The quantitative validation of non‐endoscopic disease activity indices in ulcerative colitis

Higgins, Peter; Leung, John; Schwartz, Marc; Mapili, J.; Wren, Patricia A.

doi:10.1111/j.1365-2036.2006.03205.x

Cited by 17 publications

(10 citation statements)

References 24 publications

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“…The SCCAI has been validated in a longitudinal cohort study of patients with UC undergoing colonoscopy. It was found to have excellent psychometric validity and moderate to good performance validity 6. A SCCAI score of 5 or more defines a relapse of UC 7.…”

Section: Methodsmentioning

confidence: 96%

Development of an internet-based cohort of patients with inflammatory bowel diseases (CCFA Partners): Methodology and initial results

Long

Kappelman

Martin

et al. 2012

Inflammatory Bowel Diseases

105

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Section: Methodsmentioning

confidence: 96%

Development of an internet-based cohort of patients with inflammatory bowel diseases (CCFA Partners): Methodology and initial results

Long

Kappelman

Martin

et al. 2012

Inflammatory Bowel Diseases

105

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show abstract

“…The disease activity was assessed using the SCCAI (22) that is validated and has been proven to correlate well with other indices comprising invasive methods (23,24,25,26). The primary end point was changes in SCCAI from baseline (V2) to V5.…”

Section: Methodsmentioning

confidence: 99%

First Multicenter Study of Modified Release Phosphatidylcholine “LT-02” in Ulcerative Colitis: A Randomized, Placebo-Controlled Trial in Mesalazine-Refractory Courses

Karner

Kocjan²,

Stein

et al. 2014

American Journal of Gastroenterology

101

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OBJECTIVES:Phosphatidylcholine is a key component of the mucosal barrier. Treatment with modified release phosphatidylcholine aims to improve the impaired barrier function. The primary objective is to evaluate the efficacy of LT-02, a newly designed modified release phosphatidylcholine formula, in a multicenter setting.METHODS:This is a double-blinded, randomized, placebo-controlled, superiority study conducted in 24 ambulatory referral centers in Germany, Lithuania, and Romania. A total of 156 patients with an inadequate response to mesalazine, a disease activity score (Simple Clinical Colitis Activity Index (SCCAI)) of ≥5, and bloody diarrhea underwent treatment with 0, 0.8, 1.6, or 3.2 g LT-02. The primary end point was defined a priori as changes in SCCAI from baseline to the end of treatment. The primary statistical model was a general linear least-squares model. The study was funded by the sponsor Lipid Therapeutics, Heidelberg, Germany, and registered at http://clinicaltrials.gov/show/NCT01011322.RESULTS:Baseline characteristics and dropouts were well balanced between all groups. The primary analyses revealed an SCCAI drop of 33.3% in the placebo group (from 9.0 to 6.0 points) compared with 44.3% in the 0.8 g LT-02 (from 8.8 to 4.9, P>0.05) and 40.7% in the 1.6 g groups (from 8.6 to 5.1, P>0.05). The 3.2 g group improved 51.7% from 8.5 to 4.1 (P=0.030 in comparison with placebo). The remission rate was 15% (6/40) in the placebo group compared with 31.4% (11/35) in the highest LT-02 dose group (P=0.089). Mucosal healing was achieved in 32.5% of placebo patients compared with 47.4% of LT-02 patients (P=0.098); the rates for histologic remission were 20% compared with 40.5%, respectively (P=0.016). There were 17 (48.6%) treatment-emergent adverse events in the highest dose group (and 0 serious adverse events (SAEs)) compared with 22 (55%) in the placebo group (4 SAEs).CONCLUSIONS:The primary end point analysis showed a statistically significant improvement in disease activity during LT-02 treatment in comparison with placebo. The drug was found to be very safe.

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“…endoscopy, histology, barium contrast enema or other recognised criteria). Disease activity was defined using the Crohn's Disease Activity Index (CDAI) score of biological markers of inflammation or, in the case of UC [10-12], with the Disease Activity Index (DAI) validated by St Mark's Hospital and Academic Institute, England.…”

Section: Methodsmentioning

confidence: 99%

B Lymphocyte intestinal homing in inflammatory bowel disease

et al. 2011

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BackgroundInflammatory bowel disease (IBD) is thought to be due to an abnormal interaction between the host immune system and commensal microflora. Within the intestinal immune system, B cells produce physiologically natural antibodies but pathologically atypical anti-neutrophil antibodies (xANCAs) are frequently observed in patients with IBD. The objective is to investigate the localisation of immunoglobulin-producing cells (IPCs) in samples of inflamed intestinal tissue taken from patients with IBD, and their possible relationship with clinical features.MethodsThe IPCs in small intestinal, colonic and rectal biopsy specimens of patients with IBD were analysed by means of immunofluorescence using polyclonal rabbit anti-human Ig and goat anti-human IgM. The B cell phenotype of the IPC-positive samples was assessed using monoclonal antibodies specific for CD79, CD20, CD23, CD21, CD5, λ and κ chains. Statistical correlations were sought between the histological findings and clinical expression.ResultsThe study involved 96 patients (64 with ulcerative colitis and 32 with Crohn's disease). Two different patterns of B lymphocyte infiltrates were found in the intestinal tissue: one was characterised by a strong to moderate stromal localisation of small IgM+/CD79+/CD20-/CD21-/CD23-/CD5± IPCs (42.7% of cases); in the other (57.3%) no such small IPCs were detected in stromal or epithelial tissues. IPCs were significantly less frequent in the patients with Crohn's disease than in those with ulcerative colitis (p = 0.004).ConclusionOur findings suggest that different immunopathogenetic pathways underlie chronic intestinal inflammation with different clinical expressions. The presence of small B lymphocytes resembling B-1 cells also seemed to be negatively associated with Crohn's disease. It can therefore be inferred that the gut contains an alternative population of B cells that have a regulatory function.

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The quantitative validation of non‐endoscopic disease activity indices in ulcerative colitis

Cited by 17 publications

References 24 publications

Development of an internet-based cohort of patients with inflammatory bowel diseases (CCFA Partners): Methodology and initial results

Development of an internet-based cohort of patients with inflammatory bowel diseases (CCFA Partners): Methodology and initial results

First Multicenter Study of Modified Release Phosphatidylcholine “LT-02” in Ulcerative Colitis: A Randomized, Placebo-Controlled Trial in Mesalazine-Refractory Courses

B Lymphocyte intestinal homing in inflammatory bowel disease

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