Inflamm Bowel Dis. 2020 May 25;izaa102. doi: 10.1093/ibd/izaa102. Online ahead of print.

John L Lyles ¹, Aditi A Mulgund ^2 3, Laura E Bauman ^1 4, Weizhe Su ⁵, Lin Fei ^6 7, Deepika L Chona ², Puneet Sharma ^1 7, Renee K Etter ¹, Jennifer Hellmann ^1 7, Lee A Denson ^1 7, Phillip Minar ^1 7, Dana M Dykes ^1 8, Michael J Rosen ^1 7

Author information

¹Division of Gastroenterology, Hepatology, and Nutrition, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.

²Department of Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH, USA.

³Division of Gastroenterology and Hepatology, Medical College of Wisconsin Associated Hospitals, Milwaukee, WI, USA.

⁴Department of Pediatrics, University of California San Diego, La Jolla, CA, USA.

⁵Division of Statistics and Data Science, Department of Mathematical Sciences, University of Cincinnati, Cincinnati, OH, USA.

⁶Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.

⁷Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA.

⁸GI Care for Kids, Atlanta, GA, USA.

Abstract

Background: Reports on the feasibility and effectiveness of translating proactive, antitumor necrosis factor (TNF) therapeutic drug monitoring (TDM) for inflammatory bowel disease into practice-wide quality improvement (QI) are lacking. We aimed to determine whether a TDM QI program improved outcomes at a large academic pediatric gastroenterology practice.

Methods: We instituted local anti-TNF TDM practice guidelines to proactively monitor and optimize drug levels (goal >5 μg/mL). We conducted a retrospective single-center cohort analysis of patient outcomes before (pre-TDM) and after (post-TDM) guideline institution and assessed the independent effect by multivariable regression. Primary outcome was sustained clinical remission (SCR22-52), defined as physician global assessment (PGA) of inactive from 22 to 52 weeks and off corticosteroids at 52 weeks.

Results: We identified 108 pre-TDM and 206 post-TDM patients. The SCR22-52 was achieved in 42% of pre-TDM and 59% of post-TDM patients (risk difference, 17.6%; 95% CI, 5.4-29%; P = 0.004). The post-TDM group had an increased adjusted odds of achieving SCR22-52 (odds ratio, 2.03; 95% CI, 1.27-3.26; P = 0.003). The adjusted risk of developing high titer antidrug antibodies (ADAs) was lower in the post-TDM group (hazard ratio, 0.18; 95% CI, 0.09-0.35; P < 0.001). Although the risk of anti-TNF cessation for any reason was not significantly different, there was a lower adjusted risk of cessation related to any detectable ADA in the post-TDM group (hazard ratio, 0.45; 95% CI, 0.26-0.77; P = 0.003).

Conclusions: A practice-wide proactive anti-TNF TDM QI program improved key clinical outcomes at our institution, including sustained clinical remission, incidence of high titer ADA, and anti-TNF cessation related to ADA.