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Higher infliximab trough levels are associated with perianal fistula healing in patients with Crohn's disease. Aliment Pharmacol Ther 2017 Apr;45(7):933-940

Date

02/18/2017

Pubmed ID

28211593

DOI

10.1111/apt.13970

Scopus ID

2-s2.0-85013449857 (requires institutional sign-in at Scopus site)   238 Citations

Abstract

BACKGROUND: Infliximab has been found to be efficacious in the treatment of fistulas in the setting of Crohn's disease, even though some patients do not benefit from therapy.

AIM: To assess the correlation between perianal fistula healing and trough levels of infliximab.

METHODS: In this cross-sectional study, we identified patients with Crohn's disease who had perianal fistulas and were treated with infliximab for at least 24 weeks. We excluded patients who underwent a faecal diversion procedure or proctectomy. Predictive variables included demographics, disease phenotype, disease activity, infliximab levels, anti-infliximab antibodies. The primary outcome was fistula healing defined as the absence of drainage. The secondary outcome was complete fistula closure and mucosal healing.

RESULTS: 117 patients were included. Patients with fistula healing had significantly higher median serum infliximab levels when compared to those with active fistulas [15.8 vs. 4.4 μg/mL, respectively (P < 0.0001)]. There was an incremental gain in fistula healing with higher infliximab levels. The AUC for the association between fistula healing and infliximab levels was 0.82 (P < 0.0001), while the AUC for the association of infliximab levels and fistula closure was 0.69 (P = 0.014). Patients with anti-infliximab antibodies had a lower chance of achieving fistula healing (OR: 0.04 [95%CI: 0.005-0.3], P < 0.001).

CONCLUSIONS: There is a significant association between serum infliximab levels and rates of fistula healing. Achieving infliximab levels ≥10.1 mcg/mL in patients with Crohn's disease and perianal fistulas may improve outcomes as part of a treat-to-target strategy.

Author List

Yarur AJ, Kanagala V, Stein DJ, Czul F, Quintero MA, Agrawal D, Patel A, Best K, Fox C, Idstein K, Abreu MT

Authors

Dilpesh S. Agrawal MD Assistant Professor in the Medicine department at Medical College of Wisconsin
Amir C. Patel MD Assistant Professor in the Medicine department at Medical College of Wisconsin
Daniel J. Stein MD Director, Associate Professor in the Medicine department at Medical College of Wisconsin




MESH terms used to index this publication - Major topics in bold

Adult
Crohn Disease
Cross-Sectional Studies
Dose-Response Relationship, Drug
Female
Humans
Infliximab
Male
Middle Aged
Rectal Fistula
Treatment Outcome
Wound Healing
Young Adult