Correlation Between Concentrations of Fecal Calprotectin and Outcomes of Patients With Ulcerative Colitis in a Phase 2 Trial
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Summary
This summary is machine-generated.Fecal calprotectin (FCP) levels correlate with treatment outcomes in ulcerative colitis patients receiving tofacitinib. An FCP cut-off of 150 mg/kg shows fair to good accuracy in predicting clinical and endoscopic remission.
Area Of Science
- Gastroenterology
- Clinical Pharmacology
- Biomarker Research
Background
- Accurate biomarkers are crucial for assessing disease activity and treatment response in clinical trials.
- Fecal calprotectin (FCP) is a potential biomarker for inflammatory bowel diseases.
Purpose Of The Study
- To analyze the relationship between fecal calprotectin (FCP) concentrations and clinical/endoscopic outcomes.
- To evaluate FCP as a biomarker for treatment response in moderate to severe ulcerative colitis patients receiving tofacitinib.
Main Methods
- Post hoc analysis of a phase 2, double-blind, placebo-controlled trial involving 194 patients.
- Patients received tofacitinib (0.5-15 mg twice daily) or placebo, with outcomes assessed at week 8 using Mayo scoring.
- Receiver operating characteristic (ROC) analysis was used to determine FCP cut-off values for predicting outcomes.
Main Results
- Significantly lower median FCP concentrations were observed in responders versus non-responders (P < .001).
- Area under the curve (AUC) values for ROC models ranged from 0.78 to 0.81 for clinical and endoscopic remission.
- An FCP cut-off of 150 mg/kg demonstrated fair to good accuracy (sensitivity 0.68-0.79, specificity 0.75-0.79) for predicting remission.
Conclusions
- Fecal calprotectin concentrations correlate with clinical and endoscopic outcomes in ulcerative colitis patients treated with tofacitinib.
- The agreement between FCP levels and outcomes was moderate at an individual level.
- An FCP cut-off of 150 mg/kg has fair to good accuracy for classifying clinical and endoscopic outcomes in this trial setting.