of Remicade®, an agent approved in some countries for use in inflammatory bowel disease (IBD). Controlled clinical trials have demonstrated the efficacy and safety of CT-P13 in rheumatic diseases, but not in IBD. AIMS: To assess the effectiveness and safety of CT-P13 in IBD patients in real clinical practice. METHODS: This is a prospective observational study in patients with moderate to severe Crohn's disease or ulcerative colitis treated with CT-P13. The study was performed in one single center. Patients included were naive or switched to anti-TNF treatment from the reference infliximab (Remicade®) to CT-P13. Efficacy and safety were assessed in naive and switched patients who were in remission at the time of the switch at months 3 and 6 of therapy. RESULTS: 87.5 and 83.9% of switched CD patients who were in remission at the time of the switch continued in remission, and 66.7 and 50% of naive CD patients reached remission, at months 3 and 6. In UC switched cases, 92 and 91.3% of patients in remission at the time of the switch continued in remission, at 3 and 6 months. In naive UC patients, the remission rates were 44.4 and 66.7%, at months 3 and 6. Adverse events occurred in 7.5% of patients during 6 months of study. CONCLUSIONS: CT-P13 was efficacious and well tolerated in patients with CD or UC.

Characteristics and treatment of pyoderma gangrenosum in inflammatory bowel disease.

BACKGROUND: Pyoderma gangrenosum is a serious cutaneous complication seen in approximately 1 % of patients with inflammatory bowel disease (IBD). Oral corticosteroids are the mainstay treatment, although the evidence supporting their use is weak. AIMS: The purpose of this study was to investigate the characteristics of pyoderma gangrenosum associated with Crohn's disease or ulcerative colitis and which treatments are prescribed in Spanish clinical practice. METHODS: In this retrospective, observational study, the medical records from all patients with IBD and a diagnosis of pyoderma gangrenosum attended by the gastroenterology departments of 12 Spanish hospitals were reviewed. Data on patient demographics and characteristics, underlying IBD and treatment, and pyoderma gangrenosum characteristics, treatment, and outcome were collected and analyzed. RESULTS: The data from 67 patients were analyzed (41 [61.2 %] women, 41 [61.2 %] with Crohn's disease, 25 [37.3 %] with ulcerative colitis, and 1 [1.5 %] with indeterminate disease). The underlying disease was in remission in approximately one-third of patients at the time of presentation of pyoderma gangrenosum. Healing was achieved in all patients (in 3 without any systemic therapy). Oral corticosteroids were taken by 51 patients (76.1 %), almost always as first-line treatment, although definitive healing was attained in 19 (28.4 %). Biologic agents such as infliximab and adalimumab were taken by 31 patients (46.3 %) at some point (first-line in 6 patients [9.0 %]), with definitive healing in 29 patients (93.5 %). CONCLUSIONS: Oral corticosteroid therapy remains the most common treatment for pyoderma gangrenosum associated with inflammatory bowel disease. Biologic therapies such as infliximab and adalimumab should also be considered.

Efficacy of adalimumab in patients with Crohn's disease and failure to infliximab therapy: a clinical series.

BACKGROUND: adalimumab, a human anti-TNF, is an effective induction and maintenance therapy for patients with moderate to severe Crohn's disease. It seems to be effective in patients with resistance to infliximab, too, though the experience is more limited. AIM: to evaluate the efficacy of adalimumab, in patients with Crohn's disease (CD) and failure to previous treatment with infliximab. METHODS: twenty-five patients with CD and failure to previous treatment with infliximab were enrolled; they were treated with 160/80 (24 patients) and 80/40 (1 patient) induction doses. We analyze clinical response to treatment with adalimumab by the Crohn's disease Activity Index (CDAI) and plasma concentration of C-reactive protein (CRP), steroid sparing and complete fistula closure at week 48. RESULTS: eighteen out of twenty-five patients (72%) achieved clinical remission (CDAI score < 150) at week 24 and 15/25 (60%) patients at week 48. There was a statistically significant difference(p < 0.01) in CRP serum levels from 21 to 8 mg/dl at week 48.Nine out of fifteen patients (60%) treated with corticosteroids were able to discontinue steroids. Three out of eleven patients (27%) with fistulizing Crohn's disease had complete fistula closure after the treatment. Seventy two percent of the patients (18/25) needed to increase adalimumab to weekly dose, in order to maintain clinical response. Five out of twenty-five patients (20%) had adverse events; two of them (8%) with serious adverse events (tuberculous meningitis and abdominal abscess) that forced the withdrawal of treatment. CONCLUSIONS: according to these data, adalimumab provides a clinical and analytical improvement in patients with CD and failure to previous therapy with infliximab.

