A Retrospective Observational Study to Assess the Impact of Co-morbidities on Treatment Response in Inflammatory Bowel Disease

Completed

• Conditions: Inflammatory Bowel Disease
• Interventions: Other: No Intervention

• Registration Number: NCT02861118
• Lead Sponsor: Takeda

Brief Summary

The purpose of this study was to evaluate the impact of the co-morbidities profile on treatment response to biological therapy in inflammatory bowel disease (IBD) participants.

Detailed Description

This was a retrospective, non-interventional, observational study that included participants diagnosed with ulcerative colitis (UC) or Crohn's disease (CD) who started treatment with biologics between June 2011 and June 2013. The study looked at the impact of the co-morbidities on the treatment response in IBD participants.

The study enrolled 310 patients included both UC and CD patients.

This multicenter trial was conducted in Spain. Investigator collected retrospective data in a single visit from participants who started biologic treatment between June 2011 and June 2013. Time since participants started biological treatment until study visit or until lack of treatment response or until treatment change constituted the reference period for the study.

Study Timeline

• Study First Submitted: 2016-08-05
• Study First Submitted QC: 2016-08-05
• Study First Posted: 2016-08-10
• Study Start: 2016-10-26
• Primary Completion: 2018-04-04
• Study Completion: 2018-04-04
• Results First Submitted: 2019-04-02
• Status Verified: 2019-07
• Results First Submitted QC: 2019-07-09
• Last Update Submitted: 2019-07-09
• Results First Posted: 2019-08-14
• Last Update Posted: 2019-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 310

Inclusion Criteria

• Adult participants (aged ≥18).
• Were diagnosed with UC or CD according to the "World Gastroenterology Organization Practice Guidelines for the Diagnosis and Management of inflammatory bowel disease (IBD) in 2010".
• Who were naive to biologics that started treatment with biologics between June 2011 and June 2013.
• Participants in whom biological treatment was prescribed according to clinical practice.
• Who gave written informed consent.

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Exclusion Criteria

• Were participating in a clinical trial during the study reference period.
• Participant that, according to investigator's criteria was not capable to understand and fill in the study questionnaires or to give written informed consent.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 2: Ulcerative Colitis	No Intervention	Participants with ulcerative colitis who received biological treatment between June 2011 and June 2013.
Cohort 1: Crohn's Disease	No Intervention	Participants with Crohn's disease who received biological treatment between June 2011 and June 2013.

Primary Outcome Measures

Name	Time	Method
Impact of the Comorbidities Profile in IBD Participants on Loss of Treatment Response to Biological Therapy	Up to 6 months after start of treatment with biologics	Correlation between co-morbidities profile and loss of response, adjusted for sociodemographic and clinical profile of participants, logistic regression models were conducted. Loss of response was defined as loss of drug effect along follow up with initial response i.e. reduction of 2 points from baseline in HBI score for CD or PMS for UC after 6 months of treatment with anti-TNF. HBI included general well-being (0=very well to 4=terrible), abdominal pain (0=none to 3=severe), number of liquid stools/day, abdominal mass (0=none to 3=tender), and complications (8 items; 1 score/item). The total score was sum of sub scores, \<5=remission, 5-7=mild disease, 8-16=moderate disease and \>16=severe disease. PMS score included 3 sub-scores: stool frequency (0=normal to 3=\>4 stools/day more than normal), rectal bleeding (0=none to 3=passing blood alone), and physician's global assessment (0=Normal to 3=severe). The total score was sum of sub scale scores ranging from 0=normal to 9=severe disease.
Impact of the Comorbidities Profile in Inflammatory Bowel Disease (IBD) Participants on Lack of Treatment Response to Biological Therapy	Up to 10 weeks after start of treatment with biologics	Correlation between co-morbidities profile and lack of response, adjusted for sociodemographic and clinical profile of participants, logistic regression models were conducted. Lack of response was reduction of 2 points from baseline in Harvey-Bradshaw Indices (HBI) score for CD or Partial Mayo score (PMS) for UC after 10 weeks treatment with anti-tumour necrosis factor (TNF). HBI included general well-being (0=very well to 4=terrible), abdominal pain (0=none to 3=severe), number of liquid stools/day, abdominal mass (0=none to 3=tender), and complications (8 items; 1 score/item). The total score was sum of sub scores, where score \<5=remission, 5-7=mild disease, 8-16=moderate disease and \>16-severe disease. PMS included 3 sub-scores: stool frequency (0=normal to 3=\>4 stools/day more than normal), rectal bleeding (0=none to 3=passing blood alone), and physician's global assessment (0=Normal to 3=severe). The total score was sum of sub scale scores from 0=normal to 9=severe disease.

