Reviewer’s report
Title: Vedolizumab use after failure of TNF- α antagonists in children and adolescents with
inflammatory bowel disease
Version: 0 Date: 24 Jun 2018
Reviewer: Laura Bauman
Reviewer's report:
Comments for "Vedolizumab use after failure of TNF-α antagonists in children and adolescents with
inflammatory bowel disease" 
This is a retrospective case series  examining the disease activity indices and common laboratory
markers of IBD in pediatric patients receiving vedolizumab after anti-TNF failure. The strengths of this
analysis include innovative nature of the data, given the relative lack of data about vedolizumab use in
pediatric IBD. Weaknesses include the small sample size, the difficult to understand statistics, and the
incomplete data describing the cases. There are no controls as it is a case series. 
Specific Points:
1.Please include demographic/disease related data in a table (weight for age z score, labs).
This data is reviewed in text format, but it would be better served in a table. May be helpful to
make similar charts as in Figure 2. 
2.Please include concomitant medications in one of the descriptive tables. For example,
would be interesting to know which patients are steroid dependent vs steroid refractory, on
immunomodulators, etc. 
3.Given that the main RTE drop (in UC patients) could not have a confidence interval
calculated from the sample size, I question whether this is the best statistic to describe this data.
Descriptive statistics and figures may be more appropriate for such a small sample size. 
4.Although nutritional status and lab values were secondary outcomes, this is a finding
that I think should be emphasized more in the discussion. 
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.
Yes
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:
Needs some language corrections before being published
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: 0 Date: 24 Jun 2018
Reviewer: Laura Bauman
Reviewer's report:
Comments for "Vedolizumab use after failure of TNF-α antagonists in children and adolescents with
inflammatory bowel disease" 
This is a retrospective case series  examining the disease activity indices and common laboratory
markers of IBD in pediatric patients receiving vedolizumab after anti-TNF failure. The strengths of this
analysis include innovative nature of the data, given the relative lack of data about vedolizumab use in
pediatric IBD. Weaknesses include the small sample size, the difficult to understand statistics, and the
incomplete data describing the cases. There are no controls as it is a case series. 
Specific Points:
1.Please include demographic/disease related data in a table (weight for age z score, labs).
This data is reviewed in text format, but it would be better served in a table. May be helpful to
make similar charts as in Figure 2. 
2.Please include concomitant medications in one of the descriptive tables. For example,
would be interesting to know which patients are steroid dependent vs steroid refractory, on
immunomodulators, etc. 
3.Given that the main RTE drop (in UC patients) could not have a confidence interval
calculated from the sample size, I question whether this is the best statistic to describe this data.
Descriptive statistics and figures may be more appropriate for such a small sample size. 
4.Although nutritional status and lab values were secondary outcomes, this is a finding
that I think should be emphasized more in the discussion. 
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.
Yes
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:
Needs some language corrections before being published
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: 0 Date: 24 Jun 2018
Reviewer: Laura Bauman
Reviewer's report:
Comments for "Vedolizumab use after failure of TNF-α antagonists in children and adolescents with
inflammatory bowel disease" 
This is a retrospective case series  examining the disease activity indices and common laboratory
markers of IBD in pediatric patients receiving vedolizumab after anti-TNF failure. The strengths of this
analysis include innovative nature of the data, given the relative lack of data about vedolizumab use in
pediatric IBD. Weaknesses include the small sample size, the difficult to understand statistics, and the
incomplete data describing the cases. There are no controls as it is a case series. 
Specific Points:
1.Please include demographic/disease related data in a table (weight for age z score, labs).
This data is reviewed in text format, but it would be better served in a table. May be helpful to
make similar charts as in Figure 2. 
2.Please include concomitant medications in one of the descriptive tables. For example,
would be interesting to know which patients are steroid dependent vs steroid refractory, on
immunomodulators, etc. 
3.Given that the main RTE drop (in UC patients) could not have a confidence interval
calculated from the sample size, I question whether this is the best statistic to describe this data.
Descriptive statistics and figures may be more appropriate for such a small sample size. 
4.Although nutritional status and lab values were secondary outcomes, this is a finding
that I think should be emphasized more in the discussion. 
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.
Yes
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:
Needs some language corrections before being published
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