Title: Efficacy and safety of tacrolimus in older adults with ulcerative colitis: A retrospective
study
Version: 3 Date: 28 Oct 2023
Reviewer's report:
I am very pleased to have had the opportunity to review this manuscript. This study investigated
the usefulness and safety of tacrolimus in elderly patients with ulcerative colitis. The study of
tacrolimus in elderly patients is a novel and interesting study. However, this manuscript may
require the following revisions.
Major
Introduction
#The fact that tacrolimus was shown to be useful in treating ulcerative colitis in a large-scale
clinical trial should also be mentioned in the introduction section.
Materials and Methods
#May score, which is a colonoscopy score, is confused with Mayo score, which includes partial
Mayo and Mayo endoscopic subscore. The endoscopic score should be indicated as the Mayo
endoscopic subscore.
#In TAC treatment of ulcerative colitis, a high trough is generally achieved, and then a transition
is made to a low trough. In what range was the target trough value of the TAC set?
#Was the target trough achieved in all registered patients?
Results
#It would be good to have a visual representation of the registered patients and those that were
subsequently followed. Can you show me the study flow chart?
#The remission rates for one month of TAC initiation are as stated, but what about the response
rate?
#Please indicate the p-value for the rate of change in GFR for each period in young and older
patients in Fig. 1.
-Hyperkalemia is often a clinical problem in the treatment of ulcerative colitis with tacrolimus.
Did this study not consider hyperkalemia as an adverse event?
Discussion
#In this study, TAC administration was continued based on the ECCO guidelines. Japanese
regulations indicate that the treatment period is 3 months, but are there any other Japanese papers
that consider its administration for more than 3 months?
Minor
- Not all abbreviations were explained in each table. Please add them to the table.
- The first letter of each item in adverse effects in Table 2 should be capitalized.
- The phrase "time to reach TAC trough" should be changed to "time to reach target TAC trough".
Title: Efficacy and safety of tacrolimus in older adults with ulcerative colitis: A retrospective
study
Version: 3 Date: 28 Oct 2023
Reviewer's report:
I am very pleased to have had the opportunity to review this manuscript. This study investigated
the usefulness and safety of tacrolimus in elderly patients with ulcerative colitis. The study of
tacrolimus in elderly patients is a novel and interesting study. However, this manuscript may
require the following revisions.
Major
Introduction
#The fact that tacrolimus was shown to be useful in treating ulcerative colitis in a large-scale
clinical trial should also be mentioned in the introduction section.
Materials and Methods
#May score, which is a colonoscopy score, is confused with Mayo score, which includes partial
Mayo and Mayo endoscopic subscore. The endoscopic score should be indicated as the Mayo
endoscopic subscore.
#In TAC treatment of ulcerative colitis, a high trough is generally achieved, and then a transition
is made to a low trough. In what range was the target trough value of the TAC set?
#Was the target trough achieved in all registered patients?
Results
#It would be good to have a visual representation of the registered patients and those that were
subsequently followed. Can you show me the study flow chart?
#The remission rates for one month of TAC initiation are as stated, but what about the response
rate?
#Please indicate the p-value for the rate of change in GFR for each period in young and older
patients in Fig. 1.
-Hyperkalemia is often a clinical problem in the treatment of ulcerative colitis with tacrolimus.
Did this study not consider hyperkalemia as an adverse event?
Discussion
#In this study, TAC administration was continued based on the ECCO guidelines. Japanese
regulations indicate that the treatment period is 3 months, but are there any other Japanese papers
that consider its administration for more than 3 months?
Minor
- Not all abbreviations were explained in each table. Please add them to the table.
- The first letter of each item in adverse effects in Table 2 should be capitalized.
- The phrase "time to reach TAC trough" should be changed to "time to reach target TAC trough".
Please review this paper.
user
Title: Efficacy and safety of tacrolimus in older adults with ulcerative colitis: A retrospective
study
Version: 3 Date: 28 Oct 2023
Reviewer's report:
I am very pleased to have had the opportunity to review this manuscript. This study investigated
the usefulness and safety of tacrolimus in elderly patients with ulcerative colitis. The study of
tacrolimus in elderly patients is a novel and interesting study. However, this manuscript may
require the following revisions.
Major
Introduction
#The fact that tacrolimus was shown to be useful in treating ulcerative colitis in a large-scale
clinical trial should also be mentioned in the introduction section.
Materials and Methods
#May score, which is a colonoscopy score, is confused with Mayo score, which includes partial
Mayo and Mayo endoscopic subscore. The endoscopic score should be indicated as the Mayo
endoscopic subscore.
#In TAC treatment of ulcerative colitis, a high trough is generally achieved, and then a transition
is made to a low trough. In what range was the target trough value of the TAC set?
#Was the target trough achieved in all registered patients?
Results
#It would be good to have a visual representation of the registered patients and those that were
subsequently followed. Can you show me the study flow chart?
#The remission rates for one month of TAC initiation are as stated, but what about the response
rate?
#Please indicate the p-value for the rate of change in GFR for each period in young and older
patients in Fig. 1.
-Hyperkalemia is often a clinical problem in the treatment of ulcerative colitis with tacrolimus.
Did this study not consider hyperkalemia as an adverse event?
Discussion
#In this study, TAC administration was continued based on the ECCO guidelines. Japanese
regulations indicate that the treatment period is 3 months, but are there any other Japanese papers
that consider its administration for more than 3 months?
Minor
- Not all abbreviations were explained in each table. Please add them to the table.
- The first letter of each item in adverse effects in Table 2 should be capitalized.
- The phrase "time to reach TAC trough" should be changed to "time to reach target TAC trough".
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