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: 24 Apr 2025
Reviewer's report:
We consider this to be an interesting study comparing the efficacy and safety of vedolizumab
in elderly and young patients with moderate to severe ulcerative colitis, with follow-up of 6,
14, 22, 38, 46 and 54 weeks, and is the first study conducted in China. Overall, the study is
well written, but at some points it becomes a bit confusing, especially in the presentation of the
results. Some considerations are necessary.
Among the group of elderly patients (> 60 years), it would be interesting to differentiate between
patients diagnosed after 60 years of age and those who have aged with IBD, as these are diseases
with different behaviors. It would be interesting to include this information in the article.
Methodology
1 - What are the reasons why Crohn's Disease was not included as an exclusion criterion? The
study only included patients with Ulcerative Colitis. -
2 - In the data collection section, it is necessary to better clarify the type of disease (ulcerative
colitis or Crohn's disease?). Is this information really necessary since the study only includes
patients with ulcerative colitis? The same applies to the presence or absence of perianal
disease.When referring to history of bowel-related surgery, would it be colectomy? This needs
to be made clearer, since it may refer to the presence of cases of Crohn's disease.
3 - Current literature recommends Mayo endoscopic score 0 as endoscopic remission and Mayo
1 as endoscopic response. I suggest reviewing this criterion adopted by the authors.
4 - I think that knowing the mechanism of action of Vedolizumab, different times of use (patients
received at least three VDZ infusions and others one year ago) may be a limiting factor in the
different comparisons proposed. Make it clearer whether the proportions of patients in the two
groups are the same.
5 - Clarify the reason for optimizing the VDZ dose every 6 weeks, since the optimization in the
package insert is 4/4 weeks! What is the reason for this off-label scheme?
Results
1 - Table 1: Patient characteristics. Presence of perianal disease. Are these really cases of
ulcerative colitis?
2 - Please clarify which remission would be referred to after clinical response when evaluating
clinical efficacy at week 6.
3 - Endoscopic and laboratory assessments: “In the elderly group, HGB and Alb levels at week
14 were significantly increased (P < 0.05), while the CRP levels were reduced relative to the
baseline values (P < 0.05)”. “In the younger group, HGB and Alb levels at week 14 significantly
increased (P < 0.05), while the PLT counts, CRP levels, ESR, NLR, and PLR were reduced
compared with the baseline values (P < 0.05). Please clarify whether albumin levels at week 14
were increased or decreased in elderly patients compared to younger patients.
4 -When presenting the results, we missed the occurrence or not of deaths in the different groups.
Could the authors inform whether this outcome was evaluated? Was there a difference between
the groups? It would also be interesting to distinguish frail elderly individuals in the recruited
sample, since biological age is much more impactful than chronological age itself.
Discussion:
1 - It would be interesting for the authors to address some aspects related to the frailty of the
elderly together with changes in the immune response (immunosenescence) that could influence
the response to advanced therapy in this population specifically.
2 - Explain reasons why elderly patients with Pancolitis had higher rates of adverse events.
3 - It is strange that prior exposure to anti-TNF agents only impacts the response in the elderly
group of patients and not in younger patients. Please clarify this result. Was the percentage of
comorbidity in the elderly non-responders higher?
4 - We suggest adding different times of use of Vedolizumab as a limiting factor of the study.
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: 24 Apr 2025
Reviewer's report:
We consider this to be an interesting study comparing the efficacy and safety of vedolizumab
in elderly and young patients with moderate to severe ulcerative colitis, with follow-up of 6,
14, 22, 38, 46 and 54 weeks, and is the first study conducted in China. Overall, the study is
well written, but at some points it becomes a bit confusing, especially in the presentation of the
results. Some considerations are necessary.
Among the group of elderly patients (> 60 years), it would be interesting to differentiate between
patients diagnosed after 60 years of age and those who have aged with IBD, as these are diseases
with different behaviors. It would be interesting to include this information in the article.
Methodology
1 - What are the reasons why Crohn's Disease was not included as an exclusion criterion? The
study only included patients with Ulcerative Colitis. -
2 - In the data collection section, it is necessary to better clarify the type of disease (ulcerative
colitis or Crohn's disease?). Is this information really necessary since the study only includes
patients with ulcerative colitis? The same applies to the presence or absence of perianal
disease.When referring to history of bowel-related surgery, would it be colectomy? This needs
to be made clearer, since it may refer to the presence of cases of Crohn's disease.
3 - Current literature recommends Mayo endoscopic score 0 as endoscopic remission and Mayo
1 as endoscopic response. I suggest reviewing this criterion adopted by the authors.
4 - I think that knowing the mechanism of action of Vedolizumab, different times of use (patients
received at least three VDZ infusions and others one year ago) may be a limiting factor in the
different comparisons proposed. Make it clearer whether the proportions of patients in the two
groups are the same.
5 - Clarify the reason for optimizing the VDZ dose every 6 weeks, since the optimization in the
package insert is 4/4 weeks! What is the reason for this off-label scheme?
