Adalimumab versus infliximab in pediatric patients with Crohn's disease: A propensity-score analysis and predictors of treatment escalation
Abstract
BACKGROUND: Two anti-tumor necrosis factor therapies (infliximab [IFX], adalimumab [ADA]) have been approved for the treatment of pediatric Crohn's disease (CD), but have not been compared in head-to-head trials. The aim of this study was to compare the efficacy and safety of ADA and IFX by propensity score matching in a prospective cohort of pediatric patients with luminal CD and at least 24-month follow-up.
METHODS: Among 100 patients, 75 met the inclusion criteria and 62 were matched by propensity score. We evaluated time to treatment escalation as the primary outcome and primary non-response, predictors of treatment escalation and relapse, serious adverse events (SAE), pharmacokinetics, and effect of concomitant immunomodulators (IMM) as secondary outcomes.
RESULTS: There was no difference between ADA and IFX in time to treatment escalation (HR=0.63 [95% CI 0.31-1.28] P=0.20), primary non-response (P=0.95), or SAEs. Median (IQR) trough levels at the primary outcome were 14.05 (10.88-15.40) and 6.15 (2.08-6.58) µg/mL in the ADA and IFX groups, respectively.
Upon multivariate analysis, the combination of ASCA negativity and pANCA positivity was a strong independent predictor of treatment escalation (HR 5.19, [95% CI 2.41-11.18], p<0.0001). The SES-CD score, L3 disease phenotype, and use of concomitant IMM for at least the first 6 months revealed a trend towards significance upon univariate analysis.
DISCUSSION: Propensity score matching did not reveal substantial differences in efficacy or safety between ADA and IFX. The ASCA-/pANCA+ combination is a strong predictor of treatment escalation.