Local injection of infliximab in severe fistulating perianal Crohn's disease: an open uncontrolled study.

BACKGROUND: Perianal fistulas are frequent complications of Crohn's disease. Intravenous infliximab can control perianal disease and promote perianal fistula closure. Perifistular infliximab injections have been proposed for patients who are intolerant or unresponsive to intravenous therapy. The aim of this study was to assess the long-term efficacy of surgical treatment combined with local infliximab therapy. METHODS: A prospective cohort study was designed. Twelve patients with Crohn's disease and high/complex transphincteric and intrasphincteric perianal fistulas refractory to other treatment were submitted to core-out fistulectomies, plus perifistular injections of infliximab (20-25 mg in 15-20 ml of 5% glucose) every 4-6 weeks. The main outcome measure was the clinical closure of all perianal fistulas. A 95% confidence interval was calculated for short- and long-term fistula closure rates. RESULTS: None of the procedures were associated with local or systemic adverse effects. Four patients did not complete treatment, two because of relapse of intestinal symptoms, which required intravenous infliximab. In one case, treatment with intravenous infliximab was complicated by a hypersensitivity reaction. Eight patients continued treatment until all perianal fistulas were closed and setons were removed (median: 5 sessions). Persistent closure was observed in seven (87.5%, 95% CI: 47.4-99.6) of the eight patients 12 months after completion of treatment and in five (62.5%; 95% CI: 24.5-91.5) of eight at the end of follow-up (range: 19-43 months, median: 35 months). CONCLUSIONS: The cohort we examined is small, but fistulectomy combined with repeated perifistular injections of infliximab appears to be safe and may help in fistula healing. However, in most patients, permanent closure of all fistulas is not achieved.

Pregnancy outcome in inflammatory bowel disease: prospective European case-control ECCO-EpiCom study, 2003-2006.

BACKGROUND: Inflammatory bowel disease (IBD) frequently affects women during their reproductive years. Pregnancy outcome in women with IBD is well described, particularly in retrospective studies. AIM: To evaluate the pregnancy outcome in patients with IBD in a prospective European multicentre case-control study. METHODS: Inflammatory bowel disease pregnant women from 12 European countries were enrolled between January 2003 and December 2006 and matched (1:1) to non-IBD pregnant controls by age at conception and number of previous pregnancies. Data on pregnancy and newborn outcome, disease activity and therapy were prospectively collected every third month using a standard questionnaire. Logistic regression analysis with odds ratio was used for statistical analyses. P value<0.05 was considered significant. RESULTS: A total of 332 pregnant women with IBD were included: 145 with Crohn's disease (CD) and 187 with ulcerative colitis (UC). Median age (range) at conception was 31 years (15-40) in CD and 31 (19-42) in UC patients. No statistically significant differences in frequency of abortions, preterm deliveries, caesarean sections, congenital abnormalities and birth weight were observed comparing CD and UC women with their non-IBD controls. In CD, older age was associated with congenital abnormalities and preterm delivery; smoking increased the risk of preterm delivery. For UC, older age and active disease were associated with low birth weight; while older age and combination therapy were risk factors for preterm delivery. CONCLUSION: In this prospective case-control study, women with either Crohn's disease or ulcerative colitis have a similar pregnancy outcome when compared with a population of non-inflammatory bowel disease pregnant women.

Infliximab in severe ulcerative colitis: short-term results of different infusion regimens and long-term follow-up.

BACKGROUND: Severe ulcerative colitis is a life-threatening disorder, despite i.v. glucocorticoids treatment. Infliximab has been proposed as a safe rescue therapy. AIM: To evaluate short- and long-term effectiveness and safety of infliximab in severe refractory ulcerative colitis. METHODS: Eighty-three patients with severe ulcerative colitis (i.v. glucocorticoids treatment-refractory) were treated with infliximab in 10 Italian Gastroenterology Units. Patients underwent one or more infusions according to the choice of treating physicians. Short-term outcome was colectomy/death 2 months after the first infusion. Long-term outcome was survival free from colectomy. Safety data were recorded. RESULTS: Twelve patients (15%) underwent colectomy within 2 months. One died of Legionella pneumophila infection 12 days after infliximab. Early colectomy rates were higher in patients receiving one infusion (9/26), compared with those receiving two/more infusions (3/57, P = 0.001, OR = 9.53). Seventy patients who survived colectomy and did not experience any fatal complications were followed-up for a median time of 23 months; 58 patients avoided colectomy during the follow-up. Forty-two patients were maintained on immunosuppressive drugs. No clinical features were associated with outcomes. CONCLUSIONS: Infliximab is an effective and relatively safe therapy to avoid colectomy and maintain long-term remission for patients with severe refractory ulcerative colitis. In the short term, two or more infusions seem to be more effective than one single infusion.

