03258816

October 21, 2021, 02:14

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The studies presented in this review summarize the controversiality surrounding the use of therapeutic drug monitoring in clinical practice.The author concluded that it is “difficult to prove that proactive TDM is associated with better therapeutic outcomes” but it should be considered an addition to the other tools already routinely used in practice including biomarkers (calprotectine), imaging, capsule endoscopy. There are few situations that should be discussed as exempt from this conclusion. In patients with perianal Crohn’s disease, closure of the fistula have been consistently shown to require higher trough level of infliximab (≥10 μg/ml) (IFX) than the level considered optimal for luminal Crohn’s disease (3–7 μg/ml). This finding seems to be true for both induction and maintenance phase. It needs to be recognized that most of the studies reporting on the anti-TNF levels in perianal Crohn’s disease are retrospective in design. The results of the prospective randomized controlled trial of adults with perianal fistulizing Crohn’s disease and optimized therapeutic IFX levels (PROACTIVE Trial) currently evaluates the benefit on clinical, radiological, patient-reported outcomes and economic costs of a higher than standard IFX. In patients with moderate to severe ulcerative colitis, a higher than 30 μg/ml IFX level after the induction phase and a detectable drug level at 54 weeks has been associated with greater clinical and endoscopy improvement in the post-hoc analysis of 728 patients who participated to ACT-1 and ACT-2 clinical trials. This higher level is also associated with lower colectomy rates and hospitalization (OR 9.3, P < 0.001)when compared with patients with standard IFX level. Patients with severe inflammation have lower tissue anti-TNFs levels than those in remission[13] likely due to increase clearance, although drug clearance depends on other additional factors such as albumin level, body mass and gender. For these patients, proactive TDM may represent the rescue technique for clinical improvement and colectomy sparing. TDM may be useful in managing anti-TNF therapy in IBD pregnancy where concerns of intrauterine fetal exposure has been raised, as the data showed higher than therapeutic levels for children of mothers who continue biologics beyond second trimester than for those of mothers who stopped biologics early in pregnancy. Since mother’s IFX trough levels increased during pregnancy by 4.2 μg/mL per trimester (P = 0.02), it has been suggested that late second trimester trough level of biologic may determine timing and dose of biologic agent in the third trimester. Finally, TDM may be considered in children with intrauterine drug exposure to decide the timing of safe administration of life virus vaccines. Current guidelines recommend avoiding any live vaccinations for at least 6 months following delivery unless serum levels in the infant are undetectable. We would like to thank you the authors for this comprehensive mini-review.

First, thank you very much for your professional comments on the article published in World Journal of Gastroenterology. Second, we read your comments with great interest. You are welcome to format your valuable comments into a Letter to the Editor and submit it online to World Journal of Gastroenterology at https://www.f6publishing.com. There are no restrictions on the number of words, figures (color, B/W) or authors for a Letter to the Editor. In addition, the article processing charge will be exempted for this Letter to the Editor. As with all articles published by the Baishideng Publishing Group, the Letter to the Editor will be published online after completing peer review. The guidelines for a Letter to the Editor can be found at: https://www.wjgnet.com/bpg/GerInfo/219. Finally, we look forward to receiving your high-quality Letter to the Editor, which will promote academic communication and lead the development of this discipline.

04213406

October 16, 2021, 11:12

Reader’s expertise on the topic of the manuscript

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The topic is very interesting. However, differences between neutralizing antibodies and non-neutralizing antibodies are still unclear, I mean the concept and the impact of concept is not clearly explained. Again the approach of therapeutic drug monitoring, either in the reactive or proactive setting, is not clearly presented. after extensive reviewing of literatures in each area I am still looing for conclusion/home message. Every time, I missed the opinion of authors.

Thank you very much for your comments