Real world evidence of the usage of tofacitinib in Ulcerative Colitis patients in Lebanon

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

• Name of medicine:
  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:

Documents

Study results

A3921393 Non-Interventional Study Report 11 January 2023_Redacted

Study report

A3921393 Non-Interventional Study Report Abstract 11 January 2023_Redacted

Study, other information

A3921393_Study Abstract V1.0 14 Jun 2021

A3921393_Study Abstract V2.0 29 Apr 2022