PillCamColon Capsule for the study of colonic pathology in clinical practice. Study of agreement with colonoscopy.

INTRODUCTION: several studies have pointed out the effectiveness of the PillCam colon capsule endoscopy (CCE) compared with the colonoscopy in the study of the colonic pathology. AIMS AND METHODS: the objective of our study was to assess the agreement in the diagnosis of CCE with conventional colonoscopy as well as its sensitivity and specificity, and to describe the findings of the CCE in our clinical practice. Consecutive patients with abdominal symptoms were included in the study. The CCE was performed as previously reported (with PEG and sodium phosphate as laxative agents). The nature and location of the findings, colonic transit time, complications, cleanliness degree and consistency with diagnostic colonoscopy, when performed, were analyzed. RESULTS: a total of 144 subjects (67 women and 77 men); (52.17 ± 16.71 years) with the following indications were included: screening of Colorectal cancer (88 patients), control after polipectomy (24), incomplete colonoscopy (7), rectal bleeding (10), anemia (8), diarrhea (7). The CCE exploration was complete in 134/144 cases (93%), with no case of retention. The preparation was good-very good in 88/134 (65,6%), fair in 26/134 (19,4%) and poor in 20/134 (15%) of the cases. The average colonic transit was of 140.76 min (9-603). Any adverse effect was notified.In 44 cases a colonoscopy was carried out after CCE (results were hidden from another endoscopist). Compared to colonoscopy, the rate of agreement was 75,6%, the sensitivity was 84% and the specificity 62,5%, PPV was 77,7% and NPV was 71,4%.The colonic findings in 134 CCE were: in 34 cases CCE it did not show lesions, diverticulosis in 63 explorations, polyps in 43, angiodysplasias in 15, Crohn's Disease in 9 and ulcerative colitis in other 8 cases. CONCLUSIONS: the CCE is an effective and reliable technique for the detection of lesions in colon, and because of its high agreement with the colonoscopy, it could be useful in clinical practice. Further studies with large seria and cost-effectiveness analysis are needed to confirm these data.

PillCam© Colon Capsule for the study of colonic pathology in clinical practice. Study of agreement with colonoscopy

Introduction: several studies have pointed out the effectiveness of the PillCam© colon capsule endoscopy (CCE) compared with the colonoscopy in the study of the colonic pathology. Aims and methods: the objective of our study was to assess the agreement in the diagnosis of CCE with conventional colonoscopy as well as its sensitivity and specificity, and to describe the findings of the CCE in our clinical practice. Consecutive patients with abdominal symptoms were included in the study. The CCE was performed as previously reported (with PEG and sodium phosphate as laxative agents). The nature and location of the findings, colonic transit time, complications, cleanliness degree and consistency with diagnostic colonoscopy, when performed, were analyzed. Results: a total of 144 subjects (67 women and 77 men); (52.17±16.71 years) with the following indications were included: screening of Colorectal cancer (88 patients), control after polipectomy (24), incomplete colonoscopy (7), rectal bleeding (10), anemia (8), diarrhea (7). The CCE exploration was complete in 134/144 cases (93%), with no case of retention. The preparation was good-very good in 88/134 (65,6%), fair in 26/134 (19,4%) and poor in 20/134 (15%) of the cases. The average colonic transit was of 140.76 min (9-603). Any adverse effect was notified. In 44 cases a colonoscopy was carried out after CCE (results were hidden from another endoscopist). Compared to colonoscopy, the rate of agreement was 75,6%, the sensitivity was 84% and the specificity 62,5%, PPV was 77,7% and NPV was 71,4 %. The colonic findings in 134 CCE were: in 34 cases CCE it did not show lesions, diverticulosis in 63 explorations, polyps in 43, angiodysplasias in 15, Crohn´s Disease in 9 and ulcerative colitis in other 8 cases. Conclusions: the CCE is an effective and reliable technique for the detection of lesions in colon, and because of its high agree - ment with the colonoscopy, it could be useful in clinical practice. Further studies with large seria and cost-effectiveness analysis are needed to confirm these data(AU)

Macroscopic small bowel mucosal injury caused by chronic nonsteroidal anti-inflammatory drugs (NSAID) use as assessed by capsule endoscopy.

