Reviewer ’s report  
 
Title: Real-world clinical effectiveness and safety of vedolizumab  and anti -tumor necrosis factor 
alpha treatment in ulcerative colitis and Crohn ’s disease patient s: A German retrospective chart 
review  
 
Version: 0 Date: 23 Oct 2019  
 
Reviewer: Carlos Taxonera  
 
Reviewer's report:  
 
This was a retrospective, multicenter medical chart review study that evaluated patients with IBD 
initiated with 8 vedolizumab or an anti -TNFα.  
 
The title reflect the main subject/hypothesis of the manuscript. The abstract summarize and 
reflect the work described in the manuscript. The key words reflect the focus of the manuscript. 
The manuscript describe methods in adequate detail. The resea rch objectives are achieved by the 
experiments used in this study. The manuscript is well, concisely and coherently organized and 
presented. Conclusions were concise and not speculative.  
 
The study reported important information about real life outcomes of biologics in IBD, and its 
conclusions were clinically relevant.  
 
I suggest to add results of VARSITY trial in the manuscript.  
 
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 b y the data shown?  
If not, please explain in your comments to the authors.  
 
Yes 
 
 
 
 
 
 
 
Are you able to assess any statistics in the manus cript or would you recommend an 
additional statistical review?  
If an additional statistical review is recommended, please specif y 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 complet e a declaration of competing interests, considering the following questions:  
 
1. Have you in the past five years received reimbursements, f ees, 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 t hat 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 you r reply is yes to any, please give details below.  
 
C. Taxonera has received speaker, advisory board or research fees from MSD, Abbvie, Hospira, 
Pfizer, Takeda, Janssen, Ferring, Faes Farma, Dr. Falk Pharma, Amgen and Tillots.  
 
I agree to the open peer review  policy of the journal. I understan d that my name will be included 
on my report to the authors and, if the manuscript is accepted f or publication, my named r eport 
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 con fidential comments 
to the editors, which will not be published.  
 
I agree to the open peer review policy of the journal  
Reviewer ’s report  
 
Title: Real-world clinical effectiveness and safety of vedolizumab  and anti -tumor necrosis factor 
alpha treatment in ulcerative colitis and Crohn ’s disease patient s: A German retrospective chart 
review  
 
Version: 0 Date: 23 Oct 2019  
 
Reviewer: Carlos Taxonera  
 
Reviewer's report:  
 
This was a retrospective, multicenter medical chart review study that evaluated patients with IBD 
initiated with 8 vedolizumab or an anti -TNFα.  
 
The title reflect the main subject/hypothesis of the manuscript. The abstract summarize and 
reflect the work described in the manuscript. The key words reflect the focus of the manuscript. 
The manuscript describe methods in adequate detail. The resea rch objectives are achieved by the 
experiments used in this study. The manuscript is well, concisely and coherently organized and 
presented. Conclusions were concise and not speculative.  
 
The study reported important information about real life outcomes of biologics in IBD, and its 
conclusions were clinically relevant.  
 
I suggest to add results of VARSITY trial in the manuscript.  
 
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 b y the data shown?  
If not, please explain in your comments to the authors.  
 
Yes 
 
 
 
 
 
 
 
Are you able to assess any statistics in the manus cript or would you recommend an 
additional statistical review?  
If an additional statistical review is recommended, please specif y 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 complet e a declaration of competing interests, considering the following questions:  
 
1. Have you in the past five years received reimbursements, f ees, 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 t hat 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 you r reply is yes to any, please give details below.  
 
C. Taxonera has received speaker, advisory board or research fees from MSD, Abbvie, Hospira, 
Pfizer, Takeda, Janssen, Ferring, Faes Farma, Dr. Falk Pharma, Amgen and Tillots.  
 
I agree to the open peer review  policy of the journal. I understan d that my name will be included 
on my report to the authors and, if the manuscript is accepted f or publication, my named r eport 
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 con fidential 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: Real-world clinical effectiveness and safety of vedolizumab  and anti -tumor necrosis factor 
alpha treatment in ulcerative colitis and Crohn ’s disease patient s: A German retrospective chart 
review  
 
Version: 0 Date: 23 Oct 2019  
 
Reviewer: Carlos Taxonera  
 
Reviewer's report:  
 
This was a retrospective, multicenter medical chart review study that evaluated patients with IBD 
initiated with 8 vedolizumab or an anti -TNFα.  
 
The title reflect the main subject/hypothesis of the manuscript. The abstract summarize and 
reflect the work described in the manuscript. The key words reflect the focus of the manuscript. 
The manuscript describe methods in adequate detail. The resea rch objectives are achieved by the 
experiments used in this study. The manuscript is well, concisely and coherently organized and 
presented. Conclusions were concise and not speculative.  
 
The study reported important information about real life outcomes of biologics in IBD, and its 
conclusions were clinically relevant.  
 
I suggest to add results of VARSITY trial in the manuscript.  
 
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 b y the data shown?  
If not, please explain in your comments to the authors.  
 
Yes 
 
 
 
 
 
 
 
Are you able to assess any statistics in the manus cript or would you recommend an 
additional statistical review?  
If an additional statistical review is recommended, please specif y 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 complet e a declaration of competing interests, considering the following questions:  
 
1. Have you in the past five years received reimbursements, f ees, 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 t hat 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 you r reply is yes to any, please give details below.  
 
C. Taxonera has received speaker, advisory board or research fees from MSD, Abbvie, Hospira, 
Pfizer, Takeda, Janssen, Ferring, Faes Farma, Dr. Falk Pharma, Amgen and Tillots.  
 
I agree to the open peer review  policy of the journal. I understan d that my name will be included 
on my report to the authors and, if the manuscript is accepted f or publication, my named r eport 
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 con fidential comments 
to the editors, which will not be published.  
 
I agree to the open peer review policy of the journal  
assistant