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: 2 Date: 30 Oct 2021
Reviewer's report:
Parra et al. present an interesting clinical serie of ustekinumab real world data in a Latin
American country.
Comments:
- Summary must include: an adecuate background, some data regarding this population (number,
age, number of biological naive patients...). Numerical data between biological naive and
biofailure clinical remission (for example, % of clinical remission at 52 weeks between both
groups). Finally there are no safety data.
- Methods: include persistence UST definition.
- Results: Baseline population data must include mean HBI, number of patients evaluated with
PGA, mean CRP and calpro.
Review number of A1 and A2 patients (manuscript and table do not correlate, are they 163 A1
patients? or A2?.
Clinical remission at week 16 is an secondary aim but authors do not show this results.
Factors associated with outcomes: results seem very complex, it is recommended to simplify
this results: for example, authors can show only factors associated with some periods (week 8
and 52) and for specific variables (clinical remission, biological remission). All factors included
in multivariate analysis must be pressented, including those without p > 0.005, all variables
included in multivariate analysis had statistical significance?
Finally, are there biological response or remission data at week 52?
Tables/Figures:
- Table number 2 does not contribute to your results. Value withdraw.
- Integrate Fig 5B/C on a single KM curve.
- Perhaps is more interesting include a safety table.
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: 2 Date: 30 Oct 2021
Reviewer's report:
Parra et al. present an interesting clinical serie of ustekinumab real world data in a Latin
American country.
Comments:
- Summary must include: an adecuate background, some data regarding this population (number,
age, number of biological naive patients...). Numerical data between biological naive and
biofailure clinical remission (for example, % of clinical remission at 52 weeks between both
groups). Finally there are no safety data.
- Methods: include persistence UST definition.
- Results: Baseline population data must include mean HBI, number of patients evaluated with
PGA, mean CRP and calpro.
Review number of A1 and A2 patients (manuscript and table do not correlate, are they 163 A1
patients? or A2?.
Clinical remission at week 16 is an secondary aim but authors do not show this results.
Factors associated with outcomes: results seem very complex, it is recommended to simplify
this results: for example, authors can show only factors associated with some periods (week 8
and 52) and for specific variables (clinical remission, biological remission). All factors included
in multivariate analysis must be pressented, including those without p > 0.005, all variables
included in multivariate analysis had statistical significance?
Finally, are there biological response or remission data at week 52?
Tables/Figures:
- Table number 2 does not contribute to your results. Value withdraw.
- Integrate Fig 5B/C on a single KM curve.
- Perhaps is more interesting include a safety table.
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: 2 Date: 30 Oct 2021
Reviewer's report:
Parra et al. present an interesting clinical serie of ustekinumab real world data in a Latin
American country.
Comments:
- Summary must include: an adecuate background, some data regarding this population (number,
age, number of biological naive patients...). Numerical data between biological naive and
biofailure clinical remission (for example, % of clinical remission at 52 weeks between both
groups). Finally there are no safety data.
- Methods: include persistence UST definition.
- Results: Baseline population data must include mean HBI, number of patients evaluated with
PGA, mean CRP and calpro.
Review number of A1 and A2 patients (manuscript and table do not correlate, are they 163 A1
patients? or A2?.
Clinical remission at week 16 is an secondary aim but authors do not show this results.
Factors associated with outcomes: results seem very complex, it is recommended to simplify
this results: for example, authors can show only factors associated with some periods (week 8
and 52) and for specific variables (clinical remission, biological remission). All factors included
in multivariate analysis must be pressented, including those without p > 0.005, all variables
included in multivariate analysis had statistical significance?
Finally, are there biological response or remission data at week 52?
Tables/Figures:
- Table number 2 does not contribute to your results. Value withdraw.
- Integrate Fig 5B/C on a single KM curve.
- Perhaps is more interesting include a safety table.
assistant