Title: Early assessment of treatment response in primary biliary cholangitis: key to timely
management
Version: 3 Date: 17 Jun 2025
Reviewer's report:
"PEER REVIEWER ASSESSMENTS:
OBJECTIVE - Full research articles: is there a clear objective that addresses one or several
testable research questions? (Brief or other article types: is there a clear objective?)
No - there are minor issues
DESIGN - Is the current approach (including controls and analysis protocols) appropriate for
the objective?
No - there are minor issues
EXECUTION - Are the experiments and analyses performed with sufficient technical rigor to
allow confidence in the results?
No - there are minor issues
STATISTICS - Is the use of statistics in the manuscript appropriate?
Not sure - I am not able to assess the statistics in this study
INTERPRETATION - Is the current interpretation/discussion of the results reasonable and not
overstated?
No - there are minor issues
OVERALL MANUSCRIPT POTENTIAL - Has the author addressed your concerns sufficiently
for you to now recommend the work as a technically sound contribution? If not, can further
revisions be made to make the work technically sound?
Probably - with minor revisions
PEER REVIEWER COMMENTS:
GENERAL COMMENTS: I appreciate the effort done by the authors. This study that examined
predictive factors for complete biochemical response (CBR) in primary biliary cholangitis (PBC)
patients treated with ursodeoxycholic acid (UDCA) bring additional data to the field. The main
finding is that 45% of responders to UDCA therapy according to Toronto criteria at month 6
will achieve CBR at last check-up
To reiterate , the authors used an unique endpoint in their study.
The endpoint as formulated in the rebuttal is different than formulated in the manuscript
Rebuttal  “CBR after 12 months of treatment at last check-up” (suggesting that UDCA must
have been given for 12 months)
Manuscript “Primary outcome was defined as the proportion of patients that achieved CBR,
defined as normal bilirubine and normal ALP levels, at last check-up”
In the manuscript itself there are a number of different definitions of the primary outcome
“Primary outcome was the achievement of CBR at the end of follow-up “ or
“complete biochemical response at the last check-up”
1. The readers of BMC Gastroenterology deserve clarity. Please provide clarification , which
definition is correct? Then adjust the definition to one (1) primary outcome measure
2. In the original peer review report I asked for a key reference that supports the choice of
the author for their primary endpoint. I failed to identify that from the revised version, and the
argumentation from the rebuttal is “consultation with an experienced statistician” . That is the
choice of the authors, but I want to see some reasoning here. I like the concept and the original
thinking , but please help the reader with an explanation, if a reference is absent
REQUESTED REVISIONS:
There are a number of major / minor adjustments that the authors may want consider that are
listed below
3. The issue with the many tables and figures is that they take away the focus of the main
finding of the study. Some of the table are essential  (baseline) but others do not add much to
the understanding of the data and can be summarized in the text.
4. I thank the authors to modify the first paragraph of the discussion
5. Thank you for explaining how you dealt with use of first line and second line therapy, and I
apologize that I have missed that from the manuscript
ADDITIONAL REQUESTS/SUGGESTIONS:
The authors added a line to the introduction and changed the 1st paragraph of the introduction.
In particular the last change facilitates the understanding of the paper"
Title: Early assessment of treatment response in primary biliary cholangitis: key to timely
management
Version: 3 Date: 17 Jun 2025
Reviewer's report:
"PEER REVIEWER ASSESSMENTS:
OBJECTIVE - Full research articles: is there a clear objective that addresses one or several
testable research questions? (Brief or other article types: is there a clear objective?)
No - there are minor issues
DESIGN - Is the current approach (including controls and analysis protocols) appropriate for
the objective?
No - there are minor issues
EXECUTION - Are the experiments and analyses performed with sufficient technical rigor to
allow confidence in the results?
No - there are minor issues
STATISTICS - Is the use of statistics in the manuscript appropriate?
Not sure - I am not able to assess the statistics in this study
INTERPRETATION - Is the current interpretation/discussion of the results reasonable and not
overstated?
No - there are minor issues
OVERALL MANUSCRIPT POTENTIAL - Has the author addressed your concerns sufficiently
for you to now recommend the work as a technically sound contribution? If not, can further
revisions be made to make the work technically sound?
Probably - with minor revisions
PEER REVIEWER COMMENTS:
GENERAL COMMENTS: I appreciate the effort done by the authors. This study that examined
predictive factors for complete biochemical response (CBR) in primary biliary cholangitis (PBC)
patients treated with ursodeoxycholic acid (UDCA) bring additional data to the field. The main
finding is that 45% of responders to UDCA therapy according to Toronto criteria at month 6
will achieve CBR at last check-up
To reiterate , the authors used an unique endpoint in their study.
