Reviewer’s report
Title: 
Efficacy and predictor of anti-TNF
α
 agents in patients with intestinal
Behçet's disease
Version: 
0 
Date: 
21 Nov 2021
Reviewer's report:
The authors should highlight the uniqueness of their study. Why is it important
for the discipline. There are several studies referred to this issue for example:
Hibi T, Hirohata S, Kikuchi H, Tateishi U, Sato N, Ozaki K, et al. Infliximab
therapy for intestinal, neurological, and vascular involvement in Behcet disease:
efficacy, safety, and pharmacokinetics in a multicenter, prospective, open-label,
single-arm phase 3 study. Medicine. 2016;95(24):e3863
Zou J, Ji DN, Shen Y, Guan JL, Zheng SB. Mucosal healing at 14 weeks predicts
better outcome in low-dose infliximab treatment for Chinese patients with active
intestinal Behcet's disease. Ann Clin Lab Sci. 2017;47(2):171-7
Tanida S, Inoue N, Kobayashi K, Naganuma M, Hirai F, Iizuka B, et al.
Adalimumab for the treatment of Japanese patients with intestinal Behcet's
disease. Clin Gastroenterol Hepatol. 2015;13(5):940-8.e3
Inoue N, Kobayashi K, Naganuma M, Hirai F, Ozawa M, Arikan D, et al. Long-
term safety and efficacy of adalimumab for intestinal Behcet's disease in the
open label study following a phase 3 clinical trial. Intest Res. 2017;15(3):395-
401
Vitale A, Emmi G, Lopalco G, Gentileschi S, Silvestri E, Fabiani C, et al.
Adalimumab effectiveness in Behcet's disease: short and long-term data from a
multicenter retrospective observational study. Clin Rheumatol. 2017;36(2):451-
5.
In the discussion please focus more on the comparison of your results to
previous studies and explain differences between them. 
Some important literature is missing
Park, Y., Cheon, J.H. Update on the Treatment of Behcet's Disease of the Small
Bowel with Biologic Agents. Curr Gastroenterol Rep 22, 24 (2020).
https://doi.org/10.1007/s11894-020-00759-1
Inoue N, Kobayashi K, Naganuma M, Hirai F, Ozawa M, Arikan D, Huang B,
Robinson AM, Thakkar RB, Hibi T. Long-term safety and efficacy of
adalimumab for intestinal Behçet's disease in the open label study following a
phase 3 clinical trial. Intest Res. 2017 Jul;15(3):395-401.
Sugimura N, Mizoshita T, Sugiyama T, Togawa S, Miyaki T, Suzuki T, Tanida
S, Kataoka H, Sasaki M. Real-world efficacy of adalimumab and infliximab for
refractory intestinal Behçet's disease. Dig Liver Dis. 2019 Jul;51(7):967-971.
Park J, Cheon JH. Anti-Tumor Necrosis Factor Therapy in Intestinal Behçet's
Disease. Gut Liver. 2018 Nov 15;12(6):623-632. 
Park YE, Cheon JH. Updated treatment strategies for intestinal Behçet's disease.
Korean J Intern Med. 2018;33(1):1-19. 
Vallet H, Riviere S, Sanna A, Deroux A, Moulis G, Addimanda O, Salvarani C,
Lambert M, Bielefeld P, Seve P, Sibilia J, Pasquali J, Fraison J, Marie I, Perard
L, Bouillet L, Cohen F, Sene D, Schoindre Y, Lidove O, Le Hoang P, Hachulla
E, Fain O, Mariette X, Papo T, Wechsler B, Bodaghi B, Rigon MR, Cacoub P,
Saadoun D; French Behçet Network. Efficacy of anti-TNF alpha in severe and/or
refractory Behçet's disease: Multicenter study of 124 patients. J Autoimmun.
2015 Aug;62:67-74.
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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
Reviewer’s report
Title: 
Efficacy and predictor of anti-TNF
α
 agents in patients with intestinal
Behçet's disease
Version: 
0 
Date: 
21 Nov 2021
Reviewer's report:
The authors should highlight the uniqueness of their study. Why is it important
for the discipline. There are several studies referred to this issue for example:
Hibi T, Hirohata S, Kikuchi H, Tateishi U, Sato N, Ozaki K, et al. Infliximab
therapy for intestinal, neurological, and vascular involvement in Behcet disease:
efficacy, safety, and pharmacokinetics in a multicenter, prospective, open-label,
single-arm phase 3 study. Medicine. 2016;95(24):e3863
Zou J, Ji DN, Shen Y, Guan JL, Zheng SB. Mucosal healing at 14 weeks predicts
better outcome in low-dose infliximab treatment for Chinese patients with active
intestinal Behcet's disease. Ann Clin Lab Sci. 2017;47(2):171-7
Tanida S, Inoue N, Kobayashi K, Naganuma M, Hirai F, Iizuka B, et al.
Adalimumab for the treatment of Japanese patients with intestinal Behcet's
disease. Clin Gastroenterol Hepatol. 2015;13(5):940-8.e3
Inoue N, Kobayashi K, Naganuma M, Hirai F, Ozawa M, Arikan D, et al. Long-
term safety and efficacy of adalimumab for intestinal Behcet's disease in the
open label study following a phase 3 clinical trial. Intest Res. 2017;15(3):395-
401
Vitale A, Emmi G, Lopalco G, Gentileschi S, Silvestri E, Fabiani C, et al.
Adalimumab effectiveness in Behcet's disease: short and long-term data from a
multicenter retrospective observational study. Clin Rheumatol. 2017;36(2):451-
5.
In the discussion please focus more on the comparison of your results to
previous studies and explain differences between them. 
