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

Clinical remission for CD is defined as the HBI score less than or equal to (<=) 4. HBI score is used to assess disease severity and treatment effectiveness.

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 to guselkumab discontinuation (treatment persistency) will be reported.

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.

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

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

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.

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.

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.

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

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.

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.

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.

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.

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.

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

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

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

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

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

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

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.

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).

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 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.

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.

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.

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.

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.

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.