Title: Tofacitinib as a maintenance therapy in patients with ulcerative colitis stratified by
OCTAVE Sustain baseline Mayo endoscopic subscore
Version: 2 Date: 14 Jul 2022
Reviewer's report:
Thanks for this interesting and relevant analysis with potential impact in the use of TOFA in
clinical practice.
My comments to the authors:
- The results are based on the baseline Mayo endoscopisc subscore 0 or 1. As they mention, there
is still no clear agreement in which specific cut-off should be use as remission, but actually,
regardless this fact, the truth is that there can be a bias in the interpretation of Mayo 0 and 1
because of subjective interpretation. Therefore it would be more interesting to base the results on
an histological score. Could the authors comment on this? is there any histological data available
in this sub-analysis?
- The authors focus the results in the baseline Mayo 0-1, but in real life have many patients a
clear clinical response (even remission ) and endoscopic response after induction but still some
activity, like erosions (so still "some" Mayo endoscopic score 2). It would be really interesting
in the clinical practice to know whether this justifies an intensification or extended induction of
TOFA 10mg. Is there any data around this sub-group  from the OCAVE program ?
- Rates of remission at w52 in patients with baseline Mayo 1 are higher in the group of TOFA
10mg than in the group of TOFA 5mg. Can the auhtors comment on this? Would this justify an
intensification of treatment in patients with Mayo 1 under 5mg?
- The AE ratio (p14): any clarification of why is clearly higher in the group of Mayo 1 baseline
from TOFA 5mg as compared to Mayo 1baseline from TOFA 10mg group? the authors justify
this because of higher inflammatory burden in the Mayo 1 group but this is still not explaining
why is higher in the TOFA 5mg. Could the authors comment on this?
- It would be interesting to have data on still longer term FU (at 2y)
- At long term we would also need data on de rate of patients that successfully de-escalate from
10mg to 5mg , depending on the baseline Mayo as well.
Title: Tofacitinib as a maintenance therapy in patients with ulcerative colitis stratified by
OCTAVE Sustain baseline Mayo endoscopic subscore
Version: 2 Date: 14 Jul 2022
Reviewer's report:
Thanks for this interesting and relevant analysis with potential impact in the use of TOFA in
clinical practice.
My comments to the authors:
- The results are based on the baseline Mayo endoscopisc subscore 0 or 1. As they mention, there
is still no clear agreement in which specific cut-off should be use as remission, but actually,
regardless this fact, the truth is that there can be a bias in the interpretation of Mayo 0 and 1
because of subjective interpretation. Therefore it would be more interesting to base the results on
an histological score. Could the authors comment on this? is there any histological data available
in this sub-analysis?
- The authors focus the results in the baseline Mayo 0-1, but in real life have many patients a
clear clinical response (even remission ) and endoscopic response after induction but still some
activity, like erosions (so still "some" Mayo endoscopic score 2). It would be really interesting
in the clinical practice to know whether this justifies an intensification or extended induction of
TOFA 10mg. Is there any data around this sub-group  from the OCAVE program ?
- Rates of remission at w52 in patients with baseline Mayo 1 are higher in the group of TOFA
10mg than in the group of TOFA 5mg. Can the auhtors comment on this? Would this justify an
intensification of treatment in patients with Mayo 1 under 5mg?
- The AE ratio (p14): any clarification of why is clearly higher in the group of Mayo 1 baseline
from TOFA 5mg as compared to Mayo 1baseline from TOFA 10mg group? the authors justify
this because of higher inflammatory burden in the Mayo 1 group but this is still not explaining
why is higher in the TOFA 5mg. Could the authors comment on this?
- It would be interesting to have data on still longer term FU (at 2y)
- At long term we would also need data on de rate of patients that successfully de-escalate from
10mg to 5mg , depending on the baseline Mayo as well.
Please review this paper.
user
Title: Tofacitinib as a maintenance therapy in patients with ulcerative colitis stratified by
OCTAVE Sustain baseline Mayo endoscopic subscore
Version: 2 Date: 14 Jul 2022
Reviewer's report:
Thanks for this interesting and relevant analysis with potential impact in the use of TOFA in
clinical practice.
My comments to the authors:
- The results are based on the baseline Mayo endoscopisc subscore 0 or 1. As they mention, there
is still no clear agreement in which specific cut-off should be use as remission, but actually,
regardless this fact, the truth is that there can be a bias in the interpretation of Mayo 0 and 1
because of subjective interpretation. Therefore it would be more interesting to base the results on
an histological score. Could the authors comment on this? is there any histological data available
in this sub-analysis?
- The authors focus the results in the baseline Mayo 0-1, but in real life have many patients a
clear clinical response (even remission ) and endoscopic response after induction but still some
activity, like erosions (so still "some" Mayo endoscopic score 2). It would be really interesting
in the clinical practice to know whether this justifies an intensification or extended induction of
TOFA 10mg. Is there any data around this sub-group  from the OCAVE program ?
- Rates of remission at w52 in patients with baseline Mayo 1 are higher in the group of TOFA
10mg than in the group of TOFA 5mg. Can the auhtors comment on this? Would this justify an
intensification of treatment in patients with Mayo 1 under 5mg?
- The AE ratio (p14): any clarification of why is clearly higher in the group of Mayo 1 baseline
from TOFA 5mg as compared to Mayo 1baseline from TOFA 10mg group? the authors justify
this because of higher inflammatory burden in the Mayo 1 group but this is still not explaining
why is higher in the TOFA 5mg. Could the authors comment on this?
- It would be interesting to have data on still longer term FU (at 2y)
- At long term we would also need data on de rate of patients that successfully de-escalate from
10mg to 5mg , depending on the baseline Mayo as well.
assistant