Efficacy and Safety of Discontinuing 5-ASA in Patients with Inflammatory Bowel Disease

Not Applicable

Not yet recruiting

• Conditions: Ulcerative Colitis (UC); Crohn's Disease; Inflammatory Bowel Disease (IBD)

• Registration Number: NCT06878495
• Lead Sponsor: Pusan National University Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2025-02-02
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-12
• Last Update Submitted: 2025-03-12
• Study First Posted: 2025-03-17
• Last Update Posted: 2025-03-17
• Study Start: 2025-04-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Disease relapse rate	Through study completion, an average of 9 months

Secondary Outcome Measures

Name	Time	Method
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	Bowel symptoms (Stool frequency, loose stool, abdominal bloating and pain, excessive flatulence, rectal bleeding, urge to defecate, nausea), Systemic symptoms (Fatigue, lack of energy, sleep problems, weight maintenance, general health), Emotional function (Worry, anxiety, frustration, restlessness, depression, stress, embarrassment, anger), Social function (Ability to engage in social activities, work/school, sexual activity)