Reviewer's report
Title:Long-term efficacy of infliximab for refractory ulcerative colitis: Results from
a single center experience
Version:2Date:31 January 2014
Reviewer: Gionata Fiorino
Reviewer's report:
The Authors reported the results from a retrospective cohort of patients treated
with infliximab for refractory ulcerative colitis, followed up on the long-term. They
found that about half of subjects required dose intensification with a very high
colectomy-free rate on the long-term. They also tried to investigate possible
predictors for long-term remission after dose intensification.
The topic is of high interest, since data on the efficacy of dose intensification of
infliximab over 12 months are not available. The manuscript is well written, but
can be improved in terms of clarity. Some issues should be addressed to the
Authors to make the manuscript suitable for publication.
1) The Authors evaluated different endpoints in their cohort. While the primary
endoint is clear, the secondary endpoints declared in the "Assessment" section
are not all consistent with the reported results. I suggest the Authors to detail all
the endpoints in the Results section, following the same outline they used in the
list of endpoints cited in the "Assessment" section.
2) The timeline of the study is quite hard to understand. There are different
endpoints reported for different follow-up time. In particular, the time to colectomy
is not clear in the Results section (it seems 63 months on average), as well as
the other endpoint time-to-observation. Please consider to calculate all the
endpoints at a definite timepoint (i.e. 3 or 5 years). Otherwise, specify the time of
observation for all the endpoints throughout the manuscript.
3) I suggest to discuss the results considering also the data from Cesarini et al.
2013, which investigated a similar cohort of patients with similar endpoints on the
short-term.
4) The discussion on the role of previous CMV infection should be improved. In
the Results section, details on how previous CMV positivity could affect the
therapy with infliximab are not provided. I suggest to add a brief section on this
aspect, also explaining how the Authors differentiated a CMV-related colitis from
a non significant CMV-overinfection.
5) The references need to be edited as required by the Journal guidelines.
Please check also all the lists of Authors, as some are not correct (i.e. ref. 19).
6) Figure (1): There is a mispelling on Tacrolimus. Please correct.
Level of interest: An article of importance in its field
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a statistician.
Declaration of competing interests:
I declare that I have no competing interests.
Reviewer's report
Title:Long-term efficacy of infliximab for refractory ulcerative colitis: Results from
a single center experience
Version:2Date:31 January 2014
Reviewer: Gionata Fiorino
Reviewer's report:
The Authors reported the results from a retrospective cohort of patients treated
with infliximab for refractory ulcerative colitis, followed up on the long-term. They
found that about half of subjects required dose intensification with a very high
colectomy-free rate on the long-term. They also tried to investigate possible
predictors for long-term remission after dose intensification.
The topic is of high interest, since data on the efficacy of dose intensification of
infliximab over 12 months are not available. The manuscript is well written, but
can be improved in terms of clarity. Some issues should be addressed to the
Authors to make the manuscript suitable for publication.
1) The Authors evaluated different endpoints in their cohort. While the primary
endoint is clear, the secondary endpoints declared in the "Assessment" section
are not all consistent with the reported results. I suggest the Authors to detail all
the endpoints in the Results section, following the same outline they used in the
list of endpoints cited in the "Assessment" section.
2) The timeline of the study is quite hard to understand. There are different
endpoints reported for different follow-up time. In particular, the time to colectomy
is not clear in the Results section (it seems 63 months on average), as well as
the other endpoint time-to-observation. Please consider to calculate all the
endpoints at a definite timepoint (i.e. 3 or 5 years). Otherwise, specify the time of
observation for all the endpoints throughout the manuscript.
3) I suggest to discuss the results considering also the data from Cesarini et al.
2013, which investigated a similar cohort of patients with similar endpoints on the
short-term.
4) The discussion on the role of previous CMV infection should be improved. In
the Results section, details on how previous CMV positivity could affect the
therapy with infliximab are not provided. I suggest to add a brief section on this
aspect, also explaining how the Authors differentiated a CMV-related colitis from
a non significant CMV-overinfection.
5) The references need to be edited as required by the Journal guidelines.
Please check also all the lists of Authors, as some are not correct (i.e. ref. 19).
6) Figure (1): There is a mispelling on Tacrolimus. Please correct.
Level of interest: An article of importance in its field
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a statistician.
Declaration of competing interests:
I declare that I have no competing interests.
Please review this paper.
user
Reviewer's report
Title:Long-term efficacy of infliximab for refractory ulcerative colitis: Results from
a single center experience
Version:2Date:31 January 2014
Reviewer: Gionata Fiorino
Reviewer's report:
The Authors reported the results from a retrospective cohort of patients treated
with infliximab for refractory ulcerative colitis, followed up on the long-term. They
found that about half of subjects required dose intensification with a very high
colectomy-free rate on the long-term. They also tried to investigate possible
predictors for long-term remission after dose intensification.
The topic is of high interest, since data on the efficacy of dose intensification of
infliximab over 12 months are not available. The manuscript is well written, but
can be improved in terms of clarity. Some issues should be addressed to the
Authors to make the manuscript suitable for publication.
1) The Authors evaluated different endpoints in their cohort. While the primary
endoint is clear, the secondary endpoints declared in the "Assessment" section
are not all consistent with the reported results. I suggest the Authors to detail all
the endpoints in the Results section, following the same outline they used in the
list of endpoints cited in the "Assessment" section.
2) The timeline of the study is quite hard to understand. There are different
endpoints reported for different follow-up time. In particular, the time to colectomy
is not clear in the Results section (it seems 63 months on average), as well as
the other endpoint time-to-observation. Please consider to calculate all the
endpoints at a definite timepoint (i.e. 3 or 5 years). Otherwise, specify the time of
observation for all the endpoints throughout the manuscript.
3) I suggest to discuss the results considering also the data from Cesarini et al.
2013, which investigated a similar cohort of patients with similar endpoints on the
short-term.
4) The discussion on the role of previous CMV infection should be improved. In
the Results section, details on how previous CMV positivity could affect the
therapy with infliximab are not provided. I suggest to add a brief section on this
aspect, also explaining how the Authors differentiated a CMV-related colitis from
a non significant CMV-overinfection.
5) The references need to be edited as required by the Journal guidelines.
Please check also all the lists of Authors, as some are not correct (i.e. ref. 19).
6) Figure (1): There is a mispelling on Tacrolimus. Please correct.
Level of interest: An article of importance in its field
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a statistician.
Declaration of competing interests:
I declare that I have no competing interests.
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