OBJECTIVE: To evaluate the type, frequency, and severity of macroscopic small bowel mucosal injury after chronic NSAID intake as assessed by capsule endoscopy (CE), as well as to correlate the severity of gastroduodenal and intestinal damage in these patients. MATERIAL AND METHODS: A prospective, endoscopist-blind, controlled trial. Sixteen patients (14F/2M; age: 57.06 +/- 10.16 yrs) with osteoarthritis (OA) on chronic therapy with NSAIDs underwent CE and upper gastrointestinal endoscopy (UGE). Seventeen patients with OA (9F/2M; age: 57.47 +/- 9.82 yrs) who did not take NSAIDs were included as a control group. A scale ranging from 0 to 2 (0 = no lesions, 1-minor = red spots or petechiae, denuded areas and/or 1-5 mucosal breaks; 2-major = > 5 mucosal breaks and/or strictures, or hemorrhage) was designed to assess the severity of small bowel mucosal injuries. RESULTS: CE found intestinal lesions in 75% (12/16) of patients in the study group and in 11.76% (2/17) of controls (p < 0.01). Seven out of 16 NSAID consumers (43.75%) and none in the control group (0%) had a major small bowel mucosal injury (p < 0.01). The percentages of patients with grade 1 and 2 gastroduodenopathy in the study group, as assessed by UGE, were 37.14 and 23.81%, respectively. There was no significant difference in the rate of major enteropathy between patients with none or minor gastroduodenal injury, and those with major gastroduodenopathy (43.75 vs. 40%; p = N.S.). CONCLUSIONS: Chronic NSAID intake is associated with a high rate of small bowel mucosal injuries. Our data have failed to demonstrate a relationship between the severity of gastroduodenal and intestinal injury.

Macroscopic small bowel mucosal injury caused by chronic nonsteroidal anti-inflammatory drugs (NSAID) use as assessed by capsule endoscopy

Objective: to evaluate the type, frequency, and severity of macroscopicsmall bowel mucosal injury after chronic NSAID intake asassessed by capsule endoscopy (CE), as well as to correlate the severityof gastroduodenal and intestinal damage in these patients.Material and methods: a prospective, endoscopist-blind,controlled trial. Sixteen patients (14F/2M; age: 57.06 ± 10.16yrs) with osteoarthritis (OA) on chronic therapy with NSAIDs underwentCE and upper gastrointestinal endoscopy (UGE). Seventeenpatients with OA (9F/2M; age: 57.47 ± 9.82 yrs) who didnot take NSAIDs were included as a control group. A scale rangingfrom 0 to 2 (0 = no lesions, 1-minor = red spots or petechiae,denuded areas and/or 1-5 mucosal breaks; 2-major = > 5mucosal breaks and/or strictures, or hemorrhage) was designed toassess the severity of small bowel mucosal injuries.Results: CE found intestinal lesions in 75% (12/16) of patientsin the study group and in 11.76% (2/17) of controls (p <0.01). Seven out of 16 NSAID consumers (43.75%) and none inthe control group (0%) had a major small bowel mucosal injury (p< 0.01). The percentages of patients with grade 1 and 2 gastroduodenopathyin the study group, as assessed by UGE, were37.14 and 23.81%, respectively. There was no significant differencein the rate of major enteropathy between patients withnone or minor gastroduodenal injury, and those with major gastroduodenopathy(43.75 vs. 40%; p = N.S.).Conclusions: chronic NSAID intake is associated with a highrate of small bowel mucosal injuries. Our data have failed to demonstratea relationship between the severity of gastroduodenaland intestinal injury(AU)

Sarcoma de Kaposi gástrico y Mycobacterium genavense / No disponible

No disponible

[Is capsule endoscopy useful in children with chronic abdominal pain?]. / Es útil la cápsula endoscópica en niños con dolor abdominal crónico?

Chronic abdominal pain is highly prevalent in school-aged children and is one of the most frequent disorders in our environment. The aim of the present study was to evaluate the usefulness of capsule endoscopy (CE) in patients with chronic abdominal pain. Sixteen patients (nine boys and seven girls), aged between 5 and 16 years old, with chronic abdominal pain for at least 12 months were studied. In all patients the results of hemograms, biochemical investigations, urine sediment test, Helicobacter pylori breath test and celiac serology were normal. In all children, gastroscopy, small bowel follow-through, abdominal ultrasound and colonoscopy were normal. All patients received CE by mouth. In 43.75 % of the patients studied (7/16), the capsule showed evidence of nodular lymphoid hyperplasia, mainly located in the ileum. In one girl, oxyuriasis was observed in the cecum and in another girl aphthous lesions were observed in the ileum. These lesions suggested small bowel Crohn's disease. CE mainly showed images compatible with nodular lymphoid hyperplasia, with unknown clinical significance. Consequently, we conclude that CE does not provide useful information in patients with abdominal pain without other symptoms.

