Title: Efficacy and safety of vedolizumab in elderly and younger patients with moderate-to-
severe ulcerative colitis: A retrospective real-world study in China
Version: 1 Date: 09 Apr 2025
Reviewer's report:
Dear Zhang et al.,
Thank you for this interesting and overall well-written manuscript. Although no evaluation has
been done specifically in Chinese elderly patients, efficacy and safety have been studied in
elderly populations in general. Nonetheless, the study remains relevant given the size of the
Chinese population. Below are my comments:
1. The study carries a selection bias, as physicians generally tend to avoid prescribing VDZ to
non–bio-naive patients from the outset.
2. The manuscript does not explain why only patients who had received three infusions prior to
inclusion were selected. Several other studies include patients starting from the first infusion.
3. The data collection method is not described. Was data manually extracted from patient charts?
4.It is not stated whether a univariable or multivariable regression model was used, nor how the
model was selected.
5. Information is missing on the completeness of data at each timepoint, which is particularly
relevant given the high standard deviations reported at each visit.
6. A discussion is lacking on why the follow-up duration was significantly shorter in elderly
patients compared to younger ones.
7. The authors state that concomitant corticosteroid use was associated with an increased risk of
adverse events. However, the reported OR was 0.05, which would normally indicate a protective
effect. How was this analysis performed?
8. It is stated that hemoglobin increased markedly, but the change was from 7.0 mmol/L to 7.2
mmol/L. While this may be statistically significant, is it clinically relevant?
9. I suggest that the authors perform a Cox regression analysis, given that a Kaplan-Meier plot
was presented.
Minor comments:
Some terminology used is not standard in IBD research. For example, "total colitis" is
more commonly referred to as "extensive colitis" or "pancolitis." The term "comprehensive
assessment by the physician" is unclear—does this refer to a global assessment?
Consider rephrasing the sentence on line 233.
On line 285, it is stated that only one patient had a lung infection, while line 294 states two
patients. Please clarify.
I was unable to open any of the TIFF files, despite trying several programs and converting them
to PNG.
Title: Efficacy and safety of vedolizumab in elderly and younger patients with moderate-to-
severe ulcerative colitis: A retrospective real-world study in China
Version: 1 Date: 09 Apr 2025
Reviewer's report:
Dear Zhang et al.,
Thank you for this interesting and overall well-written manuscript. Although no evaluation has
been done specifically in Chinese elderly patients, efficacy and safety have been studied in
elderly populations in general. Nonetheless, the study remains relevant given the size of the
Chinese population. Below are my comments:
1. The study carries a selection bias, as physicians generally tend to avoid prescribing VDZ to
non–bio-naive patients from the outset.
2. The manuscript does not explain why only patients who had received three infusions prior to
inclusion were selected. Several other studies include patients starting from the first infusion.
3. The data collection method is not described. Was data manually extracted from patient charts?
4.It is not stated whether a univariable or multivariable regression model was used, nor how the
model was selected.
5. Information is missing on the completeness of data at each timepoint, which is particularly
relevant given the high standard deviations reported at each visit.
6. A discussion is lacking on why the follow-up duration was significantly shorter in elderly
patients compared to younger ones.
7. The authors state that concomitant corticosteroid use was associated with an increased risk of
adverse events. However, the reported OR was 0.05, which would normally indicate a protective
effect. How was this analysis performed?
8. It is stated that hemoglobin increased markedly, but the change was from 7.0 mmol/L to 7.2
mmol/L. While this may be statistically significant, is it clinically relevant?
9. I suggest that the authors perform a Cox regression analysis, given that a Kaplan-Meier plot
was presented.
Minor comments:
Some terminology used is not standard in IBD research. For example, "total colitis" is
more commonly referred to as "extensive colitis" or "pancolitis." The term "comprehensive
assessment by the physician" is unclear—does this refer to a global assessment?
Consider rephrasing the sentence on line 233.
On line 285, it is stated that only one patient had a lung infection, while line 294 states two
patients. Please clarify.
I was unable to open any of the TIFF files, despite trying several programs and converting them
to PNG.
Please review this paper.
user
Title: Efficacy and safety of vedolizumab in elderly and younger patients with moderate-to-
severe ulcerative colitis: A retrospective real-world study in China
Version: 1 Date: 09 Apr 2025
Reviewer's report:
Dear Zhang et al.,
Thank you for this interesting and overall well-written manuscript. Although no evaluation has
been done specifically in Chinese elderly patients, efficacy and safety have been studied in
elderly populations in general. Nonetheless, the study remains relevant given the size of the
Chinese population. Below are my comments:
1. The study carries a selection bias, as physicians generally tend to avoid prescribing VDZ to
non–bio-naive patients from the outset.
2. The manuscript does not explain why only patients who had received three infusions prior to
inclusion were selected. Several other studies include patients starting from the first infusion.
3. The data collection method is not described. Was data manually extracted from patient charts?
4.It is not stated whether a univariable or multivariable regression model was used, nor how the
model was selected.
5. Information is missing on the completeness of data at each timepoint, which is particularly
relevant given the high standard deviations reported at each visit.
6. A discussion is lacking on why the follow-up duration was significantly shorter in elderly
patients compared to younger ones.
7. The authors state that concomitant corticosteroid use was associated with an increased risk of
adverse events. However, the reported OR was 0.05, which would normally indicate a protective
effect. How was this analysis performed?
8. It is stated that hemoglobin increased markedly, but the change was from 7.0 mmol/L to 7.2
mmol/L. While this may be statistically significant, is it clinically relevant?
9. I suggest that the authors perform a Cox regression analysis, given that a Kaplan-Meier plot
was presented.
Minor comments:
Some terminology used is not standard in IBD research. For example, "total colitis" is
more commonly referred to as "extensive colitis" or "pancolitis." The term "comprehensive
assessment by the physician" is unclear—does this refer to a global assessment?
Consider rephrasing the sentence on line 233.
On line 285, it is stated that only one patient had a lung infection, while line 294 states two
patients. Please clarify.
I was unable to open any of the TIFF files, despite trying several programs and converting them
to PNG.
assistant