Inflammatory Bowel Diseases Clinical Trial
Official title:
Frequency of Elevated Fecal Calprotectin Levels in Psoriatic Arthritis and Its Predictive Role for Inflammatory Bowel Disease Occurrence: a Prospective, Long-term, Controlled Study.
Background.Recent epidemiologic studies have shown an association between psoriasis,
psoriatic arthritis (PsA) and inflammatory bowel diseases (IBD). Recently, measurement of
fecal calprotectin (FC) demonstrated a good sensitivity and specificity for intestinal
inflammation.
Primary objective of present study was to evaluate the presence of occult bowel inflammation
in patients with PsA as expressed by elevated levels of FC. Secondary objectives were to
investigate the correlation between the levels FC and clinical and laboratory features, and
the outcome of CF-positive patients in terms of IBD development.
A number of studies evaluated the presence of occult intestinal inflammation by using FC
assay in patients with axial SpA. In 2000, a study conducted in PsA patients without bowel
symptoms showed at mucosa biopsies the presence of microscopic changes, increase in lamina
propria cellularity, consisting of plasma cells and lymphocytes, and lymphoid
aggregates.Present prospective case-control study was designed to investigate occult
intestinal inflammation by using FC assay in consecutive patients with PsA at onset, and who
had no abdominal symptoms. Five Italian Centers contributed to patients recruitment adopting
the same inclusion and exclusion criteria over a 3 year period.
FC levels were measured at baseline with Bühlmann fCAL Turbo, Switzerland® kit. This
automated method is a particle enhanced turbidimetric immunoassay employing polyclonal
antibodies. The manufacturer cut-off for FC positivity was 50 μg/g, with a sensitivity of
100% and a specificity of 53.1%.
The number of patients developing IBD was evaluated at the end of follow-up. Clinical and
laboratory data collection was centralized and two experts statisticians performed the data
analysis.
Statistical analysis. All demographic, clinical, and laboratory data were collected and
descriptive statistics, presented as mean value and standard deviation, were calculated using
Microsoft ® Office Excel for Windows and ©2019 Minitabs, LLC for Windows. Chi-square test was
used for categorical variables. FC test sensitivity, specificity, positive (PPV) and negative
(NPV) predictive values were calculated. Bayes's theorem was used to calculate the 95%
confidence interval (95%CI). Correlations were calculated using Spearman's correlation (rs).
P values ≤ 0.05 were accepted as statistically significant.
The median follow-up was 30 months.
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