The purpose of this study is to evaluate how long guselkumab remains in participants with moderate to severe crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are Inflammatory bowel disease, a group of inflammatory conditions of the colon and small intestine.
Study Type
OBSERVATIONAL
Enrollment
50
Gastroenterologische Praxis und Crohn-Collitis Zentrum Bern
Bern, Switzerland
RECRUITINGTime to Guselkumab Persistence
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).
Time frame: Up to Week 96
Number of Participants with Early Responses to Guselkumab Measured Using Participant Reported Outcome (PRO-2) Components
Number of participants with early responses to guselkumab will be assessed using PRO-2 components and reported via participant diaries. Measurements captured include stool frequency, rectal bleeding, and abdominal pain.
Time frame: Baseline (at Week 0), Weeks 1, 2, 4, 8 and 12
Number of Participants with Early Responses to Guselkumab Measured Using Bowel Urgency
Number of participants with early responses to guselkumab will be assessed using bowel urgency and reported via participant diaries. Bowel urgency from participants will be asked as yes or no.
Time frame: Baseline (at Week 0), Weeks 1, 2, 4, 8 and 12
Number of Participants Achieving Clinical Response for CD as Measured by Harvey-Bradshaw Index (HBI)
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.
Time frame: Weeks 12, 48 and 96
Number of Participants Achieving Clinical Response for UC as Measured by Partial Mayo Score (PMS)
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.
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Time frame: Weeks 12, 48 and 96
Number of Participants Achieving Clinical Remission for CD as Measured by HBI
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 \<= 4.
Time frame: Weeks 12, 48 and 96
Number of Participants Achieving Clinical Remission for UC as Measured by PMS
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 remission for UC is defined as the PMS \< 2 and a rectal bleeding subscore of 0.
Time frame: Weeks 12, 48 and 96
Number of Participants Achieving Corticosteroid-free Clinical Response for CD as Measured by HBI
Corticosteroid-free clinical response for CD is defined as a reduction in HBI by \>=3 points from baseline or achieving HBI \<=4 with no use of corticosteroids for at least 30 days.
Time frame: Weeks 12, 48 and 96
Number of Participants Achieving Corticosteroid-free Clinical Response for UC as Measured by PMS
Corticosteroid-free clinical response for UC is defined as PMS \<4 or \>=30% reduction from baseline and no use of steroids for at least 30 days.
Time frame: Weeks 12, 48 and 96
Number of Participants Achieving Corticosteroid-free Clinical Remission for CD as Measured by HBI
Corticosteroid-free remission for CD is defined as no use of steroids for at least 30 days and a HBI score \<=4.
Time frame: Weeks 12, 48 and 96
Number of Participants Achieving Corticosteroid-free Clinical Remission for UC as Measured by PMS
Corticosteroid-free clinical remission for UC is defined as a PMS score of \<2, no use of corticosteroids for at least 30 days and a rectal bleeding subscore of 0.
Time frame: Weeks 12, 48 and 96
Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for CD
Corticosteroid-free PRO-2 remission in CD participants is defined as 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 steroids for at least 30 days.
Time frame: Baseline (Week 0), Weeks 12, 48 and 96
Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for UC
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.
Time frame: Baseline (Week 0), Weeks 12, 48 and 96
Characteristics of Participants Receiving Guselkumab Treatment: Age
Characteristics of participants (age) receiving guselkumab treatment will be reported.
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Sex
Characteristics of participants (sex) receiving guselkumab treatment will be reported.
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Smoking Status and History
Characteristics of participants (smoking status and history) receiving guselkumab treatment will be reported.
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Height
Characteristics of participants (height) receiving guselkumab treatment will be reported.
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Weight
Characteristics of participants (weight) receiving guselkumab treatment will be reported.
Time frame: Baseline (Week 0), Weeks 4, 8, 12, 48 and 96
Characteristics of Participants Receiving Guselkumab Treatment: Age at Diagnosis
Characteristics of participants (age at diagnosis) receiving guselkumab treatment will be reported.
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Disease Duration
Characteristics of participants (disease duration) receiving guselkumab treatment will be reported.
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Disease Severity
Characteristics of participants (disease severity at index) receiving guselkumab treatment will be reported.
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Comorbid Diagnoses
Characteristics of participants (comorbid diagnoses) receiving guselkumab treatment will be reported.
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: History of UC/CD
Characteristics of participants (history of UC/CD) receiving guselkumab treatment will be reported.
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Previous Inflammatory Bowel Disease (IBD) Medication Use
Characteristics of participants (previous IBD medication use) receiving guselkumab treatment will be reported.
Time frame: At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Previous IBD-Related Surgeries
Characteristics of participants (Previous IBD-related surgeries) receiving guselkumab treatment will be reported.
Time frame: At Baseline
Number of Participants with Adverse Events (AEs)
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.
