Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis)
Conditions
Keywords
Ulcerative colitis, Crohn's disease
Brief summary
To study the efficacy of different biological treatment on patient with inflammatory bowel disease after one year of treatment in upper egypt
Detailed 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.
Interventions
BIOLOGICALadalimumab, infliximab, ustekinumab, golimumab, and vedolizumab
Efficacy of different biological treatment on patient with inflammatory bowel disease
Sponsors
Assiut University
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of different biological treatment on patient with inflammatory bowel disease after one year of treatment in upper egypt | 1 year | The primary endpoints of this study are the percentages of hospitalization, surgery, corticosteroid-free remission, and endoscopic remission in patients with inflammatory bowel disease receiving biological therapies at week 52. Patients will be considered on corticosteroids if they received a course of prednisolone, budesonide, or any other steroid medication more than six weeks after initiating the current biological therapy, excluding the induction corticosteroid course, and those who did not receive any steroid courses after this period will be considered in corticosteroid-free remission. Endoscopic remission is defined as the number of patients achieving endoscopic remission, with an Endoscopic Mayo score of 0-1 for ulcerative colitis and a Simple Endoscopic Score for Crohn's Disease (SES-CD) of 0-2 for .Surgical outcomes include patients who underwent IBD-related surgeries six weeks or more after starting the current biologic for an IBD-related issue or complications |
Contacts
CONTACTMary George Benyamin Tanious, Resident physician
CONTACTMohamed Abd Elhakim omran, Assistant literature
STUDY_DIRECTORMohamed Abaas Sabah, Professor
Assiut University
Outcome results
None listed