Title: Combination of Serological Biomarkers and Clinical Features to predict Mucosal Healing
in Crohn’s Disease: A Multicenter Cohort Study
Version: 2 Date: 23 Mar 2022
Reviewer's report:
I am very pleased to have had the opportunity to review this manuscript.
The purpose of this study is to construct a model using serological biomarkers to predict mucosal
healing of Crohn's disease (CD). The strength of this model is that the serological biomarkers
used are tests that can be performed at many facilities. However, this study may require the
following amendments.
Major revision
#Why was the inclusion criterion "(2) Corticosteroids had been discontinued for more than 12
weeks" set (page 5, line 105)?
#Why was the exclusion criterion "A previous history of taking aspirin or warfarin" set (Page
5, line 105)?
#In this study, endoscopic examinations were performed to evaluate mucosal state. Which
endoscopic examinations (colonoscopy, capsule endoscopy, or double-balloon enteroscopy)
were performed?
#The main purpose of this study is to build a model for predicting mucosal healing. However,
the definition of mucosal healing seems to be inadequate (page 6, line 135). Was the endoscopic
score, which assesses the endoscopic activity of Crohn's disease, evaluated?
#This study focuses only on IFX for advanced therapy. Were there any patients treated with other
advanced therapies, such as adalimumab (ADA), ustekinumab (UST), or vedolizumab (VDZ)?
For example, did the group of patients who were not administered IFX include patients treated
with advanced therapies other than IFX?
#There is no table of basic characteristics of all the 348 patients. Since we do not know the
characteristics of the patients in this study, a table of baseline characteristics should be added
that includes items from Table 1, such as age, disease duration, HBI, and therapeutic agents.
#Please enter the unit for each blood test in Table 2.
#Which patient groups (the pre-treatment group, the post-treatment group, or both groups) were
evaluated by the model?
#This analysis shows that the evaluation of MH in the primary model is excellent; however, this
evaluation item includes the presence or absence of IFX. Currently, in addition to IFX, there are
various other advanced therapies, such as ADA, UST, and VDZ. I think that the fact that only
the presence or absence of IFX is an evaluation item is a major constraint on the evaluation of
CDs for which there are various other treatments available.
Minor revisions
#Tables 1 and 3 do not include explanations of abbreviations.
#MH and non-MH in Table 1 are sub-groups, respectively. It should be written in lowercase
as N # n.
#P value should be described as follows; P=0.006 # P = 0.006
#Please italicize P in line 166.
Title: Combination of Serological Biomarkers and Clinical Features to predict Mucosal Healing
in Crohn’s Disease: A Multicenter Cohort Study
Version: 2 Date: 23 Mar 2022
Reviewer's report:
I am very pleased to have had the opportunity to review this manuscript.
The purpose of this study is to construct a model using serological biomarkers to predict mucosal
healing of Crohn's disease (CD). The strength of this model is that the serological biomarkers
used are tests that can be performed at many facilities. However, this study may require the
following amendments.
Major revision
#Why was the inclusion criterion "(2) Corticosteroids had been discontinued for more than 12
weeks" set (page 5, line 105)?
#Why was the exclusion criterion "A previous history of taking aspirin or warfarin" set (Page
5, line 105)?
#In this study, endoscopic examinations were performed to evaluate mucosal state. Which
endoscopic examinations (colonoscopy, capsule endoscopy, or double-balloon enteroscopy)
were performed?
#The main purpose of this study is to build a model for predicting mucosal healing. However,
the definition of mucosal healing seems to be inadequate (page 6, line 135). Was the endoscopic
score, which assesses the endoscopic activity of Crohn's disease, evaluated?
#This study focuses only on IFX for advanced therapy. Were there any patients treated with other
advanced therapies, such as adalimumab (ADA), ustekinumab (UST), or vedolizumab (VDZ)?
For example, did the group of patients who were not administered IFX include patients treated
with advanced therapies other than IFX?
#There is no table of basic characteristics of all the 348 patients. Since we do not know the
characteristics of the patients in this study, a table of baseline characteristics should be added
that includes items from Table 1, such as age, disease duration, HBI, and therapeutic agents.
#Please enter the unit for each blood test in Table 2.
#Which patient groups (the pre-treatment group, the post-treatment group, or both groups) were
evaluated by the model?
#This analysis shows that the evaluation of MH in the primary model is excellent; however, this
evaluation item includes the presence or absence of IFX. Currently, in addition to IFX, there are
various other advanced therapies, such as ADA, UST, and VDZ. I think that the fact that only
the presence or absence of IFX is an evaluation item is a major constraint on the evaluation of
CDs for which there are various other treatments available.
Minor revisions
#Tables 1 and 3 do not include explanations of abbreviations.
#MH and non-MH in Table 1 are sub-groups, respectively. It should be written in lowercase
as N # n.
#P value should be described as follows; P=0.006 # P = 0.006
#Please italicize P in line 166.
Please review this paper.
user
Title: Combination of Serological Biomarkers and Clinical Features to predict Mucosal Healing
in Crohn’s Disease: A Multicenter Cohort Study
Version: 2 Date: 23 Mar 2022
Reviewer's report:
I am very pleased to have had the opportunity to review this manuscript.
The purpose of this study is to construct a model using serological biomarkers to predict mucosal
healing of Crohn's disease (CD). The strength of this model is that the serological biomarkers
used are tests that can be performed at many facilities. However, this study may require the
following amendments.
Major revision
#Why was the inclusion criterion "(2) Corticosteroids had been discontinued for more than 12
weeks" set (page 5, line 105)?
#Why was the exclusion criterion "A previous history of taking aspirin or warfarin" set (Page
5, line 105)?
#In this study, endoscopic examinations were performed to evaluate mucosal state. Which
endoscopic examinations (colonoscopy, capsule endoscopy, or double-balloon enteroscopy)
were performed?
#The main purpose of this study is to build a model for predicting mucosal healing. However,
the definition of mucosal healing seems to be inadequate (page 6, line 135). Was the endoscopic
score, which assesses the endoscopic activity of Crohn's disease, evaluated?
#This study focuses only on IFX for advanced therapy. Were there any patients treated with other
advanced therapies, such as adalimumab (ADA), ustekinumab (UST), or vedolizumab (VDZ)?
For example, did the group of patients who were not administered IFX include patients treated
with advanced therapies other than IFX?
#There is no table of basic characteristics of all the 348 patients. Since we do not know the
characteristics of the patients in this study, a table of baseline characteristics should be added
that includes items from Table 1, such as age, disease duration, HBI, and therapeutic agents.
#Please enter the unit for each blood test in Table 2.
#Which patient groups (the pre-treatment group, the post-treatment group, or both groups) were
evaluated by the model?
#This analysis shows that the evaluation of MH in the primary model is excellent; however, this
evaluation item includes the presence or absence of IFX. Currently, in addition to IFX, there are
various other advanced therapies, such as ADA, UST, and VDZ. I think that the fact that only
the presence or absence of IFX is an evaluation item is a major constraint on the evaluation of
CDs for which there are various other treatments available.
Minor revisions
#Tables 1 and 3 do not include explanations of abbreviations.
#MH and non-MH in Table 1 are sub-groups, respectively. It should be written in lowercase
as N # n.
#P value should be described as follows; P=0.006 # P = 0.006
#Please italicize P in line 166.
assistant