Efficacy of Different Biological Treatments in Patients With Inflammatory Bowel Disease After One Year of Treatment in Upper Egypt

Assiut University

Status: Not yet enrolling

Conditions: Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis)

Treatments: Biological: adalimumab, infliximab, ustekinumab, golimumab, and vedolizumab

Study type: Observational

Funder types: Other

Identifiers

NCT07495644

Biological Treatment for IBD

Details and patient eligibility

About

To study the efficacy of different biological treatment on patient with inflammatory bowel disease after one year of treatment in upper egypt

Full description

Inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis, is a chronic inflammatory disorder that requires long-term management. Biological therapies have significantly improved outcomes in patients with moderate to severe disease; however, variability in treatment response remains a challenge.

This study aims to evaluate and compare the efficacy of different biological treatments in patients with IBD in Upper Egypt after one year of therapy. Clinical outcomes, including disease activity and remission rates, will be assessed to determine treatment effectiveness.

Enrollment: 95 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Inclusion Criteria: 1) Age ≥ 18 years; 2) Patients with moderate-to-severe ulcerative colitis, defined as a clinical Mayo score >6 with an endoscopic score of 2-3 3) Patients with moderate-to-severe Crohn's disease, defined as a Crohn's Disease Activity Index (CDAI) >220 with a Simple Endoscopic Score for Crohn's Disease (SES-CD) ≥7 4) Patients receiving adalimumab, infliximab, ustekinumab, or vedolizumab; 5) Patients who had been on the current biologic therapy for between 6 weeks and 12 months; and 6) Biologic-naïve patients (no prior biologic therapy). Patients who did not continue their treatment for 12 months due to primary or secondary treatment failure will be considered not to have achieved endoscopic remission. Additionally, patients who were hospitalized, received corticosteroids, or underwent surgery due to medication failure before 12 months of therapy will be considered treatment failures.

2. Exclusion Criteria:

   1. Patients with prior biologic therapy (biologic-experienced);
   2. Patients with incomplete outcome or therapy data;
   3. Patients receiving other concomitant biologic or small-molecule therapies for other conditions, such as rheumatological diseases;
   4. Pregnant patients;
   5. Patients with intermittent suspension of therapy during the 12-month period.