Title: TITLE: Intravenous tacrolimus is a superior induction therapy for acute severe ulcerative
colitis compared to oral tacrolimus
Version: 1 Date: 03 Oct 2021
Reviewer's report:
Shimizu H. et al. conducted a prospective cohort study to evaluate the effect of intravenous TAC
for acute severe Ulcerative colitis (ASUC). Although many biologics are available for moderate
to severe UC, treatment strategy for ASUC is limited. In that situation, authors showed that the
improvement of endoscopic finding by intravenous TAC resulted in the high colectomy-free
survival rate. It is very intriguing to suggest the new treatment option for ASUC, however, there
are several concerns in this work.
1.
This study should be more focused on the escape from colectomy in short term by intravenous
TAC. Kaplan-Meier curve of colectomy-free survival looks the better effect of intravenous TAC
compared to oral TAC at 2-5 weeks. How about the statistical analysis at 2-5 weeks?
With regard to the treatment of ASUC, the most important thing is the escape from colectomy
in short term. Therefore, if there is no statistical difference, I suggest that authors re-examine
the data by the propensity score matching analysis.
2.
Authors described that all enrolled patients received corticosteroid iv. Was corticosteroid
administered just before TAC? Are there some patients treated by IFX just before TAC? For
example, I infer that the patients with corticosteroid dependent UC, who had undergone steroid
iv previously, received IFX or TAC after the diagnosis of ASUC.
The hazard ratios for colectomy showed no statistical different in biologic agent failure, but p
value was 0.06. Can you conclude that biologic agents have not had an influence on the outcome
of colectomy?
3.
Some patients receive IFX after TAC administered. Given that the treatment after TAC has
influenced on the clinical course, it would be better to add the treatment after TAC (ex. IFX)
in the multivariable analyses using the Cox proportional hazards model for colectomy-free
survival.
4,
ASUC was defined according to the criteria given by Truelove and Witts as 6 bloody stools per
day and one or more of the following: decreased hemoglobin (10.5 g/dL), elevated erythrocyte
sedimentation rate (30 mm/h), fever (37.8C), or tachycardia (90 bpm). Furthermore, diagnostic
criteria of ASUC require hospitalization.
Does only LI score10< correspond with the criteria of ASUC?
5.
Do authors have any decision criteria for intravenous or oral TAC? Authors should mention
about the criteria.
Title: TITLE: Intravenous tacrolimus is a superior induction therapy for acute severe ulcerative
colitis compared to oral tacrolimus
Version: 1 Date: 03 Oct 2021
Reviewer's report:
Shimizu H. et al. conducted a prospective cohort study to evaluate the effect of intravenous TAC
for acute severe Ulcerative colitis (ASUC). Although many biologics are available for moderate
to severe UC, treatment strategy for ASUC is limited. In that situation, authors showed that the
improvement of endoscopic finding by intravenous TAC resulted in the high colectomy-free
survival rate. It is very intriguing to suggest the new treatment option for ASUC, however, there
are several concerns in this work.
1.
This study should be more focused on the escape from colectomy in short term by intravenous
TAC. Kaplan-Meier curve of colectomy-free survival looks the better effect of intravenous TAC
compared to oral TAC at 2-5 weeks. How about the statistical analysis at 2-5 weeks?
With regard to the treatment of ASUC, the most important thing is the escape from colectomy
in short term. Therefore, if there is no statistical difference, I suggest that authors re-examine
the data by the propensity score matching analysis.
2.
Authors described that all enrolled patients received corticosteroid iv. Was corticosteroid
administered just before TAC? Are there some patients treated by IFX just before TAC? For
example, I infer that the patients with corticosteroid dependent UC, who had undergone steroid
iv previously, received IFX or TAC after the diagnosis of ASUC.
The hazard ratios for colectomy showed no statistical different in biologic agent failure, but p
value was 0.06. Can you conclude that biologic agents have not had an influence on the outcome
of colectomy?
3.
Some patients receive IFX after TAC administered. Given that the treatment after TAC has
influenced on the clinical course, it would be better to add the treatment after TAC (ex. IFX)
in the multivariable analyses using the Cox proportional hazards model for colectomy-free
survival.
4,
ASUC was defined according to the criteria given by Truelove and Witts as 6 bloody stools per
day and one or more of the following: decreased hemoglobin (10.5 g/dL), elevated erythrocyte
sedimentation rate (30 mm/h), fever (37.8C), or tachycardia (90 bpm). Furthermore, diagnostic
criteria of ASUC require hospitalization.
Does only LI score10< correspond with the criteria of ASUC?
5.
Do authors have any decision criteria for intravenous or oral TAC? Authors should mention
about the criteria.
Please review this paper.
user
Title: TITLE: Intravenous tacrolimus is a superior induction therapy for acute severe ulcerative
colitis compared to oral tacrolimus
Version: 1 Date: 03 Oct 2021
Reviewer's report:
Shimizu H. et al. conducted a prospective cohort study to evaluate the effect of intravenous TAC
for acute severe Ulcerative colitis (ASUC). Although many biologics are available for moderate
to severe UC, treatment strategy for ASUC is limited. In that situation, authors showed that the
improvement of endoscopic finding by intravenous TAC resulted in the high colectomy-free
survival rate. It is very intriguing to suggest the new treatment option for ASUC, however, there
are several concerns in this work.
1.
This study should be more focused on the escape from colectomy in short term by intravenous
TAC. Kaplan-Meier curve of colectomy-free survival looks the better effect of intravenous TAC
compared to oral TAC at 2-5 weeks. How about the statistical analysis at 2-5 weeks?
With regard to the treatment of ASUC, the most important thing is the escape from colectomy
in short term. Therefore, if there is no statistical difference, I suggest that authors re-examine
the data by the propensity score matching analysis.
2.
Authors described that all enrolled patients received corticosteroid iv. Was corticosteroid
administered just before TAC? Are there some patients treated by IFX just before TAC? For
example, I infer that the patients with corticosteroid dependent UC, who had undergone steroid
iv previously, received IFX or TAC after the diagnosis of ASUC.
The hazard ratios for colectomy showed no statistical different in biologic agent failure, but p
value was 0.06. Can you conclude that biologic agents have not had an influence on the outcome
of colectomy?
3.
Some patients receive IFX after TAC administered. Given that the treatment after TAC has
influenced on the clinical course, it would be better to add the treatment after TAC (ex. IFX)
in the multivariable analyses using the Cox proportional hazards model for colectomy-free
survival.
4,
ASUC was defined according to the criteria given by Truelove and Witts as 6 bloody stools per
day and one or more of the following: decreased hemoglobin (10.5 g/dL), elevated erythrocyte
sedimentation rate (30 mm/h), fever (37.8C), or tachycardia (90 bpm). Furthermore, diagnostic
criteria of ASUC require hospitalization.
Does only LI score10< correspond with the criteria of ASUC?
5.
Do authors have any decision criteria for intravenous or oral TAC? Authors should mention
about the criteria.
assistant