The endpoint as formulated in the rebuttal is different than formulated in the manuscript
Rebuttal  “CBR after 12 months of treatment at last check-up” (suggesting that UDCA must
have been given for 12 months)
Manuscript “Primary outcome was defined as the proportion of patients that achieved CBR,
defined as normal bilirubine and normal ALP levels, at last check-up”
In the manuscript itself there are a number of different definitions of the primary outcome
“Primary outcome was the achievement of CBR at the end of follow-up “ or
“complete biochemical response at the last check-up”
1. The readers of BMC Gastroenterology deserve clarity. Please provide clarification , which
definition is correct? Then adjust the definition to one (1) primary outcome measure
2. In the original peer review report I asked for a key reference that supports the choice of
the author for their primary endpoint. I failed to identify that from the revised version, and the
argumentation from the rebuttal is “consultation with an experienced statistician” . That is the
choice of the authors, but I want to see some reasoning here. I like the concept and the original
thinking , but please help the reader with an explanation, if a reference is absent
REQUESTED REVISIONS:
There are a number of major / minor adjustments that the authors may want consider that are
listed below
3. The issue with the many tables and figures is that they take away the focus of the main
finding of the study. Some of the table are essential  (baseline) but others do not add much to
the understanding of the data and can be summarized in the text.
4. I thank the authors to modify the first paragraph of the discussion
5. Thank you for explaining how you dealt with use of first line and second line therapy, and I
apologize that I have missed that from the manuscript
ADDITIONAL REQUESTS/SUGGESTIONS:
The authors added a line to the introduction and changed the 1st paragraph of the introduction.
In particular the last change facilitates the understanding of the paper"
Please review this paper.
user
Title: Early assessment of treatment response in primary biliary cholangitis: key to timely
management
Version: 3 Date: 17 Jun 2025
Reviewer's report:
"PEER REVIEWER ASSESSMENTS:
OBJECTIVE - Full research articles: is there a clear objective that addresses one or several
testable research questions? (Brief or other article types: is there a clear objective?)
No - there are minor issues
DESIGN - Is the current approach (including controls and analysis protocols) appropriate for
the objective?
No - there are minor issues
EXECUTION - Are the experiments and analyses performed with sufficient technical rigor to
allow confidence in the results?
No - there are minor issues
STATISTICS - Is the use of statistics in the manuscript appropriate?
Not sure - I am not able to assess the statistics in this study
INTERPRETATION - Is the current interpretation/discussion of the results reasonable and not
overstated?
No - there are minor issues
OVERALL MANUSCRIPT POTENTIAL - Has the author addressed your concerns sufficiently
for you to now recommend the work as a technically sound contribution? If not, can further
revisions be made to make the work technically sound?
Probably - with minor revisions
PEER REVIEWER COMMENTS:
GENERAL COMMENTS: I appreciate the effort done by the authors. This study that examined
predictive factors for complete biochemical response (CBR) in primary biliary cholangitis (PBC)
patients treated with ursodeoxycholic acid (UDCA) bring additional data to the field. The main
finding is that 45% of responders to UDCA therapy according to Toronto criteria at month 6
will achieve CBR at last check-up
To reiterate , the authors used an unique endpoint in their study.
The endpoint as formulated in the rebuttal is different than formulated in the manuscript
Rebuttal  “CBR after 12 months of treatment at last check-up” (suggesting that UDCA must
have been given for 12 months)
Manuscript “Primary outcome was defined as the proportion of patients that achieved CBR,
defined as normal bilirubine and normal ALP levels, at last check-up”
In the manuscript itself there are a number of different definitions of the primary outcome
“Primary outcome was the achievement of CBR at the end of follow-up “ or
“complete biochemical response at the last check-up”
1. The readers of BMC Gastroenterology deserve clarity. Please provide clarification , which
definition is correct? Then adjust the definition to one (1) primary outcome measure
2. In the original peer review report I asked for a key reference that supports the choice of
the author for their primary endpoint. I failed to identify that from the revised version, and the
argumentation from the rebuttal is “consultation with an experienced statistician” . That is the
choice of the authors, but I want to see some reasoning here. I like the concept and the original
thinking , but please help the reader with an explanation, if a reference is absent
REQUESTED REVISIONS:
There are a number of major / minor adjustments that the authors may want consider that are
listed below
3. The issue with the many tables and figures is that they take away the focus of the main
finding of the study. Some of the table are essential  (baseline) but others do not add much to
the understanding of the data and can be summarized in the text.
4. I thank the authors to modify the first paragraph of the discussion
5. Thank you for explaining how you dealt with use of first line and second line therapy, and I
apologize that I have missed that from the manuscript
ADDITIONAL REQUESTS/SUGGESTIONS:
The authors added a line to the introduction and changed the 1st paragraph of the introduction.
In particular the last change facilitates the understanding of the paper"
assistant