This combined retrospective-prospective cohort study aims to evaluate the effectiveness, safety, and adverse events of conventional versus biologic therapy in children and adolescents with inflammatory bowel disease at Assiut University Children Hospital.
Pediatric-onset inflammatory bowel disease differs from adult-onset disease in phenotype, disease extent, and long-term prognosis. Conventional therapy (5-aminosalicylates, corticosteroids, and immunomodulators) and biologic therapy (mainly anti-TNFα agents) are used for induction and maintenance of remission. This observational cohort study will include pediatric patients with confirmed Crohn's disease, ulcerative colitis, or IBD-unclassified. Patients will be classified into conventional therapy and biologic therapy groups. Clinical remission, response rates, steroid-free remission, adverse events, and growth parameters will be assessed over a 12-month period.
Study Type
OBSERVATIONAL
Enrollment
100
Clinical remission rate
Proportion of patients achieving clinical remission at week 8-12, 6 months, and 12 months, defined as PCDAI ≤ 10 for Crohn's disease or PUCAI \< 10 for ulcerative colitis.
Time frame: At week 8-12, 6 months, and 12 months
Clinical response rate
Proportion of patients achieving clinical response, defined as a decrease from baseline of ≥12.5 points in PCDAI (Crohn's disease) or ≥20 points in PUCAI (ulcerative colitis).
Time frame: At week 8-12, 6 months, and 12 months
Steroid-free remission rate
Proportion of patients in clinical remission without systemic corticosteroid use.
Time frame: At 12 months
Incidence of adverse events
Proportion of patients experiencing adverse events (infusion/injection reactions, infections, hematologic abnormalities, hepatotoxicity), graded according to CTCAE-adapted criteria
Time frame: Through 12 months
Change in growth parameters
Change in height z-score, weight z-score, and BMI z-score from baseline.
Time frame: From baseline to 12 months
Treatment escalation or switch rate
Proportion of patients requiring treatment escalation or switching between conventional and biologic agents.
Time frame: Through 12 months
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