Conventional vs Biologic Therapy in Pediatric IBD

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.

Primary outcomes

• Clinical remission rate [At week 8-12, 6 months, and 12 months]: 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.

Secondary outcomes

• Clinical response rate [At week 8-12, 6 months, and 12 months]: 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).
• Steroid-free remission rate [At 12 months]: Proportion of patients in clinical remission without systemic corticosteroid use.
• Incidence of adverse events [Through 12 months]: Proportion of patients experiencing adverse events (infusion/injection reactions, infections, hematologic abnormalities, hepatotoxicity), graded according to CTCAE-adapted criteria
• Change in growth parameters [From baseline to 12 months]: Change in height z-score, weight z-score, and BMI z-score from baseline.
• Treatment escalation or switch rate [Through 12 months]: Proportion of patients requiring treatment escalation or switching between conventional and biologic agents.

Sex: All, ages: any to 18 Years

Inclusion Criteria:

* \- Confirmed diagnosis of Crohn's disease, ulcerative colitis, or IBD-unclassified according to revised Porto criteria
* Age at diagnosis less than 18 years
* Receipt of conventional therapy and/or biologic therapy for a minimum evaluable treatment duration
* Availability of adequate medical records
* Written informed consent (for prospective component)

Exclusion Criteria:

* \- Incomplete medical records precluding assessment of primary endpoints
* Age more than 18 years
* Discontinuation of follow-up before a minimum evaluable treatment period

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• Nafisa H Abdel-Aziz, prof, Study chair, Pediatrics Department, Assiut University Hospitals