Time frame: Up to Week 96
Number of Participants with Drug-Related Adverse Events
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 is considered drug-related if there is at least a reasonable possibility that the study drug contributed to the event.
Time frame: Up to Week 96
Number of Participants with Serious Adverse Events (SAE)
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 SAE is any event that results in death, is life-threatening, requires or prolongs hospitalization, causes significant disability, or is otherwise medically significant.
Time frame: Up to Week 96
Number of Participants with Drug-Related Serious Adverse Events
An adverse event is any untoward medical occurrence in a participant administered a medicinal product based on appropriate medical judgment. SAE is any event that results in death, is life-threatening, requires or prolongs hospitalization, causes significant disability, or is otherwise medically significant based on appropriate medical judgment. An SAE is considered drug-related if there is at least a reasonable possibility that the study drug contributed to the event.
Time frame: Up to Week 96
Number of Participants with C-reactive protein (CRP) Normalization
CRP normalization is defined as as \<= 5 milligrams/litre (mg/L) since baseline (among participants with elevated CRP at Baseline).
Time frame: Baseline (at Week 0), Weeks 4, 12, 48 and 96
Change in CRP Levels
Change in CRP levels since guselkumab initiation will be reported.
Time frame: Weeks 4, 12, 48 and 96
Number of Participants with Fecal Calprotectin Normalization
Number of participants with fecal calprotectin normalization will be reported. Normalization is defined as percentage of fecal calprotectin (fCAL) \<=250 micrograms/gram (mcg/g) since baseline (among participants with Calprotectin elevation at Baseline).
Time frame: Baseline (at Week 0), Weeks 4, 12, 48 and 96
Change in Fecal Calprotectin Levels
Change in Fecal calprotectin levels since guselkumab initiation will be reported.
Time frame: Weeks 4, 12, 48 and 96
Change in Leukocytes Count
Change in Leukocytes count will be reported.
Time frame: Baseline (at Week 0), Weeks 4, 12, 48 and 96
Change in Hemoglobin Levels
Change in hemoglobin levels to assess anaemia will be reported.
Time frame: Baseline (at Week 0), Weeks 4, 12, 48 and 96
Change in Transferrin Saturation Levels
Change in transferrin saturation Levels to assess anaemia will be reported.
Time frame: Baseline (at Week 0), Weeks 4, 12, 48 and 96
Change in Ferritin Levels
Change in Ferritin Levels to assess anaemia will be reported.
Time frame: Baseline (at Week 0), Weeks 4, 12, 48 and 96
Number of Participants Receiving Concomitant IBD Medications During Guselkumab Treatment
Number of participants receiving concomitant IBD medications during guselkumab treatment will be reported.
Time frame: Baseline up to Week 96
Change from Baseline in Health-related Quality of Life (HRQoL) as Measured by PRO-2 Components for CD
Change from baseline in HRQoL for CD will be measured by PRO-2 components. The CD PRO-2 consists of 2 items: abdominal pain (AP) and stool frequency (SF). AP is a numeric variable with a score between 0-3 and is self-reported by the participant for the 3 days preceding assessment as 0 (no pain), 1 (mild), 2 (moderate) or 3 (severe pain). SF is also a numeric variable calculated the number of liquid stools a participant has experienced over the past 3 days.
Time frame: Baseline (at Week 0), Weeks 24, 48, 72, and 96
Change from Baseline in HRQoL as Measured by PRO-2 Components for UC
Change from baseline in HRQoL for UC will be measured by PRO-2 components. The UC PRO-2 is composed of rectal bleeding and stool frequency. Rectal bleeding is a numeric variable with a score between 0-3 and is self-reported by the participants for the 3 days preceding assessment as 0 (None), 1 (Streaks of blood with stool in less than half of the cases), 2 (Obvious blood with stools in most cases) or 3 (Blood alone passes). SF is also a numeric variable calculated the number of liquid stools a participant has experienced over the past 3 days.
Time frame: Baseline (at Week 0), Weeks 24, 48, 72, and 96
Change from Baseline in HRQoL as Measured by Bowel Urgency
Change from baseline in HRQoL as measured by bowel urgency will be reported. Bowel urgency from participants will be asked as yes or no.
Time frame: Baseline (at Week 0), Weeks 1, 2, 4, 8, 12, 24, 48, 72, and 96
Changes from Baseline in HRQoL as Measured by Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
SIBDQ is a HRQoL tool measuring physical, social, and emotional status in IBD participants. The SIBDQ offers a broader evaluation of IBD-specific QoL across ten dimensions, including digestive, physical, emotional, and social aspects. The SIBDQ consists of 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, irritability, impact on leisure, impact on intimacy). The total score ranges from 10 to 70, where high score indicates better QoL.
