Review for 10.1186/s12876-021-01604-z (2021)

Reviewer’s report
Title: 
Clinical experiences and predictors of success of treatment with
vedolizumab in IBD patients: a cohort study
Version: 
0 
Date: 
03 Oct 2020
Reviewer's report:
The manuscript entitled "Clinical experiences and predictors of success of
treatment with vedolizumab in IBD patients: a cohort study" by Laura Mühl et
al. is a retrospective single-center cohort study designed to identify clinical
predictors of success of vedolizumab treatment in a cohort of patients treated
with vedolizumab at a large German tertiary referral center.
Not surprisingly, the Authors found that "Clinical parameters of disease activity
may help to predict the success of treatment" and in particular "Lower clinical
disease activity was associated with improved outcomes.".
I have no major concerns on this manuscript, and I totally agree that "real-world
reports are an important tool to assess, whether the data of the pivotal clinical
studies translate to broader and less well selected populations", however I think
that the information provided are of limited clinical relevance. In particular, 
It is not clear to me why, even if you the primary endpoint of clinical remission
of the study was set at week 17 +/- 0.5, despite having long term data ("patients
in our cohort continued to receive vedolizumab over a maximum follow-up of 3
years."). This choice implies that the study was not able to make a real
comparison with the clinical remission data from registration trials (52 weeks,
for UC Feagan et al NEJM 2013 e 2017 q4w 45% q8w 42% 13% placebo, for
CD Sandborn WJ et al NEJM 2013 39% q8w e 36.4% q4w). Moreover, the study
was not designed to collect any data about mucosal healing and deep/complete
endoscopic remission which all we know having a tremendous relevance in the
"treat to target era".
Minor concerns.
-Baseline parameters and outcomes. Data about optimization is lacking (each
patient received Vedolizumab every 8 weeks?)
-Baseline parameters and outcomes. Data about extra intestinal manifestations Is
lacking, although it represents an important factor in choosing vedolizumab
treatment 
-Results. It could be interesting looking at disease extent and phenotype, in
particular in CD (small bowel/upper gi disease) but even in UC (you have data
about it in baseline), as a predictor of success of treatment with Vedolizumab.
I have evaluated the article entitled "Clinical experiences and predictors of
success of treatment with vedolizumab in IBD patients: a cohort study" by Laura
Mühl et al. 
and I believe that the paper is valid from a methodological point of
view but could result of scarce clinical relevance. 
Anyway, the confirmatory role of results of a well conducted single-center
cohort study, make it appropriates for this journal.
Publons Reviewer Recognition
. Springer Nature can send verification of this
review directly to Publons (a subsidiary of Clarivate Analytics). If you would
like to take advantage of this service, please click on the “Yes” option below.
Your name, email address, title of the reviewed manuscript, name of the journal,
and date of your review submission (the “Review Data”) will then be transmitted
to Publons upon publication of the manuscript. If you have already registered at
Publons, they will notify you of the receipt of this review and update your profile
as per your settings and their policy. If you are not registered with Publons, you
will receive an email from them asking you to register in order for them to be
able to recognize your review on your new profile page. Publons may use the
Review Data to generate derivative metadata for the benefit of Publons and you
as a reviewer, carefully considering the sensitivity of such information. For
example, Publons may verify your record as a reviewer by updating your profile
published on its webservice if you have registered for such service or help
editors to identify candidate reviewers. Please find the details of processing in
Publons’ privacy policy 
https://publons.com/about/terms
Yes
Declaration of competing interests
Please complete a declaration of competing interests, considering the following
questions:
1
. 
Have you in the past five years received reimbursements, fees, funding, or
salary from an organisation that may in any way gain or lose financially
from the publication of this manuscript, either now or in the future?
2
. 
Do you hold any stocks or shares in an organisation that may in any way
gain or lose financially from the publication of this manuscript, either now
or in the future?
3
. 
Do you hold or are you currently applying for any patents relating to the
content of the manuscript?
4
. 
Have you received reimbursements, fees, funding, or salary from an
organization that holds or has applied for patents relating to the content of
the manuscript?
5
. 
Do you have any other financial competing interests?
6
. 
Do you have any non-financial competing interests in relation to this
paper?
If you can answer no to all of the above, write 'I declare that I have no competing
interests' below. If your reply is yes to any, please give details below.
I declare that I have no competing interests
Reviewer Publication Consent.
 I agree for my report to be made available
under an Open Access Creative Commons CC-BY License (
http://creativecommons.org/licenses/by/4.0
) if this manuscript is accepted for
publication. Any comments that I do not wish to be included in the published
report have been included as confidential comments to the editor, which will not
be published.
If you are not happy for us to publish this report, please contact the editorial
office before completing the review.
If you wish, you can include your name in your published report. Please note
you must decide whether to include your name at the start of the process and
confirm this decision whenever prompted. If you change your decision later, we
will not be able to publish your name.
I agree to the terms of the CC-BY 4.0 license; please 
do not
 publish my name
with my report. (default)
Is the study design appropriate to answer the research question (including the use
of appropriate controls), and are the conclusions supported by the evidence
presented?
Yes
Are the methods sufficiently described to allow the study to be repeated?
Yes
Is the use of statistics and treatment of uncertainties appropriate?
Yes
Is the presentation of the work clear?
Yes
Are the images in this manuscript (including electrophoretic gels and blots) free
from apparent manipulation?
Yes