Results
1 - Table 1: Patient characteristics. Presence of perianal disease. Are these really cases of
ulcerative colitis?
2 - Please clarify which remission would be referred to after clinical response when evaluating
clinical efficacy at week 6.
3 - Endoscopic and laboratory assessments: “In the elderly group, HGB and Alb levels at week
14 were significantly increased (P < 0.05), while the CRP levels were reduced relative to the
baseline values (P < 0.05)”. “In the younger group, HGB and Alb levels at week 14 significantly
increased (P < 0.05), while the PLT counts, CRP levels, ESR, NLR, and PLR were reduced
compared with the baseline values (P < 0.05). Please clarify whether albumin levels at week 14
were increased or decreased in elderly patients compared to younger patients.
4 -When presenting the results, we missed the occurrence or not of deaths in the different groups.
Could the authors inform whether this outcome was evaluated? Was there a difference between
the groups? It would also be interesting to distinguish frail elderly individuals in the recruited
sample, since biological age is much more impactful than chronological age itself.
Discussion:
1 - It would be interesting for the authors to address some aspects related to the frailty of the
elderly together with changes in the immune response (immunosenescence) that could influence
the response to advanced therapy in this population specifically.
2 - Explain reasons why elderly patients with Pancolitis had higher rates of adverse events.
3 - It is strange that prior exposure to anti-TNF agents only impacts the response in the elderly
group of patients and not in younger patients. Please clarify this result. Was the percentage of
comorbidity in the elderly non-responders higher?
4 - We suggest adding different times of use of Vedolizumab as a limiting factor of the study.
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: 24 Apr 2025
Reviewer's report:
We consider this to be an interesting study comparing the efficacy and safety of vedolizumab
in elderly and young patients with moderate to severe ulcerative colitis, with follow-up of 6,
14, 22, 38, 46 and 54 weeks, and is the first study conducted in China. Overall, the study is
well written, but at some points it becomes a bit confusing, especially in the presentation of the
results. Some considerations are necessary.
Among the group of elderly patients (> 60 years), it would be interesting to differentiate between
patients diagnosed after 60 years of age and those who have aged with IBD, as these are diseases
with different behaviors. It would be interesting to include this information in the article.
Methodology
1 - What are the reasons why Crohn's Disease was not included as an exclusion criterion? The
study only included patients with Ulcerative Colitis. -
2 - In the data collection section, it is necessary to better clarify the type of disease (ulcerative
colitis or Crohn's disease?). Is this information really necessary since the study only includes
patients with ulcerative colitis? The same applies to the presence or absence of perianal
disease.When referring to history of bowel-related surgery, would it be colectomy? This needs
to be made clearer, since it may refer to the presence of cases of Crohn's disease.
3 - Current literature recommends Mayo endoscopic score 0 as endoscopic remission and Mayo
1 as endoscopic response. I suggest reviewing this criterion adopted by the authors.
4 - I think that knowing the mechanism of action of Vedolizumab, different times of use (patients
received at least three VDZ infusions and others one year ago) may be a limiting factor in the
different comparisons proposed. Make it clearer whether the proportions of patients in the two
groups are the same.
5 - Clarify the reason for optimizing the VDZ dose every 6 weeks, since the optimization in the
package insert is 4/4 weeks! What is the reason for this off-label scheme?
Results
1 - Table 1: Patient characteristics. Presence of perianal disease. Are these really cases of
ulcerative colitis?
2 - Please clarify which remission would be referred to after clinical response when evaluating
clinical efficacy at week 6.
3 - Endoscopic and laboratory assessments: “In the elderly group, HGB and Alb levels at week
14 were significantly increased (P < 0.05), while the CRP levels were reduced relative to the
baseline values (P < 0.05)”. “In the younger group, HGB and Alb levels at week 14 significantly
increased (P < 0.05), while the PLT counts, CRP levels, ESR, NLR, and PLR were reduced
compared with the baseline values (P < 0.05). Please clarify whether albumin levels at week 14
were increased or decreased in elderly patients compared to younger patients.
4 -When presenting the results, we missed the occurrence or not of deaths in the different groups.
Could the authors inform whether this outcome was evaluated? Was there a difference between
the groups? It would also be interesting to distinguish frail elderly individuals in the recruited
sample, since biological age is much more impactful than chronological age itself.
Discussion:
1 - It would be interesting for the authors to address some aspects related to the frailty of the
elderly together with changes in the immune response (immunosenescence) that could influence
the response to advanced therapy in this population specifically.
2 - Explain reasons why elderly patients with Pancolitis had higher rates of adverse events.
3 - It is strange that prior exposure to anti-TNF agents only impacts the response in the elderly
group of patients and not in younger patients. Please clarify this result. Was the percentage of
comorbidity in the elderly non-responders higher?
4 - We suggest adding different times of use of Vedolizumab as a limiting factor of the study.
assistant