Title: Real-world characteristics, treatment experiences and corticosteroid utilisation of patients
treated with tofacitinib for moderate to severe ulcerative colitis
Version: 4 Date: 27 Dec 2021
Reviewer's report:
Chiorean et al present a retrospective study using a US claims database to describe the clinical
characteristics, treatment utilisation, and steroid use of tofacitinib-treated patients over a 14-
month period. Patients were reported and outcomes were categorised according to prior biologic.
The pool of real-world studies for tofacitinib are increasing but remain small and studies that
add to this limited cohort, particularly those with longer-term follow up, are welcomed.
It is not entirely clear why the authors chose to include patients treated with vedolizumab and
TNF inhibitors from the claims database when the focus of the manuscript and further analyses
regards tofacitinib. It appears that this is simply to highlight that these groups had a different
percentage of prior biologic exposures, but this is axiomatic given tofacitinib was approved later.
I am not sure this adds anything if there is no further analysis.
The authors report that patients receiving immunomodulators decreased from 30% to 9%
following tofacitinib initiation. However, concomitant immunomodulator use with tofacitinib is
not standard UC practice and so I suspect these are rheumatology patients. The authors briefly
mention this in the discussion and thus the cohort presented as UC are very much likely to be
a mix of both UC and RA/PsA patients.
Unfortunately, this study is significantly limited by its scope and provides little to what
is already known i.e. that tofacitinib patients are more likely to be bio-exposed (note that
tofacitinib was approved after anti-TNF and vedolizumab) and that corticosteroid use declines in
tofacitinib-treated patients (the drug was evaluated for this in the registration studies and in most
effectiveness studies since then).  The inherent limitations of studies from a claims database also
adversely impacts the validity of their findings.
Title: Real-world characteristics, treatment experiences and corticosteroid utilisation of patients
treated with tofacitinib for moderate to severe ulcerative colitis
Version: 4 Date: 27 Dec 2021
Reviewer's report:
Chiorean et al present a retrospective study using a US claims database to describe the clinical
characteristics, treatment utilisation, and steroid use of tofacitinib-treated patients over a 14-
month period. Patients were reported and outcomes were categorised according to prior biologic.
The pool of real-world studies for tofacitinib are increasing but remain small and studies that
add to this limited cohort, particularly those with longer-term follow up, are welcomed.
It is not entirely clear why the authors chose to include patients treated with vedolizumab and
TNF inhibitors from the claims database when the focus of the manuscript and further analyses
regards tofacitinib. It appears that this is simply to highlight that these groups had a different
percentage of prior biologic exposures, but this is axiomatic given tofacitinib was approved later.
I am not sure this adds anything if there is no further analysis.
The authors report that patients receiving immunomodulators decreased from 30% to 9%
following tofacitinib initiation. However, concomitant immunomodulator use with tofacitinib is
not standard UC practice and so I suspect these are rheumatology patients. The authors briefly
mention this in the discussion and thus the cohort presented as UC are very much likely to be
a mix of both UC and RA/PsA patients.
Unfortunately, this study is significantly limited by its scope and provides little to what
is already known i.e. that tofacitinib patients are more likely to be bio-exposed (note that
tofacitinib was approved after anti-TNF and vedolizumab) and that corticosteroid use declines in
tofacitinib-treated patients (the drug was evaluated for this in the registration studies and in most
effectiveness studies since then).  The inherent limitations of studies from a claims database also
adversely impacts the validity of their findings.
Please review this paper.
user
Title: Real-world characteristics, treatment experiences and corticosteroid utilisation of patients
treated with tofacitinib for moderate to severe ulcerative colitis
Version: 4 Date: 27 Dec 2021
Reviewer's report:
Chiorean et al present a retrospective study using a US claims database to describe the clinical
characteristics, treatment utilisation, and steroid use of tofacitinib-treated patients over a 14-
month period. Patients were reported and outcomes were categorised according to prior biologic.
The pool of real-world studies for tofacitinib are increasing but remain small and studies that
add to this limited cohort, particularly those with longer-term follow up, are welcomed.
It is not entirely clear why the authors chose to include patients treated with vedolizumab and
TNF inhibitors from the claims database when the focus of the manuscript and further analyses
regards tofacitinib. It appears that this is simply to highlight that these groups had a different
percentage of prior biologic exposures, but this is axiomatic given tofacitinib was approved later.
I am not sure this adds anything if there is no further analysis.
The authors report that patients receiving immunomodulators decreased from 30% to 9%
following tofacitinib initiation. However, concomitant immunomodulator use with tofacitinib is
not standard UC practice and so I suspect these are rheumatology patients. The authors briefly
mention this in the discussion and thus the cohort presented as UC are very much likely to be
a mix of both UC and RA/PsA patients.
Unfortunately, this study is significantly limited by its scope and provides little to what
is already known i.e. that tofacitinib patients are more likely to be bio-exposed (note that
tofacitinib was approved after anti-TNF and vedolizumab) and that corticosteroid use declines in
tofacitinib-treated patients (the drug was evaluated for this in the registration studies and in most
effectiveness studies since then).  The inherent limitations of studies from a claims database also
adversely impacts the validity of their findings.
assistant