Review for 10.1186/s12876-022-02143-x (2022)

Reviewer’s report
Title: 
Objective Disease Activity Assessment and Therapeutic Drug Monitoring
Prior to Biologic Therapy Changes in Routine Inflammatory Bowel Disease
Clinical Practice: TARGET-IBD
Version: 
0 
Date: 
09 Nov 2021
Reviewer's report:
This 
prospective longitudinal cohort study enrolled IBD patients receiving
biologic therapy who had a dose change or biologic discontinuation for lack of
efficacy.
The objective disease activity assessment and 
therapeutic drug monitoring prior
to changes in biologic regimen was not performed in a substantial portion of
participants.
Most of the centers were referral centers and despite this about 1/3 did not
receive objective assessment. 
This is not reassuring 
and demonstrates that guidelines are frequently
unattended. 
However, it should emphasised that more than 80% of the patients had a private
insurance and the retrospective collection of data could have missed lab exams
performed outside the hospital. The missed info might have important
consequences on the findings.
It is interesting to note that many clinicians do not believe in TDM despite the
large amount of papers published in the literature. However, clinicians seem not
to believe even in endoscopy or biochemical exams. CRP is not 
good marker for
evaluating disease activity in UC but unexpectedly 
was 
used more commnoly
than calprotectin! 
It is important to dissect the reasons for discontinuation vs dose escalation, to
know if the patient was naive or experienced to biologics and to trace the reason
for discontinuation. In particular, 640 patients change drug for OTHER reason
and the results are given on the remaining 
553 patients. 
This may affect the
generalizability of the findings.
The large number of patients enrolled in the study should allow for a more
accurate evaluation of the reasons behind the clinical decisions. More emphasis
on the need for objective evaluation should be put not only for the limited
number 
of drugs but also because most of the second choices are much more
expensive than the first one. 
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