Title: Effectiveness and safety of vedolizumab induction with or without budesonide in patients
with moderately to severely active Crohn’s disease in Europe: a retrospective observational
study
Version: 1 Date: 01 Jul 2023
Reviewer's report:
This study describes a retrospective study that focuses on a very practical topic about the best
approach during the induction with vedolizumab. In particular, the authors have evaluated if
budesonide can improve clinical remission rates. I have some comments that I would like to
share with the authors:
Revisión BMC
- The study is underpowered to find differences according to the sample size calculation, and
this is not included as a comment or limitation in the Discussion.
- In 13% of patients disease was classified as L2 (colonic), so the use of budesonide here can
be controversial.
- In patients starting VDZ therapy in this cohort, only 7-11% of patients had prior exposure
to systemic steroids, while 83-89% had been exposed to anti-TNF. This results do not clearly
match, as this subset of patients in clinical practice would be expected to receive steroids in
more than 11% of them in the past.
- Introduction: 5ASA are not recommended as a medical treatment for CD, e.g. ECCO
guidelines.
- Were any of these patients treated with VDZ for perianal disease as the main indication?
- Can the authors explain the reasoning behind using these scores and approach in the definition
of clinical remission?
- BUD dosing regimens are not described. This is  important because different doses and duration
were used, and they also describe off-label use of >9 mg/day in some cases.
- Patients receiving VDZ+BUD may be expected to be those with L1 disease and probably also
with more severe disease. How was this aspect adjusted in the study?
- Results: “In a multivariate analysis, the latter was the only nominal difference between patients
prescribed VDZ+BUD compared with VDZ alone (OR=0.28; 95% CI: 0.09, 0.91; p=0.0954).”
The results shown in the confidence interval and p-value do not match. According to the CI,
there should be statistically significant differences, but p-value is >0.05.
- According to the funding by pharma, it should be also declared the role of this company in
the study.
- References:
o Ref 1 does not seem to be the most appropriate
o Ref 3 from 2011 does not reflect “current” treatment
o Ref 5 are not the last ECCO guidelines
Title: Effectiveness and safety of vedolizumab induction with or without budesonide in patients
with moderately to severely active Crohn’s disease in Europe: a retrospective observational
study
Version: 1 Date: 01 Jul 2023
Reviewer's report:
This study describes a retrospective study that focuses on a very practical topic about the best
approach during the induction with vedolizumab. In particular, the authors have evaluated if
budesonide can improve clinical remission rates. I have some comments that I would like to
share with the authors:
Revisión BMC
- The study is underpowered to find differences according to the sample size calculation, and
this is not included as a comment or limitation in the Discussion.
- In 13% of patients disease was classified as L2 (colonic), so the use of budesonide here can
be controversial.
- In patients starting VDZ therapy in this cohort, only 7-11% of patients had prior exposure
to systemic steroids, while 83-89% had been exposed to anti-TNF. This results do not clearly
match, as this subset of patients in clinical practice would be expected to receive steroids in
more than 11% of them in the past.
- Introduction: 5ASA are not recommended as a medical treatment for CD, e.g. ECCO
guidelines.
- Were any of these patients treated with VDZ for perianal disease as the main indication?
- Can the authors explain the reasoning behind using these scores and approach in the definition
of clinical remission?
- BUD dosing regimens are not described. This is  important because different doses and duration
were used, and they also describe off-label use of >9 mg/day in some cases.
- Patients receiving VDZ+BUD may be expected to be those with L1 disease and probably also
with more severe disease. How was this aspect adjusted in the study?
- Results: “In a multivariate analysis, the latter was the only nominal difference between patients
prescribed VDZ+BUD compared with VDZ alone (OR=0.28; 95% CI: 0.09, 0.91; p=0.0954).”
The results shown in the confidence interval and p-value do not match. According to the CI,
there should be statistically significant differences, but p-value is >0.05.
- According to the funding by pharma, it should be also declared the role of this company in
the study.
- References:
o Ref 1 does not seem to be the most appropriate
o Ref 3 from 2011 does not reflect “current” treatment
o Ref 5 are not the last ECCO guidelines
Please review this paper.
user
Title: Effectiveness and safety of vedolizumab induction with or without budesonide in patients
with moderately to severely active Crohn’s disease in Europe: a retrospective observational
study
Version: 1 Date: 01 Jul 2023
Reviewer's report:
This study describes a retrospective study that focuses on a very practical topic about the best
approach during the induction with vedolizumab. In particular, the authors have evaluated if
budesonide can improve clinical remission rates. I have some comments that I would like to
share with the authors:
Revisión BMC
- The study is underpowered to find differences according to the sample size calculation, and
this is not included as a comment or limitation in the Discussion.
- In 13% of patients disease was classified as L2 (colonic), so the use of budesonide here can
be controversial.
- In patients starting VDZ therapy in this cohort, only 7-11% of patients had prior exposure
to systemic steroids, while 83-89% had been exposed to anti-TNF. This results do not clearly
match, as this subset of patients in clinical practice would be expected to receive steroids in
more than 11% of them in the past.
- Introduction: 5ASA are not recommended as a medical treatment for CD, e.g. ECCO
guidelines.
- Were any of these patients treated with VDZ for perianal disease as the main indication?
- Can the authors explain the reasoning behind using these scores and approach in the definition
of clinical remission?
- BUD dosing regimens are not described. This is  important because different doses and duration
were used, and they also describe off-label use of >9 mg/day in some cases.
- Patients receiving VDZ+BUD may be expected to be those with L1 disease and probably also
with more severe disease. How was this aspect adjusted in the study?
- Results: “In a multivariate analysis, the latter was the only nominal difference between patients
prescribed VDZ+BUD compared with VDZ alone (OR=0.28; 95% CI: 0.09, 0.91; p=0.0954).”
The results shown in the confidence interval and p-value do not match. According to the CI,
there should be statistically significant differences, but p-value is >0.05.
- According to the funding by pharma, it should be also declared the role of this company in
the study.
- References:
o Ref 1 does not seem to be the most appropriate
o Ref 3 from 2011 does not reflect “current” treatment
o Ref 5 are not the last ECCO guidelines
assistant