Comparative Effectiveness of Tofacitinib Versus Ustekinumab and Vedolizumab among Ulcerative Colitis Patients With Prior Anti- Tumor Necrosis Factor (TNF) Failure

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Retrospective study

Study drug and medical condition

• Name of medicine:
  XELJANZ

  ENTYVIO

  STELARA
• Medical condition to be studied:
  Colitis ulcerative

Population studied

• Short description of the study population:
  Patients with ulcerative colitis (UC) aged 18 years or older initiated treatment with tofacitinib, ustekinumab, or vedolizumab therapy on or after 01 May 2018 through 01 February 2022 identified from the Mass General Brigham (MGB) health system.; Inclusion Criteria:; 1. Age of 18 years or older.; 2. Initiation of tofacitinib, ustekinumab, or vedolizumab therapy for UC on or after 01 May 2018 through 01 April 2022.; 3. Prior anti-TNF exposure.; 4. Patient within the MGB health system.; ; Exclusion Criteria:; 1. History of prior colectomy.; 2. Primary indication of tofacitinib, ustekinumab, or vedolizumab therapy is not UC.; 3. Diagnosis of Crohn’s disease or indeterminate colitis.; 4. Dual therapy with tofacitinib and a biologic (eg, tofacitinib and vedolizumab or ustekinumab simultaneously) or vedolizumab/ustekinumab and a second biologic.
• 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:
  360

Study design details

• Main study objective:
  To asses how tofacitinib, ustekinumab and vedolizumab compare in real world safety and effectiveness of anti-TNF-experienced ulcerative colitis patients.
• Outcomes:
  Compare proportions of corticosteroid-free clinical remission 8-12 weeks and 52 weeks after tofacitinib, ustekinumab or vedolizumab initiation by using either SCCAI or Mayo score by greater than or equal 2 or physician global assessment. Compare drug survival (time to treatment discontinuation or colectomy) of tofacitinib versus ustekinumab and vedolizumab. Compare proportions of endoscopic response, endoscopic remission. Assess proportions of biochemical response and remission. Compare proportions of colectomy, IBD-related hospitalization, and corticosteroid use, proportions of patient-reported improvement in extra intestinal manifestations, proportions of potential complications and treatment discontinuations.
• Data analysis plan:
  After patient cohorts are identified in the MGB RPDR using the pre-specified inclusion and exclusion criteria, vedolizumab patients will be frequency matched 2:1 to tofacitinib patients by age (±3 years) and sex. The matched sample will be used for all subsequent analyses for this comparison. All eligible ustekinumab patients will be used in the tofacitinib vs ustekinumab comparison. De identified data will be imported into StataSE 17 for statistical analysis.

Documents

Study results

A3921415 Non Interventional Study Report Abstract 22 December 2022_Redacted

Study report

A3921415 Non Interventional Study Report 22 December 2022_Redacted

Study, other information

A3921415 Non Interventional Study Abstract_Amendment 1 08Apr2022_Redacted

A3921415 Non Interventional Study Abstract_Final 08Feb2022_Redacted