Secondary Outcome Measures

Name	Time	Method
Percentage of IBD Participants With Comorbidities	Day 1	Participants with CD and UC along with comorbidities were reported. Comorbidity referred to the presence of co-existing or additional diseases with reference to an initial diagnosis or with reference to the index condition.
Impact of the Extraintestinal Manifestations Profile in IBD Participants on Lack of Treatment Response to Biological Therapy	Up to 10 weeks after start of treatment with biologics	Correlation between extraintestinal manifestations profile and lack of response, adjusted for sociodemographic and clinical profile of participants, logistic regression models were conducted. Lack of response was reduction of at least 2 points from baseline in HBI score for CD or PMS for UC after 10 weeks treatment with TNF. HBI included general well-being (0=very well to 4=terrible), abdominal pain (0=none to 3=severe), number of liquid stools/day, abdominal mass (0=none to 3=tender), and complications (8 items; 1 score/item). The total score was sum of sub scores, where score \<5=remission, 5-7=mild disease, 8-16=moderate disease and \>16-severe disease. PMS included 3 sub-scores: stool frequency (0=normal to 3=\>4 stools/day more than normal), rectal bleeding (0=none to 3=passing blood alone), and physician's global assessment (0=Normal to 3=severe). The total score was sum of sub scale scores from 0=normal to 9=severe disease.
Impact of the Extraintestinal Manifestations Profile in IBD Participants on Loss of Treatment Response to Biological Therapy	Up to 6 months after start of treatment with biologics	Correlation between extraintestinal manifestations profile and loss of response, adjusted for sociodemographic and clinical profile, logistic regression models were conducted. Loss of response was defined as loss of drug effect along follow up with initial response i.e. reduction of 2 points from baseline in HBI score for CD or PMS for UC after 6 months of treatment with anti-TNF. HBI included general well-being (0=very well to 4=terrible), abdominal pain (0=none to 3=severe), number of liquid stools/day, abdominal mass (0=none to 3=tender), and complications (8 items; 1 score/item). The total score was sum of sub scores, \<5=remission, 5-7=mild disease, 8-16=moderate disease and \>16=severe disease. PMS score included 3 sub-scores: stool frequency (0=normal to 3=\>4 stools/day more than normal), rectal bleeding (0=none to 3=passing blood alone), and physician's global assessment (0=Normal to 3=severe). The total score was sum of sub scale scores ranging from 0=normal to 9=severe disease.
Percentage of CD Participants With Comorbidities According to the Level of IBD Severity	Day 1	Participants with CD were classified into IBD severe or non-severe at baseline based on the HBI scores according the following criteria:- HBI includes general well-being (0=very well to 4=terrible), abdominal pain (0=none to 3=severe), number of liquid stools per day, abdominal mass (0=none to 3=tender), and complications (8 items; 1 score/item). The total score is sum of sub scores, score \<5=remission, 5-7=mild disease, 8-16=moderate disease and \>16=severe disease.
Percentage of UC Participants With Comorbidities According to the Level of IBD Severity	Day 1	Participants with UC were classified into IBD severe or non-severe at baseline based on the PMS scores according the following criteria:- PMS score includes 3 sub-scores: stool frequency (0=normal to 3=\>4 stools/day more than normal), rectal bleeding (0=none to 3=passing blood alone), and physician's global assessment (0=Normal to 3=severe). The total score is sum of sub scale scores ranging from 0=normal to 9=severe disease.