Title: Comparative effectiveness of second-line biological therapies for ulcerative colitis and
Crohn’s disease in patients with prior failure of anti-tumour necrosis factor treatment
Version: 4 Date: 25 Nov 2021
Reviewer's report:
This is a single-centre retrospective study that compared the efficacy of second-line vedolizumab
and tofacitinib in ulcerative colitis and second-line vedolizumab and ustekinumab in Crohn’s
disease (following anti-TNF failure). In total, 94 patients were evaluated (50 in UC population
and 44 in CD population). The authors concluded that after prior anti-TNF failure, vedolizumab
and tofacitinib in UC and vedolizumab and ustekinumab in CD patients were similar in terms
of clinical efficacy. The article is well written and comprehensive, and understanding the role
of second-line therapy is an increasingly important area of IBD research.
Major comments:
• The sample size is small in each group [for UC: 37 patients vs 13 patients in vedolizumab
and tofacitinib groups respectively, for CD:28 patients vs 16 patients in vedolizumab and
ustekinumab groups respectively] which limits the statistical analysis and increases the chance
of a type 2 error
• In the CD population, it appears the vedolizumab group has a more severe phenotype (based
on Montreal classification, CDAI and lower albumin levels) which would impact on the results.
This should at least be discussed in the limitations.
• Lack of data on biochemical (CRP, faecal calprotectin) and endoscopic information limit the
results given these are current treatment endpoints in managing IBD
Title: Comparative effectiveness of second-line biological therapies for ulcerative colitis and
Crohn’s disease in patients with prior failure of anti-tumour necrosis factor treatment
Version: 4 Date: 25 Nov 2021
Reviewer's report:
This is a single-centre retrospective study that compared the efficacy of second-line vedolizumab
and tofacitinib in ulcerative colitis and second-line vedolizumab and ustekinumab in Crohn’s
disease (following anti-TNF failure). In total, 94 patients were evaluated (50 in UC population
and 44 in CD population). The authors concluded that after prior anti-TNF failure, vedolizumab
and tofacitinib in UC and vedolizumab and ustekinumab in CD patients were similar in terms
of clinical efficacy. The article is well written and comprehensive, and understanding the role
of second-line therapy is an increasingly important area of IBD research.
Major comments:
• The sample size is small in each group [for UC: 37 patients vs 13 patients in vedolizumab
and tofacitinib groups respectively, for CD:28 patients vs 16 patients in vedolizumab and
ustekinumab groups respectively] which limits the statistical analysis and increases the chance
of a type 2 error
• In the CD population, it appears the vedolizumab group has a more severe phenotype (based
on Montreal classification, CDAI and lower albumin levels) which would impact on the results.
This should at least be discussed in the limitations.
• Lack of data on biochemical (CRP, faecal calprotectin) and endoscopic information limit the
results given these are current treatment endpoints in managing IBD
Please review this paper.
user
Title: Comparative effectiveness of second-line biological therapies for ulcerative colitis and
Crohn’s disease in patients with prior failure of anti-tumour necrosis factor treatment
Version: 4 Date: 25 Nov 2021
Reviewer's report:
This is a single-centre retrospective study that compared the efficacy of second-line vedolizumab
and tofacitinib in ulcerative colitis and second-line vedolizumab and ustekinumab in Crohn’s
disease (following anti-TNF failure). In total, 94 patients were evaluated (50 in UC population
and 44 in CD population). The authors concluded that after prior anti-TNF failure, vedolizumab
and tofacitinib in UC and vedolizumab and ustekinumab in CD patients were similar in terms
of clinical efficacy. The article is well written and comprehensive, and understanding the role
of second-line therapy is an increasingly important area of IBD research.
Major comments:
• The sample size is small in each group [for UC: 37 patients vs 13 patients in vedolizumab
and tofacitinib groups respectively, for CD:28 patients vs 16 patients in vedolizumab and
ustekinumab groups respectively] which limits the statistical analysis and increases the chance
of a type 2 error
• In the CD population, it appears the vedolizumab group has a more severe phenotype (based
on Montreal classification, CDAI and lower albumin levels) which would impact on the results.
This should at least be discussed in the limitations.
• Lack of data on biochemical (CRP, faecal calprotectin) and endoscopic information limit the
results given these are current treatment endpoints in managing IBD
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