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:26 December 2008
Reviewer: Renato Caviglia
Reviewer's report:
Reviewer’s comments on Manuscript: Efficacy and safety of infliximab induction
therapy in Crohn's Disease in Central Europe - a Hungarian nationwide
observational study
This paper addresses an important and widely-investigated topic dealing with the
efficacy and safety of biologic therapy as induction treatment in Crohn’s disease.
In this retrospective study the authors evaluate a total of 363 CD patients treated
with IFX during a 6-year-period, beginning in 2000, in eleven centres in Hungary.
Major Compulsory Revisions:
1. The Authors should pay attention when using acronyms if not already
mentioned (i.e., AZA).
2. Methods. The Authors cannot state here that patients were treated according
to ECCO guidelines for IFX administration strategy in CD patients because these
guidelines were published in 2006 and this retrospective study was started in
2000.
3. Results. It would be useful to stratify patients according to the IFX treatment
strategy (on demand vs scheduled induction treatment) and perform a separate
statistical evaluation.
4. Results. The Authors should provide more information about pre-treatment
clinical data (i.e., CDAI) and biologic parameters (CRP, ESR, serum
haemoglobin levels) and how these parameters improved following treatment.
Moreover, the endoscopic findings should be included as mucosal healing is now
considered a therapeutic goal to be achieved with biologic therapy.
5. Results. It should be clearly reported how and when (i.e., how many weeks
after the last infusion) the Authors evaluated the clinical outcome following the
IFX induction regimen.
6. Results. The Authors should provide more information about the concomitant
immunomodulatory treatment that the patients were on during IFX therapy (i.e.,
dose and duration of treatment).
In conclusion, in my opinion the manuscript is not exactly positive and the text is
redundant in several parts and therefore makes reading a little boring.
However, the paper could be reconsidered for publication if the Authors take into
account the suggestions outlined above and modify the text accordingly.
Thank you for allowing me to review this paper.
Best regards.
Yours sincerely,
Renato Caviglia MD, PhD
Level of interest: An article of limited interest
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:26 December 2008
Reviewer: Renato Caviglia
Reviewer's report:
Reviewer’s comments on Manuscript: Efficacy and safety of infliximab induction
therapy in Crohn's Disease in Central Europe - a Hungarian nationwide
observational study
This paper addresses an important and widely-investigated topic dealing with the
efficacy and safety of biologic therapy as induction treatment in Crohn’s disease.
In this retrospective study the authors evaluate a total of 363 CD patients treated
with IFX during a 6-year-period, beginning in 2000, in eleven centres in Hungary.
Major Compulsory Revisions:
1. The Authors should pay attention when using acronyms if not already
mentioned (i.e., AZA).
2. Methods. The Authors cannot state here that patients were treated according
to ECCO guidelines for IFX administration strategy in CD patients because these
guidelines were published in 2006 and this retrospective study was started in
2000.
3. Results. It would be useful to stratify patients according to the IFX treatment
strategy (on demand vs scheduled induction treatment) and perform a separate
statistical evaluation.
4. Results. The Authors should provide more information about pre-treatment
clinical data (i.e., CDAI) and biologic parameters (CRP, ESR, serum
haemoglobin levels) and how these parameters improved following treatment.
Moreover, the endoscopic findings should be included as mucosal healing is now
considered a therapeutic goal to be achieved with biologic therapy.
5. Results. It should be clearly reported how and when (i.e., how many weeks
after the last infusion) the Authors evaluated the clinical outcome following the
IFX induction regimen.
6. Results. The Authors should provide more information about the concomitant
immunomodulatory treatment that the patients were on during IFX therapy (i.e.,
dose and duration of treatment).
In conclusion, in my opinion the manuscript is not exactly positive and the text is
redundant in several parts and therefore makes reading a little boring.
However, the paper could be reconsidered for publication if the Authors take into
account the suggestions outlined above and modify the text accordingly.
Thank you for allowing me to review this paper.
Best regards.
Yours sincerely,
Renato Caviglia MD, PhD
Level of interest: An article of limited interest
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:26 December 2008
Reviewer: Renato Caviglia
Reviewer's report:
Reviewer’s comments on Manuscript: Efficacy and safety of infliximab induction
therapy in Crohn's Disease in Central Europe - a Hungarian nationwide
observational study
This paper addresses an important and widely-investigated topic dealing with the
efficacy and safety of biologic therapy as induction treatment in Crohn’s disease.
In this retrospective study the authors evaluate a total of 363 CD patients treated
with IFX during a 6-year-period, beginning in 2000, in eleven centres in Hungary.
Major Compulsory Revisions:
1. The Authors should pay attention when using acronyms if not already
mentioned (i.e., AZA).
2. Methods. The Authors cannot state here that patients were treated according
to ECCO guidelines for IFX administration strategy in CD patients because these
guidelines were published in 2006 and this retrospective study was started in
2000.
3. Results. It would be useful to stratify patients according to the IFX treatment
strategy (on demand vs scheduled induction treatment) and perform a separate
statistical evaluation.
4. Results. The Authors should provide more information about pre-treatment
clinical data (i.e., CDAI) and biologic parameters (CRP, ESR, serum
haemoglobin levels) and how these parameters improved following treatment.
Moreover, the endoscopic findings should be included as mucosal healing is now
considered a therapeutic goal to be achieved with biologic therapy.
5. Results. It should be clearly reported how and when (i.e., how many weeks
after the last infusion) the Authors evaluated the clinical outcome following the
IFX induction regimen.
6. Results. The Authors should provide more information about the concomitant
immunomodulatory treatment that the patients were on during IFX therapy (i.e.,
dose and duration of treatment).
In conclusion, in my opinion the manuscript is not exactly positive and the text is
redundant in several parts and therefore makes reading a little boring.
However, the paper could be reconsidered for publication if the Authors take into
account the suggestions outlined above and modify the text accordingly.
Thank you for allowing me to review this paper.
Best regards.
Yours sincerely,
Renato Caviglia MD, PhD
Level of interest: An article of limited interest
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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