Effectiveness of adalimumab for ambulatory ulcerative colitis patients after failure of infliximab treatment: a first "real-life" experience in primary gastroenterology centers in Italy.

BACKGROUND: Adalimumab (ADA) is the key treatment for ulcerative colitis (UC) unresponsive or intolerant to standard treatments. Our aim was to assess the efficacy and safety of ADA in treating ambulatory UC patients in primary gastroenterology centers. METHODS: Fifteen patients (6 male, median age 29.9 years, range 22.8-39.9 years) were enrolled. All were previously treated with infliximab (IFX). Clinical activity and endoscopic severity were scored according to the Crohn's disease activity index (CDAI) score and Mayo subscore for endoscopy, respectively. Patients were clinically assessed at weeks 4, 8, and thereafter at weeks 16, 24, 32, 40, 48, and 54. Colonoscopy was performed before starting treatment, at weeks 24 and 54. The co-primary endpoints were clinical remission at 24 and 54 weeks. The secondary endpoints included: 1) sustained clinical remission; 2) steroid-sparing effect; 3) mucosal healing; 4) need for colectomy. Induction dose of ADA was 160 mg at week 0, and then 80 mg at week 2, while ADA maintenance treatment was 40 mg every two weeks. RESULTS: Clinical remission was obtained in 11 (73.3%) and 15 (100%) patients at weeks 24 and 54 respectively. Ten patients (66.7%) were able to discontinue steroids and were under corticosteroid-free remission at week 54. No patients underwent to colectomy. Eight patients (53.33%) at week 24 and 9 patients (60%) at week 54 achieved complete mucosal healing (Mayo endoscopic score 0). Side effects were reported in 2 of 15 patients (13.3%); none of those patients stopped treatment. CONCLUSION: ADA seems to be effective and safe in UC outpatients affected by UC, and previously treated with IFX.

Managing ambulatory ulcerative colitis patients with infliximab: a long term follow-up study in primary gastroenterology centers.

BACKGROUND: Infliximab (IFX) is the key treatment for ulcerative colitis (UC) unresponsive to standard treatments. The aim of the present study was to assess the efficacy and safety of IFX in treating ambulatory UC patients in primary gastroenterology centers. METHODS: One hundred and eighteen patients (65 M, 63 F, median age 34 years, range 19-71 years), affected by UC, were treated with IFX. Clinical efficacy, safety, mucosal healing (MH), and histological healing (HH) were assessed at a scheduled follow-up of 42 months. RESULTS: Percentage of patients with clinical remission persistence at 42-month follow-up was 70.4%. Colectomy occurred in only 3 patients (2.7%). At 42-month follow-up percentage of patients with MH was 44.6%, and percentage of patients with HH was 24.3%. HH at 6-month follow-up occurred in 13 out of 34 patients (38.2%) with C-reactive protein (CRP) <3 and in 8 out of 76 patients (10.5%) with CRP ≥ 3 (p=0.002). Side effects were reported in 16 patients (13.6%): infusion reactions occurred in 7 patients, other severe side-effects occurred in 3 patients, and opportunistic infections occurred in 3 patients (2.5%). Finally, 3 cancers (2.5%) occurred during the follow-up period (1 breast, 1 kidney and 1 rectal cancer). Both univariate and multivariate analyses showed Hb <11.5 g/dL and HH at 6-month follow-up to be significantly associated with treatment failure during follow-up. CONCLUSIONS: IFX seems to be effective and safe in long-term treatment of outpatients affected by UC.

Effectiveness and safety of infliximab and adalimumab for ambulatory Crohn's disease patients in primary gastroenterology centres.

BACKGROUND: Infliximab (IFX) and adalimumab (ADA) are the key treatments for Crohn's Disease (CD), unresponsive to standard treatments. Our aim was to compare the efficacy and safety of IFX and ADA in treating CD in clinical practice. METHODS: One hundred and twenty-six patients (61 M, 65 F, mean age 36.2 years, range 19-67 years), affected by CD, were treated with infliximab (IFX, 59 patients) or adalimumab (ADA, 66 patients). Clinical efficacy, mucosal healing (MH), histological healing (HH), and safety were assessed. MH was defined complicated if healing of ulcers occurred with deformation of bowel profile and/or complete colonoscopy was impossible because of scars. RESULTS: Patients were followed-up for 36 months. No difference was found between IFX and ADA in maintaining long-term clinical remission, MH and HH. Complicated MH was present in 17 (28.8%) patients in IFX group and in 7 (10.6%) patients in ADA group (p=0.012). In 9 (15.2%) patients in IFX group and 2 (3.0%) patients in ADA group colonoscopy was incomplete without cecal intubation or terminal ileum exploration (p=0.024). Side effects were similar in both groups. CONCLUSIONS: Both IFX and ADA seem to be effective and safe in long-term outpatient treatment of CD in clinical practice.

Increased diagnostic yield of small bowel tumors with PillCam: the role of capsule endoscopy in the diagnosis and treatment of gastrointestinal stromal tumors (GISTs). Italian single-center experience.

