A Study of Long Term Persistency of Guselkumab in Adult Participants With Inflammatory Bowel Disease (GO-ON)

Participants with confirmed diagnosis of moderate to severe crohn's disease (CD) or ulcerative colitis (UC) will be enrolled according to the approved local prescribing label and treated with guselkumab according to the local clinical practice. No drug will be provided as part of this study. Only data available from clinical practice will be collected within this study.

Time to guselkumab discontinuation will be used to measure the guselkumab persistence in participants and is defined as the time from the first administration of guselkumab to its discontinuation date (defined as the date that the last dose of treatment was administered plus 1 dosing interval).

Endoscopic improvement is defined as Mayo score <=1. The Mayo Clinic Score is a composite index with total score ranging from 0 to 12. Higher scores indicate worse disease activity.

Endoscopic normalization is defined as Mayo score =0. The Mayo Clinic Score is a composite index with a total score ranging from 0 to 12. Higher scores indicate worse disease activity.

Number of participants with early responses to guselkumab measured via bowel urgency will be assessed via participant diaries.

Number of participants with early responses to guselkumab will be assessed via participant diaries. Measurements captured for CD include stool frequency and abdominal pain (AP).

Number of participants with early responses to guselkumab will be assessed via participant diaries. Measurements captured for UC include rectal bleeding and stool frequency (SF).

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. Efficacy will be evaluated by line of treatment and subpopulation.

Clinical remission for CD is defined as a HBI score of <= 4. Efficacy will be evaluated by line of treatment and subpopulation.

Corticosteroid-free clinical response for CD is defined as the reduction in HBI >=3 points from baseline or achieving HBI <=4 with no use of corticosteroids for at least 30 days. Efficacy will be evaluated by line of treatment and subpopulation.

Corticosteroid-free clinical remission will be defined as a HBI score of <= 4 and no use of corticosteroids for at least 30 days in participants with CD. Efficacy will be evaluated by line of treatment and subpopulation.

Mayo scoring system 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 summed to give a total score that ranges from 0-12. Clinical response for UC is defined as the PMS score less than (<) 4 or >= 30 percent (%) reduction from baseline. Efficacy will be evaluated by line of treatment and subpopulation.

Clinical remission for UC is defined as the PMS score < 2 and a rectal bleeding subscore of 0. Efficacy will be evaluated by line of treatment and subpopulation.

Corticosteroid free clinical response is defined as a PMS score of <4 or >=30% reduction from baseline and no use of corticosteroids for at least 30 days. Efficacy will be evaluated by line of treatment and subpopulation.

Corticosteroid-free clinical remission will be defined as a PMS score of less than (<)2, no use of corticosteroids for at least 30 days and a rectal bleeding subscore of 0 in participants with UC. Efficacy will be evaluated by line of treatment and subpopulation.

The CD PRO-2 consists of 2 items: abdominal pain and stool frequency. An AP score <=1 and a mean SF score <=3 and no worsening of AP or SF compared with baseline and no use of corticosteroids for at least 30 days in CD participants will be defined as a corticosteroid-free PRO-2 remission. Efficacy will be evaluated by line of treatment and subpopulation.

The UC PRO-2 is composed of rectal bleeding and stool frequency. An SF subscore of 0 or 1, where it has not increased from baseline, and a PMS rectal bleeding subscore of 0 with no use of corticosteroids for at least 30 days in UC participants will be defined as a corticosteroid-free PRO-2 remission. Efficacy will be evaluated by line of treatment and subpopulation.

Age of participants receiving guselkumab treatment will be reported.

Sex of participants receiving guselkumab treatment will be reported.

The number and type of previous inflammatory bowel disease (IBD) medication used by participant will be reported.

Number of participants with current and former smoking status 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 severity per participant at baseline will be assessed.

Participant's age at diagnosis will be reported.

Participants disease duration will be reported.

Number and nature of comorbidities per participant will be reported.

Number of participants with history of UC/CD will be reported.

Number of participants who have undergone previous IBD-related surgeries and the nature of surgeries will be reported.

An adverse event is any untoward medical occurrence in a participant administered a medicinal product. An adverse event 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.

Change in CRP levels since guselkumab initiation will be reported. C-reactive protein 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. Fcal is a marker of inflammation that will be measured by physicians following routine clinical practice where higher values indicate greater intestinal inflammation.

Number of participants with concomitant IBD medications and the type of concomitant medications given during guselkumab treatment will be reported.

The SIBDQ is a health-related quality of life (HRQoL) tool measuring physical, social, and emotional status in IBD participants. 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.

Health-related Quality of life of participants receiving guselkumab treatment as assessed by bowel urgency will be reported.

Health-related Quality of life of participants receiving guselkumab treatment as assessed by PRO-2 components will be reported.

The FACIT-F scale is a 13-item instrument designed to assess fatigue/tiredness and its impact on daily activities and functioning in chronic diseases. The instrument includes items such as tiredness, weakness, listlessness, lack of energy, and the impact of these feelings on daily functioning over the last 7 days. Scores are numeric and range from 0 to 52 with higher scores indicating less fatigue.

Endoscopic response is defined as 50% improvement from baseline in SES-CD total score, or SES-CD total score <= 4. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease. If SES-CD is not available, response is defined as a reduction in ulcer size, number or extend on endoscopy compared to baseline.

Endoscopic remission is defined as SES -CD total score <= 4 with at least 2 points reduction from baseline and no subscore >1 in any individual component . SES-CD score can range from 0 to 56. Higher scores indicating more severe disease. If SES-CD is not available, response is defined as an absence of mucosal ulcers as seen on endoscopy.

Histological improvement defined by a reduction in the Nancy score by at least one point compared to baseline will be reported. The Nancy index is defined by a 5-level classification ranging from grade 0 (absence of significant histological disease activity) to grade 4 (severely active disease).

Histological remission defined by a Nancy score of 0 or 1 will be reported. The Nancy index is defined by a 5-level classification ranging from grade 0 (absence of significant histological disease activity) to grade 4 (severely active disease).

IUS response is defined as reduction of BWT of >=25% or normalization (<=3 millimeters [mm]) of the most affected segment at Weeks 24, 48, 72, 96 in participants with increased BWT (>3 mm) at baseline.

IUS remission is defined as normalization of BWT (<=3 mm) and vascularity (no signal or short signal in color Doppler of the most affected segment) at Weeks 24, 48, 72, 96, in participants with increased BWT (> 3 mm) at baseline

MRE response is defined as improvement of bowel wall thickness and contrast enhancement compared to baseline.

MRE remission is defined as bowel wall thickness <=3 mm without segmental mural hyperenhancement.

TSQM-9 is an abbreviated version of the 14-item TSQM, and is a reliable and valid measure to assess treatment satisfaction. t 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. Here, higher scores indicating greater satisfaction for that domain. A positive change from baseline indicates improvement.

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.