¿Es útil la cápsula endoscópica en niños con dolor abdominal crónico? / Is capsule endoscopy useful in children with chronic abdominal pain?

El dolor abdominal crónico afecta a un alto porcentaje de niños en edad escolar, lo que la convierte en una de las patologías más frecuentes en nuestro medio. El objetivo es valorar si la cápsula endoscópica (CE) permite identificar lesiones intestinales en estos pacientes. Se han incluido 16 pacientes (9 niños y 7 niñas) con edades comprendidas entre los 5 y 16 años con dolor abdominal crónico de más de 12 meses de evolución. Todos tenían realizados hemograma, bioquímica, sedimento de orina, test de aliento para Helicobacter pylori y serología para enfermedad celíaca, que eran negativos. A todos se les había realizado una gastroscopia, y una colonoscopia que resultaron negativas, así como un tránsito gastrointestinal y una ecografía abdominal, sin hallazgos de interés. En el 43,75 % de los pacientes estudiados (7/16) la CE mostró imágenes compatibles con hiperplasia folicular linfoide localizadas en el íleon. En una niña se observaron oxiuros en ciego y en otra, lesiones aftosas ileales compatibles con enfermedad de Crohn. La CE muestra en la mayoría de los casos imágenes compatibles con hiperplasia nodular linfoide intestinal, con dudosa significación clínica, por lo que podemos concluir que la CE no aporta nada específico en niños con dolor abdominal crónico

Chronic abdominal pain is highly prevalent in school-aged children and is one of the most frequent disorders in our environment. The aim of the present study was to evaluate the usefulness of capsule endoscopy (CE) in patients with chronic abdominal pain. Sixteen patients (nine boys and seven girls), aged between 5 and 16 years old, with chronic abdominal pain for at least 12 months were studied. In all patients the results of hemograms, biochemical investigations, urine sediment test, Helicobacter pylori breath test and celiac serology were normal. In all children, gastroscopy, small bowel follow-through, abdominal ultrasound and colonoscopy were normal. All patients received CE by mouth. In 43.75 % of the patients studied (7/16), the capsule showed evidence of nodular lymphoid hyperplasia, mainly located in the ileum. In one girl, oxyuriasis was observed in the cecum and in another girl aphthous lesions were observed in the ileum. These lesions suggested small bowel Crohn's disease. CE mainly showed images compatible with nodular lymphoid hyperplasia, with unknown clinical significance. Consequently, we conclude that CE does not provide useful information in patients with abdominal pain without other symptoms

Diagnostic yield of 335 push video-enteroscopies.

BACKGROUND AND OBJECTIVES: The diagnostic yield of push enteroscopy (PE) varies widely from 13 to 78% of cases, according to the various series. The aim of this retrospective cohort study was to determine the endoscopic and histological yield of PE in our health area. PATIENTS AND METHODS: A total of 355 consecutive patients (190 males/165 females; mean age 45 years, range 15-89) underwent PE over a 6-year period, from 1997 to 2003. PE was performed under sedation and without overtube. Small-bowel mucosa biopsies were taken in 199 explorations (56%). Clinical indications for PE included: chronic diarrhea (35%), occult digestive bleeding (ODB) or iron-deficiency anemia (28%), suspected small-bowel malignancy (16%), chronic abdominal pain (28/355; 8%), follow-up of polyposis or malabsorption syndromes (7%), and abnormal radiographic findings (6%). RESULTS: PE detected lesions in 122 cases (34%); in 6 cases (6%) lesions were within the reach of esophagogastroduodenoscopy. A normal macroscopic appearance of the small intestinal mucosa with an abnormal histological study was seen in 16 patients (6%). Major findings included: malabsorptive diseases (14%), nonspecific enteropathy (5%), angiodysplasia (3,5%), lymphangiectasia (3%); jejunal polyps (2%), Crohn s disease (2%), intestinal tumors (2%), extrinsic jejunal strictures (0.5%), and other (10/355; 3%). Abnormal radiographic findings (62%), chronic diarrhea (37%) and ODB (31%) were the indications with a higher diagnostic yield. No major complications were seen. CONCLUSIONS: According to our experience, PE is a safe and useful tool for the evaluation of small-bowel disease, especially in some indications (abnormal radiographic findings, chronic diarrhea, and ODB). Small-bowel biopsy increases PE's diagnostic yield in patients with chronic diarrhea.

