Title: Efficacy and Safety of Mirikizumab for Ulcerative Colitis: A Systematic Review and
Meta-analysis of Randomized Controlled
Version: 2 Date: 03 Dec 2024
Reviewer's report:
The authors conducted a systematic review and meta-analysis to summarize the available data
on the efficacy and safety of mirikizumab for ulcerative colitis.
Below are some remarks for the authors to consider:
Title:
The use of "Effectiveness" is incorrect and should be replaced with "Efficacy." Additionally,
the phrase "patients responses" is unclear. The title could be streamlined to:
"Efficacy and safety of mirikizumab for ulcerative colitis: A systematic review and meta-
analysis of randomized controlled trials."
Methods:
- It is essential to include a section that clearly defines all outcomes (e.g., clinical remission,
endoscopic remission) as assessed across all trials. Consistency in defining these outcomes will
enhance the transparency and comparability of the findings.
- The clustering of all adverse events (AEs) together reduces the specificity of the results. It
would be far more informative to provide sub-analyses for major categories of AEs, such as
infections and malignancies.
Discussion:
The limitations of the study should explicitly address the absence of subgroup analyses based
on prior exposure to advanced therapies (e.g., biologic-naive vs. biologic-experienced patients).
This could provide valuable insights into the differential efficacy and safety of mirikizumab in
these populations.
Title: Efficacy and Safety of Mirikizumab for Ulcerative Colitis: A Systematic Review and
Meta-analysis of Randomized Controlled
Version: 2 Date: 03 Dec 2024
Reviewer's report:
The authors conducted a systematic review and meta-analysis to summarize the available data
on the efficacy and safety of mirikizumab for ulcerative colitis.
Below are some remarks for the authors to consider:
Title:
The use of "Effectiveness" is incorrect and should be replaced with "Efficacy." Additionally,
the phrase "patients responses" is unclear. The title could be streamlined to:
"Efficacy and safety of mirikizumab for ulcerative colitis: A systematic review and meta-
analysis of randomized controlled trials."
Methods:
- It is essential to include a section that clearly defines all outcomes (e.g., clinical remission,
endoscopic remission) as assessed across all trials. Consistency in defining these outcomes will
enhance the transparency and comparability of the findings.
- The clustering of all adverse events (AEs) together reduces the specificity of the results. It
would be far more informative to provide sub-analyses for major categories of AEs, such as
infections and malignancies.
Discussion:
The limitations of the study should explicitly address the absence of subgroup analyses based
on prior exposure to advanced therapies (e.g., biologic-naive vs. biologic-experienced patients).
This could provide valuable insights into the differential efficacy and safety of mirikizumab in
these populations.
Please review this paper.
user
Title: Efficacy and Safety of Mirikizumab for Ulcerative Colitis: A Systematic Review and
Meta-analysis of Randomized Controlled
Version: 2 Date: 03 Dec 2024
Reviewer's report:
The authors conducted a systematic review and meta-analysis to summarize the available data
on the efficacy and safety of mirikizumab for ulcerative colitis.
Below are some remarks for the authors to consider:
Title:
The use of "Effectiveness" is incorrect and should be replaced with "Efficacy." Additionally,
the phrase "patients responses" is unclear. The title could be streamlined to:
"Efficacy and safety of mirikizumab for ulcerative colitis: A systematic review and meta-
analysis of randomized controlled trials."
Methods:
- It is essential to include a section that clearly defines all outcomes (e.g., clinical remission,
endoscopic remission) as assessed across all trials. Consistency in defining these outcomes will
enhance the transparency and comparability of the findings.
- The clustering of all adverse events (AEs) together reduces the specificity of the results. It
would be far more informative to provide sub-analyses for major categories of AEs, such as
infections and malignancies.
Discussion:
The limitations of the study should explicitly address the absence of subgroup analyses based
on prior exposure to advanced therapies (e.g., biologic-naive vs. biologic-experienced patients).
This could provide valuable insights into the differential efficacy and safety of mirikizumab in
these populations.
assistant