Title: Effectiveness and Safety of Tofacitinib in the Management of Ulcerative Colitis: A
Brazilian Observational Multicentric Study.
Version: 1 Date: 16 Dec 2024
Reviewer:  Anwar Ashraf Abouelnasr
Reviewer's report:
Dear Authors, please address the following points below
-The introduction could expand a little more on the specific mechanisms of action of JAK
inhibitors like tofacitinib to better explain why this class of drugs is relevant to UC treatment.
-While it is clear that tofacitinib has been studied in international real-world settings, a brief
mention of the limitations or gaps in those studies could provide a more balanced view of the
existing literature before emphasizing the importance of this current study.
-While the study design is solid, it would benefit from a clearer description of how potential
confounders (e.g., comorbidities, prior treatments) were controlled for in the analysis. Although
there is mention of baseline characteristics, a more detailed explanation of how these factors
were adjusted for in the statistical analysis would strengthen the methodology.
-The exclusion of patients with severe disease or those who had undergone colectomy may limit
the generalizability of the findings to the most severe UC cases, as these patients are often the
ones who would benefit most from advanced therapies like tofacitinib.
-While the authors mention limitations such as the retrospective nature of the study and potential
selection biases, there is room for further discussion on how these issues might specifically
impact the interpretation of the results. For instance, more details on how differences in treatment
protocols across centers (e.g., steroid reduction strategies) might have influenced outcomes
would provide a fuller understanding of the study’s limitations.
-The authors report no significant difference in clinical remission rates between biologic-naïve
and biologic-exposed patients in the short term (12–16 weeks and 6 months), but they do find
a significant difference at 1 year. This finding is important but could be further explained. For
example, why might biologic-naïve patients experience more sustained remission at 1 year, and
what does this suggest about the role of tofacitinib in these populations?
Title: Effectiveness and Safety of Tofacitinib in the Management of Ulcerative Colitis: A
Brazilian Observational Multicentric Study.
Version: 1 Date: 16 Dec 2024
Reviewer:  Anwar Ashraf Abouelnasr
Reviewer's report:
Dear Authors, please address the following points below
-The introduction could expand a little more on the specific mechanisms of action of JAK
inhibitors like tofacitinib to better explain why this class of drugs is relevant to UC treatment.
-While it is clear that tofacitinib has been studied in international real-world settings, a brief
mention of the limitations or gaps in those studies could provide a more balanced view of the
existing literature before emphasizing the importance of this current study.
-While the study design is solid, it would benefit from a clearer description of how potential
confounders (e.g., comorbidities, prior treatments) were controlled for in the analysis. Although
there is mention of baseline characteristics, a more detailed explanation of how these factors
were adjusted for in the statistical analysis would strengthen the methodology.
-The exclusion of patients with severe disease or those who had undergone colectomy may limit
the generalizability of the findings to the most severe UC cases, as these patients are often the
ones who would benefit most from advanced therapies like tofacitinib.
-While the authors mention limitations such as the retrospective nature of the study and potential
selection biases, there is room for further discussion on how these issues might specifically
impact the interpretation of the results. For instance, more details on how differences in treatment
protocols across centers (e.g., steroid reduction strategies) might have influenced outcomes
would provide a fuller understanding of the study’s limitations.
-The authors report no significant difference in clinical remission rates between biologic-naïve
and biologic-exposed patients in the short term (12–16 weeks and 6 months), but they do find
a significant difference at 1 year. This finding is important but could be further explained. For
example, why might biologic-naïve patients experience more sustained remission at 1 year, and
what does this suggest about the role of tofacitinib in these populations?
Please review this paper.
user
Title: Effectiveness and Safety of Tofacitinib in the Management of Ulcerative Colitis: A
Brazilian Observational Multicentric Study.
Version: 1 Date: 16 Dec 2024
Reviewer:  Anwar Ashraf Abouelnasr
Reviewer's report:
Dear Authors, please address the following points below
-The introduction could expand a little more on the specific mechanisms of action of JAK
inhibitors like tofacitinib to better explain why this class of drugs is relevant to UC treatment.
-While it is clear that tofacitinib has been studied in international real-world settings, a brief
mention of the limitations or gaps in those studies could provide a more balanced view of the
existing literature before emphasizing the importance of this current study.
-While the study design is solid, it would benefit from a clearer description of how potential
confounders (e.g., comorbidities, prior treatments) were controlled for in the analysis. Although
there is mention of baseline characteristics, a more detailed explanation of how these factors
were adjusted for in the statistical analysis would strengthen the methodology.
-The exclusion of patients with severe disease or those who had undergone colectomy may limit
the generalizability of the findings to the most severe UC cases, as these patients are often the
ones who would benefit most from advanced therapies like tofacitinib.
-While the authors mention limitations such as the retrospective nature of the study and potential
selection biases, there is room for further discussion on how these issues might specifically
impact the interpretation of the results. For instance, more details on how differences in treatment
protocols across centers (e.g., steroid reduction strategies) might have influenced outcomes
would provide a fuller understanding of the study’s limitations.
-The authors report no significant difference in clinical remission rates between biologic-naïve
and biologic-exposed patients in the short term (12–16 weeks and 6 months), but they do find
a significant difference at 1 year. This finding is important but could be further explained. For
example, why might biologic-naïve patients experience more sustained remission at 1 year, and
what does this suggest about the role of tofacitinib in these populations?
assistant