Title: Real-world characteristics, treatment experiences and corticosteroid utilisation of patients
treated with tofacitinib for moderate to severe ulcerative colitis
Version: 4 Date: 08 Jan 2022
Reviewer's report:
In this paper, the authors use big data to investigate the efficacy and continuation of tofacitinib
treatment for refractory UC, mainly in the early stages of treatment.  This Real world analysis
highlights the clinical characteristics of patients with UC treated by tofacitinib, and also reveals
that it reduces the need for oral steroid therapy, even in patients who are refractory to multiple
optional therapy.  These results are considered to be clinically important facts,even in actual
UC medical care. For these reasons, this paper is judged to be suitable for publication in
BMC Gastroenterology.  However, we believe that the following points need to be added or
commented.
(1) It would be better to show the study design using this Big Data in a figure.
(2) Is it possible that the FDA alert or the timing of health approval of tofacitinib affected the
reason for the very low number of biologic-naïve in patients treated with tofacitinib?
(3) It is necessary to add the history of treatment with oral corticosteroids in the baseline period
to the demographic table of patients treated by tofacitinib and Biologics.
(4) In this study, the authors reported a decrease in the proportion of patients with UC treated
with TOF who received concomitant oral corticosteroids, comparing the index date with the 6-
month follow-up period. It would be desirable to show, if possible, whether the dose of oral
corticosteroids was also reduced for overall patients treated with tofacitinib.
(5) In this paper, the authors show that for UC patients treated with tofacitinib, the comorbidity
of extra-intestinal manifestations at 12 month baseline was 44.4%. The comorbidity of extra-
intestinal manifestations in patients treated with biologics should also be explained in the
discussion. This is because it is clinically important as one of the background factors for UC
patients treated with each drug, and may influence drug selection.
Title: Real-world characteristics, treatment experiences and corticosteroid utilisation of patients
treated with tofacitinib for moderate to severe ulcerative colitis
Version: 4 Date: 08 Jan 2022
Reviewer's report:
In this paper, the authors use big data to investigate the efficacy and continuation of tofacitinib
treatment for refractory UC, mainly in the early stages of treatment.  This Real world analysis
highlights the clinical characteristics of patients with UC treated by tofacitinib, and also reveals
that it reduces the need for oral steroid therapy, even in patients who are refractory to multiple
optional therapy.  These results are considered to be clinically important facts,even in actual
UC medical care. For these reasons, this paper is judged to be suitable for publication in
BMC Gastroenterology.  However, we believe that the following points need to be added or
commented.
(1) It would be better to show the study design using this Big Data in a figure.
(2) Is it possible that the FDA alert or the timing of health approval of tofacitinib affected the
reason for the very low number of biologic-naïve in patients treated with tofacitinib?
(3) It is necessary to add the history of treatment with oral corticosteroids in the baseline period
to the demographic table of patients treated by tofacitinib and Biologics.
(4) In this study, the authors reported a decrease in the proportion of patients with UC treated
with TOF who received concomitant oral corticosteroids, comparing the index date with the 6-
month follow-up period. It would be desirable to show, if possible, whether the dose of oral
corticosteroids was also reduced for overall patients treated with tofacitinib.
(5) In this paper, the authors show that for UC patients treated with tofacitinib, the comorbidity
of extra-intestinal manifestations at 12 month baseline was 44.4%. The comorbidity of extra-
intestinal manifestations in patients treated with biologics should also be explained in the
discussion. This is because it is clinically important as one of the background factors for UC
patients treated with each drug, and may influence drug selection.
Please review this paper.
user
Title: Real-world characteristics, treatment experiences and corticosteroid utilisation of patients
treated with tofacitinib for moderate to severe ulcerative colitis
Version: 4 Date: 08 Jan 2022
Reviewer's report:
In this paper, the authors use big data to investigate the efficacy and continuation of tofacitinib
treatment for refractory UC, mainly in the early stages of treatment.  This Real world analysis
highlights the clinical characteristics of patients with UC treated by tofacitinib, and also reveals
that it reduces the need for oral steroid therapy, even in patients who are refractory to multiple
optional therapy.  These results are considered to be clinically important facts,even in actual
UC medical care. For these reasons, this paper is judged to be suitable for publication in
BMC Gastroenterology.  However, we believe that the following points need to be added or
commented.
(1) It would be better to show the study design using this Big Data in a figure.
(2) Is it possible that the FDA alert or the timing of health approval of tofacitinib affected the
reason for the very low number of biologic-naïve in patients treated with tofacitinib?
(3) It is necessary to add the history of treatment with oral corticosteroids in the baseline period
to the demographic table of patients treated by tofacitinib and Biologics.
(4) In this study, the authors reported a decrease in the proportion of patients with UC treated
with TOF who received concomitant oral corticosteroids, comparing the index date with the 6-
month follow-up period. It would be desirable to show, if possible, whether the dose of oral
corticosteroids was also reduced for overall patients treated with tofacitinib.
(5) In this paper, the authors show that for UC patients treated with tofacitinib, the comorbidity
of extra-intestinal manifestations at 12 month baseline was 44.4%. The comorbidity of extra-
intestinal manifestations in patients treated with biologics should also be explained in the
discussion. This is because it is clinically important as one of the background factors for UC
patients treated with each drug, and may influence drug selection.
assistant