Title: Effectiveness and safety of adalimumab in patients with intestinal Behçet’s disease: a
real-world prospective observational study in South Korea
Version: 4 Date: 01 Aug 2023
Reviewer's report:
Few points that need to be addressed in the manuscript are as follows:
1. The mean disease duration is mentioned as 57.1±55 years while the mean age of the patients
is 47.5±14.8 years; these two seem not going with each other. Please check.
2. 72% the patients were taking intestinal anti-inflammatory agents at baseline. Please mention
the specific agents being taken. Also, this indicates that 72% patients were having intestinal
inflammation at baseline, most likely IBD. At baseline, a relatively high proportion of patients
were taking immunosuppressants and systemic corticosteroids.
How was it ensured that the existing comorbidity (IBD) and medication (s) not interfered with
the study findings? Or were any statistical methods adopted to handle these confounding factors?
3. During study, what were the other treatments allowed for the disease condition per se?
4. There was a high incidence of serious adverse events (26%; 13 patients; 37 events) in the study
population. The results section should also include a description of SAEs and serious adverse
reactions.
5. What was the incidence of TEAEs (treatment emergent adverse events)?
6. How was the sample size calculation performed? In the STROBE checklist, it is mentioned
at page no. 6, while there is no such description in the manuscript.
7. Please give details on who did the endoscopic and DAIBD assessment. Were any steps taken
to eliminate the subjective/ observer bias associated with these assessments?
8. Which bio-chemical method was utilised to estimate serum CRP levels?
Title: Effectiveness and safety of adalimumab in patients with intestinal Behçet’s disease: a
real-world prospective observational study in South Korea
Version: 4 Date: 01 Aug 2023
Reviewer's report:
Few points that need to be addressed in the manuscript are as follows:
1. The mean disease duration is mentioned as 57.1±55 years while the mean age of the patients
is 47.5±14.8 years; these two seem not going with each other. Please check.
2. 72% the patients were taking intestinal anti-inflammatory agents at baseline. Please mention
the specific agents being taken. Also, this indicates that 72% patients were having intestinal
inflammation at baseline, most likely IBD. At baseline, a relatively high proportion of patients
were taking immunosuppressants and systemic corticosteroids.
How was it ensured that the existing comorbidity (IBD) and medication (s) not interfered with
the study findings? Or were any statistical methods adopted to handle these confounding factors?
3. During study, what were the other treatments allowed for the disease condition per se?
4. There was a high incidence of serious adverse events (26%; 13 patients; 37 events) in the study
population. The results section should also include a description of SAEs and serious adverse
reactions.
5. What was the incidence of TEAEs (treatment emergent adverse events)?
6. How was the sample size calculation performed? In the STROBE checklist, it is mentioned
at page no. 6, while there is no such description in the manuscript.
7. Please give details on who did the endoscopic and DAIBD assessment. Were any steps taken
to eliminate the subjective/ observer bias associated with these assessments?
8. Which bio-chemical method was utilised to estimate serum CRP levels?
Please review this paper.
user
Title: Effectiveness and safety of adalimumab in patients with intestinal Behçet’s disease: a
real-world prospective observational study in South Korea
Version: 4 Date: 01 Aug 2023
Reviewer's report:
Few points that need to be addressed in the manuscript are as follows:
1. The mean disease duration is mentioned as 57.1±55 years while the mean age of the patients
is 47.5±14.8 years; these two seem not going with each other. Please check.
2. 72% the patients were taking intestinal anti-inflammatory agents at baseline. Please mention
the specific agents being taken. Also, this indicates that 72% patients were having intestinal
inflammation at baseline, most likely IBD. At baseline, a relatively high proportion of patients
were taking immunosuppressants and systemic corticosteroids.
How was it ensured that the existing comorbidity (IBD) and medication (s) not interfered with
the study findings? Or were any statistical methods adopted to handle these confounding factors?
3. During study, what were the other treatments allowed for the disease condition per se?
4. There was a high incidence of serious adverse events (26%; 13 patients; 37 events) in the study
population. The results section should also include a description of SAEs and serious adverse
reactions.
5. What was the incidence of TEAEs (treatment emergent adverse events)?
6. How was the sample size calculation performed? In the STROBE checklist, it is mentioned
at page no. 6, while there is no such description in the manuscript.
7. Please give details on who did the endoscopic and DAIBD assessment. Were any steps taken
to eliminate the subjective/ observer bias associated with these assessments?
8. Which bio-chemical method was utilised to estimate serum CRP levels?
assistant