A Study to Generate Real-world Evidence of Guselkumab Effectiveness in Inflammatory Bowel Disease in Germany

Time to Guselkumab Discontinuation

Time to guselkumab discontinuation (treatment persistency) will be reported.

Time frame: Up to Week 96

Change in Stool Frequency Within the First 4 Weeks of Guselkumab Administration

Change in stool frequency for participants will be asked, that is, how many bowel movements they had in last 24 hours, how many of those were very soft or liquid, or how many has occurred during the night.

Time frame: Up to Week 4

Change in Rectal Bleeding Within First 4 Weeks of Guselkumab Administration

Change in rectal bleeding for participants will be asked, that is, how severe were the rectal bleedings in the last 24 hours.

Time frame: Up to Week 4

Change in Abdominal Pain Within the First 4 Weeks of Guselkumab Administration

Change in abdominal pain for participants will be asked, that is, how severe was the abdominal pain in the last 24 hours.

Time frame: Up to Week 4

Change in Bowel Urgency and Nocturnal Bowel Movement (NBM) Within the First 4 Weeks of Guselkumab Administration

Change in bowel urgency and NBM for participants will be asked, that is, how severe were the bowel urgency and NBM in the last 24 hours.

Time frame: Up to Week 4

Percentage of Participants Achieving Clinical Response for CD as Measured by HBI

Clinical response for CD is defined as the HBI Score \<=4 or a decrease by greater than or equal to (\>=) 3. HBI score is used to assess disease severity and treatment effectiveness.

Time frame: Up to Week 96

Percentage of Participants Achieving Clinical Response for UC as Measured by PMS

Clinical response for UC is defined as the PMS \<4 or \>=30% reduction of baseline PMS. Mayo scoring system is used to assess disease severity and treatment effectiveness.

Time frame: Up to Week 96

Percentage of Participants Achieving Clinical Remission for CD as Measured by HBI

Clinical remission for CD is defined as the HBI Score \<=4. HBI score is used to assess disease severity and treatment effectiveness.

Time frame: Up to Week 96

Percentage of Participants Achieving Clinical Remission for UC as Measured by PMS

Clinical remission for UC is defined as the PMS score \<=2 and a rectal bleeding subscore of 0. Mayo scoring system is used to assess disease severity and treatment effectiveness.

Time frame: Up to Week 96

Percentage of Participants Achieving Corticosteroid-free Clinical Response for CD as Measured by HBI

Corticosteroid-free clinical response for CD is defined as HBI score \<=4 or decrease in HBI score \>=3 from baseline and no use of steroids for at least 30 days. HBI score is used to assess disease severity and treatment effectiveness.

Time frame: Up to Week 96

Percentage of Participants Achieving Corticosteroid-free Clinical Response for UC as Measured by PMS

Corticosteroid-free clinical response for UC is defined as the PMS Score \<=4 or \>= 30% reduction of baseline and no use of steroids for at least 30 days. Mayo scoring system is used to assess disease severity and treatment effectiveness.

Time frame: Up to Week 96

Percentage of Participants Achieving Corticosteroid-free Clinical Remission for CD as Measured by HBI

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

Time frame: Up to Week 96

Percentage of Participants Achieving Corticosteroid-free Clinical Remission for UC as Measured by PMS

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

Time frame: Up to Week 96

Percentage of Participants with C-reactive Protein (CRP) Less Than or Equal to 5 milligram/litre (mg/L)

Percentage of participants with CRP level \<=5 mg/L, indicating normalization of systemic inflammation will be reported.

Time frame: Up to Week 96

Change in CRP Levels

Change in CRP levels will be reported to assess inflammation status.

Time frame: Up to Week 96

Percentage of Participants with Fecal Calprotectin (fCAL) Levels Less Than or Equal to 250 microgram/gram (mcg/g)

Percentage of participants with fCal levels \<=250 mcg/g will be reported.

Time frame: Up to Week 96

Change in fCAL Levels

Change in fCAL levels indicating progression or improvement in inflammation will be reported.

Time frame: Up to Week 96

Change in Hemoglobin Levels

Change in hemoglobin levels to assess anemia, measured in gram per deciliter (g/dL) will be reported.

Time frame: Up to Week 96

Change in Transferrin Saturation

Serum iron and total iron binding capacity will be combined to report transferrin saturation in percentage (%).

Time frame: Up to Week 96

Change from Baseline in Health-related Quality of Life (HRQoL) as Measured by IBD Symptoms

Health related quality of life changes as measured by IBD symptoms (abdominal pain, bowel urgency, nocturnal bowel movements (NBM), rectal bleeding, stool frequency) will be reported. IBD related symptoms changes will be reported by patient diary.

Time frame: Baseline up to Week 96

Change from Baseline in General Quality of Life Measured by Short Health Scale (SHS) Score

Quality of life will be assessed by SHS score. SHS is a health related quality of life questionnaire in which the participants rate the disease impact on 4 important aspects of subjective health (symptoms, function, worry, and general well-being). Responses are scored on 100-millimeter (mm) visual analogue scales and presented as individual scores for each of the four questions. The scores are then added for a total score. Total score ranges from 0 (low disease activity) to 100 (high disease activity).

Time frame: Baseline up to Week 96

Change from Baseline in IBD-Specific Quality of Life Measured by Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Scale Score

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).

Time frame: Baseline up to Week 96

Change from Baseline in Fatigue Measured by Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) Score

FACIT-F is a 13-item questionnaire that evaluates the impact of fatigue on a participants daily life over the past week. It measures various aspects, including: emotional well-being, physical well-being, functional well-being and social/family well-being. The total FACIT-Fatigue score ranges from 0 to 52, with a higher score indicating less fatigue.

Time frame: Baseline up to Week 96

Change from Baseline in Treatment Satisfaction Measured by Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) Scores

TSQM-9 is a 9-item general instrument that measures the major dimensions of satisfaction with a medication. The questionnaire consists of 3 domains: effectiveness, convenience and side effects. The scores of each domain range from 0 to 100 with higher scores representing higher satisfaction on that domain.

Time frame: Baseline up to Week 96

Change from Baseline in Work Productivity and Activity Impairment Measured by Work Productivity and Activity Impairment (WPAI) Questionnaire

The WPAI consist of four types of scores: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment. Outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity that is worse outcomes.

Time frame: Baseline up to Week 96

Change from Baseline in Sexuality Measured by Intimacy and Sexuality Questionnaire (ISQ)-IBD

The ISQ-IBD is a 5-item questionnaire designed to assess the impact of chronic IBD on participants sexual well-being. Participants are asked to evaluate their situation over the past seven days, with responses tailored to include individuals who may not currently be sexually active. The questionnaire measures various aspects, including: impact of disease on sexual life, satisfaction with physical affection, fear of sexual activity, perceived fear from partner and satisfaction with sexual activity frequency.

Time frame: Baseline up to Week 96

Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. An SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product and is an important medical event.

Time frame: Up to Week 108

Number of Participants with Special Situations

Special Situations include safety events of interest that require reporting for safety evaluation, but are not limited to: drug exposure during pregnancy; exposure to a product from breastfeeding; overdose of a product; suspected abuse/misuse of a product; inadvertent or accidental exposure; any failure of expected pharmacological action; unexpected therapeutic or clinical benefit from use of a product; medication error; suspected transmission of any infectious agent or Off-label use of a product.

Time frame: Up to Week 108