Title: Predictive modeling to evaluate long-term treatment effectiveness of darvadstrocel in
patients with complex perianal fistulas in Crohn’s disease
Version: 5 Date: 12 Jul 2024
Reviewer's report:
Thank you for the invitation to review the manuscript by Karki et al entitled " Predictive
modeling to evaluate long-term treatment effectiveness of darvadstrocel in patients with
complex perianal fistulas in Crohn’s disease”.
Treatment of CPF of CD is a challenge, there have been no major breakthroughs in recent years.
In this study, a comparative analysis of SoC vs DVS was performed in a statistical viewpoint
based on retrospective and RCT data and demonstrated that DVS was predicted to provide
greater long-term effectiveness than SoC.
The topic is interesting and emerging. The paper is well-written; however, the statistical
methodology is difficult to follow. Here are some comments that suggested to be clarified in a
revised version of the manuscript:
- In the Background section, the superiority of anti-TNFs may be highlight in contrast with
antibiotics or immunomodulators (ECCO guideline suggest against). Reference 4. may be
upgraded by 2024 releases.
- In the Background/Discussion section, preliminary results of ADMIRE-II may be commented.
- A high proportion of missing data of PDAI data from the PREFACE study was set as cause of
bias, please complete the manuscript with the ratios of missing data.
Title: Predictive modeling to evaluate long-term treatment effectiveness of darvadstrocel in
patients with complex perianal fistulas in Crohn’s disease
Version: 5 Date: 12 Jul 2024
Reviewer's report:
Thank you for the invitation to review the manuscript by Karki et al entitled " Predictive
modeling to evaluate long-term treatment effectiveness of darvadstrocel in patients with
complex perianal fistulas in Crohn’s disease”.
Treatment of CPF of CD is a challenge, there have been no major breakthroughs in recent years.
In this study, a comparative analysis of SoC vs DVS was performed in a statistical viewpoint
based on retrospective and RCT data and demonstrated that DVS was predicted to provide
greater long-term effectiveness than SoC.
The topic is interesting and emerging. The paper is well-written; however, the statistical
methodology is difficult to follow. Here are some comments that suggested to be clarified in a
revised version of the manuscript:
- In the Background section, the superiority of anti-TNFs may be highlight in contrast with
antibiotics or immunomodulators (ECCO guideline suggest against). Reference 4. may be
upgraded by 2024 releases.
- In the Background/Discussion section, preliminary results of ADMIRE-II may be commented.
- A high proportion of missing data of PDAI data from the PREFACE study was set as cause of
bias, please complete the manuscript with the ratios of missing data.
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: 5 Date: 12 Jul 2024
Reviewer's report:
Thank you for the invitation to review the manuscript by Karki et al entitled " Predictive
modeling to evaluate long-term treatment effectiveness of darvadstrocel in patients with
complex perianal fistulas in Crohn’s disease”.
Treatment of CPF of CD is a challenge, there have been no major breakthroughs in recent years.
In this study, a comparative analysis of SoC vs DVS was performed in a statistical viewpoint
based on retrospective and RCT data and demonstrated that DVS was predicted to provide
greater long-term effectiveness than SoC.
The topic is interesting and emerging. The paper is well-written; however, the statistical
methodology is difficult to follow. Here are some comments that suggested to be clarified in a
revised version of the manuscript:
- In the Background section, the superiority of anti-TNFs may be highlight in contrast with
antibiotics or immunomodulators (ECCO guideline suggest against). Reference 4. may be
upgraded by 2024 releases.
- In the Background/Discussion section, preliminary results of ADMIRE-II may be commented.
- A high proportion of missing data of PDAI data from the PREFACE study was set as cause of
bias, please complete the manuscript with the ratios of missing data.
assistant