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

Browse trials for

• Intestinal Diseases 963
• Inflammatory Bowel Diseases 1,460

Keywords

• Drug Therapy

Intestinal Diseases

963 studies on the registry are indexed under Intestinal Diseases; 174 are open to participants now.

This study's enrollment of 310 is above the median of 140 across 377 observational studies indexed under Intestinal Diseases.

Lead sponsor

Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.

Study population

Groups and cohorts

• Cohort 1: Crohn's Disease

  Participants with Crohn's disease who received biological treatment between June 2011 and June 2013.

  Other: No Intervention

• Cohort 2: Ulcerative Colitis

  Participants with ulcerative colitis who received biological treatment between June 2011 and June 2013.

  Other: No Intervention

Interventions

• OtherNo Intervention

Primary outcomes

1. Impact of the Comorbidities Profile in Inflammatory Bowel Disease (IBD) Participants on Lack of Treatment Response to Biological Therapy

   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.

   Time frame: Up to 10 weeks after start of treatment with biologics

2. Impact of the Comorbidities Profile in IBD Participants on Loss of Treatment Response to Biological Therapy

   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.

   Time frame: Up to 6 months after start of treatment with biologics

Secondary outcomes

1. Impact of the Extraintestinal Manifestations Profile in IBD Participants on Lack of Treatment Response to Biological Therapy

   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.

   Time frame: Up to 10 weeks after start of treatment with biologics

2. Impact of the Extraintestinal Manifestations Profile in IBD Participants on Loss of Treatment Response to Biological Therapy

   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.

   Time frame: Up to 6 months after start of treatment with biologics

3. Percentage of IBD Participants With Comorbidities

   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.

   Time frame: Day 1

4. Percentage of CD Participants With Comorbidities According to the Level of IBD Severity

   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.

   Time frame: Day 1

5. Percentage of UC Participants With Comorbidities According to the Level of IBD Severity

   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.

   Time frame: Day 1

Baseline characteristics

Publications

• Marin-Jimenez I, Bastida G, Fores A, Garcia-Planella E, Arguelles-Arias F, Sarasa P, Tagarro I, Fernandez-Nistal A, Montoto C, Aguas M, Santos-Fernandez J, Bosca-Watts MM, Ferreiro R, Merino O, Aldeguer X, Cortes X, Sicilia B, Mesonero F, Barreiro-de Acosta M. Impact of comorbidities on anti-TNFalpha response and relapse in patients with inflammatory bowel disease: the VERNE study. BMJ Open Gastroenterol. 2020 Mar 26;7(1):e000351. doi: 10.1136/bmjgast-2019-000351. eCollection 2020. PubMed 32337054 ↗

Study documents

• Statistical analysis plan · Feb 15, 2017
• Study protocol · Apr 13, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.