The purpose of this study is to find out how long a participant keeps taking guselkumab or continues with their treatment plan without stopping (treatment persistence) in participants with moderate to severe Crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are inflammatory bowel diseases, a group of inflammatory conditions of the colon and small intestine.
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
Participant must have a confirmed diagnosis of moderate-to-severe CD or UC recorded in their medical records
Participant must sign an informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements
Contraindicated to guselkumab per the label
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 receiving guselkumab in routine clinical practice.
Cohort
Prospective
Not listed
Time to Guselkumab Discontinuation
Persistence with guselkumab treatment will be assessed through time to guselkumab discontinuation which is defined as the time at which the next infusion should have taken place for a participant after their last scheduled infusion. It will be used to measure the guselkumab persistence in participants.
Number of Participants with Early Responses to Guselkumab Measured Using Bowel Urgency
Number of participants with early responses to guselkumab measured using bowel urgency will be assessed via participant diaries.
Number of Participants with Early Responses to Guselkumab Measured Using Patient Reported Outcome (PRO-2) Components
Number of participants with early responses to guselkumab will be assessed using PRO-2 components and reported via participant diaries. Measurements captured include stool frequency, rectal bleeding, and abdominal pain.
Number of Participants Achieving Clinical Response for CD as Measured by Harvey-Bradshaw Index (HBI) Score
HBI score is used to assess disease severity and treatment effectiveness. The HBI consists of a 5-part questionnaire, assessing general wellbeing, abdominal pain, number of liquid stools per day, abdominal mass and complications. Clinical response for CD is defined as the reduction in HBI by greater than or equal to (\>=)3 points from baseline or achieving HBI less than or equal to (\<=) 4.
Number of Participants Achieving Clinical Response for Ulcerative Colitis (UC) as Measured by Partial Mayo Score (PMS)
PMS is used to assess disease severity and treatment effectiveness. The PMS comprises 3 categories: rectal bleeding, SF, and physician assessment. These are rated from 0-3 and are totaled to give a total score that ranges from 0-12. Higher score indicates severe disease. Clinical response for UC is defined as the PMS score less than (\<) 4 or \>= 30 percent (%) reduction from baseline.
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