BACKGROUND: Gastrointestinal stromal tumors (GISTs) are rare tumors, accounting for 1-3% of all gastrointestinal malignancies; they are, however, the most common gastric and small bowel mesenchymal tumors. The length and relative inaccessibility of the small bowel have long constrained the diagnosis of GISTs mainly presenting with chronic or intermittent bleeding as the sole clinical manifestation. AIM: To report on the prevalence of small bowel GISTs in a prospectively recorded series of patients undergoing capsule endoscopy (CE). PATIENTS AND METHODS: Between 2001 and 2007 five hundred patients were referred to our endoscopy unit for small bowel evaluation with capsule endoscopy. We retrospectively evaluated all charts. The main indications for CE were obscure-occult or obscure-overt bleeding. Two hundred eighty-nine patients underwent CE for either obscure-occult or obscure-overt bleeding and 211 for other indications. Patient outcome and care processes were measured by follow-up telephone interviews and chart review. Statistical computations were performed using Fisher's exact test and Student's t-test. RESULTS: CE identified a small bowel tumor in 20 patients (4.0%) and 9 tumors turned out to be GISTs (45.0%). Traditional endoscopic and radiological imaging failed to detect the GIST in all these cases. In one case a small bowel GIST was diagnosed by angiography and CE proved false negative. Overall, CE was able to diagnose a small bowel GIST in 9 out of 10 cases. All patients underwent surgical treatment and showed normalized hemoglobin levels at follow-up. The main limitation of this study is the small number of cases. CONCLUSIONS: CE is an effective and sensitive diagnostic device compared with conventional radiology and plays an important role in the algorithm for the diagnostic work-up of suspected small bowel tumors.

Obscure-occult bleeding: resolution of unexplained chronic sideropenic anaemia by colonoscopic removal of a colonic leiomyoma.

Although leiomyomas of the stomach or small intestine are relatively common, those of the colon or rectum are rare. Several cases of endoscopic resection of colorectal leiomyomas have been described. However, conventional polypectomy of leiomyomas can result in perforation. To reduce the risk of perforation, submucosal injection can be performed before removal. We report a case of chronic sideropenic anaemia in a patient affected by leiomyoma of the sigmoid colon in which after complete endoscopic enucleation of the lesion we obtained the stable resolution of anaemia.

Unexplained iron deficiency anaemia: Is it worthwhile to perform capsule endoscopy?

BACKGROUND: In around 30% of iron deficiency anaemia (IDA) cases a definite diagnosis cannot be made. AIM: To investigate the role of capsule endoscopy (CE) in detecting lesions in patients with unexplained IDA after a negative endoscopic, serologic and haematologic diagnostic work up and its possible role in influencing clinical outcome. METHODS: 138 patients suffering from IDA were identified among 650 consecutive patients undergoing CE at our unit. RESULTS: CE revealed the following positive findings in 91/138 patients: angiodysplasias in 51 patients; jejunal and/or ileal micro-ulcerations in 12; tumours/polyps in 9; erosive gastritis in 4; Crohn's disease in 5; jejunal villous atrophy in 5; a solitary ileal ulcer in 1 and active bleeding in the last 4 patients. Follow up data were available for 80/91 patients (87.9%). In 15 out of 46 patients with angiodysplasias IDA spontaneously resolved without any treatment; 9 patients required iron supplementation; 10 patients healed after lanreotide administration; APC was performed in 9 out of 46 patients and 3 patients underwent regular blood transfusion without any success on IDA. 10 out of the 12 patients with small bowel micro-ulcers spontaneously recovered from IDA whilst 2 patients after iron supplementation. All 9 patients affected by tumours/polyps were surgically addressed. In all erosive gastritis cases, patients recovered from IDA after PPI and Helicobacter pylori eradication. Four patients with Crohn's disease diagnosis restored to health with medical therapy. One out of the 4 patients with jejunal villous atrophy and the sole patient with a solitary ileal ulcer spontaneously healed. In 1 out of 3 patients with active bleeding IDA resolved without further treatment after blood transfusion whilst 2 patients were referred for surgical treatment. At follow up, complete resolution of IDA was achieved in 96.25%. CONCLUSIONS: Small bowel investigation is a matter of great importance in IDA patients after negative upper and lower gastrointestinal endoscopy.

Obscure gastrointestinal bleeding as first symptom of eosinophilic jejunitis in a liver transplant recipient: diagnosis and treatment with single balloon enteroscopy.

The small bowel is only partially accessible to traditional endoscopic techniques. The recently introduced push-and-pull enteroscopy technique allows endoscopists to examine the small bowel in its entirety and enables them to take biopsy specimens and administer treatment. We report the case of a liver transplant recipient presenting with obscure gastrointestinal bleeding, whose diagnosis of eosinophilic enteritis was achieved following a single balloon enteroscopy examination. The patient was discharged 3 days after endoscopic treatment. Eosinophilic enteritis is still not a well known disease. The modality of treatment was suggested by our endoscopic experience and not from codified guidelines. The patient's haemoglobin value was normal 12 months after treatment.