A real-world study focused on the effectiveness and safety of adalimumab as first-line anti-TNF treatment for paediatric Crohn's disease

Abstract

Abstract Background and objectives Adalimumab (ADA), a monoclonal humanised anti-TNF antibody, is usually prescribed as a second-line treatment in paediatric Crohn's disease (CD) patients who have become unresponsive or developed intolerance to infliximab (IFX). In the case series reported, more than 70% of patients had initially been treated with IFX. Data on short- and long-term efficacy of ADA in anti-TNF naive patients is limited. The aim of this study is to describe our experience with ADA as a first-line anti-TNF in paediatric CD patients. Material and methods This is a multicentre retrospective study including anti-TNF naive paediatric CD patients treated with ADA as first-line anti-TNF. Results Sixty-two patients (34 males), with a mean age of 13.0 ± 2.4 years and a disease duration of 7.3 (IQR 2.7–21) months were included. Median wPCDAI was 35 (IQR 24.3–47.5). Fifty-eight out of 62 (93.5%) were on combo therapy at baseline. Clinical remission at week 12 was achieved in 50 out of 62 (80.6%) and in 57 out of 60 (95.0%) at week 52. Eight patients (13%) reported adverse events. Mean height, growth rate and BMI z-scores improved significantly between baseline and week 52, especially in patients with growth failure. Conclusions ADA treatment leads to lasting clinical remission in anti-TNF naive paediatric patients with CD. ADA significantly improved growth rate in children with CD who had growth delay at baseline. Some patients remain in remission for prolonged time periods under monotherapy; however, some patients would require dose escalation.