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Fecal calprotectin not a strong biomarker to classify outcomes in ulcerative colitis
Only a fair to good correlation was found between the concentration of fecal calprotectin, with a cut-off value of 150 mg/kg, and clinical and endoscopic outcomes in patients with moderate to severe ulcerative colitis prescribed Xeljanz in an analysis of phase 2 trial data.
William J. Sandborn, MD, of the division of gastroenterology, University of California San Diego, La Jolla, California, and colleagues conducted a post hoc analysis to examine the relationship between the concentration of fecal calprotectin (FCP) and clinical and endoscopic outcomes.
The data analyzed was from a double-blind, placebo-controlled trial with 194 patients who had moderate to severe UC. The patients were randomly assigned to receive either Xeljanz (0.5, 3, 10, or 15 mg twice daily; tofacitinib citrate, Pfizer) or placebo. At 8 weeks, the Mayo scoring system was used to evaluate clinical and endoscopic outcomes.
At 8 weeks, the researchers found that the median FCP concentrations were significantly lower in patients who achieved clinical response (P < .001; 156 vs. 725 mg/kg), clinical remission (64 vs 617 mg/kg), endoscopic remission (44 vs. 489 mg/kg) and mucosal healing (127 vs 753 mg/kg).
“The [area under the curve] for FCP [receiver operating characteristic] models identified that FCP cut-off concentrations of 150 mg/kg resulted in the highest summation of specificity and sensitivity for clinical remission and endoscopic remission,” the researchers wrote. “However, the agreement values (k coefficients) for clinical remission and endoscopic remission were only 0.44 and 0.38, respectively. Positive predictive values were low for both endpoints, and negative predictive values were moderate to substantial for both endpoints. Thus, although a similar treatment effect was seen with the FCP cut-off concentration of 150 mg/kg, FCP concentrations had only fair to good accuracy in classifying the clinical and endoscopic outcomes of individual patients. Thus, whatever physiologic change FCP serves as a biomarker for does not have a high agreement with clinical or endoscopic remission.” by Suzanne Reist
Disclosures: Sandborn reports receiving consulting fees from Pfizer. Please see the full study for a list of all other authors’ relevant financial disclosures.