Reviewer ’s report  
 
Title: Safety and Effectiveness of Granulocyte and Monocyte A dsorptive Apheresis in Patients 
with Inflammatory Bowel Disease in Special Situations: A Multicentre Cohort Study  
 
Version: 0 Date: 25 Aug 2019  
 
Reviewer: Flaminia Cavallaro  
 
Reviewer's report:  
 
In the  present manuscript, the Authors conducted a retrospective multicenter study to assess 
safety and effectiveness of granulocyte and monocyte adsorbtive apheresis in an IBD population 
with special situations.  
 
The paper is clear and well written and the figur es clearly display the results obtained by 
Authors. Indeed, the present manuscript is interesting, as includes a real -life population with 
subgroups of delicate patients or patients with comorbidities generally not included in routine 
clinical trials.   
 
The study has some limitations due to the retrospective nature and the absence of controls, but 
these limitations are noticed by the Authors in the Conclusion paragraph.  
 
 
I have a few remarks:  
 
Major comments:  
 
It would be better to replace the "special situat ions" locution with a more descriptive phrase of 
these special situations that includes delicate patients such as the elderly and with comorbidities 
such as anemia or renal failure.  
 
The AEs are not sufficiently highlighted; they should be represented in Ta ble 2, rather being 
Supplementary.  
 
In patients with CD the assessment of the disease activity should be performed with a more 
frequently used and more validated index such as CDAI or HBI.  
 
 
Minor Comments:  
 
In the Background paragraph, Authors should name th e new biological agents, in addition to 
anti-TNF, used in current clinical practice.  
 
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.  
 
No 
 
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 manus cript or would you recommend an 
additional statistical review?  
If an additiona l statistical review is recommended, please speci fy what aspects require further 
assessment in your comments to the editors.  
 
Not relevant to this manuscript  
 
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, f ees, funding, or salary 
from an organisation that may in any way gain o r lose financial ly 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 
futur e? 
 
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 t he 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 compet ing 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 understan d that my name will be included 
on my report to the authors and, if the manuscript is ac cepted f or 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://creativecommo ns.org/licenses/by/4.0/ ). I understand that any comments 
which I do not wish to be included in my named report can be in cluded 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: Safety and Effectiveness of Granulocyte and Monocyte A dsorptive Apheresis in Patients 
with Inflammatory Bowel Disease in Special Situations: A Multicentre Cohort Study  
 
Version: 0 Date: 25 Aug 2019  
 
Reviewer: Flaminia Cavallaro  
 
Reviewer's report:  
 
In the  present manuscript, the Authors conducted a retrospective multicenter study to assess 
safety and effectiveness of granulocyte and monocyte adsorbtive apheresis in an IBD population 
with special situations.  
 
The paper is clear and well written and the figur es clearly display the results obtained by 
Authors. Indeed, the present manuscript is interesting, as includes a real -life population with 
subgroups of delicate patients or patients with comorbidities generally not included in routine 
clinical trials.   
 
The study has some limitations due to the retrospective nature and the absence of controls, but 
these limitations are noticed by the Authors in the Conclusion paragraph.  
 
 
I have a few remarks:  
 
Major comments:  
 
It would be better to replace the "special situat ions" locution with a more descriptive phrase of 
these special situations that includes delicate patients such as the elderly and with comorbidities 
such as anemia or renal failure.  
 
The AEs are not sufficiently highlighted; they should be represented in Ta ble 2, rather being 
Supplementary.  
 
In patients with CD the assessment of the disease activity should be performed with a more 
frequently used and more validated index such as CDAI or HBI.  
 
 
Minor Comments:  
 
In the Background paragraph, Authors should name th e new biological agents, in addition to 
anti-TNF, used in current clinical practice.  
 
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.  
 
No 
 
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 manus cript or would you recommend an 
additional statistical review?  
If an additiona l statistical review is recommended, please speci fy what aspects require further 
assessment in your comments to the editors.  
 
Not relevant to this manuscript  
 
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, f ees, funding, or salary 
from an organisation that may in any way gain o r lose financial ly 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 
futur e? 
 
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 t he 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 compet ing 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 understan d that my name will be included 
on my report to the authors and, if the manuscript is ac cepted f or 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://creativecommo ns.org/licenses/by/4.0/ ). I understand that any comments 
which I do not wish to be included in my named report can be in cluded 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: Safety and Effectiveness of Granulocyte and Monocyte A dsorptive Apheresis in Patients 
with Inflammatory Bowel Disease in Special Situations: A Multicentre Cohort Study  
 
Version: 0 Date: 25 Aug 2019  
 
Reviewer: Flaminia Cavallaro  
 
Reviewer's report:  
 
In the  present manuscript, the Authors conducted a retrospective multicenter study to assess 
safety and effectiveness of granulocyte and monocyte adsorbtive apheresis in an IBD population 
with special situations.  
 
The paper is clear and well written and the figur es clearly display the results obtained by 
Authors. Indeed, the present manuscript is interesting, as includes a real -life population with 
subgroups of delicate patients or patients with comorbidities generally not included in routine 
clinical trials.   
 
The study has some limitations due to the retrospective nature and the absence of controls, but 
these limitations are noticed by the Authors in the Conclusion paragraph.  
 
 
I have a few remarks:  
 
Major comments:  
 
It would be better to replace the "special situat ions" locution with a more descriptive phrase of 
these special situations that includes delicate patients such as the elderly and with comorbidities 
such as anemia or renal failure.  
 
The AEs are not sufficiently highlighted; they should be represented in Ta ble 2, rather being 
Supplementary.  
 
In patients with CD the assessment of the disease activity should be performed with a more 
frequently used and more validated index such as CDAI or HBI.  
 
 
Minor Comments:  
 
In the Background paragraph, Authors should name th e new biological agents, in addition to 
anti-TNF, used in current clinical practice.  
 
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.  
 
No 
 
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 manus cript or would you recommend an 
additional statistical review?  
If an additiona l statistical review is recommended, please speci fy what aspects require further 
assessment in your comments to the editors.  
 
Not relevant to this manuscript  
 
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, f ees, funding, or salary 
from an organisation that may in any way gain o r lose financial ly 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 
futur e? 
 
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 t he 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 compet ing 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 understan d that my name will be included 
on my report to the authors and, if the manuscript is ac cepted f or 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://creativecommo ns.org/licenses/by/4.0/ ). I understand that any comments 
which I do not wish to be included in my named report can be in cluded as confidential comments 
to the editors, which will not be published.  
 
I agree to the open peer review policy of the journal  
assistant