Title: The efficacy of CT-P13, a biosimilar of infliximab, in inflammatory bowel diseases: A
systematic review and meta-analysis
Version: 0 Date: 03 Jul 2024
Reviewer:  Mukesh Ranjan
Reviewer's report:
I congratulate the authors for their effort in gathering recent evidence for biosimilar and
originator molecules. Though the findings are similar to previous studies, the current study is
commendable as it has also looked at the mucosal healing rates in UC. But the study mostly
relies on the results of observational studies as the number of RCTs are very few. However, it
is a nice study. There are certain suggestions that need to be addressed.
• Abstract: conclusion “CT-P13 is effective in the short and long term”- The result of the abstract
does not have data on follow up or mean duration of remission. So, the efficacy in long term
does not get supported.
• Introduction: “Another meta-analysis conducted after two years reported the same result.”
Please provide a reference for this statement.
• Methods: The authors are requested to provide the criteria they assumed for clinical response,
clinical remission in various studies. It is possible that not all the studies have uniform
definitions. In this regard, it becomes important to provide a definition considered for these
outcomes (clinical remission and response). In fact, these definitions might be a good tool to
include or exclude studies.
• Results: “The 26 included clinical trials studies were classified according to whether or not
patients underwent switching of the therapeutic agent.”- I think this is a mistake. The number
included is 29.
• Results: Did the RCTs look at treatment naïve and transitioned groups separately?
Title: The efficacy of CT-P13, a biosimilar of infliximab, in inflammatory bowel diseases: A
systematic review and meta-analysis
Version: 0 Date: 03 Jul 2024
Reviewer:  Mukesh Ranjan
Reviewer's report:
I congratulate the authors for their effort in gathering recent evidence for biosimilar and
originator molecules. Though the findings are similar to previous studies, the current study is
commendable as it has also looked at the mucosal healing rates in UC. But the study mostly
relies on the results of observational studies as the number of RCTs are very few. However, it
is a nice study. There are certain suggestions that need to be addressed.
• Abstract: conclusion “CT-P13 is effective in the short and long term”- The result of the abstract
does not have data on follow up or mean duration of remission. So, the efficacy in long term
does not get supported.
• Introduction: “Another meta-analysis conducted after two years reported the same result.”
Please provide a reference for this statement.
• Methods: The authors are requested to provide the criteria they assumed for clinical response,
clinical remission in various studies. It is possible that not all the studies have uniform
definitions. In this regard, it becomes important to provide a definition considered for these
outcomes (clinical remission and response). In fact, these definitions might be a good tool to
include or exclude studies.
• Results: “The 26 included clinical trials studies were classified according to whether or not
patients underwent switching of the therapeutic agent.”- I think this is a mistake. The number
included is 29.
• Results: Did the RCTs look at treatment naïve and transitioned groups separately?
Please review this paper.
user
Title: The efficacy of CT-P13, a biosimilar of infliximab, in inflammatory bowel diseases: A
systematic review and meta-analysis
Version: 0 Date: 03 Jul 2024
Reviewer:  Mukesh Ranjan
Reviewer's report:
I congratulate the authors for their effort in gathering recent evidence for biosimilar and
originator molecules. Though the findings are similar to previous studies, the current study is
commendable as it has also looked at the mucosal healing rates in UC. But the study mostly
relies on the results of observational studies as the number of RCTs are very few. However, it
is a nice study. There are certain suggestions that need to be addressed.
• Abstract: conclusion “CT-P13 is effective in the short and long term”- The result of the abstract
does not have data on follow up or mean duration of remission. So, the efficacy in long term
does not get supported.
• Introduction: “Another meta-analysis conducted after two years reported the same result.”
Please provide a reference for this statement.
• Methods: The authors are requested to provide the criteria they assumed for clinical response,
clinical remission in various studies. It is possible that not all the studies have uniform
definitions. In this regard, it becomes important to provide a definition considered for these
outcomes (clinical remission and response). In fact, these definitions might be a good tool to
include or exclude studies.
• Results: “The 26 included clinical trials studies were classified according to whether or not
patients underwent switching of the therapeutic agent.”- I think this is a mistake. The number
included is 29.
• Results: Did the RCTs look at treatment naïve and transitioned groups separately?
assistant