A Study to Assess Guselkumab in Participants With Moderate-to-Severe Inflammatory Bowel Disease in Real Life Italian Setting

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 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 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 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.

Percentage of participants reporting effectiveness with treatment guselkumab will be measured through the PMS for UC. The PMS comprises 3 categories: rectal bleeding, stool frequency, and physician assessment. Clinical response for UC is defined as the PMS score less than (<) 4 or >= 30 percent (%) reduction from baseline.

Corticosteroid-free clinical remission for UC is defined as no use of steroids for at least 30 days and PMS less than (<) 2 and a rectal bleeding subscore of 0. Mayo scoring system is used to assess disease severity and treatment effectiveness.

Corticosteroid-free clinical remission for CD is defined as no use of steroids for at least 30 days and HBI score less than or equal to (<=)4. HBI score is used to assess disease severity and treatment effectiveness.

Age of participants receiving guselkumab treatment will be reported.

Sex of participants receiving guselkumab treatment will be reported.

Weight of participants receiving guselkumab treatment will be reported.

BMI of participants receiving guselkumab treatment will be reported.

Vital signs (SBP and DBP) of participants will be reported.

Number of participants with comorbidities will be reported.

Number of participants with smoking status and history will be reported.

Participants IBD related data at diagnosis will be reported.

Participants age at diagnosis will be reported.

Participants with a previous diagnosis of plaque psoriasis, arthritic psoriasis and previous use of IBD treatment will be reported.

Participants reporting the disease severity will be assessed.

Participants disease location will be assessed.

Participants disease extent will be assessed.

Participants with presence of extraintestinal manifestations will be assessed.

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.

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.

Percentage of participants receiving concomitant IBD medications for UC and CD will be reported.

SIBDQ is a 10-item instrument developed to assess the participants perception of their health status specifically related to IBD over the past two weeks. The SIBDQ evaluates the following dimensions: psychological well-being (feelings of emotional health and stability), physical well-being (the impact of disease symptoms on physical health), social function (the influence of the disease on social activities and interactions) and digestive function (the effect of gastrointestinal symptoms on daily life). The total score ranges from 10 (worst health) to 70 (best health).

FACIT-F scale is a 13-item instrument that evaluates fatigue/tiredness and its impact on daily activities and functioning in chronic diseases. It includes items such as tiredness, weakness, listlessness, lack of energy, and the impact of these feelings on daily functioning (for example, sleeping and social activities) over the last 7 days. The total FACIT-F score ranges from 0 to 52, with a higher score indicating less fatigue.

Endoscopic response in participants with CD 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 (Week 0) and no sub-score >1 in any individual component total score (terminal ileum, right colon, transverse colon, left colon, rectum).

Endoscopic improvement in participants with UC is defined as a Mayo endoscopic score (MES) <=1.

Endoscopic normalization in participants with UC is defined as a Mayo score =0.

Histologic improvement is defined as neutrophil infiltration in <5% of crypts, no crypt destruction, and no erosions, ulcerations or granulation tissue according to the Geboes grading system, that is, Geboes score <=3.1.

Histologic remission is defined as the absence of neutrophils from the mucosa (both lamina propria and epithelium), no crypt destruction, and no erosions, ulcerations or granulation tissue according to the Geboes grading system, that is, Geboes score <=2B.0.

IUS (transmural) response in CD participants is defined as reduction of bowel wall thickness (BWT) of >=25% or normalization [<=3 millimeter {mm}] of the most affected segment.

IUS (transmural) remission in CD participants is defined as normalization of BWT (<=3 mm) and vascularity (no signal or short signal in color doppler of the most affected segment), in participants with increased BWT (>3 mm) or alternatively a Bowel Ultrasound Score (BUSS) <=3.52.

IUS response is defined as a decrease in Milan Ultrasound Criteria (MUC) >=2 points. The MUC is a validated ultrasound-based scoring system used to assess disease activity in UC. It combines BWT and vascularization (using Doppler imaging) to predict disease course.

IUS Remission is defined as normalization of BWT and of all other IUS parameters or as a MUC < 4.3. The MUC is a validated ultrasound-based scoring system used to assess disease activity in UC. It combines BWT and vascularization (using Doppler imaging) to predict disease course. MUC score < 4.3 is considered a significant indicator of endoscopic remission MES= 0.

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. with higher score indicating higher treatment satisfaction.

Percentage of participants receiving previous IBD-related surgeries will be reported.

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.

mIBD-disk includes 10+1 items assessing abdominal pain, defecation, social life, professional life, sleep, energy, anxiety, self-image, sexual functions, joint pain and dietary habits. Participants rate each item on an 11-point visual analogue scale, ranging from 0 ("absolutely disagree") to 10 ("absolutely agree"). An average total IBD-Disk score of 40 (44 for the mIBD version) or higher is generally associated with a moderate-to-severe level of disability in individuals with IBD.

The assessment of the evolution of EIMs during guselkumab treatment will be performed by the physician on a 4-point Likert scale (1 = Recovered: the EIM has resolved completely; 2 = Improved: the EIM has shown clinical improvement but is not fully resolved. 3 = Unchanged: no change in the severity or status of the EIM; 4 = Worsened: the EIM has deteriorated or increased in severity from previous visit).