Reviewer’s report
Title: Vedolizumab use after failure of TNF- α antagonists in children and adolescents with
inflammatory bowel disease
Version: 1 Date: 19 Jul 2018
Reviewer: Oren Ledder
Reviewer's report:
This work is a praiseworthy attempt to help boost the data on Vedolizumab in pediatric IBD. However
the major concern is the small sample size when 3 sizable retrospective reports have already been
published. The contribution from this study is hence somewhat limited.
Specific comments:
All data must be presented as mean (+/- SD) or median (+/- IQR).
It is difficult to ascertain how much of the response was related to adjunct therapies (eg corticosteroids,
tacrolimus) as opposed to just VDZ. The data should be presented in a format whereby this is easily
understood from the text, or better yet, from the figures or tables.
Along the same line, corticosteroid-free or EEN-free remission would be a better representation of drug
effect rather then just clinical remission.
In  the  discussion  the  text  "In  the  largest  paediatric  cohort  study  on  vedolizumab  thus  far,  no
improvement in height velocity and no significant weight gain were observed during treatment" is
repeated in the adjacent paragraph.
Are the methods appropriate and well described?
If not, please specify what is required in your comments to the authors.
Yes
Does the work include the necessary controls?
If not, please specify which controls are required in your comments to the authors.
Yes
Are the conclusions drawn adequately supported by the data shown?
If not, please explain in your comments to the authors.
Unable to assess
Are you able to assess any statistics in the manuscript or would you recommend an additional 
statistical review?
If an additional statistical review is recommended, please specify what aspects require further 
assessment in your comments to the editors.
I am able to assess the statistics
Quality of written English
Please indicate the quality of language in the manuscript:
Acceptable
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
I agree to the open peer review policy of the journal. I understand that my name will be included on my
report to the authors and, if the manuscript is accepted for publication, my named report including any 
attachments I upload will be posted on the website along with the authors' responses. 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/ ). I understand that any comments which I do not wish to 
be included in my named report can be included as confidential comments to the editors, which will not
be published.
I agree to the open peer review policy of the journal
Reviewer’s report
Title: Vedolizumab use after failure of TNF- α antagonists in children and adolescents with
inflammatory bowel disease
Version: 1 Date: 19 Jul 2018
Reviewer: Oren Ledder
Reviewer's report:
This work is a praiseworthy attempt to help boost the data on Vedolizumab in pediatric IBD. However
the major concern is the small sample size when 3 sizable retrospective reports have already been
published. The contribution from this study is hence somewhat limited.
Specific comments:
All data must be presented as mean (+/- SD) or median (+/- IQR).
It is difficult to ascertain how much of the response was related to adjunct therapies (eg corticosteroids,
tacrolimus) as opposed to just VDZ. The data should be presented in a format whereby this is easily
understood from the text, or better yet, from the figures or tables.
Along the same line, corticosteroid-free or EEN-free remission would be a better representation of drug
effect rather then just clinical remission.
In  the  discussion  the  text  "In  the  largest  paediatric  cohort  study  on  vedolizumab  thus  far,  no
improvement in height velocity and no significant weight gain were observed during treatment" is
repeated in the adjacent paragraph.
Are the methods appropriate and well described?
If not, please specify what is required in your comments to the authors.
Yes
Does the work include the necessary controls?
If not, please specify which controls are required in your comments to the authors.
Yes
Are the conclusions drawn adequately supported by the data shown?
If not, please explain in your comments to the authors.
Unable to assess
Are you able to assess any statistics in the manuscript or would you recommend an additional 
statistical review?
If an additional statistical review is recommended, please specify what aspects require further 
assessment in your comments to the editors.
I am able to assess the statistics
Quality of written English
Please indicate the quality of language in the manuscript:
Acceptable
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
I agree to the open peer review policy of the journal. I understand that my name will be included on my
report to the authors and, if the manuscript is accepted for publication, my named report including any 
attachments I upload will be posted on the website along with the authors' responses. 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/ ). I understand that any comments which I do not wish to 
be included in my named report can be included as confidential comments to the editors, which will not
be published.
I agree to the open peer review policy of the journal
Please review this paper.
user
Reviewer’s report
Title: Vedolizumab use after failure of TNF- α antagonists in children and adolescents with
inflammatory bowel disease
Version: 1 Date: 19 Jul 2018
Reviewer: Oren Ledder
Reviewer's report:
This work is a praiseworthy attempt to help boost the data on Vedolizumab in pediatric IBD. However
the major concern is the small sample size when 3 sizable retrospective reports have already been
published. The contribution from this study is hence somewhat limited.
Specific comments:
All data must be presented as mean (+/- SD) or median (+/- IQR).
It is difficult to ascertain how much of the response was related to adjunct therapies (eg corticosteroids,
tacrolimus) as opposed to just VDZ. The data should be presented in a format whereby this is easily
understood from the text, or better yet, from the figures or tables.
Along the same line, corticosteroid-free or EEN-free remission would be a better representation of drug
effect rather then just clinical remission.
In  the  discussion  the  text  "In  the  largest  paediatric  cohort  study  on  vedolizumab  thus  far,  no
improvement in height velocity and no significant weight gain were observed during treatment" is
repeated in the adjacent paragraph.
Are the methods appropriate and well described?
If not, please specify what is required in your comments to the authors.
Yes
Does the work include the necessary controls?
If not, please specify which controls are required in your comments to the authors.
Yes
Are the conclusions drawn adequately supported by the data shown?
If not, please explain in your comments to the authors.
Unable to assess
Are you able to assess any statistics in the manuscript or would you recommend an additional 
statistical review?
If an additional statistical review is recommended, please specify what aspects require further 
assessment in your comments to the editors.
I am able to assess the statistics
Quality of written English
Please indicate the quality of language in the manuscript:
Acceptable
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
I agree to the open peer review policy of the journal. I understand that my name will be included on my
report to the authors and, if the manuscript is accepted for publication, my named report including any 
attachments I upload will be posted on the website along with the authors' responses. 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/ ). I understand that any comments which I do not wish to 
be included in my named report can be included as confidential comments to the editors, which will not
be published.
I agree to the open peer review policy of the journal
assistant