The main aim of the study is to observe adult participants in South Korea that are being treated with vedolizumab injected just under the skin (subcutaneous or SC) to treat ulcerative colitis (UC) or Crohn's disease (CD) who have had an in-adequate response with, lost response to, or had too many side effects in response to either conventional therapy or a Tumor Necrosis Factor-alpha (TNF-α) antagonist. This study will observe the side effects and potential benefit to UC and CD participants related to vedolizumab SC treatment with data collection from medical files. There is no treatment involved in this study, this is only an observational review of current collected data relating to adults in South Korea with UC or CD treated with vedolizumab SC.

This is a prospective, non-interventional, post-marketing study of adult participants with moderately to severely active UC or CD, who have had an inadequate response with, lost response to, or were intolerant to conventional therapy or a TNF-α antagonist. This study will evaluate the safety and effectiveness of vedolizumab SC in a routine clinical practice setting under real world condition.

This study will enroll approximately 600 participants. The data will be prospectively collected, at the centers and recorded into electronic case report forms (e-CRFs). All participants will be enrolled in a single observational group:

• Participants with UC or CD

This multi-center trial will be conducted in South Korea. The overall time for data collection in the study will be approximately 6 years.

Inclusion Criteria:

1. With moderately to severely active UC or CD, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF-α antagonist
2. With evidence of therapeutic benefit after at least 2 vedolizumab intravenous infusions

Exclusion Criteria:

1. With hypersensitivity such as dyspnea, bronchospasm, urticaria, flushing and increased heart rate to the vedolizumab substance or to any of its excipients
2. With active severe infections such as tuberculosis, cytomegalovirus, sepsis, listeriosis and opportunistic infections such as Progressive Multifocal Leukoencephalopathy (PML)
3. For whom vedolizumab SC is contraindicated as per product label

This study will enroll participant with moderately to severely active UC and CD, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF-α antagonist.

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.