Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Drug utilisation

Data collection methods

Secondary data collection
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

ADALIMUMAB
GOLIMUMAB
INFLIXIMAB
TOFACITINIB
VEDOLIZUMAB

Medical condition to be studied

Colitis ulcerative
Population studied

Short description of the study population

Tofacitinib cohort
Inclusion criteria
Patients will be new users of tofacitinib between January 1st, 2015 and December 31st, 2019 AND with a diagnosis OR a co-payemnt exemption code for UC in the lookback period or in the follow up OR a visit in a gastroenterological ward (code: 058) in the year before the index date. Index date will be the date of the first supply. We define new users each subject without supply of tofacitinib in the look-back period (5 years before the index date). Patients will be followed up for one or two years after the index date.
Exclusion criteria
a) Patients with less than 5 years of records in the look back period
b) Patients with less than 1 year of follow-up
c) Patients receiving more than one of the advanced therapy (table 1) at the index date
d) patients with a diagnosis or a co-payment exemption code for Crohn’s disease, rheumatoid arthritis, psoriasis, multiple sclerosis (G35.-), axial spondyloarthritis and ankylosing spondylitis (M45.-), psoriatic arthritis (L40.-), hidradenitis suppurativa / acne inversa (L73.2), uveitis intermedia, uveitis posterior und panuveitis (H20.-, H30.-) at any time in the look-back period. This criterion will identify only patients with prompt record (clinically relevant conditions)
e) patients aged ≤ 18 at index date
f) patients with records of visits in rheumatology ward (071) or dermatology ward (052) in the 1 year before the index date

Adalimumab cohort
Inclusion criteria
Patients will be new users of an adalimumab between January 1st, 2015 and December 31st, 2019 AND with a diagnosis OR a co-payment exemption code for UC in the lookback period or in the follow up OR a visit in a gastroenterology ward (code: 058) in the year before the index date. Index date will be the date of the first supply. We define new users each subject without supply of adalimumab in the look-back period (5 years before the index date). Patients will be followed up for
one or two years after the index date.

Exclusion criteria
a) Patients with less than 5 years of records in the look back period
b) Patients with less than 1 year of follow-up
c) Patients receiving more than one of the advanced therapy (table 1) at the index date
d) Patients with a diagnosis or a co-payment exemption code for Crohn’s disease, rheumatoid arthritis, psoriasis, multiple sclerosis (G35.-), axial spondyloarthritis and ankylosing spondylitis (M45.-), psoriatic arthritis (L40.-), hidradenitis suppurativa / acne inversa (L73.2), uveitis intermedia, uveitis posterior und panuveitis (H20.-, H30.-) at any time during in the look-back period. This criterion will identify only patients with prompt record (clinically relevant conditions)
e) patients aged ≤ 18 at index date
f) patients with record of use of oral budesonide (box 1) in the 5 years before cohort entry
g) patients with records of visits in rheumatology ward (071) or dermatology ward (052) in the 1 years before cohort entry

Golimumab cohort

Inclusion criteria
Patients will be new users of an golimumab between January 1st, 2015 and December 31st, 2019 AND with a diagnosis OR a tax exemption code for UC in the lookback period or in the follow up OR a visit in a gastroenterology ward (code: 058) in the year before the index date. Index date will be the date of the first supply. We define new users each subject without supply of golimumab in the lookback period (5 years before the index date). Patients will be followed up for one or two years after the index date.

Exclusion criteria
a) Patients with less than 5 years of records in the look back period
b) Patients with less than 1 year of follow-up
c) Patients receiving more than one of the advanced therapy (table 1) at the index date
d) patients with a diagnosis or a co-payment exemption code for Crohn’s disease, rheumatoid arthritis, psoriasis, multiple sclerosis (G35.-), axial spondyloarthritis and ankylosing spondylitis (M45.-), psoriatic arthritis (L40.-), hidradenitis suppurativa / acne inversa (L73.2), uveitis intermedia, uveitis posterior und panuveitis (H20.-, H30.-) at any time during in the look-back period. This criterion will identify only patients with prompt record (clinically relevant conditions)
e) patients aged ≤ 18 at index date
f) patients with records of visits in rheumatology ward (071) or dermatology ward (052) in the 1 years before index date

Infliximab cohort
Inclusion criteria
Patients will be new users of an infliximab between January 1st, 2015 and December 31st, 2019 AND with a diagnosis OR a co-payment exemption code for UC in the lookback period or in the follow up OR a visit in a gastroenterology ward (code: 058) in the year before the index date. Index date will be the date of the first supply. We define new users each subject without supply of infliximab in the look-back period (5 years before the index date). Patients will be followed up for one or two year after the index date.

Exclusion criteria
a) Patients with less than 5 years of records in the look back period
b) Patients with less than 1 year of follow-up
c) Patients receiving more than one of the advanced therapy (table 1) at the index date
d) patients with a diagnosis or a co-payment exemption code for Crohn’s disease, rheumatoid arthritis, psoriasis, multiple sclerosis (G35.-), axial spondyloarthritis and ankylosing spondylitis (M45.-), psoriatic arthritis (L40.-), hidradenitis suppurativa / acne inversa (L73.2), uveitis intermedia, uveitis
posterior und panuveitis (H20.-, H30.-) at any time during in the look-back period. This criterion will identify only patients with prompt record (clinically relevant conditions)
e) patients aged ≤ 18 at index date
f) patients with record of use of oral budesonide (box 1) in the 5 years before cohort entry
g) patients with records of visits in rheumatology ward (071) or dermatology ward (052) in the 1 years before index date.

Vedolizumab cohort
Inclusion criteria
Patients will be new users of an vedolizumab between January 1st, 2015 and December 31st, 2019 AND with a diagnosis OR a tax exemption code for UC in the lookback period or in the follow up OR a visit in a gastroenterology ward (code: 058) in the year before the index date. Index date will be the date of the first supply. We define new users each subject without supply of infliximab in the look-back period (5 years before the index date). Patients will be followed up for one or two years after the index date.

Exclusion criteria
a) Patients with less than 5 years of records in the look back period
b) Patients with less than 1 year of follow-up
c) Patients receiving more than one of the advanced therapy (table 1) at the index date
d) patients with a diagnosis or a co-payment exemption code for Crohn’s disease, rheumatoid arthritis, psoriasis, multiple sclerosis (G35.-), axial spondyloarthritis and ankylosing spondylitis (M45.-), psoriatic arthritis (L40.-), hidradenitis suppurativa / acne inversa (L73.2), uveitis intermedia, uveitis posterior und panuveitis (H20.-, H30.-) at any time during in the look-back period. This criterion will identify only patients with prompt record (clinically relevant conditions)
e) patients aged ≤ 18 at index date
f) patients with record of use of oral budesonide (box 1) in the 5 years before index date

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Special population of interest

Immunocompromised

Estimated number of subjects

500
Study design details

Main study objective

This study will describe the population of users of advanced treatments for Ulcerative Colitis in Tuscany (Italy) by means of real world data. This study will also analyze health direct costs (drugs, hospitalizations, ED accesses, specialist encounters) associated with the management of this population when treated with advanced treatment.

Data analysis plan

Descriptive analysis
Documents
Study results
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