Study type

Study topic

Human medicinal product
Disease /health condition

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

Observational retrospective study
Study drug and medical condition

Medicinal product name

XELJANZ

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

TOFACITINIB CITRATE

Medical condition to be studied

Colitis ulcerative
Inflammatory bowel disease
Crohn's disease
Population studied

Short description of the study population

The study population involved patients aged 18 years or older diagnosed with ulcerative colitis initiated treatment with tofacitinib identified from the database of American University of Beirut Medical Center (AUBMC).
Inclusion Criteria:
1. Male or female patients 18 years or older by the time of starting tofacitinib treatment
2. Confirmed diagnosis of ulcerative colitis.
3. Patients who have received treatment with tofacitinib for ulcerative Colitis with minimal follow-up period of 12 weeks.

Exclusion Criteria:
1. Current or previous (within the last 2 years) indeterminate or not classified colitis.
2. Changing of IBD type (ie, from UC to Crohn’s disease (CD), etc.) within the last 2 years.
3. Any combinations of tofacitinib with other advanced therapies.
4. Any previous use and discontinuation of tofacitinib.

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

Other

Special population of interest, other

Patients with ulcerative colitis

Estimated number of subjects

62
Study design details

Main study objective

The objective of this study is to describe the effectiveness of tofacitinib in the treatment of ulcerative colitis in a Lebanese cohort

Outcomes

Proportion of patients achieving clinical remission by 8 weeks, 26 weeks, and 52 weeks. Proportion of patients achieving endoscopic remission and response in ulcerative colitis as determined by the endoscopic Mayo score at 24 weeks, Proportion of patients that are still on tofacitinib treatment at 1 year. Proportion of patients requiring IBD surgery after 1 year of follow up. Changes in Calprotectin, CRP, Hemoglobin and LDL at 12 weeks compared with baseline following treatment with tofacitinib

Data analysis plan

All collected data will be analyzed. Analysis will be done by the Statistical Program for the Social Sciences (SPSS). All covariates will be summarized to get information about frequency distribution and mean, median or standard deviation. Numbers and percentages of patients who are in complete remission will be presented for weeks 8, 26, and 52 when performing descriptive analysis of categorical data. Means, medians, standard deviations will be provided for continuous variables when performing descriptive analysis of continuous data. The bivariate analysis will be conducted to determine if there is any association between the outcome and the exposure (the covariates). Unadjusted comparisons of baseline characteristics for 8, 26, and 52 weeks after complete remission against outcome measures will be provided. Appropriate tests will be used based on the distribution of the measure: