Retrospective observational study on the effect of vedolizumab treatment on patients with inflammatory bowel disease and extraintestinal manifestations. The EMOTIVE study

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

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

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective multi-national, multi-centre medical chart review study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  VEDOLIZUMAB
• Medical condition to be studied:
  Inflammatory bowel disease

  Colitis ulcerative

  Crohn's disease

Population studied

• Short description of the study population:
  The study population consisted of adult patients with IBD and EIMs who initiated treatment with VDZ during the defined Eligibility Period.; ; Inclusion Criteria:; Patient eligibility was determined according to the following criteria prior to entry into the study:;  The patient diagnosed with moderate to severe UC or CD documented on the medical records;  The patient ≥18 years of age at initiation of VDZ (index date);  The patient presented, at least, one EIM documented on the medical records at maximum 2 months before VDZ treatment initiation and it had not been resolved by the time of initiation;  The patient received at least one dose of VDZ following standard practice for the treatment of IBD, attended at least one visit after induction and follow-up information was available for at least 6 months after VDZ initiation;  The patient, or when applicable, the patient’s legally acceptable representative signed and dated a written, informed consent form and any required privacy authorisation prior to the initiation of any study procedures, when required as per local regulations; ; Exclusion Criteria:; Any patient who met any of the below mentioned criteria did not qualify for entry into the study:;  Index date occurred as part of an interventional clinical trial or patient participated in an interventional clinical trial during the follow-up period;  The patient was diagnosed with indeterminate/an unspecified type of IBD;  The patient initiated VDZ treatment as combination therapy with other biological agents
• 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:
  Immunocompromised
• Estimated number of subjects:
  200

Study design details

• Main study objective:
  The primary objective of this study is to describe the percentage of patients treated with vedolizumab experiencing resolution of EIMs within 6 months post-treatment initiation.
• Outcomes:
  Primary outcome measure includes the demographic and clinical characteristics, percentage of patients with resolution of EIMs 6 month’s post-treatment initiation with vedolizumab. The secondary outcome includes clinical effectiveness at 14 weeks post induction, Month 6 and 12 post treatment initiation, change in physician assessment, disappearance of inflammatory lesions, change in level of C-reactive protein and faecal calprotectin, percentage of patients with EIMs resolution at Month 12, persistence rate at Month 12, time to treatment discontinuation, and safety events.
• Data analysis plan:
  Continuous variables will be described with number of patients with valid or missing observations, mean, standard deviation (SD), median, 25 and 75 percentiles (P25 and P75 respectively), minimum and maximum.

Documents

Study results

Vedolizumab-5041 CSR Synopsis BV 06Apr2022_Redacted Final

Vedolizumab-5041-Synopsis-08Apr2021