The purpose of this study is to evaluate the clinical effectiveness (how well the treatment works) of Guselkumab, by lines of treatment and subpopulations, and what are the outcomes of treatment (clinical outcomes) in adult participants with moderately to severely active Ulcerative Colitis (UC) or Crohn's Disease (CD) under real-world settings. CD and UC are the main type of Inflammatory bowel disease, a group of inflammatory conditions of the colon and small intestine.

A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disease in the United Kingdom (UK)

Colitis, Ulcerative

Ulcerative Colitis

Gastrointestinal diseases

Immune system conditions

Crohn's Disease

Crohn Disease

Crohns Disease

Fistulizing Crohns Disease

Perianal Crohns Disease

Inflammatory Bowel Disease

Real World Observation of Guselkumab Treatment in Patients With Ulcerative Colitis and Crohn's Disease - a Study of Treatment Outcomes in the UK

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 remission for CD is defined as the HBI score less than or equal to (<=) 4.

Mayo scoring system 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.

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 by greater than or equal to (>=) 3.

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

Corticosteroid-free 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.

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

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

Participants with corticosteroid-free remission by PRO-2 will be assessed. An abdominal pain (AP) score <=1 and a mean stool frequency (SF) score <=3 and no worsening of AP or SF compared with baseline and no use of corticosteroids for at least 30 days will be defined as a PRO-2 corticosteroid-free remission.

Participants with corticosteroid-free remission by PRO-2 will be assessed. An SF score of 0 or 1, where it has not increased from baseline, and a rectal bleeding score of 0 with no use of corticosteroids for at least 30 days will be defined as a corticosteroid-free PRO-2 remission.

Participants with early responses to guselkumab using PRO-2 components will be assessed and reported via patient diary card.

Participants with early responses to guselkumab using bowel urgency will be assessed and reported via patient diary card. Change in bowel urgency for participants will be asked, that is, how severe were the bowel urgency.

Persistence with guselkumab will be measured through time to discontinuation (defined as time at which the next infusion should have taken place for a participant after their last scheduled infusion).

Characteristics of participants (age) receiving guselkumab treatment will be reported.

Characteristics of participants (sex) receiving guselkumab treatment will be reported.

Characteristics of participants (previous IBD medication use, smoking status and history, history of UC and history of CD) receiving guselkumab treatment will be reported.

Characteristics of participants (height) receiving guselkumab treatment will be reported.

Characteristics of participants (weight) receiving guselkumab treatment will be reported.

Characteristics of participants (disease severity at index) receiving guselkumab treatment will be reported.

Characteristics of participants (age at diagnosis) receiving guselkumab treatment will be reported.

Characteristics of participants (disease duration) receiving guselkumab treatment will be reported.

Characteristics of participants (comorbid diagnoses) receiving guselkumab treatment will be reported.

Characteristics of participants (IBD-related surgeries) receiving guselkumab treatment will be reported.

An adverse event is any untoward medical occurrence in a patient 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.

Participants with CRP normalization (among participants with CRP elevated at baseline) since guselkumab initiation will be reported.

Change in Fcal levels since guselkumab initiation will be reported.

Participants with Fcal normalization (among participants with faecal calprotectin [Fcal] elevated at baseline) since guselkumab initiation will be reported.

Change in albumin levels to assess anaemia and nutritional status will be reported.

Change in hemoglobin levels to assess anaemia and nutritional status will be reported.

Change in platelets levels to assess anaemia and nutritional status will be reported.

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

Health related quality of life changes as measured by SIBDQ 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).

Health related quality of life changes as measured by bowel urgency will be reported. Change in bowel urgency for participants will be asked, that is, how severe were the bowel urgency.

PRO-2 components that is change in SF and AP will be reported. Change in SF 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 AP for participants will be asked, that is, how severe was the abdominal pain in the last 24 hours.

PRO-2 components that is change in SF and rectal bleeding will be reported. Change in SF 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.

Health related quality of life changes as measured by ICHOM will be reported. ICHOM measures overall disease control from the participants perspective.

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

Endoscopic remission is defined as SES-CD total score <4 with at least 2 points reduction from baseline and no sub-score >1 in any individual component.

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

Endoscopic normalization 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 Response is defined as reduction of 25% in bowel wall thickness (BWT) or a reduction from baseline of BWT >2 millimeter (mm) or reduction from baseline BWT >1 mm plus a decrease from baseline in color doppler >1 point per baseline pathological segment.

