Efficacy and safety of proactive drug monitoring in inflammatory bowel disease treated with anti-TNF agents: A systematic review and meta-analysis

Background and aims: A systematic review and a meta -analysis of the literature was conducted to assess efficacy and safety of proactive therapeutic drug monitoring (TDM) versus conventional management during maintenance treatment with anti -tumour necrosis factor (anti-TNF alpha) in patients with inflammatory bowel disease (IBD). Methods: A search was conducted up to January 2022 (MEDLINE, EMBASE, and the Cochrane Library). The primary outcome was the ability to maintain clinical remission at 12 months. The certainty of evidence was determined using the GRADE approach. Results: Nine studies were identified: one systematic review, six randomised clinical trials, and two cohort studies. No superior efficacy of proactive TDM [relative risk 1.16; 95% confidence interval (CI): 0.98-1.37, n = 528; I2 = 55%] was shown. Proactive TDM could improve the durability of anti-TNF alpha treatment [odds ratio (OR) 0.12; 95%CI: 0.05-0.27; n = 390; I2 = 45%), prevent acute infusion reactions (OR 0.21; 95%CI: 0.05-0.82; n = 390; I2 = 0%), decrease adverse events (OR 0.38; 95%CI: 0.15-0.98; n = 390; I2 = 14%), and reduce the probability of surgery, at lower economical expenditure. Conclusions: The analysed evidence did not confirm the superiority of proactive TDM of anti-TNF alpha treatment over conventional management in patients with IBD, so proactive TDM should not currently be recommended. (c) 2023 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.