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: 0 Date: 16 Dec 2023
Reviewer's report:
This study utilizes a large clinical database to compare the incidence of adverse outcomes
between first- and second-line therapies in patients with inflammatory bowel disease. While the
study addresses a clinically significant topic, there are several critiques to be addressed.
1. A major limitation is the absence of disease activity measurement. Disease activity
significantly influences treatment choice and efficacy, making it a key confounder in the
analysis of adverse outcomes. The failure to adjust the results for disease activity challenges the
interpretability of the study's findings.
2. The inclusion period for patient treatment was between 2013 and 2020. It's noteworthy that
several advanced therapies emerged around 2020. The study should consider the potential impact
of the era of treatment on its results.
3. It is unclear why vedolizumab was not considered a second-line therapy for Crohn's disease.
4. The rationale behind the differing definitions of infection for ulcerative colitis and Crohn's
disease is not explained. For instance, Clostridioides difficile infection is a significant concern
in ulcerative colitis as well.
5. The study should specify the observation period for each drug. Moreover, given that the
observation periods might vary across drugs, the choice of using incidence rates as the primary
endpoint instead of the time to the occurrence of adverse outcomes warrants further explanation.
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: 0 Date: 16 Dec 2023
Reviewer's report:
This study utilizes a large clinical database to compare the incidence of adverse outcomes
between first- and second-line therapies in patients with inflammatory bowel disease. While the
study addresses a clinically significant topic, there are several critiques to be addressed.
1. A major limitation is the absence of disease activity measurement. Disease activity
significantly influences treatment choice and efficacy, making it a key confounder in the
analysis of adverse outcomes. The failure to adjust the results for disease activity challenges the
interpretability of the study's findings.
2. The inclusion period for patient treatment was between 2013 and 2020. It's noteworthy that
several advanced therapies emerged around 2020. The study should consider the potential impact
of the era of treatment on its results.
3. It is unclear why vedolizumab was not considered a second-line therapy for Crohn's disease.
4. The rationale behind the differing definitions of infection for ulcerative colitis and Crohn's
disease is not explained. For instance, Clostridioides difficile infection is a significant concern
in ulcerative colitis as well.
5. The study should specify the observation period for each drug. Moreover, given that the
observation periods might vary across drugs, the choice of using incidence rates as the primary
endpoint instead of the time to the occurrence of adverse outcomes warrants further explanation.
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: 0 Date: 16 Dec 2023
Reviewer's report:
This study utilizes a large clinical database to compare the incidence of adverse outcomes
between first- and second-line therapies in patients with inflammatory bowel disease. While the
study addresses a clinically significant topic, there are several critiques to be addressed.
1. A major limitation is the absence of disease activity measurement. Disease activity
significantly influences treatment choice and efficacy, making it a key confounder in the
analysis of adverse outcomes. The failure to adjust the results for disease activity challenges the
interpretability of the study's findings.
2. The inclusion period for patient treatment was between 2013 and 2020. It's noteworthy that
several advanced therapies emerged around 2020. The study should consider the potential impact
of the era of treatment on its results.
3. It is unclear why vedolizumab was not considered a second-line therapy for Crohn's disease.
4. The rationale behind the differing definitions of infection for ulcerative colitis and Crohn's
disease is not explained. For instance, Clostridioides difficile infection is a significant concern
in ulcerative colitis as well.
5. The study should specify the observation period for each drug. Moreover, given that the
observation periods might vary across drugs, the choice of using incidence rates as the primary
endpoint instead of the time to the occurrence of adverse outcomes warrants further explanation.
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