Time frame: Baseline (at Week 0), Weeks 12, 24, 48, 72 and 96
Changes from Baseline in HRQoL as Measured by Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) Questionnnaire
FACIT-F consists of 13 items to characterize fatigue symptoms and their impact on daily activities and function. 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.
Time frame: Baseline (at Week 0), Weeks 12, 24, 48, 72 and 96
Change from Baseline in HRQoL as Measured by Treatment Satisfaction Questionnaire for Medication (TSQM-9)
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.
Time frame: Baseline (at Week 0), Weeks 12, 24, 48, 72 and 96
Change from Baseline in HRQol as Measured by Work Productivity and Activity Questionnaire (WPAI)
WPAI assesses impairment of work and regular activities due to overall health and symptoms. WPAI measures past-7-day work and activity that impact in Scores range from 0% (no impairment) to 100% (complete impairment); higher = worse. Absenteeism, presenteeism, and overall work impairment are for employed participant and activity impairment is for all participants.
Time frame: Baseline (at Week 0), Weeks 12, 24, 48, 72 and 96
Change from Baseline in HRQoL as Measured by PROMIS Sleep Disturbance Short Form 8b (PROMIS 8b)
The PROMIS 8b is a questionnaire based on the PROMIS sleep disturbance and sleep-related Impairment item banks. It contains the 8 best-performing items of these banks belonging to categories relating to qualitative, quantitative, behavioral, and symptom based dimensions of sleep and was found to provide greater measurement precision compared with other assessment instruments.
Time frame: Baseline (at Week 0), Weeks 12, 24, 48, 72 and 96
Change from Baseline in HRQoL as Measured by Short-CONFIDE Survey for IBD (s-CS-IBD)
s-CS-IBD is shortened version of the CONFIDE questionnaire (Short-CONFIDE Survey for IBD consisting of 5 selected questions to better understand how IBD impacts sexual activity and if guselkumab treatment can improve this situation.
Time frame: Baseline (at Week 0), Weeks 12, 24, 48, 72 and 96
Number of Participants Achieving Endoscopic Response in Participants with CD as Measured by Simple Endoscopy Score-CD (SES-CD)
Endoscopic response is defined as 50% improvement from baseline in SES-CD total score, or SES-CD total score \<= 4.
Time frame: Baseline (at Week 0), Weeks 48 and 96
Number of Participants Achieving Endoscopic Remission in Participants with CD as Measured by SES-CD
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.
Time frame: Baseline (at Week 0), Weeks 48 and 96
Number of Participants Achieving Endoscopic Improvement in Participants with UC as Measured by Mayo Score
Endoscopic Improvement is defined as a Mayo score \<=1.
Time frame: Baseline (at Week 0), Weeks 12, 48 and 96
Number of Participants Achieving Endoscopic Normalization in Participants with UC as Measured by Mayo Score
Endoscopic normalization is defined as a Mayo score =0.
Time frame: Baseline (at Week 0), Weeks 12, 48 and 96
Number of Participants Achieving Histologic Improvement
Histologic improvement is defined as neutrophil infiltration in \< 5% of crypts, no crypt destruction, no erosions and ulcerations or granulation tissue according to the Geboes grading system, that is, Geboes score \<=3.1.
Time frame: At Weeks 0, 48 and 96
Number of Participants Achieving Histologic Remission
Histologic remission is defined as the absence of neutrophils from the mucosa (both lamina propria and epithelium), no crypt destruction, no erosions, and ulcerations or granulation tissue according to the Geboes grading system, that is, Geboes score \<=2B.0.
Time frame: At Weeks 0, 48 and 96
Number of Participants with CD Achieving Intestinal Ultrasound (IUS) Response
IUS Response is defined as reduction of bowel wall thickness (BWT) of \>= 25% or normalization (\<= 3 millimeter \[mm\]) of the most affected segment in participants with increased BWT (\>3 mm) at baseline.
Time frame: Baseline (at Week 0), Weeks 24, 48, 72, and 96
Number of Participants with CD Achieving IUS Remission
IUS Remission 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 (\>3mm) at baseline.
Time frame: Baseline (at Week 0), Weeks 24, 48, 72, and 96
Change from Baseline in Number of UC/CD Emergency Room Visits
Change from baseline in the number of emergency room visits for treatment of UC/CD will be reported.
Time frame: Baseline (at Week 0), Weeks 12, 48 and 96
Change from Baseline in Number of UC/CD-Hospitalizations
Change from baseline in the number of hospitalizations for treatment of UC/CD will be reported.
Time frame: Baseline (at Week 0), Weeks 12, 48 and 96
Change from Baseline in Number of UC/CD Surgeries
Change from baseline in the number of surgeries for treatment of UC/CD will be reported.
Time frame: Baseline (at Week 0), Weeks 12, 48 and 96