Increased prevalence of Helicobacter pylori in patients with diabetes mellitus.

BACKGROUND: Whilst upper gastrointestinal disturbances are frequently observed in patients with diabetes mellitus, little is known about the prevalence of Helicobacter pylori infection and peptic disease in these patients. AIM: To evaluate prevalence of Helicobacter pylori infection and peptic disease lesions in diabetics with dyspeptic symptoms. PATIENTS AND METHODS: Study population comprises 74 consecutive diabetes mellitus patients with dyspepsia and 117 consecutive non diabetic dyspeptic patients. Upon enrolment, each patient completed an interview screening questionnaire to obtain information concerning presence and severity of dyspepsia. All patients underwent upper gastrointestinal endoscopy with biopsy specimens being collected from gastric antrum and body Helicobacter pylori was evaluated in each patient by rapid urease test and histology (Giemsa). Gastritis was classified according to the Sydney System. Statistical analysis was performed by chi-square, Fisher exact or t test and logistic regression analysis. A p value <0.05 was considered significant. RESULTS: Prevalence of Helicobacter pylori infection was found to be significantly higher in diabetics than in controls. The prevalence rate of endoscopic lesions was comparable in the two groups, but the association between endoscopic lesions and Helicobacter pylori infection was significantly higher in diabetics. Overall, the presence of chronic gastritis, both non atrophic and atrophic, as well as intestinal metaplasia were comparable in the two groups of patients, whilst the association between chronic gastritis and Helicobacter pylori infection or gastritis activity were significantly higher in diabetics. In neither group, was any correlation found between severity of dyspepsia and presence of endoscopic lesions, chronic gastritis or Helicobacter pylori infection. CONCLUSIONS: These data show a higher prevalence of Helicobacter pylori infection in diabetes mellitus patients with dyspepsia. Helicobacter pylori infection was significantly associated both with the presence of endoscopic lesions and chronic gastritis in diabetic patients, but not in the controls.

Evaluation of Crohn disease activity with magnetic resonance imaging.

BACKGROUND: The purpose of this study was to assess the accuracy of magnetic resonance imaging (MRI) in evaluating Crohn disease (CD) activity. The intestinal inflammatory activity is usually present in patients under pharmacologic treatment, despite their clinical remission. METHODS: Twenty patients with CD, all under pharmacologic treatment, were prospectively studied by MRI at 1.5 T as a periodic control. Positivity of three acute-phase reactants was considered an index of biologic activity (BA). T2-weighted, T2-weighted fat-suppressed turbo spin-echo, and breath-hold T1-weighted turbo field-echo sequences, before and after gadolinium intravenous injection, were obtained. A negative superparamagnetic contrast agent was orally administered. The following MRI parameters were qualitatively evaluated by three radiologists at the level of the affected bowel and compared with clinical data: wall thickness (WT), wall T2-weighted signal (T2W), wall contrast enhancement (WE), amount of fibrofatty proliferation (FP), and T2-weighted signal of fibrofatty proliferation on fat-suppressed images (T2FP). The kappa coefficient of agreement was calculated. The Spearman rank correlation was used for the analysis of clinical and radiologic data. RESULTS: Nineteen of 20 patients were in clinical remission (Crohn Disease Activity Index < 150). On the basis of laboratory tests, nine of 20 patients had biologically active disease. An excellent correlation was found between BA and WE, T2W, and T2FP (0.900, 0.927 and 0.961, respectively; p < 0.0001), and a lower correlation was found between BA and WT and between BA and FP (0.78 and 0.62). Excellent statistical correlation was also found between WE and T2W and between WE and T2FP (0.876 and 0.892). CONCLUSIONS: An excellent statistical correlation was found between biologically "active" disease and the following MRI parameters: wall gadolinium enhancement, wall hyperintensity on T2-weighted fat-suppressed images, and hyperintensity of fibrofatty proliferation on T2-weighted fat-suppressed images. Therefore, MRI can be valuable in assessing CD activity.