Title: Long-term effectiveness and safety of ustekinumab in bio-naïve and bio-experienced anti-
tumor necrosis factor patients with Crohn’s disease: a real-world multicenter Brazilian study
Version: 4 Date: 13 Mar 2022
Reviewer's report:
Rogério Serafim Parra and col. have analyzed and answered adequatelly all my questions,
comments and suggestions. In order to enhance your results I leave some comments after my
second review.
Summary:
- There is not necessary to repeat the number of bionaive and bioexposed at the end of “No
significant differences in either clinical or biological remission were noted”.
Results:
- Population: Mean HBI must be accompanied with standard deviation instead range. Is is
preferred to express with median and range. Use exact number, without decimals (for example
mean HBI 11 (not 10.5). C Reactive protein and calprotectin can be accompanied with decimals,
but they must also been expressed with median value (not mean) and range.
- Mean age can be expressed as 40 years old, with standard deviation, not range.
- Probably my comment has been misunderstood or I expresed wrong. Univariate analysis
(described in Supplementary Table) must include all variables that have been analyzed in
each period (not only variables with p< 0.2). Multivariate analysis has to be done with all
variables with p< 0.05 obtained in univariate analysis. For example, multivariate analysis must
be performed only with perianal disease and combotherapy for clinical remission at week 8 (for
example).
- Safety profile is well described but in real world studies worsening of the disease or surgical
requierement are not considered as adverse events either severe adverse events. This is same
for pregnancy. I suggest this should be adjusted because this safety data seems to be higher
than other series (you comment some in discussion). I would consider to recalculate this data
(SAE). In safety definitions you can add that worse disease/surgical requirement that force to
ustekinumab withdrawal will not be considered as severe adverse events.
Title: Long-term effectiveness and safety of ustekinumab in bio-naïve and bio-experienced anti-
tumor necrosis factor patients with Crohn’s disease: a real-world multicenter Brazilian study
Version: 4 Date: 13 Mar 2022
Reviewer's report:
Rogério Serafim Parra and col. have analyzed and answered adequatelly all my questions,
comments and suggestions. In order to enhance your results I leave some comments after my
second review.
Summary:
- There is not necessary to repeat the number of bionaive and bioexposed at the end of “No
significant differences in either clinical or biological remission were noted”.
Results:
- Population: Mean HBI must be accompanied with standard deviation instead range. Is is
preferred to express with median and range. Use exact number, without decimals (for example
mean HBI 11 (not 10.5). C Reactive protein and calprotectin can be accompanied with decimals,
but they must also been expressed with median value (not mean) and range.
- Mean age can be expressed as 40 years old, with standard deviation, not range.
- Probably my comment has been misunderstood or I expresed wrong. Univariate analysis
(described in Supplementary Table) must include all variables that have been analyzed in
each period (not only variables with p< 0.2). Multivariate analysis has to be done with all
variables with p< 0.05 obtained in univariate analysis. For example, multivariate analysis must
be performed only with perianal disease and combotherapy for clinical remission at week 8 (for
example).
- Safety profile is well described but in real world studies worsening of the disease or surgical
requierement are not considered as adverse events either severe adverse events. This is same
for pregnancy. I suggest this should be adjusted because this safety data seems to be higher
than other series (you comment some in discussion). I would consider to recalculate this data
(SAE). In safety definitions you can add that worse disease/surgical requirement that force to
ustekinumab withdrawal will not be considered as severe adverse events.
Please review this paper.
user
Title: Long-term effectiveness and safety of ustekinumab in bio-naïve and bio-experienced anti-
tumor necrosis factor patients with Crohn’s disease: a real-world multicenter Brazilian study
Version: 4 Date: 13 Mar 2022
Reviewer's report:
Rogério Serafim Parra and col. have analyzed and answered adequatelly all my questions,
comments and suggestions. In order to enhance your results I leave some comments after my
second review.
Summary:
- There is not necessary to repeat the number of bionaive and bioexposed at the end of “No
significant differences in either clinical or biological remission were noted”.
Results:
- Population: Mean HBI must be accompanied with standard deviation instead range. Is is
preferred to express with median and range. Use exact number, without decimals (for example
mean HBI 11 (not 10.5). C Reactive protein and calprotectin can be accompanied with decimals,
but they must also been expressed with median value (not mean) and range.
- Mean age can be expressed as 40 years old, with standard deviation, not range.
- Probably my comment has been misunderstood or I expresed wrong. Univariate analysis
(described in Supplementary Table) must include all variables that have been analyzed in
each period (not only variables with p< 0.2). Multivariate analysis has to be done with all
variables with p< 0.05 obtained in univariate analysis. For example, multivariate analysis must
be performed only with perianal disease and combotherapy for clinical remission at week 8 (for
example).
- Safety profile is well described but in real world studies worsening of the disease or surgical
requierement are not considered as adverse events either severe adverse events. This is same
for pregnancy. I suggest this should be adjusted because this safety data seems to be higher
than other series (you comment some in discussion). I would consider to recalculate this data
(SAE). In safety definitions you can add that worse disease/surgical requirement that force to
ustekinumab withdrawal will not be considered as severe adverse events.
assistant