Utilization Analysis of Tofacitinib and Other Drugs Among Individuals with Ulcerative Colitis: Feasibility Analysis

Utilization Analysis of Tofacitinib and Other Drugs Among Individuals with Ulcerative Colitis: Feasibility Analysis

Utilization Analysis of Tofacitinib and Other Drugs Among Individuals with Ulcerative Colitis: Feasibility Analysis

OS0003

Overview

What is the issue?
  • Tofacitinib, a Janus Kinase (JAK) inhibitor, is used to treat moderate to severe ulcerative colitis and other inflammatory diseases in adults.
  • Safety concerns with the use of tofacitinib have emerged from studies reporting increased risks of major adverse cardiovascular events (MACE), thrombotic events, and cancer. As a result, regulatory agencies have issued warnings and labelling recommendations.
  • However, these safety signals were detected in older patients who were treated with tofacitinib for rheumatoid arthritis and may not be generalizable to individuals treated for ulcerative colitis, who tend to be younger with fewer comorbidities. In addition, existing safety data from studies with Canadian population are limited.
What was the aim of the study?
  • This drug utilization study aimed to describe the use of tofacitinib and other therapies among individuals diagnosed with ulcerative colitis and determine the feasibility of a comparative safety study of MACE, hospitalized thrombotic events, and cancer.
How was the study conducted?
  • We conducted a retrospective cohort study using administrative health databases from 3 Canadian provinces (Manitoba, Ontario, and Saskatchewan) and the United States.
  • In each database, we established a base cohort of individuals with a ulcerative colitis diagnosis between January 1, 2010 and March 31, 2023.
  • From this base cohort, we created treatment cohorts for the following 4 categories between January 1, 2018 and March 31, 2023: new users of tofacitinib, new users of a tumor necrosis factor (TNF) alpha inhibitor, new users of vedolizumab or ustekinumab, and new users of a conventional therapy.
  • Patient characteristics were described within each treatment cohort, and the crude incidence rates of MACE, hospitalized thrombotic events and cancer were estimated.
What did the study find?
  • We identified 401,651 adults diagnosed with ulcerative colitis between 2010 and 2023. Of these, 399 initiated tofacitinib, 2,463 a TNF alpha inhibitor, 1,279 vedolizumab or ustekinumab, and 51,052 a conventional therapy between January 1, 2018, and March 31, 2023.
  • Tofacitinib was rarely used for ulcerative colitis, and when it was, it was mostly used as a third-line or fourth-line treatment.
  • The overall duration of follow-up was short, with the median durations ranging from less than 0.5 years to approximately 1.5 years.
  • A limited number of outcome events were observed among new users of tofacitinib and other treatment groups. There were no MACE and either 0 or less than 6 thrombotic events among individuals taking tofacitinib, and cancer rates could not be estimated.
Implications
  • The outcome rates estimated are crude and should be interpreted with caution given the rarity of events and lack of statistical adjustment.
  • These findings suggest that detailed safety studies of tofacitinib in ulcerative colitis are not currently feasible in our data holdings.
Key messages
  • Due to the limited number of events observed in our study, it is not possible to draw conclusions regarding associations between the use of tofacitinib in ulcerative colitis and the safety events that we studied.

Manuscripts

Presentations

Project Team

Project Co-Lead
Anat Fisher MD, PhD
Project Co-Lead
Colin R. Dormuth ScD
Content Expert
Alain Bitton
Lead Analyst
Matthew Dahl BSc
Research Assistant
Audray St-Jean MSc
Site Investigator
Colin R. Dormuth ScD
MarketScan
Site Investigator
Donica Janzen PhD
Saskatchewan
Site Investigator
Michael Paterson MSc
Ontario
Site Investigator
Silvia Alessi-Severini BSc (Pharm), PhD
Manitoba
Analyst
Jason Kim MPH, BHSc
MarketScan
Analyst
Ayodele Ajayi
MarketScan
Analyst
Xinya Lu PhD
Saskatchewan
Analyst
Fangyun Wu MSc
Ontario
Analyst
Matthew Dahl BSc
Manitoba