A Real-World Study of Guselkumab in Ulcerative Colitis and Crohn's Disease in Saudi Arabia

Time to guselkumab discontinuation is defined as time at which the next infusion should have taken place for a participant after their last scheduled infusion.

Number of participants with early responses to guselkumab will be assessed using PRO-2 components for CD. Measurements captured include abdominal pain (AP) and stool frequency (SF).

Number of participants with early responses to guselkumab will be assessed using PRO-2 components for UC. Measurements captured include rectal bleeding and stool frequency.

Number of participants with early responses to guselkumab will be assessed using bowel urgency. Bowel urgency from participants will be asked as yes or no outcome.

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 HBI score less than or equal to (<=) 4 or a decrease in HBI by greater than or equal to (>=) 3 from baseline.

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 totaled 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.

Participants Achieving Corticosteroid-free remission for UC will be reported.

Participants Achieving Corticosteroid-free remission for CD will be reported.

Corticosteroid-free PRO-2 remission in UC participants is defined as a SF score of 0 or 1, where it has not increased from baseline, and a rectal bleeding sub score of 0 with no use of steroids for at least 30 days.

Corticosteroid-free PRO-2 remission in CD participants is defined as an AP score less than or equal to (<=)1 and a mean SF score <=3 and no worsening of AP or SF compared with baseline and no use of steroids for at least 30 days.

Age of participants receiving guselkumab treatment will be reported.

Sex of participants receiving guselkumab treatment will be reported.

Number of participants using the previous inflammatory bowel disease (IBD) medication 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.

Number of participants reporting the disease severity will be assessed.

Participants age at diagnosis will be reported.

Participants disease duration will be reported.

Number of participants with Comorbid Diagnoses will be reported.

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

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

An adverse event is any untoward medical occurrence in a participant administered a medicinal product based on appropriate medical judgment. 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.

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. The Fcal is a marker of inflammation that will be measured by physicians following routine clinical practice.

Number of participants receiving concomitant IBD medications during guselkumab treatment will be reported.

SIBDQ is a HRQoL tool measuring physical, social, and emotional status in IBD patients 45. 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.

TSQM-9 is an abbreviated version of the 14-item TSQM, and is a reliable and valid measure to assess treatment satisfaction. 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. Higher score indicating higher treatment satisfaction.

Endoscopic response is defined as 50% improvement from baseline in SES-CD total score, or SES-CD total score <=4.

Endoscopic remission in participants with CD is defined as SES-CD total score <= 4 with at least 2 points reduction from baseline and no subscore greater than (>)1 in any individual component.

Endoscopic Improvement is defined as a Mayo score <=1.

Endoscopic normalization is defined as a Mayo score =0.

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.