Reviewer's report
Title:Efficacy and safety of infliximab induction therapy in Crohn's Disease in
Central Europe - a Hungarian nationwide observational study
Version: 1Date:5 February 2009
Reviewer: Johanna Escher
Reviewer's report:
The authors did a fine job collecting the data on efficacy of infliximab induction
therapy from all over Hungary. It is however one of the many reports on
infliximab that have been published in the past years. I think the paper can
improve by doing some essential revisions based on the comments below:
Major:
1. The report is aimed only at induction treatment, but data collection was done in
a 6-year period. It should be possible to give some information about
maintenance treatment, even given the fact that some patients were not allowed
to get it for financial reasons. A flowchart with numbers of patients going into
maintenance treatment and duration of remission would improve the paper
significantly.
2. The study is partly retrospective, partly prospective. The authors should in the
discussion elaborate on the effect this may have on data collection (bias? better
reporting of side effects, etc).
3. The authors need to describe in more detail the indication for infliximab
treatment. For instance, how do they define refractory disease both when it is
luminal but also fistulas (the majority of patients).
4. Quite a few post-surgical patients were included, they represent a different
group and should be mentioned in the tables as well
Minor:
1. response rate in fistulizing disease: it seems that two different definitions are
used (50% closure or number of discharging fistulas compare to baseline)
2. tuberculosis: explain the policy in Hungary about doing (or not doing) a PPD
before starting IFX
3. in the results, the better response rate in younger patients is mentioned twice
on consectuive pages.
Level of interest: An article whose findings are important to those with closely
related research interests
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:Efficacy and safety of infliximab induction therapy in Crohn's Disease in
Central Europe - a Hungarian nationwide observational study
Version: 1Date:5 February 2009
Reviewer: Johanna Escher
Reviewer's report:
The authors did a fine job collecting the data on efficacy of infliximab induction
therapy from all over Hungary. It is however one of the many reports on
infliximab that have been published in the past years. I think the paper can
improve by doing some essential revisions based on the comments below:
Major:
1. The report is aimed only at induction treatment, but data collection was done in
a 6-year period. It should be possible to give some information about
maintenance treatment, even given the fact that some patients were not allowed
to get it for financial reasons. A flowchart with numbers of patients going into
maintenance treatment and duration of remission would improve the paper
significantly.
2. The study is partly retrospective, partly prospective. The authors should in the
discussion elaborate on the effect this may have on data collection (bias? better
reporting of side effects, etc).
3. The authors need to describe in more detail the indication for infliximab
treatment. For instance, how do they define refractory disease both when it is
luminal but also fistulas (the majority of patients).
4. Quite a few post-surgical patients were included, they represent a different
group and should be mentioned in the tables as well
Minor:
1. response rate in fistulizing disease: it seems that two different definitions are
used (50% closure or number of discharging fistulas compare to baseline)
2. tuberculosis: explain the policy in Hungary about doing (or not doing) a PPD
before starting IFX
3. in the results, the better response rate in younger patients is mentioned twice
on consectuive pages.
Level of interest: An article whose findings are important to those with closely
related research interests
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:Efficacy and safety of infliximab induction therapy in Crohn's Disease in
Central Europe - a Hungarian nationwide observational study
Version: 1Date:5 February 2009
Reviewer: Johanna Escher
Reviewer's report:
The authors did a fine job collecting the data on efficacy of infliximab induction
therapy from all over Hungary. It is however one of the many reports on
infliximab that have been published in the past years. I think the paper can
improve by doing some essential revisions based on the comments below:
Major:
1. The report is aimed only at induction treatment, but data collection was done in
a 6-year period. It should be possible to give some information about
maintenance treatment, even given the fact that some patients were not allowed
to get it for financial reasons. A flowchart with numbers of patients going into
maintenance treatment and duration of remission would improve the paper
significantly.
2. The study is partly retrospective, partly prospective. The authors should in the
discussion elaborate on the effect this may have on data collection (bias? better
reporting of side effects, etc).
3. The authors need to describe in more detail the indication for infliximab
treatment. For instance, how do they define refractory disease both when it is
luminal but also fistulas (the majority of patients).
4. Quite a few post-surgical patients were included, they represent a different
group and should be mentioned in the tables as well
Minor:
1. response rate in fistulizing disease: it seems that two different definitions are
used (50% closure or number of discharging fistulas compare to baseline)
2. tuberculosis: explain the policy in Hungary about doing (or not doing) a PPD
before starting IFX
3. in the results, the better response rate in younger patients is mentioned twice
on consectuive pages.
Level of interest: An article whose findings are important to those with closely
related research interests
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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