A network meta-analysis of real-world studies comparing tofacitinib with other advanced therapies in the treatment of moderate-to-severe ulcerative colitis

Study type

• Study topic:
  Human medicinal product
• Study type:
  Not applicable
• Scope of the study:
  Feasibility analysis
• If ‘Not applicable’, further details on the study type:
  Network meta-analysis

Study drug and medical condition

• Name of medicine:
  XELJANZ
• Study drug International non-proprietary name (INN) or common name:
  TOFACITINIB CITRATE
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AF01) tofacitinib

  tofacitinib
• Medical condition to be studied:
  Colitis ulcerative

Population studied

• Short description of the study population:
  A total of 246 studies will be included in this network meta analysis; the actual number of patients in each study will be determined after data analysis.
• 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)

Study design details

• Main study objective:
  To compare the effectiveness and safety of tofacitinib with other advanced therapies in real-world studies for the treatment of patients with moderate-to-severe UC.
• Outcomes:
  1.To estimate the difference in the likelihood of achieving a clinically meaningful response, in terms of effectiveness outcomes, between patients treated with tofacitinib compared to other advanced therapies. ; 2. To estimate the relative risk of serious adverse events (AEs) between patients treated with tofacitinib versus other advanced therapies ; Are there secondary outcomes? ; 3. To estimate the incidence rate (IR) of various AEs, and of mortality, on each therapy.
• Data analysis plan:
  In the following, two approaches have been planned to performing the NMA, (i) contrast-based models which perform the synthesis of data on relative treatment effects between study arms, and (ii) arm-based models which perform the synthesis of data on absolute effects across study arms. Both approaches can be applied to estimate an overall pooled relative effect.

Documents

Study report

A3921447 Study Report 27Jan2025.pdf

A3921447 Study Report Abstract.pdf