Impact of Co-morbidities on Treatment Response in Inflammatory Bowel Disease: VERNE Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 310
- 主要终点
- Impact of the Comorbidities Profile in IBD Participants on Loss of Treatment Response to Biological Therapy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Participants in whom biological treatment was prescribed according to clinical practice.
- •Who gave written informed consent.
排除标准
- •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.
结局指标
主要结局
Impact of the Comorbidities Profile in IBD Participants on Loss of Treatment Response to Biological Therapy
时间窗: 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
时间窗: 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.
次要结局
- Percentage of IBD Participants With Comorbidities(Day 1)
- 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)
- 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)
- Percentage of CD Participants With Comorbidities According to the Level of IBD Severity(Day 1)
- Percentage of UC Participants With Comorbidities According to the Level of IBD Severity(Day 1)