The purpose of this study is to evaluate how long participants with moderate-to-severe Crohn's Disease (CD) and Ulcerative Colitis (UC) continue treatment with guselkumab in a real-world setting. CD and UC are long-term diseases that cause inflammation in intestine (part of digestive system).
Participant must be eligible for biologic treatment and initiate guselkumab according to the approved indications as described in the current version of the summary of product characteristics (SmPC) of the drug. Decision to prescribe must solely be made by the treating physician. Participant must have been at least 8 weeks under guselkumab treatment before being included in the study, regardless if they are still on guselkumab treatment or not
Participant must have a confirmed diagnosis of moderate-to-severe or Crohn's Disease (CD) or Ulcerative Colitis (UC) recorded in their medical records: Harvey-Bradshaw Index (HBI) greater than (>)4 for CD and Partial Mayo Score (pMS)>2 for UC
Participant [and/or their legally-acceptable representative where applicable] must sign a participation agreement/informed consent form (ICF) allowing source data verification in accordance with local requirements
Contraindicated to guselkumab per the label
It is currently enrolled in an interventional clinical study
Has been previously exposed to interleukin (IL)-23 inhibitors, including Tremfya® (guselkumab), Skyrizi® (risankizumab) and Omvoh® (mirikizumab). As an exception, participants with history of ustekinumab exposure, may be included
History of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and/or small molecules)
The study population will include participants with confirmed diagnosis of moderate-to-severe Crohn's disease (CD) or Ulcerative colitis (UC) disease.
Cohort
Other
Not listed
Persistence of Treatment with Guselkumab
Persistence of treatment with guselkumab will be measured through time to guselkumab discontinuation defined as the time at which the next infusion should have taken place for a participant after their last scheduled infusion.
Number of Participants Achieving Clinical Response for Crohn's disease (CD) as Measured by Harvey-Bradshaw Index (HBI)
Participants reporting effectiveness with treatment of guselkumab will be measured through the HBI for CD. Clinical response for CD is defined as the HBI score less than or equal to (\<=) 4 or a decrease in HBI by greater than or equal to (\>=) 3 from baseline. The HBI consists of a 5-part questionnaire, assessing general wellbeing, abdominal pain (AP), number of liquid stools per day, abdominal mass and complications.
Number of Participants Achieving Clinical Response for CD as Measured by Patient Reported Outcome (PRO-2)
Number of participants with clinical response to guselkumab will be assessed using PRO-2, including stool frequency and abdominal pain in CD participants through the patient's electronic (e)-diary.
Number of Participants Achieving Clinical Response for Ulcerative colitis (UC) as Measured by Partial Mayo Score (PMS)
Participants reporting effectiveness with treatment of guselkumab will be measured through the PMS for UC. Clinical response for UC is defined as the PMS score \< 4 or \>= 30 percent (%) reduction from baseline. PMS comprises 3 categories: rectal bleeding, stool frequency, and physician assessment.
Number of Participants Achieving Clinical Response for UC as Measured by PRO-2
Number of participants achieving clinical response to guselkumab will be assessed using PRO-2, including stool frequency and rectal bleeding in UC participants through the patient's e-diary.
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