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:19 January 2009
Reviewer: Gert van Assche
Reviewer's report:
This retrospective analysis describes the experience with the use of infliximab in
Hungary in the past 8 years and includes 363 patients. It is in line with several
other previous cohort studies and confirms the high efficacy of infliximab
induction therapy in clinical practice. The original part of this work is that it would
be the first report from a Hungarian cohort. However, I have several questions on
trial design and on the interpretation of the results. The main methodological
concern is the lack of multivariate analysis.
Specific remarks.
1. The abstract result section can be shortened.
2. Since many of the patient charts were analyzed retrospectively it is unclear
how CDAIs were calculated in these patients. Also, we wonder how many
patients had missing values?
3. The methods section on the statistical analysis is incomplete since no
reference is made to proportional data.
4. It appears that both in luminal and fistulizing Crohn’s disease several
parameters were associated with response: immunosuppressives, age…
However, a multivariate analysis is needed to establish the independent
predictive value of these factors.
5. Several p values are missing in the result section.
6. The absence of a full induction therapy, long drug holidays and other factors
have been associated with infusion reactions to infliximab. Was this analyzed?
7. The situation in Hungary appears to favour episodic infliximab therapy,
therefore it would be highly valuable if long term response rates and survival
analysis would be performed.
8. The discussion should not mention recommendations as they are often based
on a few patients only.
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:19 January 2009
Reviewer: Gert van Assche
Reviewer's report:
This retrospective analysis describes the experience with the use of infliximab in
Hungary in the past 8 years and includes 363 patients. It is in line with several
other previous cohort studies and confirms the high efficacy of infliximab
induction therapy in clinical practice. The original part of this work is that it would
be the first report from a Hungarian cohort. However, I have several questions on
trial design and on the interpretation of the results. The main methodological
concern is the lack of multivariate analysis.
Specific remarks.
1. The abstract result section can be shortened.
2. Since many of the patient charts were analyzed retrospectively it is unclear
how CDAIs were calculated in these patients. Also, we wonder how many
patients had missing values?
3. The methods section on the statistical analysis is incomplete since no
reference is made to proportional data.
4. It appears that both in luminal and fistulizing Crohn’s disease several
parameters were associated with response: immunosuppressives, age…
However, a multivariate analysis is needed to establish the independent
predictive value of these factors.
5. Several p values are missing in the result section.
6. The absence of a full induction therapy, long drug holidays and other factors
have been associated with infusion reactions to infliximab. Was this analyzed?
7. The situation in Hungary appears to favour episodic infliximab therapy,
therefore it would be highly valuable if long term response rates and survival
analysis would be performed.
8. The discussion should not mention recommendations as they are often based
on a few patients only.
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:19 January 2009
Reviewer: Gert van Assche
Reviewer's report:
This retrospective analysis describes the experience with the use of infliximab in
Hungary in the past 8 years and includes 363 patients. It is in line with several
other previous cohort studies and confirms the high efficacy of infliximab
induction therapy in clinical practice. The original part of this work is that it would
be the first report from a Hungarian cohort. However, I have several questions on
trial design and on the interpretation of the results. The main methodological
concern is the lack of multivariate analysis.
Specific remarks.
1. The abstract result section can be shortened.
2. Since many of the patient charts were analyzed retrospectively it is unclear
how CDAIs were calculated in these patients. Also, we wonder how many
patients had missing values?
3. The methods section on the statistical analysis is incomplete since no
reference is made to proportional data.
4. It appears that both in luminal and fistulizing Crohn’s disease several
parameters were associated with response: immunosuppressives, age…
However, a multivariate analysis is needed to establish the independent
predictive value of these factors.
5. Several p values are missing in the result section.
6. The absence of a full induction therapy, long drug holidays and other factors
have been associated with infusion reactions to infliximab. Was this analyzed?
7. The situation in Hungary appears to favour episodic infliximab therapy,
therefore it would be highly valuable if long term response rates and survival
analysis would be performed.
8. The discussion should not mention recommendations as they are often based
on a few patients only.
assistant