Reviewer's report
Title:Interferon beta-1a for the maintenance of remission in patients with Crohn's
disease: results of a phase II dose-finding study
Version: 1Date:6 August 2008
Reviewer: E Ebert
Reviewer's report:
Interferon beta 1a for the maintenance of remission in patients with Crohn’s
disease: results of a phase 2 dose-finding study
The authors claim that interferon beta is no different in efficacy than placebo in
patients with Crohn’s disease.
Major compulsory revisions:
1. Two major problems with the study are the small numbers of patients and the
large drop-out due to treatment failures. Surprisingly, these problems are not
mentioned in the Abstract or Discussion. There is no information regarding the
treatment failures.
2. Interferon may in fact worsen the disease process as suggested by the
increased ESR and C-reactive protein compared to placebo. (Is this difference
significant?) In addition, the only significant finding was a worsening of disease
with interferon at week 52. Furthermore, the placebo group had a smaller mean
increase in CDAI score than the interferon group (Is this difference significant?
The changes in the CDAI score should be included.) The fact that interferon may
worsen the disease should be addressed in the Abstract and Discussion.
Minor essential revisions:
The significantly different values are from week 52. This should be stated in the
legend.
The abstract should indicate that the protocol was a steroid taper.
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:Interferon beta-1a for the maintenance of remission in patients with Crohn's
disease: results of a phase II dose-finding study
Version: 1Date:6 August 2008
Reviewer: E Ebert
Reviewer's report:
Interferon beta 1a for the maintenance of remission in patients with Crohn’s
disease: results of a phase 2 dose-finding study
The authors claim that interferon beta is no different in efficacy than placebo in
patients with Crohn’s disease.
Major compulsory revisions:
1. Two major problems with the study are the small numbers of patients and the
large drop-out due to treatment failures. Surprisingly, these problems are not
mentioned in the Abstract or Discussion. There is no information regarding the
treatment failures.
2. Interferon may in fact worsen the disease process as suggested by the
increased ESR and C-reactive protein compared to placebo. (Is this difference
significant?) In addition, the only significant finding was a worsening of disease
with interferon at week 52. Furthermore, the placebo group had a smaller mean
increase in CDAI score than the interferon group (Is this difference significant?
The changes in the CDAI score should be included.) The fact that interferon may
worsen the disease should be addressed in the Abstract and Discussion.
Minor essential revisions:
The significantly different values are from week 52. This should be stated in the
legend.
The abstract should indicate that the protocol was a steroid taper.
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:Interferon beta-1a for the maintenance of remission in patients with Crohn's
disease: results of a phase II dose-finding study
Version: 1Date:6 August 2008
Reviewer: E Ebert
Reviewer's report:
Interferon beta 1a for the maintenance of remission in patients with Crohn’s
disease: results of a phase 2 dose-finding study
The authors claim that interferon beta is no different in efficacy than placebo in
patients with Crohn’s disease.
Major compulsory revisions:
1. Two major problems with the study are the small numbers of patients and the
large drop-out due to treatment failures. Surprisingly, these problems are not
mentioned in the Abstract or Discussion. There is no information regarding the
treatment failures.
2. Interferon may in fact worsen the disease process as suggested by the
increased ESR and C-reactive protein compared to placebo. (Is this difference
significant?) In addition, the only significant finding was a worsening of disease
with interferon at week 52. Furthermore, the placebo group had a smaller mean
increase in CDAI score than the interferon group (Is this difference significant?
The changes in the CDAI score should be included.) The fact that interferon may
worsen the disease should be addressed in the Abstract and Discussion.
Minor essential revisions:
The significantly different values are from week 52. This should be stated in the
legend.
The abstract should indicate that the protocol was a steroid taper.
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
assistant