A Real-World Study of Guselkumab Persistence and Effectiveness in Participants With Crohn's Disease or Ulcerative Colitis (GALILEO)

Participants with confirmed diagnosis of moderate-to-severe UC or CD receiving guselkumab according to clinical practice will be enrolled. Only data available within clinical routine as standard of care will be documented for this study.

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.

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 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.

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 to guselkumab will be assessed using PRO-2, including stool frequency and rectal bleeding in UC participants through the patient's e-diary.

Age of participants receiving guselkumab treatment will be reported.

Sex of participants receiving guselkumab treatment will be reported.

Participants with previous IBD medication use will be reported.

Smoking status and history of participants receiving guselkumab treatment will be reported.

Height of participants receiving guselkumab treatment will be reported.

Weight of participants receiving guselkumab treatment will be reported.

Disease status of participants receiving guselkumab treatment will be reported.

Disease severity of participants will be reported.

Age at diagnosis of participants receiving guselkumab treatment will be reported.

Participants disease duration at study initiation will be reported.

Participants with comorbid diagnoses will be reported.

Participants with history of UC/CD and previous IBD-related therapy use and surgeries will be reported.

Participants receiving concomitant IBD medications for UC and CD will be reported.

The SIBDQ is a 10-item survey measuring HRQoL over the last 2 weeks (frequency of bowel movement, abdominal cramps, fatigue, lack of energy, worry of surgery, fear of no toilet, ability to relax, irritable, impact on leisure, impact on intimacy). The total score ranges from 10 to 70, where high score indicates better QoL.

The TSQM-9 is an abbreviated version of the 14-item TSQM, and is a reliable and valid measure to assess treatment satisfaction in naturalistic study designs, in which there is potential that the administration of the side effects domain of the TSQM would interfere with routine clinical care. It consists of 9 items distributed in the domains: side effects, effectiveness, convenience, and global satisfaction, with scores at each domain ranging from 0 to 100, with higher score indicating higher treatment satisfaction.

Change in the number of emergency room visits for treatment of UC/CD will be reported.

Change in the number of hospitalizations for treatment of UC/CD will be reported.

Change in the number of surgeries for treatment of UC/CD will be reported.

Change in CRP levels since guselkumab initiation will be reported. CRP is a marker of inflammation that will be measured by physicians following routine clinical practice.

Change in Fcal levels since guselkumab initiation will be reported. The Fcal is a marker of inflammation that will be measured by physicians following routine clinical practice.

An adverse event is any untoward medical occurrence in a participant administered a medicinal product. An AE does not necessarily have a causal relationship with the treatment. An adverse event can be any unfavorable and unintended sign (including an abnormal finding or lack of expected pharmacological action), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product.