Optimizing IBD Management: A Comparative Study on the Efficacy and Safety of 5-ASA De-escalation in Patients With Ulcerative Colitis and Crohn's Disease on Stable Biologic or Immunomodulator Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Disease relapse rate
研究概览
简要总结
This study aims to evaluate the long-term outcomes of discontinuing 5-ASA in UC and CD patients receiving stable biologic or immunomodulator therapy using a prospective cohort based in the Busan-Ulsan-Gyeongnam region. It seeks to determine whether discontinuing 5-ASA is a safe treatment strategy in modern IBD management.
详细描述
In inflammatory bowel disease (IBD), 5-aminosalicylic acid (5-ASA) is widely used as a first-line treatment for ulcerative colitis (UC) and is still prescribed for Crohn's disease (CD). However, for patients who do not respond to conventional therapy, anti-tumor necrosis factor (anti-TNF) agents have become an effective alternative. This has led to ongoing debate about whether continued use of 5-ASA is necessary after transitioning to anti-TNF therapy.
Recent retrospective studies have reported that discontinuing 5-ASA after initiating anti-TNF therapy in UC and CD patients does not increase the risk of clinical adverse outcomes such as new steroid use, hospitalization, or bowel surgery. However, a study based on U.S. data had a median follow-up period of less than one year, making it difficult to assess long-term effects. Additionally, studies on relapse risk after discontinuing 5-ASA have identified younger age, extensive disease, and frequent relapses as risk factors, but detailed analyses for patients receiving anti-TNF therapy remain insufficient.
Another critical issue is the economic burden of continued 5-ASA treatment. In South Korea, the annual cost of the most commonly used 5-ASA formulations constitutes a significant portion of overall healthcare expenses. Discontinuing 5-ASA could reduce treatment costs, simplify therapy, improve patient adherence, and minimize adverse effects associated with polypharmacy. Regarding colorectal cancer (CRC) prevention, recent trends indicate a decreasing incidence of CRC in IBD patients. Since mucosal inflammation is considered a primary driver of CRC, additional 5-ASA use may not be necessary if mucosal healing is achieved through biologics or small-molecule therapies.
Accordingly, this study aims to evaluate the long-term outcomes of discontinuing 5-ASA in UC and CD patients receiving stable biologic or immunomodulator therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •o Patients diagnosed with ulcerative colitis (UC) or Crohn's disease (CD) based on standard diagnostic criteria, including clinical, endoscopic, and histologic findings.
- •Treatment Status
- •Patients who have been continuously treated with biologic agents (e.g., anti-TNF agents, integrin inhibitors, JAK inhibitors) or immunomodulators (e.g., azathioprine, methotrexate) for at least three months.
- •Patients who have been on a stable dose of 5-ASA (mesalamine) for at least three months before study enrollment.
- •Disease Activity
- •o Patients in clinical remission for at least three months, as defined by the Mayo score for UC or the Crohn's Disease Activity Index (CDAI) for CD.
- •o Adults aged 19 years or older.
- •Informed Consent
- •o Patients capable of providing written informed consent for study participation.
- •Compliance with Study Protocol
- •o Patients who can adhere to the study protocol and visit schedule.
- •General Health Condition
- •o Patients without severe medical conditions that could impact the study or patient safety, such as significant cardiac, renal, or hepatic diseases.
- •No recent medication changes
- •Patients who have not had any new prescriptions or dose adjustments of corticosteroids, antibiotics, or other medications that could affect IBD within a specified period (e.g., four weeks) before enrollment.
排除标准
- •Patients with severe active UC or CD at the time of study enrollment.
- •Patients who have been recently hospitalized for IBD-related reasons or undergone IBD-related surgery within three months before enrollment.
- •Patients who have had dose modifications of biologics, immunomodulators, or corticosteroids for IBD within three months before enrollment.
- •Patients receiving concomitant therapy with other medications that may affect disease activity (e.g., additional anti-inflammatory agents, IBD-related antibiotics).
- •Patients with severe cardiac, renal, or hepatic disease or other medical conditions that could interfere with the study.
- •Pregnant or breastfeeding women.
- •Patients with known allergies or intolerance to 5-ASA or related medications.
- •Patients currently participating in another clinical study that may interfere with this study.
- •Patients unable to provide informed consent or unlikely to comply with the study protocol and visit schedule.
- •Patients with a history of non-response or intolerance to their current biologic or immunomodulator therapy.
- •Patients with a history of severe psychiatric disorders that may affect their ability to participate in the study.
研究组 & 干预措施
5-ASA Discontinuation Group
The group discontinuing 5-ASA.
干预措施: Discontinuation of 5-ASA (Other)
结局指标
主要结局
Disease relapse rate
时间窗: Through study completion, an average of 9 months
次要结局
- Changes in serum C-reactive protein (CRP) level(Through study completion, an average of 9 months)
- Changes in fecal calprotectin level(Through study completion, an average of 9 months)
- Number of hospitalizations(Through study completion, an average of 9 months)
- Number of emergency department visits(Through study completion, an average of 9 months)
- Quality of life assessment (32-Item Inflammatory Bowel Disease Questionnaire)(Through study completion, an average of 9 months)
研究者
Seung Min Hong
Professor
Pusan National University Hospital