IUS Remission is defined as BWT <3 mm for ileum and colon plus Color Doppler signal (CDS) 0 in all segments.

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.

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.

Participants with confirmed diagnosis of moderate-to-severe UC or CD treated with guselkumab as per standard clinical practice will be enrolled. No drug will be provided as part of this study. Only data available from standard clinical practice and medical records will be collected.

The purpose of this study is to evaluate the clinical effectiveness (how well the
treatment works) of Guselkumab, by lines of treatment and subpopulations, and what are
the outcomes of treatment (clinical outcomes) in adult participants with moderately to
severely active Ulcerative Colitis (UC) or Crohn's Disease (CD) under real-world
settings. CD and UC are the main type of Inflammatory bowel disease, a group of
inflammatory conditions of the colon and small intestine.

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 remission for CD is
defined as the HBI score less than or equal to (<=) 4.

Mayo scoring system 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.

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 by greater than or
equal to (>=) 3.

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

Corticosteroid-free 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.

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

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

Participants with corticosteroid-free remission by PRO-2 will be assessed. An abdominal
pain (AP) score <=1 and a mean stool frequency (SF) score <=3 and no worsening of AP or
SF compared with baseline and no use of corticosteroids for at least 30 days will be
defined as a PRO-2 corticosteroid-free remission.

Participants with corticosteroid-free remission by PRO-2 will be assessed. An SF score of
0 or 1, where it has not increased from baseline, and a rectal bleeding score of 0 with
no use of corticosteroids for at least 30 days will be defined as a corticosteroid-free
PRO-2 remission.

Participants with early responses to guselkumab using PRO-2 components will be assessed
and reported via patient diary card.

Participants with early responses to guselkumab using bowel urgency will be assessed and
reported via patient diary card. Change in bowel urgency for participants will be asked,
that is, how severe were the bowel urgency.

Persistence with guselkumab will be measured through time to discontinuation (defined as
time at which the next infusion should have taken place for a participant after their
last scheduled infusion).

Characteristics of participants (previous IBD medication use, smoking status and history,
history of UC and history of CD) receiving guselkumab treatment will be reported.

Characteristics of participants (disease severity at index) receiving guselkumab
treatment will be reported.

Characteristics of participants (age at diagnosis) receiving guselkumab treatment will be
reported.

Characteristics of participants (disease duration) receiving guselkumab treatment will be
reported.

Characteristics of participants (comorbid diagnoses) receiving guselkumab treatment will
be reported.

Characteristics of participants (IBD-related surgeries) receiving guselkumab treatment
will be reported.

An adverse event is any untoward medical occurrence in a patient 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.

Participants with CRP normalization (among participants with CRP elevated at baseline)
since guselkumab initiation will be reported.

Participants with Fcal normalization (among participants with faecal calprotectin [Fcal]
elevated at baseline) since guselkumab initiation will be reported.

Health related quality of life changes as measured by SIBDQ 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).

Health related quality of life changes as measured by bowel urgency will be reported.
Change in bowel urgency for participants will be asked, that is, how severe were the
bowel urgency.

PRO-2 components that is change in SF and AP will be reported. Change in SF 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 AP for participants will be asked, that is, how severe was the abdominal pain
in the last 24 hours.

PRO-2 components that is change in SF and rectal bleeding will be reported. Change in SF
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.

Health related quality of life changes as measured by ICHOM will be reported. ICHOM
measures overall disease control from the participants perspective.

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

Endoscopic remission is defined as SES-CD total score <4 with at least 2 points reduction
from baseline and no sub-score >1 in any individual component.

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 Response is defined as reduction of 25% in bowel wall thickness (BWT) or a reduction
from baseline of BWT >2 millimeter (mm) or reduction from baseline BWT >1 mm plus a
decrease from baseline in color doppler >1 point per baseline pathological segment.

IUS Remission is defined as BWT <3 mm for ileum and colon plus Color Doppler signal (CDS)
0 in all segments.

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.

Participants with confirmed diagnosis of moderate-to-severe UC or CD treated with
guselkumab as per standard clinical practice will be enrolled. No drug will be provided
as part of this study. Only data available from standard clinical practice and medical
records will be collected.

A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disease in the United Kingdom (UK)

Trials at a glance

Trials at a glance