Bradshaw Index (bradshaw + index)

Distribution by Scientific Domains

Selected Abstracts

Efficacy of infliximab in pediatric Crohn's disease: A randomized multicenter open-label trial comparing scheduled to on demand maintenance therapy

Frank M. Ruemmele MD
Abstract Background: Infliximab (IFX) is efficacious in inducing remission in severe forms of pediatric Crohn's disease (CD). Adult studies indicate that IFX is also safe and well tolerated as maintenance therapy. The present study aimed to evaluate in a prospective manner the efficacy and safety of IFX as maintenance therapy of severe pediatric CD comparing scheduled and "on demand" treatment strategies. Methods: Forty children with CD (nonpenetrating, nonstricturing as well as penetrating forms, mean age: 13.9 2.2 years) with a severe flare-up (Harvey,Bradshaw Index [HBI] ,5, erythrocyte sedimentation rate [ESR] >20 mm/h) despite well-conducted immunomodulator therapy (n = 36 azathioprine, n = 1 mercaptopurine, n = 3 methotrexate) combined with steroids were included in this randomized, multicenter, open-label study. Three IFX infusions (5 mg/kg) were administered at week (W)0/W2/W6. At W10, clinical remission (HBI <5) and steroid withdrawal were analyzed and IFX responders were randomized to maintenance therapy over 1 year: group A, scheduled every 2 months; group B, "on demand" on relapse. Results: In all, 34/40 children came into remission during IFX induction therapy (HBI: 6.7 2.5 (WO) vs. 1.1 1.5 (W10); P < 0.001). At the end of phase 2, 15/18 (83%) patients were in remission in group A compared to 8/13 (61%) children in group B (P < 0.01), with a mean HBI of 0.5 versus 3.2 points (group A versus B, P = 0.011). In group A, 3/13 (23.1%) children experienced a relapse compared to 11/12 (92%) children in group B. No severe adverse event occurred during this trial. Conclusions: IFX is well tolerated and safe as maintenance therapy for pediatric CD, with a clear advantage when used on a scheduled 2-month basis compared to an "on demand" basis. (Inflamm Bowel Dis 2009) [source]

Effect of concurrent elemental diet on infliximab treatment for Crohn's disease

Torao Tanaka
Abstract Background:, Infliximab and elemental diet (ED) have been shown to be effective in the management of Crohn's disease. However, few experiences have been reported regarding their combination therapy. The aim of the present study was to investigate the efficacy and safety of infliximab in Japanese patients, the first such study in Asia, as well as the effect of concomitant ED. Methods:, One hundred and ten consecutive patients receiving infliximab were followed up to week 16 after the last infusion, and clinical response and primary outcome were collected. A response was defined as a reduction in Harvey,Bradshaw Index for inflammatory disease and closure of fistula in fistulizing disease. Results:, Out of 75 inflammatory and 35 fistulizing disease patients, 68 (90.7%) and 25 (71.4%) responded at week 4, and 38 (50.7%) and 14 (40.0%) continued to respond until week 16, respectively. Interestingly, inflammatory disease patients with concurrent ED had a significantly higher response rate at week 16 (68.4%) than those without ED (32.4%, P = 0.0026). The effects of ED were independent of the usage of azathioprine and smoking habit. Conclusions:, Infliximab was clinically useful in the treatment of Crohn's disease in Japanese patients as well as in those in Western countries. The efficacy of concurrent ED was suggestive and should be confirmed in a randomized controlled study. [source]

Efficacy and safety of antiviral therapy in patients with Crohn's disease and chronic hepatitis C

Summary Background, Efficacy and safety of antiviral combination therapy in patients with Crohn's disease (CD) and chronic hepatitis C (CHC) is presently not established and consequently CHC is rarely treated in CD patients. Aim, To analyse the efficacy and tolerability of antiviral interferon/ribavirin therapy in patients with CHC and CD. Methods, Eleven HCV-infected CD patients received either 3 1.5 ,g/kg/week interferon-,-2b or 180 ,g/week peginterferon-,-2a (PEGASYS; Roche, Basel, Switzerland) as monotherapy (n = 1) or in combination with 800,1200 mg/day ribavirin (COPEGUS; Roche) (n = 10) for 24,54 weeks according to HCV-genotype and initial response respectively. Eight patients were under CD-specific therapy. Results, Five (46%) patients (HCV-1: n = 3; HCV-2: n = 0; HCV-3: n = 1; unknown: n = 1) achieved a sustained virological response, three (27%) patients relapsed, three (27%) were nonresponders (all GT 1b). At baseline, the Harvey,Bradshaw Index was 0 (0,8) [median (range)], increased on antiviral therapy to 4 (1,15) (P = 0.005) and decreased to baseline level 0 (0,6) after 6-month follow-up. Conclusions, This preliminary experience demonstrates that treatment of CHC in patients with CD is comparable to the treatment of CHC in those without CD. However, gastrointestinal symptoms may be temporarily exacerbated and haemopoietic growth factors may be required. [source]

