Reviewer's report
Title:Therapeutic Effect of Intensive Granulocyte and Monocyte Adsorption
Apheresis Combined with Thiopurines for Steroid- and Biologics-Naive Japanese
Patients with Early-Diagnosed Crohn's Disease
Version:1Date:26 April 2014
Reviewer: Piero Vernia
Reviewer's report:
The article is new and interesting, and reports for the first time in my knowledge
data on intensive GMA plus thiopurines in “early” Crohn’s disease. Results are
really interesting and prompt, as suggested by the authors, further controlled
studies.
Some issues , however, require more details.
Minor essential revisions:
- Patients should be better defined according to disease behavior ( inflammatory,
structuring, perforating CD) and presence / absence of periananal disease.
- I realize that the number of enrolled patients is small, but does this subgrouping
have effects on the response to therapy ?
- Thiopurine dosage requires more details. “Dose adjusted to < 5000 WBC” is not
enough. What was the mean daily dose? Which was the reduction in those
patients experiencing side-effects?
- “Pts responding to GMAA kept receiving thiopurines for 52 wks”.. And those
who did not?
- Mucosal heakling. It is unclear the number of patients to whom data refer both
in the results section and in Fig 2. I should anticipate that this was not evaluated
in patients with small bowel disease and in those ( how many?) in which the
terminal ileum was not evaluated .
Discretionary revisions:
- A new and interesting observation is that clinical remission was attained in 77%
of pts at week 6, and in 81-86% at week 13/26. This suggests that the further
advantage over GMA offered by thiopurines is relatively small. In my opinion this
requires some comments.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Needs some language corrections before being
published
Statistical review: No, the manuscript does not need to be seen by a statistician.
Declaration of competing interests:
In the last 5 years I have been lecturing for the Otsuka company in Europe.
Reviewer's report
Title:Therapeutic Effect of Intensive Granulocyte and Monocyte Adsorption
Apheresis Combined with Thiopurines for Steroid- and Biologics-Naive Japanese
Patients with Early-Diagnosed Crohn's Disease
Version:1Date:26 April 2014
Reviewer: Piero Vernia
Reviewer's report:
The article is new and interesting, and reports for the first time in my knowledge
data on intensive GMA plus thiopurines in “early” Crohn’s disease. Results are
really interesting and prompt, as suggested by the authors, further controlled
studies.
Some issues , however, require more details.
Minor essential revisions:
- Patients should be better defined according to disease behavior ( inflammatory,
structuring, perforating CD) and presence / absence of periananal disease.
- I realize that the number of enrolled patients is small, but does this subgrouping
have effects on the response to therapy ?
- Thiopurine dosage requires more details. “Dose adjusted to < 5000 WBC” is not
enough. What was the mean daily dose? Which was the reduction in those
patients experiencing side-effects?
- “Pts responding to GMAA kept receiving thiopurines for 52 wks”.. And those
who did not?
- Mucosal heakling. It is unclear the number of patients to whom data refer both
in the results section and in Fig 2. I should anticipate that this was not evaluated
in patients with small bowel disease and in those ( how many?) in which the
terminal ileum was not evaluated .
Discretionary revisions:
- A new and interesting observation is that clinical remission was attained in 77%
of pts at week 6, and in 81-86% at week 13/26. This suggests that the further
advantage over GMA offered by thiopurines is relatively small. In my opinion this
requires some comments.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Needs some language corrections before being
published
Statistical review: No, the manuscript does not need to be seen by a statistician.
Declaration of competing interests:
In the last 5 years I have been lecturing for the Otsuka company in Europe.
Please review this paper.
user
Reviewer's report
Title:Therapeutic Effect of Intensive Granulocyte and Monocyte Adsorption
Apheresis Combined with Thiopurines for Steroid- and Biologics-Naive Japanese
Patients with Early-Diagnosed Crohn's Disease
Version:1Date:26 April 2014
Reviewer: Piero Vernia
Reviewer's report:
The article is new and interesting, and reports for the first time in my knowledge
data on intensive GMA plus thiopurines in “early” Crohn’s disease. Results are
really interesting and prompt, as suggested by the authors, further controlled
studies.
Some issues , however, require more details.
Minor essential revisions:
- Patients should be better defined according to disease behavior ( inflammatory,
structuring, perforating CD) and presence / absence of periananal disease.
- I realize that the number of enrolled patients is small, but does this subgrouping
have effects on the response to therapy ?
- Thiopurine dosage requires more details. “Dose adjusted to < 5000 WBC” is not
enough. What was the mean daily dose? Which was the reduction in those
patients experiencing side-effects?
- “Pts responding to GMAA kept receiving thiopurines for 52 wks”.. And those
who did not?
- Mucosal heakling. It is unclear the number of patients to whom data refer both
in the results section and in Fig 2. I should anticipate that this was not evaluated
in patients with small bowel disease and in those ( how many?) in which the
terminal ileum was not evaluated .
Discretionary revisions:
- A new and interesting observation is that clinical remission was attained in 77%
of pts at week 6, and in 81-86% at week 13/26. This suggests that the further
advantage over GMA offered by thiopurines is relatively small. In my opinion this
requires some comments.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Needs some language corrections before being
published
Statistical review: No, the manuscript does not need to be seen by a statistician.
Declaration of competing interests:
In the last 5 years I have been lecturing for the Otsuka company in Europe.
assistant