Title: Safety and effectiveness of tofacitinib in Korean adult patients with ulcerative colitis:
post-marketing surveillance study
Version: 1 Date: 05 Apr 2024
Reviewer's report:
This article is very valuable because it examines the efficacy and safety of tofacitinib for
ulcerative colitis in a prospective one-year observation of patients treated with tofacitinib.
Please consider the following
1) Regarding the patient disposition of the study in Fig. 1
What is the reason for excluding three patients who were treated with Tofa for less than 8 W?
Are cases of discontinuation due to lack of therapeutic effect included?
Similarly, 41 cases were excluded for a duration of less than 52 W. What was the reason for this?
2) Do you know the overall treatment retention rate of the patients, and if so, How about the
Kaplan-Meier curve?
3) About the patient demographic and baseline characteristics in Table 1
In the previous UC treatment you mention biologics, do you know how many biologics patients
have used?
The treatment effect is divided into bio naïve and experienced, but the information on
experienced should be described in detail.
Immnosuppressants are used in 70 cases, but thiopurine is used in 39 cases. What other drugs
have been used?
4) Safety
What is set as the Hb level or lower for anemia?
5) I am very surprised to see 0% occurrence of HZ.
Authors mention vaccination, but do authors know what the incidence of varicella itself was?
6) AEs in Table 2
I think ulcerative colitis is better than Colitis ulcerative.
Title: Safety and effectiveness of tofacitinib in Korean adult patients with ulcerative colitis:
post-marketing surveillance study
Version: 1 Date: 05 Apr 2024
Reviewer's report:
This article is very valuable because it examines the efficacy and safety of tofacitinib for
ulcerative colitis in a prospective one-year observation of patients treated with tofacitinib.
Please consider the following
1) Regarding the patient disposition of the study in Fig. 1
What is the reason for excluding three patients who were treated with Tofa for less than 8 W?
Are cases of discontinuation due to lack of therapeutic effect included?
Similarly, 41 cases were excluded for a duration of less than 52 W. What was the reason for this?
2) Do you know the overall treatment retention rate of the patients, and if so, How about the
Kaplan-Meier curve?
3) About the patient demographic and baseline characteristics in Table 1
In the previous UC treatment you mention biologics, do you know how many biologics patients
have used?
The treatment effect is divided into bio naïve and experienced, but the information on
experienced should be described in detail.
Immnosuppressants are used in 70 cases, but thiopurine is used in 39 cases. What other drugs
have been used?
4) Safety
What is set as the Hb level or lower for anemia?
5) I am very surprised to see 0% occurrence of HZ.
Authors mention vaccination, but do authors know what the incidence of varicella itself was?
6) AEs in Table 2
I think ulcerative colitis is better than Colitis ulcerative.
Please review this paper.
user
Title: Safety and effectiveness of tofacitinib in Korean adult patients with ulcerative colitis:
post-marketing surveillance study
Version: 1 Date: 05 Apr 2024
Reviewer's report:
This article is very valuable because it examines the efficacy and safety of tofacitinib for
ulcerative colitis in a prospective one-year observation of patients treated with tofacitinib.
Please consider the following
1) Regarding the patient disposition of the study in Fig. 1
What is the reason for excluding three patients who were treated with Tofa for less than 8 W?
Are cases of discontinuation due to lack of therapeutic effect included?
Similarly, 41 cases were excluded for a duration of less than 52 W. What was the reason for this?
2) Do you know the overall treatment retention rate of the patients, and if so, How about the
Kaplan-Meier curve?
3) About the patient demographic and baseline characteristics in Table 1
In the previous UC treatment you mention biologics, do you know how many biologics patients
have used?
The treatment effect is divided into bio naïve and experienced, but the information on
experienced should be described in detail.
Immnosuppressants are used in 70 cases, but thiopurine is used in 39 cases. What other drugs
have been used?
4) Safety
What is set as the Hb level or lower for anemia?
5) I am very surprised to see 0% occurrence of HZ.
Authors mention vaccination, but do authors know what the incidence of varicella itself was?
6) AEs in Table 2
I think ulcerative colitis is better than Colitis ulcerative.
assistant