Does primary sclerosing cholangitis impact quality of life in patients with inflammatory bowel disease?

Ashwin N. Ananthakrishnan MD
Abstract Background: Impairment of health-related quality of life (HRQoL) is an important concern in inflammatory bowel disease (IBD; ulcerative colitis [UC], Crohn's disease [CD]). Between 2%,10% of patients with IBD have primary sclerosing cholangitis (PSC). There has been limited examination of the disease-specific HRQoL in this population compared to non-PSC IBD controls. Methods: This was a retrospective, case,control study performed at a tertiary referral center. Cases comprised 26 patients with a known diagnosis of PSC and IBD (17 UC, 9 CD). Three random controls were selected for each case after matching for IBD type, gender, age, and duration of disease. Disease-specific HRQoL was measured using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ). Disease activity for CD was measured using the Harvey,Bradshaw index (HB) and using the UC activity index for UC. Independent predictors of HRQoL were identified. Results: There was no significant difference in the age, gender distribution, or disease duration between PSC-IBD and controls. There was no difference in use of immunomodulators or biologics between the 2 groups. Mean SIBDQ score was comparable between PSC-IBD patients (54.5) and controls (54.1), both for UC and CD. Likewise, the disease activity scores were also similar (2.8 versus 3.1, P = 0.35). On multivariate analysis, higher disease activity score (,1.33, 95% confidence interval [CI] 95% CI ,1.85 to ,0.82) and shorter disease duration were predictive of lower HRQoL. Coexisting PSC did not influence IBD-related HRQoL. There was a higher proportion of permanent work disability in PSC-IBD (7.7%) compared to controls (0%). Conclusions: PSC does not seem to influence disease-specific HRQoL in our patients with IBD but is associated with a higher rate of work disability. (Inflamm Bowel Dis 2010) [source]

Fecal calprotectin is useful in predicting disease relapse in pediatric inflammatory bowel disease

Dorota Walkiewicz MD
Abstract Background: Fecal calprotectin (FC) has been proposed as a noninvasive surrogate marker to determine the degree of intestinal inflammation and predicting relapse in patients with inflammatory bowel disease (IBD). The aim was to compare FC levels in IBD and healthy controls, to correlate FC levels with clinical disease activity, and to assess whether FC levels can be used to predict clinical relapse in children with IBD. Methods: Enzyme-linked immunosorbent assay (ELISA) determined levels of FC were measured in more than 1 stool samples (n) from 32 IBD patients (n = 97) and from 34 healthy controls (n = 37). Disease activity was assessed by the Harvey,Bradshaw index in Crohn's disease (CD) and by Physician's Global Assessment (PGA) in both CD and ulcerative colitis (UC). Clinical events were recorded up to 9 months following stool collection in CD patients. Wilcoxon rank sum test and Fisher's exact tests were used to compare FC levels in IBD patients and in control. Kaplan,Meyer analysis was used to determine a risk of clinical relapse in relation to FC levels. Results: The IBD group had higher FC levels (range 17,7500 g/g) compared with control (16,750 g/g, P < 0.0001). FC levels were higher during relapse (CD, 3214 2186; UC, 2819 1610) compared to remission (CD, 1373 1630; UC, 764 869; P < 0.0001). Among those with clinical relapse, 90% had FC levels more than 400 ,g/g in CD. Eighty-nine percent of CD encounters with FC levels less than 400 ,g/g remained in clinical remission. Conclusions: FC levels differentiate active IBD from controls. Among children with CD and in remission, FC levels may be useful in predicting impending clinical relapse. (Inflamm Bowel Dis 2008) [source]