Title: Predictive modeling to evaluate long-term treatment effectiveness of darvadstrocel in
patients with complex perianal fistulas in Crohn’s disease
Version: 8 Date: 15 Sep 2024
Reviewer's report:
Dear authors,
I would like to congratulate you on this nice manuscript that comprehensively outlines the used
complex methodology  to show long-term beneficial effects of DVS compared to standard of
care based on RWE from the ADMIRE-CD, INSPECT and PREFACE study.
Nonetheless, I would like to make some remarks/suggestions:
Introduction section:
-  Page 3 line 60-61: apart from infliximab other advanced medical treatment options have shown
good potential in subgroup analyses from RCT’s. Furthermore, there are currently dedicated
studies ongoing to evaluated efficacy of guselkumab (FUZION study) and ustekinumab (USTAP
study) compared to placebo in treatment of PFCD.
- Page 4 line 81-83 section on ADMIRE-CD: please add data and/or comments on the recent
result of ADMIRE-CD II
Methodology section:
- did you consider to add data from the ADMIRE-CD II trial and/or the INSPIRE registry?
- it might be good to specify what is meant with "standard of care" (in the PREFACE study)
- could you comment on why you did not use the same endpoints as the ones used in the
ADMIRE/INSPECT?
Results section:
- I would suggest to add numbers and p-values to  the findings described in the text
Discussion section:
- please provide some comments on cost-effectiveness of DVS compared to SoC, particularly
in light of the findings of ADMIRE-CD II
As a general minor comment, I would suggest to use the abbreviation PFCD to describe perianal
fistulising Crohn's disease, as I feel this is more commonly used in literature.
Best wishes
Title: Predictive modeling to evaluate long-term treatment effectiveness of darvadstrocel in
patients with complex perianal fistulas in Crohn’s disease
Version: 8 Date: 15 Sep 2024
Reviewer's report:
Dear authors,
I would like to congratulate you on this nice manuscript that comprehensively outlines the used
complex methodology  to show long-term beneficial effects of DVS compared to standard of
care based on RWE from the ADMIRE-CD, INSPECT and PREFACE study.
Nonetheless, I would like to make some remarks/suggestions:
Introduction section:
-  Page 3 line 60-61: apart from infliximab other advanced medical treatment options have shown
good potential in subgroup analyses from RCT’s. Furthermore, there are currently dedicated
studies ongoing to evaluated efficacy of guselkumab (FUZION study) and ustekinumab (USTAP
study) compared to placebo in treatment of PFCD.
- Page 4 line 81-83 section on ADMIRE-CD: please add data and/or comments on the recent
result of ADMIRE-CD II
Methodology section:
- did you consider to add data from the ADMIRE-CD II trial and/or the INSPIRE registry?
- it might be good to specify what is meant with "standard of care" (in the PREFACE study)
- could you comment on why you did not use the same endpoints as the ones used in the
ADMIRE/INSPECT?
Results section:
- I would suggest to add numbers and p-values to  the findings described in the text
Discussion section:
- please provide some comments on cost-effectiveness of DVS compared to SoC, particularly
in light of the findings of ADMIRE-CD II
As a general minor comment, I would suggest to use the abbreviation PFCD to describe perianal
fistulising Crohn's disease, as I feel this is more commonly used in literature.
Best wishes
Please review this paper.
user
Title: Predictive modeling to evaluate long-term treatment effectiveness of darvadstrocel in
patients with complex perianal fistulas in Crohn’s disease
Version: 8 Date: 15 Sep 2024
Reviewer's report:
Dear authors,
I would like to congratulate you on this nice manuscript that comprehensively outlines the used
complex methodology  to show long-term beneficial effects of DVS compared to standard of
care based on RWE from the ADMIRE-CD, INSPECT and PREFACE study.
Nonetheless, I would like to make some remarks/suggestions:
Introduction section:
-  Page 3 line 60-61: apart from infliximab other advanced medical treatment options have shown
good potential in subgroup analyses from RCT’s. Furthermore, there are currently dedicated
studies ongoing to evaluated efficacy of guselkumab (FUZION study) and ustekinumab (USTAP
study) compared to placebo in treatment of PFCD.
- Page 4 line 81-83 section on ADMIRE-CD: please add data and/or comments on the recent
result of ADMIRE-CD II
Methodology section:
- did you consider to add data from the ADMIRE-CD II trial and/or the INSPIRE registry?
- it might be good to specify what is meant with "standard of care" (in the PREFACE study)
- could you comment on why you did not use the same endpoints as the ones used in the
ADMIRE/INSPECT?
Results section:
- I would suggest to add numbers and p-values to  the findings described in the text
Discussion section:
- please provide some comments on cost-effectiveness of DVS compared to SoC, particularly
in light of the findings of ADMIRE-CD II
As a general minor comment, I would suggest to use the abbreviation PFCD to describe perianal
fistulising Crohn's disease, as I feel this is more commonly used in literature.
Best wishes
assistant