Fecal lactoferrin predicts primary non-response to biologic agents in inflammatory bowel disease.

Introduction Fecal Lactoferrin (FL) is a timely and accurate marker of inflammation in ulcerative colitis (UC) and Crohn's disease (CD). Aim of this study was to verify whether FL can predict primary non-response (PNR) to biologic agents during induction. Methods Retrospective outcome review in 27 patients (13 with CD and 14 with UC) tested for baseline FL and re-tested within a week after the first and second induction doses. Clinical/biochemical outcomes were evaluated at end of induction and at follow up (3-24 months). Results Compared to baseline, changes of the Harvey-Bradshaw (CD) and Partial Mayo Scoring (UC) indices at end of induction separated responders (18/27 or 67%) from non-responders (9/17 or 33%). In all patients the initial FL value at induction decreased compared to baseline, continuing to decrease after the following dose in clinical responders while bouncing back in the others. Models targeting the two consecutively decreased FL values or the second FL value compared to baseline or the second FL value compared to the first were able to accurately predict response at end of induction. Follow-up assessment confirmed clinical remission in initial responders (with FL values reduced on the average by 94±10% compared to baseline). Conclusions In CD and UC patients during induction with biologic agents early FL measurements accurately separate clinical responders from those experiencing PNR. The method described here offers several potential advantages over other strategies to assess and manage these patients.