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:28 August 2008
Reviewer: Susanna Nikolaus
Reviewer's report:
the authors report results of a multicentre controlled phase II dose-finding study
with Interferon ß-1a for maintenance of remission in Crohn´s disease. 67 patients
were included in the trial and were randomized to either IFN-ß 44 µg biw, 44 µg
tiw, 66µg tiw or placebo. The primary endpoint was relapse-free remission at
week 26. After an interim analysis of the week 26-data, the trial was terminated
because there were no differences in between the four groups in the proportion
of patients who remained in relapse-free remission.
The study was well designed and results were presented and discussed
adequately. Because the results of a planned interim analysis at week 26
showed no significant benefit of interferon beta in comparison with placebo, the
trial was terminated. Due to the unplanned early termination the number of
patients in each treatment arm that finished the study became very small. To
facilitate an easy overview, the authors additionally provided the study design as
a flow chart with the numbers of patients in each group at each time point.
Major essential revisions:
The introduction should be overworked. The statement that CD is a condition of
T-cell activation is only one hypothesis to explain the pathogenesis of CD. Other
conditions (like genetics, enviromental factors, other immunological conditions)
should also be shortly mentiontioned.
Discussion/References:
The authors sould discuss previous experiences with interferon in Crohn´s
disease as well as results from controlled trials with IFN-b in ulcerative colitis.
none of the original articles about Interferon a/b (pilot trials or phase II-trials) in
IBD were cited.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Acceptable
Statistical review: Yes, but I do not feel adequately qualified to assess the
statistics.
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:28 August 2008
Reviewer: Susanna Nikolaus
Reviewer's report:
the authors report results of a multicentre controlled phase II dose-finding study
with Interferon ß-1a for maintenance of remission in Crohn´s disease. 67 patients
were included in the trial and were randomized to either IFN-ß 44 µg biw, 44 µg
tiw, 66µg tiw or placebo. The primary endpoint was relapse-free remission at
week 26. After an interim analysis of the week 26-data, the trial was terminated
because there were no differences in between the four groups in the proportion
of patients who remained in relapse-free remission.
The study was well designed and results were presented and discussed
adequately. Because the results of a planned interim analysis at week 26
showed no significant benefit of interferon beta in comparison with placebo, the
trial was terminated. Due to the unplanned early termination the number of
patients in each treatment arm that finished the study became very small. To
facilitate an easy overview, the authors additionally provided the study design as
a flow chart with the numbers of patients in each group at each time point.
Major essential revisions:
The introduction should be overworked. The statement that CD is a condition of
T-cell activation is only one hypothesis to explain the pathogenesis of CD. Other
conditions (like genetics, enviromental factors, other immunological conditions)
should also be shortly mentiontioned.
Discussion/References:
The authors sould discuss previous experiences with interferon in Crohn´s
disease as well as results from controlled trials with IFN-b in ulcerative colitis.
none of the original articles about Interferon a/b (pilot trials or phase II-trials) in
IBD were cited.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Acceptable
Statistical review: Yes, but I do not feel adequately qualified to assess the
statistics.
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:28 August 2008
Reviewer: Susanna Nikolaus
Reviewer's report:
the authors report results of a multicentre controlled phase II dose-finding study
with Interferon ß-1a for maintenance of remission in Crohn´s disease. 67 patients
were included in the trial and were randomized to either IFN-ß 44 µg biw, 44 µg
tiw, 66µg tiw or placebo. The primary endpoint was relapse-free remission at
week 26. After an interim analysis of the week 26-data, the trial was terminated
because there were no differences in between the four groups in the proportion
of patients who remained in relapse-free remission.
The study was well designed and results were presented and discussed
adequately. Because the results of a planned interim analysis at week 26
showed no significant benefit of interferon beta in comparison with placebo, the
trial was terminated. Due to the unplanned early termination the number of
patients in each treatment arm that finished the study became very small. To
facilitate an easy overview, the authors additionally provided the study design as
a flow chart with the numbers of patients in each group at each time point.
Major essential revisions:
The introduction should be overworked. The statement that CD is a condition of
T-cell activation is only one hypothesis to explain the pathogenesis of CD. Other
conditions (like genetics, enviromental factors, other immunological conditions)
should also be shortly mentiontioned.
Discussion/References:
The authors sould discuss previous experiences with interferon in Crohn´s
disease as well as results from controlled trials with IFN-b in ulcerative colitis.
none of the original articles about Interferon a/b (pilot trials or phase II-trials) in
IBD were cited.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Acceptable
Statistical review: Yes, but I do not feel adequately qualified to assess the
statistics.
assistant