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

Prior treatment

• 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).

Other illness

• Patients with severe cardiac, renal, or hepatic disease or other medical conditions that could interfere with the study.
• Patients with known allergies or intolerance to 5-ASA or related medications.
• 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.

Other

• Patients with severe active UC or CD at the time of study enrollment.
• Pregnant or breastfeeding women.
• 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.

• Diagnosis
  • 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.
• Age
  • 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.