Title: Long-Term Safety of Brazikumab in the Open-Label Period of a Randomized Phase 2a
Study of Patients With Crohn’s Disease
Version: 2 Date: 07 Jul 2023
Reviewer's report:
Overall, manuscript is well written and presents the data well.
Below are some comments for consideration of the editor and authors.
1) Abstract/Results: Regarding "TEAEs led to brazikumab discontinuation in 12 (11.5%)
patients."
Please specify also % discontinued due to lack of response  to brazikumab (14.4%), which was
the highest % among total (45.2%).
2) Statistical Analysis: Regarding " Per protocol, patients with a clinically meaningful increase
in corticosteroid dose were also considered nonresponders."
What was the increase in CS dose, and was it predefined or based on clinical judgment?
3)Baseline Demographics and Clinical Characteristics:
Specify mean CDAI at baseline
4)TEAEs in the Open-Label Period: Regarding "The total numbers of SAEs were similar
between treatment groups (12 in the placebo/brazikumab group and 16 in the brazikumab/
brazikumab group). "
Can you specify the source in Table 1?
Also recommend to specify TEAEs of # grade 3 severity. (# of subjects in each group).
5) Abstract/Results: Regarding using "Serious TEAEs" did the authors mean SAEs? Please
clarify. Also "There were 5 serious TEAEs of infection, none of which were opportunistic. "
seems to be SAEs according to text.
6) Efficacy: Specify group order and add Table/Figure if possible .
Thank you for the opportunity to review.
Title: Long-Term Safety of Brazikumab in the Open-Label Period of a Randomized Phase 2a
Study of Patients With Crohn’s Disease
Version: 2 Date: 07 Jul 2023
Reviewer's report:
Overall, manuscript is well written and presents the data well.
Below are some comments for consideration of the editor and authors.
1) Abstract/Results: Regarding "TEAEs led to brazikumab discontinuation in 12 (11.5%)
patients."
Please specify also % discontinued due to lack of response  to brazikumab (14.4%), which was
the highest % among total (45.2%).
2) Statistical Analysis: Regarding " Per protocol, patients with a clinically meaningful increase
in corticosteroid dose were also considered nonresponders."
What was the increase in CS dose, and was it predefined or based on clinical judgment?
3)Baseline Demographics and Clinical Characteristics:
Specify mean CDAI at baseline
4)TEAEs in the Open-Label Period: Regarding "The total numbers of SAEs were similar
between treatment groups (12 in the placebo/brazikumab group and 16 in the brazikumab/
brazikumab group). "
Can you specify the source in Table 1?
Also recommend to specify TEAEs of # grade 3 severity. (# of subjects in each group).
5) Abstract/Results: Regarding using "Serious TEAEs" did the authors mean SAEs? Please
clarify. Also "There were 5 serious TEAEs of infection, none of which were opportunistic. "
seems to be SAEs according to text.
6) Efficacy: Specify group order and add Table/Figure if possible .
Thank you for the opportunity to review.
Please review this paper.
user
Title: Long-Term Safety of Brazikumab in the Open-Label Period of a Randomized Phase 2a
Study of Patients With Crohn’s Disease
Version: 2 Date: 07 Jul 2023
Reviewer's report:
Overall, manuscript is well written and presents the data well.
Below are some comments for consideration of the editor and authors.
1) Abstract/Results: Regarding "TEAEs led to brazikumab discontinuation in 12 (11.5%)
patients."
Please specify also % discontinued due to lack of response  to brazikumab (14.4%), which was
the highest % among total (45.2%).
2) Statistical Analysis: Regarding " Per protocol, patients with a clinically meaningful increase
in corticosteroid dose were also considered nonresponders."
What was the increase in CS dose, and was it predefined or based on clinical judgment?
3)Baseline Demographics and Clinical Characteristics:
Specify mean CDAI at baseline
4)TEAEs in the Open-Label Period: Regarding "The total numbers of SAEs were similar
between treatment groups (12 in the placebo/brazikumab group and 16 in the brazikumab/
brazikumab group). "
Can you specify the source in Table 1?
Also recommend to specify TEAEs of # grade 3 severity. (# of subjects in each group).
5) Abstract/Results: Regarding using "Serious TEAEs" did the authors mean SAEs? Please
clarify. Also "There were 5 serious TEAEs of infection, none of which were opportunistic. "
seems to be SAEs according to text.
6) Efficacy: Specify group order and add Table/Figure if possible .
Thank you for the opportunity to review.
assistant