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P521. Efficacy and safety of adalimumab in children with Crohn's disease previously treated with infliximab

A. Jacob1, M. Fumery2, J. Salleron3, L. Michaud1, C. Spyckerelle4, J.-F. Colombel5, C. Gower-Rousseau6, D. Turck1, 1University Hospital, Pediatric Unit, Lille, France, 2Amiens University and Hospital, Gastroenterology, Amiens, France, 3University Hospital EA 2694, Biostatistics, Lille, France, 4St Vincent Hospital, Paediatric Unit, Lille, France, 5University Hospital, Gastroenterology, Lille, France, 6University Hospital, Epidemiology EA 2694, Lille, France

Background

Adalimumab (ADA) is effective in the treatment of Crohn's disease (CD) in children naive to infliximab (IFX) [1]. The objective of this study was to evaluate the effectiveness and safety of ADA in children with CD refractory or intolerant to IFX.

Methods

This retrospective study included all children with CD from a paediatric-onset population-based cohort who received ADA before the age of 18 because of failure or intolerance to IFX. Response to ADA was evaluated with the PGA. The effectiveness of ADA was defined as clinical remission (PGA=1) or clinical response defined by a decrease of at least 2 points of PGA 6 months after the introduction of ADA. The following parameters were recorded from ADA initiation to maximal follow-up: growth (height/ageZ-score); nutritional status (BMI/age Zscore); and inflammatory biomarkers. Adverse effects due to ADA were also detailed.

Results

27 CD patients diagnosed from 2001 to 2010 were included. Median age at CD diagnosis and at ADA initiation were 11 y [Q1=10-Q3=12] and 15 y [13–15], respectively. Indication of ADA was primary failure to IFX in 4 patients (14%), loss of response to IFX in 16 (60%) and intolerance to IFX in 7 (26%). At ADA induction 5 patients received systemic steroids and 2 azathioprine. Median duration of ADA treatment was 10 months [6–18]. After a follow-up of 9 mo ADA was considered effective in 19 patients (70%). 8 patients had a primary failure (30%) and 5/19 (26%) a secondary failure. Optimizing therapy (increase of ADA dose and/or decrease of intervals between ADA injections) was required in 14 patients. 11 patients (40%) had a total of 19 adverse effects. The main adverse events were: 1) cutaneous (xerosis; n = 6, depigmentation; n = 3, acne; n-2 and psoriasis: n = 1); 2) local reactions (pain, inflammatory reaction) at the injection site (n = 3); and 3) transient arthralgia and/or myalgia (n = 4). None of these adverse effects resulted in ADA discontinuation. There was no significant change in growth and nutritional status over the study period but there was a significant decrease of median CRP from ADA initiation to maximal follow-up (18 mg/L [5–39] vs 7 [3–19]; p = 0.026) and median orosomucoid (1.64 g/L [1.50–2.56] vs. 1.17 [0.88–1.89]; p < 0.001).

Conclusion

In this cohort of paediatric-onset CD patients previously treated with IFX, treatment with ADA was safe and effective in 70% after a median follow-up of 9 months. Controlled trials are needed.

1. Hyams JS, (2012), Safety and efficacy of adalimumab for moderate to severe Crohn's disease in children., Gastroenterology