Rendimiento diagnóstico de 355 videoenteroscopias por pulsión / Diagnostic yield of 335 push video-enteroscopies

Introducción y objetivos: el rendimiento diagnóstico de la enteroscopia por pulsión (EP) varía ampliamente (13-78%) según las series. El objetivo de este estudio retrospectivo fue determinar el rendimiento endoscópico e histológico de la EP en nuestra área sanitaria. Pacientes y métodos: un total de 355 pacientes consecutivos (190 hombres/165 mujeres; media de edad 45 años, rango 15-89), fueron sometidos a EP en un periodo de 6 años, entre 1997 y 2003. Las EP fueron realizadas bajo sedación y sin sobretubo, tomándose biopsias de la mucosa de intestino delgado en 199 exploraciones (56%). Las indicaciones clínicas fueron: diarrea crónica (126/355; 35%), hemorragia digestiva de origen oscuro o anemia ferropénica (99/355; 28%), sospecha de tumor intestinal (56/355; 16%), dolor abdominal crónico (28/355; 8%), seguimiento de síndromes de poliposis o cuadros malabsortivos (25/355; 7%), y confirmación de anormalidades radiográficas (21/355; 6%). Resultados: la EP identificó lesiones en 122 pacientes (34%), observándose lesiones al alcance del gastroscopio convencional en 6 casos (6%). En 16 pacientes (6%) el aspecto macroscópico de la mucosa intestinal fue normal, objetivándose hallazgos diagnósticos en el estudio histológico. Los principales hallazgos encontrados fueron: proceso malabsortivo (50/355; 14%), enteropatía inespecífica (19/355, 5%), angiodisplasia (13/355; 3,5%), linfangiectasia (10/355; 3%), pólipos yeyunales (6/355; 2%), enfermedad de Crohn (6/355; 2%), tumor intestinal (6/355; 2%), estenosis intestinal extrínseca (2/355; 0,5%), y otros (10/355; 3%). Las indicaciones con mayor rendimiento diagnóstico fueron: confirmación de anormalidades radiográficas (13/21; 62%), diarrea crónica (46/126; 37%), y hemorragia digestiva de origen oscuro (31/99; 31%). No se objetivaron complicaciones graves. Conclusiones: según nuestra experiencia, la EP es una técnica segura y útil para la evaluación de las patologías del intestino delgado, especialmente en ciertas indicaciones (anormalidades radiográficas, diarrea crónica, y hemorragia digestiva de origen oscuro). La biopsia intestinal aumenta el rendimiento diagnóstico de la EP en pacientes con diarrea crónica

Background and objectives: the diagnostic yield of push enteroscopy (PE) varies widely from 13 to 78% of cases, according to the various series. The aim of this retrospective cohort study was to determine the endoscopic and histological yield of PE in our health area. Patients and methods: a total of 355 consecutive patients (190 males/165 females; mean age 45 years, range 15-89) underwent PE over a 6-year period, from 1997 to 2003. PE was performed under sedation and without overtube. Small-bowel mucosa biopsies were taken in 199 explorations (56%). Clinical indications for PE included: chronic diarrhea (35%), occult digestive bleeding (ODB) or iron-deficiency anemia (28%), suspected small-bowel malignancy (16%), chronic abdominal pain (28/355; 8%), follow-up of polyposis or malabsorption syndromes (7%), and abnormal radiographic findings (6%). Results: PE detected lesions in 122 cases (34%); in 6 cases (6%) lesions were within the reach of esophagogastroduodenoscopy. A normal macroscopic appearance of the small intestinal mucosa with an abnormal histological study was seen in 16 patients (6%). Major findings included: malabsorptive diseases (14%), nonspecific enteropathy (5%), angiodysplasia (3,5%), lymphangiectasia (3%); jejunal polyps (2%), Crohn´s disease (2%), intestinal tumors (2%), extrinsic jejunal strictures (0.5%), and other (10/355; 3%). Abnormal radiographic findings (62%), chronic diarrhea (37%) and ODB (31%) were the indications with a higher diagnostic yield. No major complications were seen. Conclusions: according to our experience, PE is a safe and useful tool for the evaluation of small-bowel disease, especially in some indications (abnormal radiographic findings, chronic diarrhea, and ODB). Small-bowel biopsy increases PE’s diagnostic yield in patients with chronic diarrhea