Some important literature is missing
Park, Y., Cheon, J.H. Update on the Treatment of Behcet's Disease of the Small
Bowel with Biologic Agents. Curr Gastroenterol Rep 22, 24 (2020).
https://doi.org/10.1007/s11894-020-00759-1
Inoue N, Kobayashi K, Naganuma M, Hirai F, Ozawa M, Arikan D, Huang B,
Robinson AM, Thakkar RB, Hibi T. Long-term safety and efficacy of
adalimumab for intestinal Behçet's disease in the open label study following a
phase 3 clinical trial. Intest Res. 2017 Jul;15(3):395-401.
Sugimura N, Mizoshita T, Sugiyama T, Togawa S, Miyaki T, Suzuki T, Tanida
S, Kataoka H, Sasaki M. Real-world efficacy of adalimumab and infliximab for
refractory intestinal Behçet's disease. Dig Liver Dis. 2019 Jul;51(7):967-971.
Park J, Cheon JH. Anti-Tumor Necrosis Factor Therapy in Intestinal Behçet's
Disease. Gut Liver. 2018 Nov 15;12(6):623-632. 
Park YE, Cheon JH. Updated treatment strategies for intestinal Behçet's disease.
Korean J Intern Med. 2018;33(1):1-19. 
Vallet H, Riviere S, Sanna A, Deroux A, Moulis G, Addimanda O, Salvarani C,
Lambert M, Bielefeld P, Seve P, Sibilia J, Pasquali J, Fraison J, Marie I, Perard
L, Bouillet L, Cohen F, Sene D, Schoindre Y, Lidove O, Le Hoang P, Hachulla
E, Fain O, Mariette X, Papo T, Wechsler B, Bodaghi B, Rigon MR, Cacoub P,
Saadoun D; French Behçet Network. Efficacy of anti-TNF alpha in severe and/or
refractory Behçet's disease: Multicenter study of 124 patients. J Autoimmun.
2015 Aug;62:67-74.
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 after the final decision on the manuscript has been made. 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
Please review this paper.
user
Reviewer’s report
Title: 
Efficacy and predictor of anti-TNF
α
 agents in patients with intestinal
Behçet's disease
Version: 
0 
Date: 
21 Nov 2021
Reviewer's report:
The authors should highlight the uniqueness of their study. Why is it important
for the discipline. There are several studies referred to this issue for example:
Hibi T, Hirohata S, Kikuchi H, Tateishi U, Sato N, Ozaki K, et al. Infliximab
therapy for intestinal, neurological, and vascular involvement in Behcet disease:
efficacy, safety, and pharmacokinetics in a multicenter, prospective, open-label,
single-arm phase 3 study. Medicine. 2016;95(24):e3863
Zou J, Ji DN, Shen Y, Guan JL, Zheng SB. Mucosal healing at 14 weeks predicts
better outcome in low-dose infliximab treatment for Chinese patients with active
intestinal Behcet's disease. Ann Clin Lab Sci. 2017;47(2):171-7
Tanida S, Inoue N, Kobayashi K, Naganuma M, Hirai F, Iizuka B, et al.
Adalimumab for the treatment of Japanese patients with intestinal Behcet's
disease. Clin Gastroenterol Hepatol. 2015;13(5):940-8.e3
Inoue N, Kobayashi K, Naganuma M, Hirai F, Ozawa M, Arikan D, et al. Long-
term safety and efficacy of adalimumab for intestinal Behcet's disease in the
open label study following a phase 3 clinical trial. Intest Res. 2017;15(3):395-
401
Vitale A, Emmi G, Lopalco G, Gentileschi S, Silvestri E, Fabiani C, et al.
Adalimumab effectiveness in Behcet's disease: short and long-term data from a
multicenter retrospective observational study. Clin Rheumatol. 2017;36(2):451-
5.
In the discussion please focus more on the comparison of your results to
previous studies and explain differences between them. 
Some important literature is missing
Park, Y., Cheon, J.H. Update on the Treatment of Behcet's Disease of the Small
Bowel with Biologic Agents. Curr Gastroenterol Rep 22, 24 (2020).
https://doi.org/10.1007/s11894-020-00759-1
Inoue N, Kobayashi K, Naganuma M, Hirai F, Ozawa M, Arikan D, Huang B,
Robinson AM, Thakkar RB, Hibi T. Long-term safety and efficacy of
adalimumab for intestinal Behçet's disease in the open label study following a
phase 3 clinical trial. Intest Res. 2017 Jul;15(3):395-401.
Sugimura N, Mizoshita T, Sugiyama T, Togawa S, Miyaki T, Suzuki T, Tanida
S, Kataoka H, Sasaki M. Real-world efficacy of adalimumab and infliximab for
refractory intestinal Behçet's disease. Dig Liver Dis. 2019 Jul;51(7):967-971.
Park J, Cheon JH. Anti-Tumor Necrosis Factor Therapy in Intestinal Behçet's
Disease. Gut Liver. 2018 Nov 15;12(6):623-632. 
Park YE, Cheon JH. Updated treatment strategies for intestinal Behçet's disease.
Korean J Intern Med. 2018;33(1):1-19. 
Vallet H, Riviere S, Sanna A, Deroux A, Moulis G, Addimanda O, Salvarani C,
Lambert M, Bielefeld P, Seve P, Sibilia J, Pasquali J, Fraison J, Marie I, Perard
L, Bouillet L, Cohen F, Sene D, Schoindre Y, Lidove O, Le Hoang P, Hachulla
E, Fain O, Mariette X, Papo T, Wechsler B, Bodaghi B, Rigon MR, Cacoub P,
Saadoun D; French Behçet Network. Efficacy of anti-TNF alpha in severe and/or
refractory Behçet's disease: Multicenter study of 124 patients. J Autoimmun.
2015 Aug;62:67-74.
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 after the final decision on the manuscript has been made. 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
assistant