Undetectable anti‐TNF drug levels in patients with long‐term remission predict successful drug withdrawal. Issue 3 (1st June 2015)

• Record Type: Journal Article
• Authors: Ben‐Horin, S.; Chowers, Y.; Ungar, B.; Kopylov, U.; Loebstein, R.; Weiss, B.; Eliakim, R.; Del Tedesco, E.; Paul, S.; Roblin, X.
• Is Part Of: Alimentary pharmacology & therapeutics. Volume 42:Issue 3(2015)
• Page Start: 356
• Page End: 364
• Publication Date: 2015-06-01
• Subjects: Digestive organs -- Diseases -- Treatment -- Periodicals; Digestive organs -- Effect of drugs on -- Periodicals; Gastrointestinal system -- Diseases -- Treatment -- Periodicals; Gastrointestinal system -- Effect of drugs on -- Periodicals; 615.73
• DOI: 10.1111/apt.13268
• Languages: English
• ISSNs: 0269-2813

Abstract

<abstract abstract-type="main" id="apt13268-abs-0001"> <title>Summary</title> <sec id="apt13268-sec-0001" sec-type="section"> <title>Background</title> <p>Low drug levels are associated with emerging loss of response to anti‐TNF. However, this may not be the case in patients with long‐term remission.</p> </sec> <sec id="apt13268-sec-0002" sec-type="section"> <title>Aim</title> <p>To investigate the outcome of anti‐TNF discontinuation in patients with long‐term remission and incidental undetectable drug levels.</p> </sec> <sec id="apt13268-sec-0003" sec-type="section"> <title>Methods</title> <p>A retrospective cohort study examining the duration of relapse‐free survival in IBD patients in remission who discontinued infliximab or adalimumab having undetectable drug levels.</p> </sec> <sec id="apt13268-sec-0004" sec-type="section"> <title>Results</title> <p>Forty eight patients who discontinued anti‐TNF while in remission and had available drug levels were identified in two centres in France and Israel (infliximab‐treated 35, adalimumab‐13, Crohn's disease 30, ulcerative colitis 18, mean treatment duration of 22.7 ± 12.4 months). Endoscopy/MRE before stopping showed absence of active inflammation in 40/42 (95%) of evaluated patients, while inflammatory biomarkers (CRP and/or Calprotectin) were completely normal in only 31/48 (65%) of patients. During 12 months median follow‐up, relapse occurred in 16/20 (80%) of patients who stopped anti‐TNF while having measurable drug levels compared with 9/28 (32%) of patients who had undetectable drug levels (OR: 8.4, 95% CI: 2.2–32, <italic>P</italic> = 0.002). Relapse‐free survival after anti‐TNF cessation was significantly longer in patients with absent drug compared to those with detectable drug (<italic>P</italic> < 0.001, log rank test). On multivariate analysis, a patient's decision to stop therapy was weakly associated and abnormal inflammatory biomarkers and detectable drug levels were both strongly and independently associated with a higher risk of relapse after drug discontinuation.</p> </sec> <sec id="apt13268-sec-0005" sec-type="section"> <title>Conclusion</title> <p>Incidental finding of undetectable anti‐TNF drug levels in patients with stable long‐term deep remission may identify a subset of patients whose clinical remission is no longer dependent on anti‐TNF treatment.</p> </sec> </abstract>