Title: Evaluation of adverse clinical outcomes in patients with inflammatory bowel disease
receiving different sequences of first- and second-line biologic treatments: findings from
ROTARY
Version: 1 Date: 06 Apr 2024
Reviewer's report:
Thank you for the opportunity to review this manuscript once more. The manuscript
addresses the increasingly complex landscape of Inflammatory Bowel Disease (IBD) treatment,
highlighting the critical issue of therapeutic sequencing amidst a growing arsenal of options
with novel mechanisms of action. The authors' focus on safety outcomes of these sequencing
strategies is not only original but also highly pertinent, potentially guiding physicians in making
more informed clinical decisions.
However, certain limitations within the manuscript significantly undermine the clarity and
interpretability of its results and conclusions. Primarily, the analysis presents a critical oversight
by relying solely on the absolute number of adverse events, without considering the duration
of treatment (e.g., incidence per patient-years). This lack of normalization complicates the
interpretation of the data, as it does not account for variations in exposure length across different
therapeutic options. Furthermore, the manuscript does not adjust for disease severity or activity,
factors often gauged by the use of steroids, number of hospital admissions, and other clinical
indicators. Such normalization is crucial for ensuring that the comparative safety profiles of the
therapeutic options are not misleadingly represented, offering a more accurate and contextually
relevant insight into their relative risks and benefits.
These gaps in the analytical approach detract significantly from the manuscript's ability to
provide a robust and reliable guide for clinical decision-making. Addressing these issues would
not only bolster the credibility of the findings but also enhance their practical value to the medical
community.
Title: Evaluation of adverse clinical outcomes in patients with inflammatory bowel disease
receiving different sequences of first- and second-line biologic treatments: findings from
ROTARY
Version: 1 Date: 06 Apr 2024
Reviewer's report:
Thank you for the opportunity to review this manuscript once more. The manuscript
addresses the increasingly complex landscape of Inflammatory Bowel Disease (IBD) treatment,
highlighting the critical issue of therapeutic sequencing amidst a growing arsenal of options
with novel mechanisms of action. The authors' focus on safety outcomes of these sequencing
strategies is not only original but also highly pertinent, potentially guiding physicians in making
more informed clinical decisions.
However, certain limitations within the manuscript significantly undermine the clarity and
interpretability of its results and conclusions. Primarily, the analysis presents a critical oversight
by relying solely on the absolute number of adverse events, without considering the duration
of treatment (e.g., incidence per patient-years). This lack of normalization complicates the
interpretation of the data, as it does not account for variations in exposure length across different
therapeutic options. Furthermore, the manuscript does not adjust for disease severity or activity,
factors often gauged by the use of steroids, number of hospital admissions, and other clinical
indicators. Such normalization is crucial for ensuring that the comparative safety profiles of the
therapeutic options are not misleadingly represented, offering a more accurate and contextually
relevant insight into their relative risks and benefits.
These gaps in the analytical approach detract significantly from the manuscript's ability to
provide a robust and reliable guide for clinical decision-making. Addressing these issues would
not only bolster the credibility of the findings but also enhance their practical value to the medical
community.
Please review this paper.
user
Title: Evaluation of adverse clinical outcomes in patients with inflammatory bowel disease
receiving different sequences of first- and second-line biologic treatments: findings from
ROTARY
Version: 1 Date: 06 Apr 2024
Reviewer's report:
Thank you for the opportunity to review this manuscript once more. The manuscript
addresses the increasingly complex landscape of Inflammatory Bowel Disease (IBD) treatment,
highlighting the critical issue of therapeutic sequencing amidst a growing arsenal of options
with novel mechanisms of action. The authors' focus on safety outcomes of these sequencing
strategies is not only original but also highly pertinent, potentially guiding physicians in making
more informed clinical decisions.
However, certain limitations within the manuscript significantly undermine the clarity and
interpretability of its results and conclusions. Primarily, the analysis presents a critical oversight
by relying solely on the absolute number of adverse events, without considering the duration
of treatment (e.g., incidence per patient-years). This lack of normalization complicates the
interpretation of the data, as it does not account for variations in exposure length across different
therapeutic options. Furthermore, the manuscript does not adjust for disease severity or activity,
factors often gauged by the use of steroids, number of hospital admissions, and other clinical
indicators. Such normalization is crucial for ensuring that the comparative safety profiles of the
therapeutic options are not misleadingly represented, offering a more accurate and contextually
relevant insight into their relative risks and benefits.
These gaps in the analytical approach detract significantly from the manuscript's ability to
provide a robust and reliable guide for clinical decision-making. Addressing these issues would
not only bolster the credibility of the findings but also enhance their practical value to the medical
community.
assistant