TY - JOUR
T1 - Incorporating Fecal Calprotectin into Clinical Practice for Patients with Moderate-to-Severely Active Ulcerative Colitis Treated with Biologics or Small-Molecule Inhibitors
AU - Dulai, Parambir S.
AU - Battat, Robert
AU - Barsky, Maria
AU - Nguyen, Nghia H.
AU - Ma, Christopher
AU - Narula, Neeraj
AU - Mosli, Mahmoud
AU - Vande Casteele, Niels
AU - Boland, Brigid S.
AU - Prokop, Larry
AU - Murad, M. Hassan
AU - D'Haens, Geert
AU - Feagan, Brian G.
AU - Sandborn, William J.
AU - Jairath, Vipul
AU - Singh, Siddharth
N1 - Publisher Copyright:
© 2020 Wolters Kluwer Health. All rights reserved.
PY - 2020/6/1
Y1 - 2020/6/1
N2 - INTRODUCTION:We applied the Grading of Recommendations, Assessment, Development, and Evaluation framework to evaluate the performance of fecal calprotectin (FC) as an alternative to endoscopy in patients with moderate-to-severe ulcerative colitis (UC) treated with a biologic agent or tofacitinib.METHODS:Individual participant data from the trials of infliximab, golimumab, vedolizumab, and tofacitinib for UC were pooled to generate prevalence of endoscopic activity (Mayo endoscopy score) across different combinations of the rectal bleeding score (RBS) and stool frequency score (SFS). These estimates were then combined with the data from an updated systematic review of the operating properties of FC to generate clinical scenario-specific assessments of the performance of FC as a predictor of endoscopic disease activity. A prespecified threshold of acceptability for false-negative (FN) and false-positive (FP) test results was set at 5%.RESULTS:For patients with UC achieving RBS 0 + SFS 0/1, FC ≤ 50 g/g may avoid endoscopy in 50% patients with a FN rate <5%. Similarly, for patients with RBS 2/3 + SFS 2/3, FC ≥ 250 g/g potentially avoids endoscopy in approximately 50% patients with an FP rate <5%. The greatest uncertainty in the diagnostic performance for FC was observed in patients with UC achieving RBS 0 but having SFS 2/3, where FN and FP rates were consistently >10%, and endoscopic evaluation may be warranted.DISCUSSION:Two clinical scenarios were identified where FC can be used with confidence for monitoring treatment response to biologics or tofacitinib in patients with UC without the requirement for endoscopy.
AB - INTRODUCTION:We applied the Grading of Recommendations, Assessment, Development, and Evaluation framework to evaluate the performance of fecal calprotectin (FC) as an alternative to endoscopy in patients with moderate-to-severe ulcerative colitis (UC) treated with a biologic agent or tofacitinib.METHODS:Individual participant data from the trials of infliximab, golimumab, vedolizumab, and tofacitinib for UC were pooled to generate prevalence of endoscopic activity (Mayo endoscopy score) across different combinations of the rectal bleeding score (RBS) and stool frequency score (SFS). These estimates were then combined with the data from an updated systematic review of the operating properties of FC to generate clinical scenario-specific assessments of the performance of FC as a predictor of endoscopic disease activity. A prespecified threshold of acceptability for false-negative (FN) and false-positive (FP) test results was set at 5%.RESULTS:For patients with UC achieving RBS 0 + SFS 0/1, FC ≤ 50 g/g may avoid endoscopy in 50% patients with a FN rate <5%. Similarly, for patients with RBS 2/3 + SFS 2/3, FC ≥ 250 g/g potentially avoids endoscopy in approximately 50% patients with an FP rate <5%. The greatest uncertainty in the diagnostic performance for FC was observed in patients with UC achieving RBS 0 but having SFS 2/3, where FN and FP rates were consistently >10%, and endoscopic evaluation may be warranted.DISCUSSION:Two clinical scenarios were identified where FC can be used with confidence for monitoring treatment response to biologics or tofacitinib in patients with UC without the requirement for endoscopy.
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U2 - 10.14309/ajg.0000000000000596
DO - 10.14309/ajg.0000000000000596
M3 - Article
C2 - 32384283
AN - SCOPUS:85086051035
SN - 0002-9270
VL - 115
SP - 885
EP - 894
JO - American Journal of Gastroenterology
JF - American Journal of Gastroenterology
IS - 6
ER -