Entyvio(vedolizumab) long-term safety study

• Research type

  Research Study

• Full title

  Entyvio (vedolizumab) long-term safety study: An international observational prospective cohort study comparing vedolizumab to other biologic agents in patients with ulcerative colitis or Crohn’s Disease.

• IRAS ID

  164916

• Contact name

  Shaji Sebastian

• Contact email

  shaji.sebastian@hey.nhs.uk

• Sponsor organisation

  Takeda Development Centre Europe

• Duration of Study in the UK

  6 years, 2 months, 30 days

• Research summary

  Summary of Research

  This is a non-interventional study to be conducted at a number of locations in various countries around the world, primarily to assess the long-term safety of vedolizumab versus other biologic agents in patients with Ulcerative Colitis (UC) or Chron's Disease (CD).Approximately 2500 patients per treatment cohort (vedolizumab versus other biologic agents) will be enrolled and followed for the course of the study(7 YEARS).Adult patients, 18 years or older, who are initiating vedolizumab for approved indications, or similar patients who are initiating another biologic agent for UC or CD, will be recruited. Eligible patients will be enrolled in the study, provide baseline information, and be followed until termination of the study. Study assessments will be collected at least every 6 months by their treating physician. Serious adverse events, adverse events of special interest, and adverse reactions will be recorded at all visits.The secondary objective is to describe changes in UC/CD disease activity, using disease activity scores, health resources used,and quality of life (QoL) results, during the course of the study.

  Summary of Results

  The researchers wanted to learn if it is safe for patients with UC or CD to take vedolizumab for a long time compared to other biologic agents. To do this, the researchers checked how many patients who received vedolizumab, including those who switched from other biologic agents in Group B to vedolizumab, had serious infections over the duration of the study compared to patients who received other biologic agents. The researchers also looked at other certain medical conditions.
  The researchers found out that the occurrence of serious infections among those who received vedolizumab was similar to those who received other biologic agents.
  They also saw the same result for the other certain medical conditions that they looked at:

  • Infections involving the GI tract
  • Cancer
  • Reactions to the infusion of medicines • Liver injury

  The researchers also looked at the combined results of patients who had either infections of the chest (lower respiratory tract infection) or infections of the nose, sinuses, or throat (upper respiratory tract infection). The researchers found out that having side effects of lower and upper respiratory tract infections was more common to those who received vedolizumab than those who received other biologic agents.
  For the patients who became pregnant during the study, there was no difference in the outcomes of the pregnancy between those who received vedolizumab and those who received other biologic agents.

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  15/SW/0089

• Date of REC Opinion

  25 Mar 2015

• REC opinion

  Favourable Opinion