Safety and efficacy of adalimumab 40 mg every 3 weeks in pediatric-onset Crohn's disease.

Abstract

Objectives: Dose de-escalation of biologic therapies such as adalimumab (ADA) has the potential to reduce healthcare costs and mitigate adverse events. However, evidence supporting this approach in pediatric populations is limited, with existing studies primarily focused on adult cohorts. This study aimed to evaluate the safety and efficacy of ADA dose de-escalation in children diagnosed with Crohn's disease (CD).

Methods: We conducted a retrospective cohort study involving pediatric CD patients from two inflammatory bowel disease units in Israel. All patients were in stable steroid-free clinical and biochemical remission for at least 12 months on a standard ADA regimen of 40 mg every 2 weeks. Following this period, ADA was de-escalated to 40 mg every 3 weeks. Clinical, biochemical, endoscopic, and imaging outcomes were assessed, including rates of disease exacerbation, re-escalation, or discontinuation of ADA therapy.

Results: Fourteen pediatric CD patients were included, with a median follow-up duration of 12.5 months post de-escalation (range 7-20 months). During follow-up, two patients (14%) experienced disease exacerbation, three patients (21%) required reescalation to ADA 40 mg every 2 weeks, including one patient (7%) who required subsequent escalation to 40 mg weekly. One patient (7%) discontinued ADA therapy due to sustained deep remission. Notably, no patients were hospitalized, developed new-onset abscesses or fistulas, required steroid therapy, or switched to alternative therapies.

Conclusions: ADA dose de-escalation to 40 mg every 3 weeks appears to be a safe and effective strategy for pediatric CD patients in sustained clinical and biochemical remission. Larger, randomized prospective trials are warranted to further validate these findings and to identify potential predictors of successful dose de-escalation.