The purpose of this study is to characterize participants with Crohn's Disease (CD) and Ulcerative Colitis (UC) receiving guselkumab in a real-world setting, and to evaluate treatment persistence (continuation) and clinical effectiveness (how well it works) in the overall population and in predefined participant subgroups. The study will also assess patient-reported outcomes, including fatigue (low energy), health-related quality of life (HRQoL), and treatment satisfaction. CD and UC are long-term diseases that cause inflammation in intestine (part of digestive system).
The participant must have a confirmed diagnosis of moderate-to-severe CD or UC recorded in the medical records
The participant must be eligible for biologic treatment and scheduled to initiate treatment with guselkumab for CD or UC management as per physician decision under routine clinical practice conditions, and according to the summary of product characteristics (SmPC) of the drug
The participant has provided signed informed consent
The participant is currently enrolled in an interventional clinical study
The participant has been previously exposed to interleukin (IL)-23 inhibitors, including guselkumab (Tremfya), risankizumab (Skyrizi) or mirikizumab (Omvoh). As an exception, participants who had previously received ustekinumab may be included
The participant has a history of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy, including biologics and/or small molecules
The participant is unable to provide the informed consent form (ICF) and/or unable to complete the questionnaires/scales and patient's diary to address the study objectives
The study population will include participants with confirmed diagnosis of moderate-to-severe Crohn's disease (CD) or Ulcerative colitis (UC) disease.
Cohort
Prospective
Not listed
Persistence of Treatment with Guselkumab
Persistence of treatment with guselkumab will be defined as the time elapsed from the date of the first administration of guselkumab to its discontinuation date. The discontinuation date will be defined as the date that the next administration of guselkumab should have taken place for a paticipant after the last dose of treatment was administered.
Percentage of Participants with Early Responses to Guselkumab Measured Using Patient Reported Outcome (PRO-2) for Crohn's Disease (CD)
Percentage of participants with early responses to guselkumab will be assessed using PRO-2, including stool frequency and abdominal pain in CD participants through the patient's electronic (e)-diary.
Percentage of Participants with Early Responses to Guselkumab Measured Using PRO-2 for Ulcerative Colitis (UC)
Percentage of participants with early responses to guselkumab will be assessed using PRO-2, including stool frequency and rectal bleeding in UC participants through the patient's e-diary.
Percentage of Participants with Early Responses to Guselkumab Measured Using Bowel Urgency (BU)
Percentage of participants with early responses to guselkumab using bowel urgency will be assessed and reported via patient e-diary. BU is defined as the sudden or immediate need to have a bowel movement, will be assessed using both a qualitative and a quantitative approach. For the qualitative assessment the presence as a binary yes/no outcome of the symptoms will be collected; for the quantitative assessment the severity of BU will be evaluated using the urgency numerical rating scale (UNRS) ranging from 0 to 10, where 0 = no urgency and 10 = worst possible urgency.
Percentage of Participants Achieving Clinical Response for CD as Measured by Harvey-Bradshaw Index (HBI)
Percentage of participants reporting effectiveness with treatment guselkumab will be measured through the HBI for CD. The HBI consists of a 5-part questionnaire, assessing general wellbeing, AP, number of liquid stools per day, abdominal mass and complications. 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.
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